Federal law questions

If Ciprofloxacin pills accidentally fall on the pharmacy floor, and are unknowingly dispensed by a pharmacist to a patient, the dispensing drug should be defined as: a. Adulterated b. Misbranded

Answer: (a) Adulterated, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 501,351]. A drug shall be deemed to be adulterated: ____________________________________ (a). If it consists in whole or in part of any filthy, putrid, or decomposed substance. (b). If it has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (c). If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. (d). If its container is composed, in whole or in part, of any poisonous or deleterious substance, which may render the contents injurious to health. (e). It bears or contains, for purposes of coloring only, a color additive that is unsafe. (f). If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. (g). If it is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength or substituted wholly or in part thereof.

The dispensing container shall bear a label with all of the following EXCEPT: a. name, address and phone number of the manufacturer. b. unique identification number of the prescription. c. name of the prescribing practitioner. d. initials or an identification code of the dispensing pharmacist.

Answer: (a) At the time of delivery of the drug, the dispensing container shall bear a label with at least the following information, [21CFR1306.14 and 21CFR1306.24]: (1). name, address and phone number of the pharmacy (not the manufacturer); (2). unique identification number of the prescription; (3). date the prescription is dispensed; (4). initials or an identification code of the dispensing pharmacist; (5). name of the prescribing practitioner; (6). name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner; (7). instructions for use; (8). quantity dispensed; (9). appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol; (10). if the prescription is for a Schedule II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"; (11). if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed; (12). the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant in compliance; (13). the name and strength of the actual drug product dispensed, unless otherwise directed by the prescribing practitioner.

Which of the following is/are true about dispensing controlled substances for detoxification or maintenance treatment? I. To prescribe controlled drugs for a detoxification program, a practitioner must require a separate DEA registration. II. The practitioner who may not be registered specifically with DEA for prescribing controlled substance for Detoxify Program cannot administer controlled drugs to a narcotic dependent person. III. The practitioner who may not be registered specifically with DEA for prescribing controlled substances to a narcotic treatment program cannot administer controlled substances to a narcotic dependent person for more than 7 days. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is true, [21CFR1306.07(a)-to-(d)]. 1. A practitioner must require a separate DEA registration to prescribe controlled drugs for a narcotic detoxification program. 2. The practitioner can administer a narcotic drug to a narcotic dependent person without being specifically registered with DEA. 3. A physician who is not specifically registered to conduct a narcotic treatment program may administer (but cannot prescribe) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for the treatment. Not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.

Which of the following therapeutic classifications has the fastest approval rate? I. Type-P II. Type-S III. Type-I a. I only b. I and II only c. II and III only d. All

Answer: (a) New drugs are generally classified in two subcategories; Type-P or Type-S. A drug classified under Type-P has priority. To be classified under Type-P, the drug must meet one of the following criteria: 1. The drug must be superior in its class than currently marketed drugs. 2. The new drug has a unique ability to treat symptoms or a disease for which there are no drugs available in the market. A type S category is described as Standard Review. The product classifies under this category has a slow approval rate compared to the product classifies under the Type-P.

An ARCOS registrant reporting only its own controlled substance transactions and inventories to DEA is known as: a. Single Reporter b. Registered Central Reporter c. Non-registered Central Reporter d. Non-registered Single Reporter

Answer: (a) Single Reporter, [http://www.deadiversion.usdoj.gov/arcos/faq.htm]. An ARCOS registrant is a manufacturer or distributor required to report controlled substance inventories and transactions to DEA. There are three types of ARCOS reporters: (1). single reporters, (2). registered central reporters, and (3). non-registered central reporters. Single Reporter An ARCOS registrant reporting only its own controlled substance transactions and inventories to DEA (ARCOS) is a single reporter. If an ARCOS registrant is a subsidiary of a larger corporate entity and submits its own ARCOS reports, it must follow the instructions for a single reporter. Registered Central Reporter A registered central reporter has a DEA registration as a manufacturer or distributor and reports-controlled substance transactions and inventories for itself and other ARCOS registrants within its corporate structure. Non-registered Central Reporter A non-registered central reporter neither manufactures nor distributes controlled substances, does not have a DEA registration, and does not have controlled substance transactions or inventories, but reports the controlled substance transactions and inventories of the ARCOS registrants within its corporate structure.

A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required for those additional registered sites at the retail pharmacy or other approved central location. a. True b. False

Answer: (a) True, [21CFR1304.04(a)(2),(b)]. (2). A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required by this part for those additional registered sites at the retail pharmacy or other approved central location. (b). All registrants that are authorized to maintain a central recordkeeping system shall be subject to the following conditions: (1). The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location. (2). If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable. (3). The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind. (4). In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location.

A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to patients. a. True b. False

Answer: (a) True, [21CFR1307.11]. (a). A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to-- (1). Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that-- (i). The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance; (ii). The distribution is recorded by the distributing practitioner in accordance with 1304.22(c) of this chapter and by the receiving practitioner in accordance with 1304.22(c) of this chapter; (iii). If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and (iv). The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year. (2). A reverse distributor who is registered to receive such controlled substances. (b). If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to paragraph (a)(1) of this section and 1301.25 of this chapter will exceed 5 percent of this total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall obtain a registration to distribute controlled substances.

The easily compromise controlled release formulation employed in preparation of Oxycontin is one of the reasons to abuse it easily. a. True b. False

Answer: (a) True, [http://www.deadiversion.usdoj.gov/drug_chem_info/oxycodone/oxycontin_faq.htm]. DEA has expressed its concerns to Purdue regarding the diversion and abuse of their OxyContin products. DEA recognizes the therapeutic value of long-acting opioids in the treatment of chronic pain. However, it has been found that the controlled release formulation used in OxyContin products can be easily compromised. The ability to quickly release a high dose of Oxycodone that is intended for slow release, whether intentional or not, makes this product both attractive to abusers and dangerous to individuals who have not developed a tolerance to opioids. DEA has not asked Purdue to withdraw the 160 mg tablet and recognizes that this dosage may be appropriate for a limited number of patients. The Associate Press reported on May 11, 2001, that Purdue stated that government pressure played no part in its decision to suspend distribution of OxyContin 160 mg tablets.

A separate CSOS Signing Certificate is required for each DEA Registrant number. a. True b. False

Answer: (a) True, [http://www.deaecom.gov/qanda.html]. A separate CSOS Signing Certificate is required for each DEA Registrant number. In cases where a person represents multiple Registrants or DEA Registrant numbers, then multiple Certificates will be issued. Example 1: An individual representing multiple locations will list each DEA Registration for which he/she would like to be associated on his/her CSOS Certificate Application. For applicants approved for purchasing controlled substances, a separate CSOS Signing Certificate will be issued to that individual for each location. Each CSOS Coordinator will be approved by DEA to fulfill the role of Coordinator for each location but will be issued only one CSOS Administrative Certificate. Example 2: A company with multiple locations (DEA Registrations) may order their controlled substances from a central distribution warehouse. In this case, Power of Attorneys would represent multiple Registrants to consolidate the ordering process and each purchaser would need a separate CSOS Certificate for each DEA Registrant.

CSOS Certificates expire when the DEA Registration to which they are associated expires. a. True b. False

Answer: (a) True, [http://www.deaecom.gov/qanda.html]. CSOS Certificates expire when the DEA Registration to which they are associated expires. The CSOS RA will send an email notifying the Subscriber's CSOS Coordinator 45 days prior to the expiration date of the Subscriber's CSOS certificate and will provide instructions on how to process digital certificate renewals.

CSOS transactions must be submitted within two (2) business days from when the order was filled. a. True b. False

Answer: (a) True, [http://www.deaecom.gov/qanda.html]. There is a new CSOS EDI record format for suppliers submitting transaction records electronically to DEA. Each reporter must enroll for CSOS reporting, after which they will be issued a user name and password. The user name and password may then be used to access a secure CSOS Reporting Web site in order to submit CSOS reports. All suppliers must report CSOS transactions using CSOS Reporting. All CSOS transactions must be submitted within two (2) business days from when the order was filled. You do not need to submit a CSOS Report if no transactions occurred. When an order is partially filled one day, with the rest of the order filled later, each line item of the order should be reported according to the day it was filled. CSOS transaction records require an NDC number. As with the paper Form-222 system, controlled substance orders may be made using a generic description rather than NDC number. The supplier may use the NDC number for the controlled substance supplied. The ARCOS Registrant Handbook contains NDC numbers by drug category. These numbers may be used when the supplied controlled substance does not have an NDC number.

Oxygen is a drug and therefore requires prescribing in all but emergency situations. a. True b. False

Answer: (a) True. Oxygen is a drug and therefore requires prescribing in all but emergency situations. In the emergency situation oxygen prescription is not required. Before oxygen therapy is prescribed there are guidelines or criteria that must be met. These criteria involve a blood test. (These blood test criteria must also be met for Medicare and other insurers to pay for the oxygen costs.) Medical experts produced the criteria. They establish what the levels of oxygen in the blood must be for oxygen therapy to be needed. These guidelines describe three conditions that require the use of oxygen therapy: 1. PaO2 is less than or equal to 55 mmHg. Or hemoglobin oxygen saturation (SaO2) measured by pulse oximeter is less than or equal to 88 percent when breathing room air at rest. 2. PaO2 of 56-59 mmHg. Or if the hemoglobin oxygen saturation (SaO2) is equal to or greater than 89 percent when linked to specific conditions. These may include Cor Pulmonale, congestive heart failure or erythrocytosis, (with a hematocrit of greater than 56 percent). (Erythrocytosis means there are more red cells in the blood than normal. Hematocrit measures the percentage of cells in a sample of blood.) 3. Some individuals do not qualify for oxygen therapy while at rest. But they may require oxygen while walking, exercising or during sleep. Oxygen therapy is needed in these cases when the hemoglobin oxygen saturation (SaO2) falls to less than or equal to 88 percent. Also, for the costs of oxygen to be covered by insurance there must be proof that the oxygen therapy used during exercise or sleep improves the individual's hypoxemia. A physician must write a prescription for oxygen therapy prior to delivery. The prescription will indicate the flow rate, how much oxygen you need per minute -- referred to as liters per minute (LPM) -- and when a patient needs to use oxygen. Also necessary is Diagnosis, portability (if needed), and length of need. Some people use oxygen therapy only while sleeping, others only while exercising, and still others need oxygen continuously. The physician will order a blood test or oximetry test that will indicate what the patient's oxygen level is and help determine what his/her needs are. A written prescription is required prior to delivery. Certain insurance policies may pay for all your oxygen, but payment is based on laboratory results, diagnosis, and other information. The information listed below will help to determine insurance coverage. Medicare - In addition to a prescription, Medicare requires a Certificate of Medical Necessity (CMN) to be filled out by your physician. CMN Oxygen requirements are as follows: 1. Length of need 2. Diagnosis, a respiratory ailment showing the need for oxygen 3. Oxygen Blood Gas to be 56-59 or below, or Oxygen Saturation level to be 89 or below 4. How the test was taken, room air, during exercise, or while sleeping 5. The testing facility where blood gasses or oximetry was performed 6. Portability if needed 7. Liter flow prescribed 8. Physicians Signature 9. Date

May a practitioner use his own digital certificate to sign an electronic controlled substance prescription? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. Yes, the interim final rule allows any practitioner to use his own digital certificate to sign electronic prescriptions for controlled substances. If the practitioner and his application provider wish to do so, the two-factor authentication credential can be a digital certificate specific to the practitioner that the practitioner obtains from a Certification Authority that is cross-certified with the Federal Bridge Certification Authority at the basic assurance level.

Company ABC has 1,000 locations with 6 central facilities. If these facilities are responsible for reporting, then Company ABC would have: a. 1000 DEA numbers b. 1000 DEA numbers and 6 CRN numbers c. 6 DEA numbers d. 1000 CRN numbers and 1000 DEA numbers

Answer: (b) 1000 DEA numbers and 6 CRN numbers, [http://www.deaecom.gov/qanda.html]. A central reporter number (CRN) is given when a company has multiple facilities, each of which sends their reports to the central office. The central office then sends the reports to the DEA. For example: Company ABC has 1,000 locations, but 6 central facilities. If these facilities are responsible for reporting, then Company ABC would have 1,000 DEA numbers and 6 central reporter numbers. Therefore, CSOS knows which facility has submitted their reports and who the point of contact for each central facility is.

Which of the following agencies helps in the reimbursement of healthcare expenditure? a. FTC b. DRG c. CDC d. CFR

Answer: (b) Diagnosis-related group (DRG) is a system to classify hospital cases into one of approximately 500 groups, also referred to as DRGs, expected to have similar hospital resource use, developed for Medicare as part of the prospective payment system. DRGs are assigned by a "grouper" program based on ICD diagnoses, procedures, age, sex, and the presence of complications or comorbidities. DRGs have been used since 1983 to determine how much Medicare pays the hospital, since patients within each category are similar clinically and are expected to use the same level of hospital resources. DRGs may be further grouped into Major Diagnostic Categories (MDCs).

Which of the following is/are exempt from the Tamper Resistant Packaging Act? I. Tolnaftate cream II. Cepacol lozenges III. Vicks Night Time Relief syrup a. I only b. I and II only c. II and III only d. All

Answer: (b) Each manufacturer and packer who packages an OTC drug product (Except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale.

The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations may require to obtain the distributor license under the section 21CFR1307.11 if total distributions of controlled substances exceed the 5% threshold limit set by Federal Law in any given calender year. a. True b. False

Answer: (b) False, [21CFR 1307.11(c)]. 1. The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year. 2. If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to paragraph (a)(1) of this section and 1301.25 of this chapter will exceed 5 percent of this total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall obtain a registration to distribute controlled substances. 3. The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs 1 and 2 of this section.

A hard-copy printout of each day's controlled substance prescription order refill data must be verified, dated, and initialed by an individual pharmacist. a. True b. False

Answer: (b) False, [21CFR Section 1306.22(f)(3)]. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application. If such an application provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated are correct and then sign (NOT initial) this document in the same manner as he would sign a check or legal document ( e.g., J.H. Smith, or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill.

A registered individual practitioner is NOT required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the course of maintenance or detoxification treatment of an individual. a. True b. False

Answer: (b) False, [21CFR1304.03(b)to(d)]. (b). A registered individual practitioner is required to keep records, as described in 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful course of professional practice. (c). Except as provided in 1304.06, a registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual. (d). A registered individual practitioner is not required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxification treatment of an individual.

Financial and shipping records such as invoices and packing slips or executed order forms may be kept at a central location, rather than at the registered location, if the registrant has notified the Administration of his intention to keep central records. a. True b. False

Answer: (b) False, [21CFR1304.04(a)(1)]. Financial and shipping records (such as invoices and packing slips but NOT executed order forms (DEA 222) subject to 1305.17 and 1305.27 of this chapter) may be kept at a central location, rather than at the registered location, if the registrant has notified the Administration of his intention to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the Administration in the area in which the registrant is located. Unless the registrant is informed by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge. All notifications must include the following: (i). The nature of the records to be kept centrally. (ii). The exact location where the records will be kept. (iii). The name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally. (iv). Whether central records will be maintained in a manual, or computer readable, form.

A registrant must report any suspected or actual unauthorized access to his/her CSOS Certificate to DEA Diversion E-Commerce Support within 48 hours of such incident. a. True b. False

Answer: (b) False, [http://www.deaecom.gov/qanda.html]. A registrant must report any suspected or actual unauthorized access to his/her CSOS Certificate to DEA Diversion E-Commerce Support IMMEDIATELY. The CSOS Certificate will be revoked and the Support Desk will assist the registrant in enrolling for a new CSOS Certificate.

A CSOS permits reverse distribution only when the supplier is a non-ARCOS participant. a. True b. False

Answer: (b) False, [http://www.deaecom.gov/qanda.html]. Reverse distribution transactions require a paper form DEA-222 or digitally signed electronic order (using CSOS). The supplier is required to report each transaction. Since only ARCOS participating DEA Registrants are eligible to report CSOS transactions, reverse distribution is not permitted when the supplier is a non-ARCOS participant. For example, a pharmacy or hospital may only accept a paper 222 order from a reverse distributor or wholesaler when returning controlled substances because the pharmacy/hospital is not able to report this transaction electronically. If the controlled substance supplier in the reverse distribution transaction IS a DEA ARCOS participant, then reverse distribution using an electronic CSOS order is permitted. One scenario where reverse distribution is permitted would be with a DEA ARCOS registered wholesaler fulfilling an order from a reverse distributor.

Which of the following drug(s) is/are NOT exempt from the PPPA? I. Aspirin tablets (more than 25 tablets per container) II. A unit does pack of Acetaminophen containing 4 tablets; each weighing 500 mg III. A single unit dose tablet of Ibuprofen weighing 600 mg a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are NOT exempt. The PPPA is known as the Poison Prevention Packaging Act. It was issued in 1970 to protect children under 5 years of age from accidental poisoning [[15 U.S.C. § 1471n]. The drugs which are NOT exempt from the PPPA may include: 1. Aspirin: Any aspirin-containing preparation for human use in oral dosage form. 2. Iron-Containing Drugs: Non-injectable animal and human drugs providing iron for therapeutic or prophylactic purposes which contain a total amount of elemental iron equivalent to 250 milligrams or more per package. 3. Iron-Containing Dietary Supplements: Most dietary supplements that contain an equivalent of 250 milligrams or more of elemental iron per package. 4. Acetaminophen: Preparations for human use in oral dosage forms containing more than 1 gram of acetaminophen in a single package. 5. Diphenhydramine: Preparations for human use in oral dosage forms containing more than the equivalent of 66 milligrams of diphenhydramine base in a single package. 6. Ibuprofen: Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package. 7. Loperamide: Preparations for human use in oral dosage forms containing more than 0.045 milligrams of loperamide in a single package. 8. Mouthwash: Most mouthwash containing 3 grams or more of ethanol in a single package. 9. Lidocaine: Products containing more than 5 milligrams of lidocaine in a single package. 10. Dibucaine: Products containing more than 0.5 milligrams of dibucaine in a single package. 11. Naproxen: Preparations for human use in oral dosage forms containing 250 milligrams or more of naproxen in a single package. 12. Ketoprofen: Preparations for human use in oral dosage forms containing more than 50 milligrams of ketoprofen in a single package. 13. Fluoride: Products containing more than 50 milligrams of elemental fluoride and more than 0.5 % fluoride in a single package. 14. Minoxidil: Preparations for human use containing more than 14 milligrams of minoxidil in a single package. 15. Over-the-Counter Drug Products: Preparations in oral dosage forms that contain any active ingredient that was previously available for oral administration only by prescription. Aspirin was the first substance to be regulated under the PPPA. Note that while acetaminophen is regulated at a level of more than 1 gram per package, no level has been established for aspirin and aspirin-containing products. Thus a substance containing any amount of aspirin is required to be in special packaging. There are two exemptions to each of these regulations; each based primarily upon physical characteristics of the dosage forms, which have been found to inhibit or limit unintentional ingestion of these products by children. These exemptions are: 1. Effervescent tablets or granules containing not more than 15 % acetaminophen or aspirin, provided the dry tablet or granules have an oral LD50 of 5 grams or more per kilogram of body weight. 2. Unflavored acetaminophen or aspirin containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 13 grains of acetaminophen or 15.4 grains of aspirin per unit dose.

Which of the following information must be retrievable by the prescription number? I. The name and dosage form of the controlled substance. II. The date filled or refilled. III. The initials of the preparing technician for each refill. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR Section 1306.22(c)]. Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist (a preparing technician initial is NOT required) for each refill. (5). The total number of refills for that prescription. If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full-face amount of the prescription has been dispensed.

Which of the following is/are TRUE about possessing prescription drug samples by hospital pharmacies? I. Samples of prescription drugs cannot be sold to patients. II. Samples of prescription drugs must be stored separately from a regular stock. III. The hospital must be registered as a drug distributor to distribute drug samples. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR203.20]. Hospital can possess the samples of prescription drugs only if such drugs sample cannot be sold to patients and must be stored separately from a regular stock.

Who reports to ARCOS? I. Manufacturers II. Distributors III. Research conducting institutions a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [http://www.deadiversion.usdoj.gov/arcos/faq.htm]. ARCOS is defined as "Automation of Reports and Consolidated Orders System". Manufacturers and Distributors ONLY reports to ARCOS. Manufacturers of bulk and/or dosage form-controlled substances must report inventories, acquisitions, and dispositions of all substances in Schedules I and II, and narcotic and Gamma-Hydroxybutyric Acid (GHB) substances in Schedule III to ARCOS. Additionally, manufacturers must report synthesizing activities involving all substances in Schedules I and II, narcotic and Gamma-Hydroxybutyric Acid (GHB) substances in Schedule III and selected psychotropic controlled substances in Schedules III and IV to ARCOS. Distributors of bulk and/or dosage form-controlled substances must report inventories, acquisitions, and dispositions of all substances in Schedules I and II, and narcotic and Gamma-Hydroxybutyric Acid (GHB) substances in Schedule III to ARCOS.

"Prescription" means: I. An order given individually for the person for whom prescribed, directly from the practitioner, or the practitioner's agent, to a pharmacist. II. A chart order written for an inpatient specifying drugs which he or she is to take home upon discharge. III. A chart order written for an inpatient for use while he or she is an inpatient. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only. 1. "Prescription" means: (a). An order given individually for the person for whom prescribed, directly from the practitioner, or the practitioner's agent, to a pharmacist or indirectly by means of an order signed by the practitioner or an electronic transmission from the practitioner to a pharmacist. (b). A chart order written for an inpatient specifying drugs which he or she is to take home upon discharge. 2. "Prescription" does not include a chart order written for an inpatient for use while he or she is an inpatient.

Which of the following is/are TRUE regarding destruction of controlled substances by using authorized reverse distributors? I. A pharmacy may at any time forward controlled substances to DEA register reverse distributors who handle the disposal of drugs. II. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. III. A DEA Form-41 along with DEA Form-222 should be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only. A pharmacy may at any time forward controlled substances to DEA register reverse distributors who handle the disposal of drugs. The pharmacist may contact their local DEA Diversion Field Office for an updated list of those reverse distributors in their area. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. When Schedule III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy should document in writing the drug name, dosage form, strength, quantity and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form-41 to the DEA when the drugs have been destroyed. A DEA Form-41 should not be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor, [21CFR1300, 1301, 1304, 1305, and 1307].

Which of the following information is/are TRUE about Belviq and Qsymia? I. Both are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 or higher. II. The physician must personally meet face to-face with the patient, at a minimum, every 30 days while continue prescribing these drugs. III. Both are classified as Schedule III controlled drugs. a. I only b. I and II only c. All d. None of the above

Answer: (b) I and II only. Qsymia (phentermine and topiramate extended-release) and Belviq (lorcaserin hydrochloride) are Food and Drug Administration (FDA)-approved Schedule IV medications. They are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 or higher. The drugs may also be used for overweight adults with a BMI of 27 or higher and at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Both drugs are specifically designed for chronic weight management in adults. Since they are controlled substances, the prescriber must personally meet face to-face with the patient, at a minimum, every 30 days. The patient may be switched to one of the new drugs after 12 weeks on phentermine if there is no interruption in treatment. To refill a prescription that had refills issued with it, it is pharmacist's responsibility to contact the doctor and document whether a true face-to-face meeting occurred or not.

If a bottle of 250 mg of Cephalexin contains 500 mg of Cephalexin, the product should be classified as a(n): a. Adulterated b. Misbranded

Answer: (b) Misbranded, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 502,352]. A drug shall be classified as misbranded if: ____________________________________ (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

If a pharmacy technician, an accidentally, mixes two bottles of Tylenol syrup with the same strength but different lot numbers and expiration dates, the resultant mixture should be classified as a(n): a. Adulterated b. Misbranded

Answer: (b) Misbranded, [Food, Drugs And Cosmetics 53-1-109]. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

Correct Care Pharmacy on an average receives 40 prescriptions per month for compounding 2% Sulfur-Salicyclic acid ointment. If a pharmacist compounds 200 prescriptions worth of ointment in anticipation of getting more prescriptions, would the pharmacist's action be considered legal under State Pharmacy Law? a. Yes b. No

Answer: (b) No, [FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding]. Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription, or in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug products that are commercially available in the marketplace. When a compounded product is to be substituted for a commercially available product, both the patient and also the prescriber must authorize the use of the compounded product. Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such products compounded at the pharmacy. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered MANUFACTURING. Pharmacists shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.

If transmission of an electronic prescription fails, may the intermediary convert the electronic prescription to another form (e.g. facsimile) for transmission? a. Yes b. No

Answer: (b) No, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. No, an electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. If an intermediary cannot complete a transmission of a controlled substance prescription, the intermediary must notify the practitioner. Under such circumstances, if the prescription is for a schedule III, IV, or V controlled substance, the practitioner can print the prescription, manually sign it, and fax the prescription directly to the pharmacy. This prescription must indicate that it was originally transmitted to, and provide the name of, a specific pharmacy, the date and time of transmission, and the fact that the electronic transmission failed.

Once an electronic controlled substance prescription is signed, must it be transmitted to the pharmacy immediately? a. Yes b. No

Answer: (b) No, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. No, signing and transmitting an electronic controlled substance prescription are two distinct actions. Electronic prescriptions for controlled substances should be transmitted as soon as possible after signing, however, it is understood that practitioners may prefer to sign prescriptions before office staff add pharmacy or insurance information, therefore, DEA is not requiring that transmission of the prescription occur simultaneously with signing the prescription.

If all community chain pharmacies in Baltimore city were determined to charge the dispensing fee of $5.25 to all customers, this would be considered the violation of: a. Robinson-Patman Act b. Sherman Antitrust Act c. Durham Humphrey Act d. Dingle Bill Act

Answer: (b) The Sherman Antitrust Act has been introduced to prevent restrains of a trade or the establishment of monopolies. According to this law, companies or a group of companies may not have agreements among themselves, which may affect the general public or restrain a trade. The above illustration is considered as price fixing.

MS is an owner of Morgancare Pharmacy. Upon discontinuing his business, what shall be done with unused DEA 222 order forms? a. They must be properly destroyed. b. They must be marked "VOID" and sent to the nearest office of the DEA. c. The registrant shall destroy them after marking them "VOID". d. They must be destroyed in presence of DEA officers.

Answer: (b) They must be marked "VOID" and sent to the nearest office of the DEA, [21CFR1305.18]. In the case of discontinuation of controlled substance business, a registrant must notify the nearest DEA office 14 days prior to the date of discontinuation of the business. If a business has been transferred to another person, the registrant must return the registration certificate and unused DEA 222 forms to the DEA. The unused forms must be marked "VOID" before sending to the DEA. In the case of discontinuing a business without transferring it to another, the registrant still needs to return the certificate of registration and unexecuted DEA 222 order forms to the DEA.

Ampicillin powder (10 grams) is reconstituted with sufficient amount of distilled water. What would be an approximate expiration date of the compounded product according to FDA guidelines? a. 1 month from the date it is compounded. b. 14 days from the date it is compounded. c. 3 weeks from the date it is compounded. d. 6 months from the date it is compounded.

Answer: (b) Under FDA guidelines, the approximate expiration date for an aqueous compounded product should be 14 days from the date it is compounded.

Which of the following acts is required to seal a two-piece hard gelatin capsule using an acceptable tamper-evident technology? a. PPPA b. Federal Anti-Tampering Act c. Dingle Bill Act d. Durham Humphrey Act

Answer: (b) Under the Federal Anti-Tampering Act, it is required to seal two-piece hard gelatin capsule using an acceptable tamper-evident technology to prevent deliberate tampering of OTC products.

A retrospective DUR is conducted by: a. Pharmacists b. Prescribers c. States' Health Improvement Facilities d. Nurses

Answer: (c) A retrospective DUR is defined as a study of Drug Utilization Review after dispensing has occurred, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. For example, a patient has received a prescription for Bactrim for the treatment of UTI. After taking the drug, the patient has suffered from severe hypersensitivity reactions and admitted to a hospital. Upon reviewing his case study, it has been found that the patient is allergic to sulfa drugs. This type of Drug Utilization Review where the problem is encountered after dispensing the drug is defined as a retrospective DUR. It is usually conducted by the States' Health Improvement Facilities.

A pharmacist receive a new prescription for Synthroid from a prescriber. The prescription is stamped with "Brand Medically Necessary". Which of the following is TRUE? a. Fill the prescription for Synthroid. b. Fill the prescription for Levothyroxine. c. Call and verify with the physician. d. Fill the prescription for either one.

Answer: (c) Call and verify with the physician. A prescribing practitioner may specify in writing or by a telephonic or other electronic communication that there shall be no substitution for the specified brand name drug product in any prescription, provided that the phrase "BRAND MEDICALLY NECESSARY", shall be in the practitioner's HANDWRITING on the prescription form or on an electronically-produced copy of the prescription form or, if the prohibition was communicated by telephonic or other electronic communication that did not reproduce the practitioner's handwriting, a statement to that effect appears on the form. The phrase "BRAND MEDICALLY NECESSARY" shall NOT be preprinted or stamped or initialed on the form. The pharmacist or the pharmacist's agent shall inform the person receiving the drug pursuant to the prescription drug order of the selection of an equivalent drug product and of the person's right to refuse the product selected. A pharmacist shall, upon request of the prescribing practitioner, provide information regarding substitutions of equivalent drug products.

Which of the following requires a tamper-evident packaging? a. Cold EZ lozenges b. Tolnaftate cream c. Prilosec capsules d. Sensodyne fluoride tooth paste

Answer: (c) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

After frequent uses, which of the following loses a child-resistant characteristic? I. Glass container II. Plastic container III. Plastic closure a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only. After frequent uses, the plastic closure and the container normally lose the child-resistant characteristic.

Which of the following is NOT TRUE about issuing a prescription for controlled substances? I. The individual practitioner must issue the prescription for legitimate medical purposes. II. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. III. The individual practitioners may issue a controlled prescription for the purpose of general dispensing to patients. a. I and III only b. II only c. III only d. II and III only

Answer: (c) III is NOT True, [21CFR1306.04(b)]. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.

If a schedule V Over The Counter drug is dispensed pursuant to the prescription order of a practitioner, the dispensing container shall be labeled according to: a. OTC labeling requirement. b. Non-controlled RX requirement. c. Controlled RX requirement. d. Does not require labeling.

Answer: (c) If a schedule V drug is dispensed pursuant to the prescription order of a practitioner, the prescription shall be labeled according to controlled substances prescription labeling requirement, and the order shall be filed in accordance with the requirements for schedule III and IV orders. If a schedule V drug is dispensed other than pursuant to a prescription order, the dispenser shall make the record required by the law, in a bound controlled substance V register at the time of the transaction.

Which of the following is a statewide electronic database which collects designated data on substances dispensed in the state? a. FDA b. DEA c. PDMP d. NASPER

Answer: (c) PDMP, [http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm]. According to the National Alliance for Model State Drug Laws (NAMSDL), a prescription drug monitoring program (PDMP) is a statewide electronic database which collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The housing agency distributes data from the database to individuals who are authorized under state law to receive the information for purposes of their profession.

Which of the following controls the product listing in formulary? a. FTC b. HCFF c. Pharmacy and Therapeutic Committee d. NABP

Answer: (c) Pharmacy and Therapeutic committee controls the product listing in formulary. The formulary helps cut down cost of pharmacies by providing a substitution of more economical drugs within the same therapeutic class. It also discourages institutions to keep a large drug-inventory.

A central pharmacy with one or more remote sites in which all sites are connected via computer link, video link, and audio link is defined as: a. Remote pharmacy b. Satellite consultation site c. Telepharmacy d. Telepharmacy in hospitals

Answer: (c) Telepharmacy. 1. Remote site means a pharmacy staffed by a registered pharmacy technician with access to its main pharmacy and registered pharmacists by computer link, video link, and audio link while open. 2. Satellite consultation site means a telepharmacy where any filled prescriptions ready for dispensing is prepared at another pharmacy and delivered to the satellite for dispensing via computer, video link, and audio link to the main pharmacy and a licensed pharmacist. 3. Telepharmacy means a central pharmacy with one or more remote sites in which all sites are connected via computer link, video link, and audio link. 4. Telepharmacy in hospitals means a central hospital pharmacy with one or more remote sites in which all sites are connected via computer, video link, and audio link.

The immediate container of a radioactive drug shall be labeled with all of the following EXCEPT: a. Name of radionuclide. b. Name of chemical form. c. Amount of radioactive material contained. d. Prescription number.

Answer: (c) The amount of radioactive material contained normally present on the label of the outer container. The immediate outer container of a radioactive drug, diagnostic agent or device to be dispensed shall be labeled to include: A). The standard radiation symbol; B). The words, "Caution-Radioactive Material"; C). The name of the radionuclide; D). The name of the chemical form; E). The amount of radioactive material contained, in millicuries or microcuries, in the container contents at the time of calibration; F). If the container contents are in liquid form, the volume in milliliters; G). The requested calibration time for the amount of radioactivity contained; H). The prescription number; and I). The name or initials of the nuclear pharmacist filling the prescription. 2). The immediate container shall be labeled with: A). The standard radiation symbol; B). The words, "Caution-Radioactive Material"; C). The name and address of the pharmacy; D). The prescription number; E). Name of radionuclide; and F). Name of chemical form.

A bound record book for dispensing OTC controlled substances must contain all of the following information EXCEPT: a. the name and address of a purchaser. b. the date of each purchase. c. the name and address of a physician. d. the name and quantity of controlled substance purchased.

Answer: (c) The name and address of the physician does not require for purchasing over-the-counter controlled substances, [21CFR1306.26(e)]. The bound record book must contain: 1. the name and address of the purchaser. 2. the date of each purchase. 3. the name or initials of the pharmacist who dispensed the substance to the purchaser. 4. the name and quantity of controlled substance purchased.

To be classified as a bioequivalent, the testing drug must meet all of the following requirements of the reference drug EXCEPT: a. Distribution b. Metabolism c. Dissolution d. Absorption

Answer: (c) To be classified as a bioequivalent, the testing drug must meet absorption, distribution, metabolism and elimination (ADME) requirements of the standard or reference drug.

Vaccine-related adverse events shall be reported to the: a. FDA. b. CSA. c. CDC. d. MedWatch.

Answer: (c) Vaccine-related adverse events shall be reported to the CDC. The CDC is a major operating division of the Department of Health and Human Services, located in Atlanta, GA. CDC sponsors programs in school health, health education, and HIV/AIDS prevention. All these activities give the CDC a role in substance abuse prevention as well. It also provides strategies for prevention and control of disease and develops guidelines for proper use of antimicrobial products.

Long-term detoxification programs generally range from: a. 10 to 30 days b. 30 to 60 days c. 60 to 240 days d. 30 to 180 days

Answer: (d) 30 to 180 days, [21CFR1300.01 Definitions-10(i),(ii)]. The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. There are two types of detoxification treatment: Short-term detoxification treatment and long-term detoxification treatment. (i). Short-term detoxification treatment is for a period not in excess of 30 days. (ii). Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days.

A pharmacist is NOT required to provide a patient counseling when: a. A prescription is a refill, but the dose is changed. b. A patient speaks only Spanish. c. Appropriate auxiliary and cautionary labels have been attached. d. A patient refuses to be counseled.

Answer: (d) A pharmacist is not required to provide a patient counseling when the patient refuses to be counseled, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. To optimize a drug therapy, a pharmacist shall counsel the patient or patient's agent regarding: 1. The name and description of the drug or device. 2. Dosage form, dosage, route of administration, and duration of drug therapy. 3. Special direction and precautions for preparation, administration, and use by the patient. 4. Common severe side or adverse effects or interactions and therapeutic contraindications that may occur with the therapy. 5. Techniques for self-monitoring of drug therapy. 6. Proper storage of medication. 7. Refill information. 8. Action to be taken in the event of a missed dose.

Which of the following is/are NOT TRUE about not receiving a cover prescription for Demerol from the prescriber for the emergency dispensing? I. Contact the patient to get a cover prescription. II. Contact the state board of pharmacy. III. Contact the nurse who administered Demerol to a patient. a. I only b. I and II only c. II and III only d. All

Answer: (d) All are not true, [21CFR1306.11(d)(4)]. 1. Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Sec. 1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. 2. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. 3. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. 4. The pharmacist shall notify the nearest office of the Administration (Drug Enforcement Administration) if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with which of the following information? I. The date of the original dispensing. II. The number of refills remaining and the date(s) and locations of previous refills. III. The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR Section 1306.25 (b)(4)]. Paragraph (b)(4): For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data: (i). The date of the original dispensing. (ii). The number of refills remaining and the date(s) and locations of previous refills. (iii). The transferring pharmacy's name, address, DEA registration number, and prescription number for each dispensing. (iv). The name of the pharmacist transferring the prescription. (v). The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (b)(4) of this section.

Which of the following is/are TRUE about the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V? I. Each partial filling is recorded in the same manner as a refilling. II. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. III. No dispensing occurs after 6 months after the date on which the prescription was issued. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR Section 1306.23]. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (a). Each partial filling is recorded in the same manner as a refilling, (b). The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and (c). No dispensing occurs after 6 months after the date on which the prescription was issued.

Which of the following require(s) a code of identification on an individual dosage unit? I. Diphenhydramine capsule II. Metronidazole Er capsule III. Azithromycin tablet a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR206.10]. No drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature.

Which of the following should be part of Drug Utilization Review? I. Drug-drug interaction. II. Duplication of therapy. III. Direction for use. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. A Drug Utilization Review may include: ________________________________ 1. known allergies. 2. rational therapy-contraindication. 3. reasonable dose, direction for use and route of administration. 4. duplication of therapy. 5. drug-drug, drug-food and drug-disease interactions. 6. adverse drug reactions. 7. overutilization or underutilization of prescribed drugs.

To sign electronic prescriptions for controlled substances by a practitioner, what two-factor credentials will be acceptable? I. Something you know II. Something you have III. Something you are a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. Under the interim final rule, DEA is allowing the use of two of the following - something you know (a knowledge factor), something you have (a hard token stored separately from the computer being accessed), and something you are (biometric information). The hard token, if used, must be a cryptographic device or a one-time-password device that meets Federal Information Processing Standard 140-2 Security Level 1.

Which of the following is/are TRUE about using two-factor credential? I. The practitioner will use the two-factor credential to sign the prescription. II. When the credential is used, the application must digitally sign and archive at least the DEA-required information contained in the prescription. III. Using the two-factor credential will constitute the legal signature of the DEA-registered prescribing practitioner. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. The practitioner will use the two-factor credential to sign the prescription; that is, using the two-factor credential will constitute the legal signature of the DEA-registered prescribing practitioner. When the credential is used, the application must digitally sign and archive at least the DEA-required information contained in the prescription. Because the record will be digitally signed and archived at that point, the proposed requirement for a lock-out period is not needed and is not part of the interim final rule.

What is/are the benefit(s) of having a PDMP? I. Identify and deter or prevent drug abuse and diversion. II. Inform public health initiatives through outlining of use and abuse trends. III. Address prescription drug abuse, addiction and diversion. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm]. The overview provided by NAMSDL clearly identifies the benefits of a PDMP: as a tool used by states to address prescription drug abuse, addiction and diversion, it may serve several purposes such as: 1. support access to legitimate medical use of controlled substances, 2. identify and deter or prevent drug abuse and diversion, 3. facilitate and encourage the identification, intervention with and treatment of persons addicted to prescription drugs, 4. inform public health initiatives through outlining of use and abuse trends, and 5. educate individuals about PDMPs and the use, abuse and diversion of and addiction to prescription drugs.

A testing drug is classified a bioequivalent to the reference drug if its: I. AUC is similar to the reference drug. II. Time to reach a peak plasma concentration is similar to the reference drug. III. Peak plasma concentration is similar to the reference drug. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. In order to classify the testing drug to be a bioequivalent to the standard drug, the area under the curve (AUC), the time to reach peak plasma concentration and the peak plasma concentration of the testing drug must be similar to those of the reference drug.

A pharmacist shall question the validity of controlled substance prescription if a patient: I. receiving reported drugs from multiple prescriber. II. requesting the dispensing of a reported drug from a prescription issued by a prescriber who is located out-of-state or the prescriber is outside the usual pharmacy geographic prescriber care area. III. repeatedly asks for early refills. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Prior to dispensing a prescription, each dispenser licensed by a regulatory agency in this state who dispenses a controlled substance to a patient, for the treatment of pain or anxiety shall, at a minimum, request and review a prescription drug monitoring report covering at least a one-year time period or another state's report, or both reports, when applicable, if the dispenser becomes aware of a person currently: a. Receiving reported drugs from multiple prescriber; b. Receiving reported drugs for more than twelve consecutive weeks; c. Abusing or misusing reported drugs (i.e., over-utilization; early refills; appears overly sedated or intoxicated upon presenting a prescription for a reported drug; or an unfamiliar patient requesting a reported drug by specific name, street name, color, or identifying marks); d. Requesting the dispensing of a reported drug from a prescription issued by a prescriber with whom the dispenser is unfamiliar (i.e., the prescriber is located out-of-state or the prescriber is outside the usual pharmacy geographic prescriber care area); OR e. Presenting a prescription for reported drugs when the patient resides outside the usual pharmacy geographic patient population.

A National Drug Code (NDC) for Coumadin 10 mg tablet contains all of the following EXCEPT: a. Name of a drug b. Strength of a drug c. Dosage form of a drug d. Expiration date of a drug

Answer: (d) An NDC consists of 10 to 11 numbers. The first five numbers (assigned by the FDA) represent the manufacturer or distributor, the middle four numbers represent the product ID includes the name, the strength and dosage form of the drug and the last two numbers represent the package ID (package sizes and types) of the drug.

All of the following are elements of Prospective DUR EXCEPT: a. Therapeutic duplications. b. Drug-drug interactions. c. Drug-allergy interactions. d. Overutilization of drugs.

Answer: (d) Overutilization or underutilization of drugs is not an element of Prospective DUR, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. Retrospective DUR must: _____________________ (1). Be based on the guidelines established by the Board; and (2). Use the mechanized drug claims processing and information retrieval system to analyze claims data to do the following: (A). Identify patterns of fraud, abuse, gross overuse, and inappropriate or medically unnecessary care. (B). Assess data on drug use against explicit predetermined standards that are based on the compendia and other sources to monitor the following: (i). Therapeutic appropriateness. (ii). Overutilization or underutilization. (iii). Therapeutic duplication. (iv). Drug-disease contraindications. (v). Drug-drug interactions. (vi). Incorrect drug dosage or duration of drug treatment. (vii). Clinical abuse and misuse. Prospective DUR must be based on the guidelines established by the Board and must provide that prior to the prescription being filled or delivered a review will be conducted by the pharmacist at the point of sale to screen for potential drug therapy problems resulting from the following: (1). Therapeutic duplication. (2). Drug-drug interactions. (3). Incorrect dosage and duration of treatment. (4). Drug-allergy interactions. (5). Clinical abuse and misuse.

Which of the following drugs is being evolved as the most abused controlled substance in a recent time? a. Dilaudid b. Percocet c. MS Contin d. Oxycontin

Answer: (d) Oxycontin, [http://www.deadiversion.usdoj.gov/drug_chem_info/oxycodone/oxycontin_faq.htm]. Since its introduction in 1996, the number of OxyContin prescriptions dispensed has increased 20-fold to about 6 million in 2000. During this same time, medical examiners, drug treatment centers, law enforcement personnel, and pharmacists have reported a substantial increase in the abuse of this product. Information received from the Drug Abuse Warning Network (DAWN) indicates that instances of emergency department episodes and medical examiners reports involving Oxycodone, the active ingredient in OxyContin, have increased significantly since 1996. Reports from 20 metropolitan areas within the continental U.S. indicate that oxycodone-related deaths and emergency department episodes have increased 400 percent and 100 percent, respectively. Most deaths reported in the media and attributed to OxyContin have generally occurred in areas outside the DAWN system, such as Maine, West Virginia, and rural Kentucky. DEA has been actively collecting and evaluating data from medical examiners in these areas to more clearly ascertain the extent of abuse problems. Drug treatment programs have also provided evidence regarding an increase in OxyContin abuse. Programs in West Virginia, Pennsylvania, Kentucky, and Virginia, the states that have been most severely affected by this trend, report that 50 to 90 percent of newly admitted patients identified OxyContin as their primary drug of abuse.

A pharmacy technician may perform all of the following duties EXCEPT: a. initiating and receiving refill authorization requests. b. entering prescription data into a data processing system. c. taking a stock bottle from the shelf for a prescription. d. taking a new order from a prescriber

Answer: (d) Pharmacy technicians may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs, including but not limited to the following: (1). initiating and receiving refill authorization requests; (2). entering prescription data into a data processing system; (3). taking a stock bottle from the shelf for a prescription; (4). preparing and packaging prescription drug orders (i.e. counting tablets/capsules, measuring liquids and placing them in the prescription container); (5). affixing prescription labels and auxiliary labels to the prescription container provided by the pharmacy technician: (6). reconstituting medications; (7). prepackaging and labeling prepackaged drugs; (8). loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use; (9). compounding non-sterile prescription drug orders; and (10). bulk compounding.

A digital identity issued by the DEA's CSOS Certification Authority (CSOS CA) that allows for electronic ordering for Schedule I, II, III or IV controlled substances is called: a. DEA-EO Certificate b. ARCOS Certificate c. E-DEA 222 Elite Certificate d. CSOS Certificate

Answer: (d) The CSOS Certificate, [http://www.deaecom.gov/qanda.html]. A CSOS Certificate is a digital identity issued by the DEA's CSOS Certification Authority (CSOS CA) that allows for electronic ordering for Schedule I and II (as well as III-V) controlled substances. A CSOS Certificate is the digital equivalent of the identification information contained on a DEA Form-222. CSOS Certificates are issued to individuals and are required for electronic ordering of Schedule I and II controlled substances. A CSOS Certificate enables DEA Registrants and Power of Attorneys to conduct electronic ordering of controlled substances by providing identification, authentication, and non-repudiation through the use of digital signature technology. While the paper DEA Form-222 ordering process is still allowed, CSOS is the only method for ordering Schedule I and II controlled substances electronically. The benefits of CSOS for end users include: 1. The allowance for electronic ordering of Schedule I and II controlled substances 2. Timely and accurately validation of a purchaser's (CSOS Subscriber's) DEA credentials 3. Reduced number of ordering errors 4. No line item limit on a single order 5. Reduced amount of paper in the ordering process 6. Faster transaction times 7. Lower cost per transaction

Who is responsible for administering the National Precursor Log Exchange (NPLEx)? a. FDA b. DEA c. State Pharmacy Monitoring Program d. NADDI

Answer: (d) The National Association of Drug Diversion Investigators (NADDI). The National Precursor Log Exchange (NPLEx) is administered by the National Association of Drug Diversion Investigators (NADDI). A retailer shall, before completing a sale of a product containing a pseudoephedrine product, electronically submit the required information to the National Precursor Log Exchange (NPLEx), provided that the NPLEx system is available to retailers in the State without a charge for accessing the system and the retailer has Internet access. The seller shall not complete the sale if the system generates a stop alert.

When filling a prescription for Tylenol no. 3, the pharmacist may assign the maximum number of available refills: a. 5 times b. 10 times c. As needed d. 0 times

Answer: (a) 5 times only, [21CFR1306.22(a)]. No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. Tylenol No. 3 (Acetaminophen and Codeine) is classified as a schedule III controlled drug, and cannot be filled more than five times within a six-month period.

DEA form 224a should be used for: a. Renewal of registration for dispensing controlled substances. b. New registration for dispensing controlled substances. c. Reporting theft or loss of controlled substances. d. None of the above.

Answer: (a) A DEA 224a form should be used for renewal of registration for dispensing controlled substances, [21CFR1301.13]. Below is the list of forms and their uses: __________________________________ 1. DEA 222: For purchase and transfer of Schedule II controlled substances. 2. DEA 224: New registration for Dispensing. 3. DEA 225: New registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 4. DEA 363: New registration for Narcotic Treatment Program. 5. DEA 224A: Renewal of registration for Dispensing. 6. DEA 225A: Renewal of registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 7. DEA 363A: Renewal of registration for Narcotic Treatment Program. 8. DEA 106: For reporting theft or loss of controlled substances. 9. DEA 41: For disposal or destruction of controlled substances.

Who may dispense an OTC Robitussin A/C? I. A registered pharmacist II. A registered pharmacy-intern III. A certified pharmacy technician a. I only b. I and II only c. II and III only d. All

Answer: (a) A registered pharmacist, [21CFR1306.26(a)]. Only a registered pharmacist can dispense an OTC Robitussin A/C (not by a non-pharmacist employee even if under the direct supervision of a pharmacist), although after the pharmacist has fulfilled his professional and legal responsibilities, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist .

Which of the following organizations promotes the Prescription Drug Safety Program? a. AWARxE b. RXSafety c. StopRxAbuse d. RXDisposal

Answer: (a) AWARxE, [NABP News Letter 2015]. AWARxE was originally created and implemented by the Minnesota Pharmacists Foundation in 2007 in memory of Justin Pearson, who died following an accidental drug overdose involving prescription drugs he purchased online. In 2010, the NABP Foundation TM purchased the program to take AWARxE's message to a national audience. Prescription drug abuse in the United States has reached epidemic levels, with Centers for Disease Control and Prevention reporting over 22,000 overdose deaths in 2012 alone. Although data from many states indicate that prescription drug overdose deaths are decreasing, there has also been a large increase in the use of heroin. Most experts now believe that these issues are connected. In response to these trends, AWARxE has expanded efforts to raise awareness at both the national and community levels. In 2012, AWARxE launched its biweekly electronic AWARxE Prescription Drug Safety News which is sent to over 16,000 subscribers. The AWARxE® Prescription Drug Safety Program has served as an information source for consumers nationwide, providing authoritative resources about medication safety, prescription drug abuse, medication disposal, and safely purchasing medications online. As AWARxE celebrates this milestone, the program will continue to share vital information through the AWARxE website, electronic newsletter, social media pages, public service announcements (PSAs), and community events.

What is the maximum amount of Kapectolin PG can be dispensed to the same purchaser within the period of 48-hour? a. 240 cc b. 120 cc c. 60 cc d. 480 cc

Answer: (a) According to Federal Pharmacy Law, not more than 8 ounces (240 cc) over-the-counter preparation containing opium can be dispensed to the same purchaser within 48-hour period, [21CFR1306.26(b). Kapectolin PG contains 100mg opium per 100ml of solution, and it is classified as a schedule V controlled substance, [21CFR1308.15].

If a bulk bottle of Amoxicillin 500 mg indicates an expiration date of August 2018, the drug is most likely good until: a. August 31, 2018. b. July 31, 2018. c. August 15, 2018. d. September 15, 2018.

Answer: (a) August 31, 2018.

A prescription for Vicodin can be refilled how many times? a. Cannot be refilled b. 5 times c. As Needed within 1-year d. Maximum 10 times

Answer: (a) Cannot be refilled, [http://www.nabp.net/news/dea-reschedules-hydrocodone-combination-products-as-schedule-ii]. Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register. The change imposes Schedule II regulatory controls and sanctions on anyone handling hydrocodone combination products, effective October 6, 2014. DEA first published the proposed rules in March 2014, in response to a Food and Drug Administration recommendation. DEA received almost 600 public comments regarding the proposed rules after they were published, with a small majority of the commenters supporting the change, a DEA press release notes.

Ingredients generally recognized as safe, effective and not misbranded are classified under OTC: I. Category I II. Category II III. Category III a. I only b. I and II only c. II and III only d. All

Answer: (a) Category I, [21 CFR 330]. 1. Category I includes those ingredients that are generally recognized as safe, effective and not misbranded. 2. Category II includes those ingredients that are NOT generally recognized as safe and effective or that are misbranded. 3. Category III includes ingredients for which data available are insufficient to permit classification.

Which of the following acts prohibits the shipping of drugs between two states by manufacturing companies without a registration? a. Dingle Bill Act b. Orphan Drug Act c. Medical Device Act d. FDA Modernization Act

Answer: (a) Dingle Bill Act (Prescription Marketing Act of 1987) prohibits the shipping of drugs between two states without a registration.

The first five digits of NDC generally identify the: a. Manufacturer b. Drug c. Dosage form d. Package size

Answer: (a) Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for human drugs. It generally consists of ten digits. 1. The first segment, the labeler code, is 4 or 5 digits long and assigned by the Food and Drug Administration (FDA) upon submission of a Labeler Code Request. A labeler is any firm that manufactures, repacks or distributes a drug product. 2. The second segment, the product code, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm. 3. The third segment, the package code, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional cases, product and package segments may have contained characters other than digits. NDC codes exist in one of the following groupings of digits into segments: 4-4-2, 5-3-2, or 5-4-1, but all NDC codes have 10 digits. The official FDA format for NDCs separates the 3 segments with dashes. This is the format in which the NDC must be submitted by labelers since mandatory electronic listing was established in June 2009. The Centers for Medicare and Medicaid Services (CMS) had created an 11-digit NDC derivative, which pads the labeler, product, or package code segments of the NDC with leading zeroes wherever they are needed to result in a fixed length 5-4-2 configuration (but always written without dashes). This format was adopted by data standards selected pursuant to HIPAA regulation, thus other government agencies' lists and databases may contain the 11-digit derivative of the original NDC.

Which of the following publications provides the latest information regarding new regulations in the pharmaceutical field? I. Federal Register II. USP/DI volume II III. USP/DI Volume I a. I only b. I and II only c. II and III only d. All

Answer: (a) Federal Register. Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. It is updated daily by 6 a.m. and is published Monday through Friday, except Federal holidays.

Which fo the following is/are NOT TRUE about CSOS Administrative Certificates issued to CSOS Coordinators? I. CSOS Administrative Certificates expire five years from the date the certificate was issued. II. CSOS Administrative Certificates are not associated with a DEA Registration and therefore are not valid for signing electronic orders for controlled substances. III. CSOS Administrative Certificates must contain the subscriber name and subscriber's email address. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is NOT True, [http://www.deaecom.gov/about_certificates.html and 21CFR Section 1311]. A digital certificate is essentially an authorized digital identity that contains information about its owner. CSOS digital certificates, issued by the CSOS Certification Authority (CSOS CA) for electronic ordering of controlled substances, contain subscriber data used for controlled substance orders. The CSOS CA acts as a "trusted party", meaning that others can trust that the information in your digital certificate is valid because the CSOS CA issued it after verifying your information. When placing an electronic controlled substance order, the order is "signed" with the digital certificate. Suppliers verify each ordering certificate with DEA before an order may be fulfilled. CSOS Signing Certificates contain the following information: 1. Subscriber name 2. Subscriber E-mail address 3. Registrant location name as it is registered with DEA 4. Registrant location address as it is registered with DEA 5. Registrant DEA Number ("hashed", or encoded) 6. Authorized ordering schedules 7. Certificate validity period - ending when the associated DEA Registration expires CSOS Administrative Certificates are issued to CSOS Coordinators for communication purposes. These Administrative Certificates are not associated with a DEA Registration and therefore are not valid for signing electronic orders for controlled substances. Administrative Certificates contain the following information: 1. Subscriber name - name of a CSOS Registrant or Coordinator subscriber. 2. Subscriber E-mail address. 3. Certificate validity period - ending three years (NOT five years) from the date the certificate was issued.

Which of the following is/are NOT TRUE about dispensing a controlled substance listed in Schedule II upon receiving an emergency oral authorization from a licensed individual practitioner? I. The pharmacist can only dispense 30 units of the prescribed drug. II. The prescriber should send cover prescription within 7 days after authorizing an emergency controlled drug. III. The pharmacist shall make a reasonable effort to ensure that the information provided by the prescriber is correct. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is not true, [21CFR1306.11(d)(1-to-4)]. In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1). The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner); (2). The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in §1306.05, except for the signature of the prescribing individual practitioner; (3). If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (4). Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of §1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. (5). The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. (6). Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. (7). The pharmacist shall notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

Which of the following is/are NOT TRUE about dispensing Schedule V OTC controlled drugs? I. The purchaser at retail is at least 21 years of age. II. Dispensing should be done only by a registered pharmacist. III. A record of dispensing must be entered to the Schedule V bound book. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is not true, [21CFR1306.26(a)-to-(e)]. The dispensing of Schedule V OTC controlled substances should be done only by a registered pharmacist. The purchaser at retail should be at least 18 years of age. A record of dispensing must be entered to the Schedule V bound book. No more than 240 cc or 48 dosage units of any controlled substance that contains opium, or more than 120 cc or 24 dosage units of any other controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period. The pharmacist must maintain a bound record book with the following information: 1. Name and address of he purchaser. 2. Name and quantity of the controlled substance. 3. Date of the purchase. 4. Initial of the dispensing pharmacist.

Which of the following is/are classified as Mid-Level practitioners? I. RN II. MD III. DDS a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [21CFR1300.01(b)(28]. The term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as Answer: (a) I only, [21CFR1300.01(b)(28]. The term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense and/or prescribe controlled substances by the state in which they practice. who are authorized to dispense and/or prescribe controlled substances by the state in which they practice.

"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is not required for a Schedule II controlled drug if the schedule II: I. Drug is used for a double blind study. II. Drug is dispensed for terminally ill patients. III. Drug is dispensed when discharging a patient from an LTCF. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [21CFR290.5]. The label of any drug listed as a "controlled substance" in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." This statement is not required to appear on the label of a controlled substance dispensed for use in clinical investigations (e.g. a double blind study) which are "blind".

The dispensing of Methadone, for a period in excess of 21 days, for the treatment of heroin addiction is defined as: a. Maintenance treatment b. Detoxification treatment c. Concurrent treatment d. None of the above

Answer: (a) Maintenance treatment, [21 CFR 1300.01(b)(26) and 21 CFR 1300.01(b)(10)]. The term maintenance treatment means the dispensing for a period in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug. The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. There are two types of detoxification treatment: Short-term detoxification treatment and long-term detoxification treatment. (i). Short-term detoxification treatment is for a period not in excess of 30 days. (ii). Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days.

Which of the following Medicare Plan(s) offer(s) a prescription coverage? I. Part D II. Part X III. Part A a. I only b. I and II only c. II and III only d. All

Answer: (a) Medicare offers prescription drug coverage (Part D) for everyone with Medicare. To get Medicare drug coverage, a patient must join a plan run by an insurance company or other private company approved by Medicare. Each plan can vary in cost and drugs covered. If patients want Medicare drug coverage, they need to choose a plan that works with their health coverage. There are two ways to get Medicare prescription drug coverage: (1). Medicare Prescription Drug Plans: These plans (sometimes called "PDPs") add drug coverage to Original Medicare, some Medicare Cost Plans, some Medicare Private Fee-for-Service (PFFS) Plans, and Medicare Medical Savings Account (MSA) Plans. (2). Medicare Advantage Plans (like an HMO or PPO): Patients get all of Part A and Part B coverage, including prescription drug coverage (Part D), through these plans. Medicare Advantage Plans with prescription drug coverage are sometimes called "MA-PDs."

Which of the following is a Schedule II controlled drug? a. MS Contin b. Tylenol No. 3 c. Librium d. Redux

Answer: (a) Morphine sulfate (MS Contin) is classified as schedule II controlled substances, [21CFR1308.12]. The drug in this class has a high potential for abuse. Schedule II controlled substances cannot be refilled under any circumstances. The schedule II controlled substances must be ordered by using the DEA 222 order form.

After dispensing a Schedule II drug based on oral authorization of a prescribing individual practitioner, the pharmacist shall contact which of the following upon not receiving a written prescription from the prescriber within 7 days? I. Nearest DEA Office II. Patient III. State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (a) Nearest DEA office, [21CFR1306.11(d)(4)]. Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

Once a prescription is created electronically, all records of the prescription must be retained electronically for a period of: a. 2 years b. 4 years c. 6 years d. forever

Answer: (a) Once a prescription is created electronically, all records of the prescription must be retained electronically for a period of two years, [https://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/pharmacies.htm]. Once a prescription is created electronically, all records of the prescription must be retained electronically. As is the case with paper prescription records, electronic controlled substance prescription records must be kept for a minimum period of two years. Pharmacy application service providers must back up files daily. Also, although it is not required, DEA recommends as a best practice that pharmacies store their back-up copies at another location to prevent the loss of the records in the event of natural disasters, fires, or system failures.

All of the following are classified as controlled II barbiturates EXCEPT: a. Phenobarbital b. Amobarbital c. Secobarbital d. Pentobarbital

Answer: (a) Phenobarbital is classified as a Schedule IV controlled drug, [21CFR1308.14]. The other barbiturates such as Amobarbital, Secobarbital and Pentobarbital are classified as Schedule II controlled substances, [21CFR1308.12].

A type of drug recall in which there is a reasonable probability that the use of or exposure to a marketed product will cause serious adverse health consequences or death is known as: a. Class I recall b. Class II recall c. Class III recall d. Class IV recall

Answer: (a) Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. The severity of recall depends upon the adverse effect exhibited by the drug. Based on severity, drug recall are classified into three categories. Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Which of the following is required to order Schedule I and II controlled drugs? a. DEA 222 b. DEA 106 c. DEA 41 d. DEA 351

Answer: (a) Schedule I and II controlled drugs can be ordered by filling out a DEA 222 form, [21CFR1305.03]. (a). A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to the supplier and retain Copy 3 in the purchaser's files. (b). A supplier may fill the order, if possible and if the supplier desires to do so, and must record on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section. (c). The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section. (d). The supplier must retain Copy 1 of the DEA Form 222 for his or her files and forward Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. Copy 2 must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, Copy 2 must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires. (e). The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser. (f). DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order. (g). Only persons who are registered with DEA to handle Schedule I or II controlled substances, and persons who are registered with DEA to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for these substances. Persons not registered to handle Schedule I or II controlled substances and persons registered only to import controlled substances are not entitled to obtain Form 222 or issue electronic orders for these substances. An order for Schedule I or II controlled substances may be executed only on behalf of the registrant named on the order and only if his or her registration for the substances being purchased has not expired or been revoked or suspended.

A 72-year old patient is recently diagnosed with lymphocytic leukemia (a terminal illness). A prescriber calls a pharmacy and asks: "Will you be able to partially fill a prescription for OxyContin for this patient?" The pharmacist may reply: a. Yes b. No

Answer: (a) Schedule II controlled substance can be partially filled for terminally ill patients or patients reside in LTCF. The patient is diagnosed with terminal illness and therefore, the pharmacist may reply yes to the prescriber, [21CFR1306.13(b)]. 1. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. 2. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. 3. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." 4. A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. 5. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. 6. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. 7. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. 8. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial dispensing later than 30 days after the prescription is written and no later than 72 hours in emergency situations. 21 U.S.C. § 829(f)(2).

U.S. Health Coalition message: "Double Check, Don't Double Up" is in reference to which of the following? a. Acetaminophen b. Digoxin c. Levothyroxine d. Oxycodone

Answer: (a) The Acetaminophen Awareness Coalition is launching a nationwide initiative today calling on consumers to double check their medicine labels so they don't double up on medicines that contain acetaminophen during the cold and flu season. Acetaminophen is the most common drug ingredient in America. It is found in more than 600 different medicines, including prescription (Rx) and over-the-counter (OTC) pain relievers, fever reducers, sleep aids and numerous cough, cold and flu medicines. It is safe and effective when used as directed, but there is a limit to how much can be taken in one day. Taking more than directed is an overdose and can lead to liver damage. Each year, Americans catch an estimated one billion colds, and as many as 20 percent get the flu. Seven in 10 consumers use over-the-counter medicines, many of which contain acetaminophen, to treat their symptoms. The Coalition is targeting its "Double Check, Don't Double Up" message to the more than 50 million Americans who use acetaminophen weekly for conditions such as headache and chronic pain, and directing them to double check their medicine labels before taking a cold or flu medicine that also contains acetaminophen. When taking medicines for cough, cold or flu this coming season, consumers should follow these four simple acetaminophen safety steps: 1. Know if medicines contain acetaminophen, which is in bold type or highlighted in the "active ingredients" section of over-the-counter medicine labels and sometimes listed as "APAP" or "acetam" on prescription labels. 2. Never take two medicines that contain acetaminophen at the same time. 3. Always read and follow the medicine label. 4. Ask your healthcare provider or a pharmacist if you have questions about dosing instructions or medicines that contain acetaminophen.

Which of the following has the final authority to convert prescription drugs to OTC status? a. FDA b. NDAC c. DEA d. CSA

Answer: (a) The FDA has the final authority to convert prescription drug to OTC status, [21CFR330]. The process of reclassifying drugs from prescription to OTC status is referred to as an "Rx to OTC switch." Drugs are commonly switched one of two ways: under the "OTC drug review," or by a manufacturer's submission of additional information to the original new drug application. The OTC drug review, which began in 1972, is an ongoing assessment of the safety and effectiveness of all nonprescription drugs. In the first phase of the OTC drug review, panels of nongovernment experts review active ingredients in marketed OTC drug products to determine whether they can be classified as safe and effective. The panels also review prescription ingredients to determine whether some are appropriate for OTC marketing. About 40 former prescription-only drug ingredients have been switched by this process. The second common path to OTC approval is under the new drug application process. Under this process, manufacturers submit data to the FDA showing the drug is appropriate for self-administration. Data are submitted in a new drug application or a supplement to an already approved drug application. Often the submission includes studies showing that the product's labeling can be read, understood, and followed by the consumer without the guidance of a health care provider. The FDA reviews the new data, along with any information known about the drug from its prescription use. Under the new drug application process, some drugs are approved initially as OTC drugs, but most are first approved for prescription use and later switched to OTC.

OBRA '90 mandates the offer to counsel patients about their prescriptions by a pharmacist. a. True b. False

Answer: (a) The Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which mandates the offer to counsel patients about their prescriptions, also specifies the components of patient counseling. If the patient accepts the offer to counsel, the following items should be addressed: 1. Name of drug 2. Intended use and expected action 3. Route, dosage form, dosage, and administration schedule 4. Common side effects that may be encountered, including their avoidance and the action required if they occur 5. Techniques for self-monitoring of drug therapy 6. Proper storage 7. Potential drug-drug or drug-food interactions or other therapeutic contraindications 8. Prescription refill information 9. Action to be taken in the event of a missed dose The Omnibus Budget Reconciliation Act of 1990 (or OBRA-90, Pub.L. 101-508, 104 Stat. 1388, enacted November 5, 1990) is a United States statute enacted pursuant to the budget reconciliation process to reduce the United States federal budget deficit. OBRA 1990 gave states permission to create Drug Utilization Review ("DUR") boards to manage state specific drug purchasing and formulary decisions for state purchased health care such as Medicaid programs, injured workers programs, and state employee benefits. As a result, these boards (now sometimes called "pharmacy and therapeutics" committees), define lists of drugs classes and drugs within those classes in which no drug on the list is felt to be any more effective or less safe than another. This decision is made by a body of independent physicians and pharmacists who are not seen as having a financial conflict of interest. OBRA stipulates the decision must be made in conjunction with a compilation of evidence, as well as public comment, to generate the class wide drug comparison. Once the drug makes the list, it can also be chosen as a "preferred drug". Preferred drugs are typically cheap generic drugs. OBRA specified that pharmacists can substitute for a preferred drug, (if one exists in that state), and must offer counseling to the patient on the substitution.

To prevent accidental poisoning in young children, which of the following laws was developed? a. PPPA b. CSA c. PPI d. FTC

Answer: (a) The PPPA (Poison Prevention Packaging Act) was passed in 1970 to protect young children from accidental poisoning from drugs. The Commission, may establish in accordance with the provisions of this Act, by regulation, standards for the special packaging of any household substance if it finds that— (1). the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance; and (2). the special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.

Which of the following Therapeutic Equivalence "TE" codes allows substitution of two or more drugs based on therapeutic equivalence? a. AB b. BC c. BE d. BT

Answer: (a) The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if: 1. A drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug. 2. Those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected. 3. Some drug products have more than one TE Code. 4. Those products which the FDA does not deem to be therapeutically equivalent are "B" rated. Over-the-counter drugs are not assigned TE codes. AA: Products in conventional dosage forms not presenting bioequivalence problems. AB: Products meeting necessary bioequivalence requirements. AN: Solutions and powders for aerosolization are considered therapeutically equivalent to other pharmaceutically equivalent products. AP: Injectable aqueous solutions that are considered therapeutically equivalent to other pharmaceutically equivalent products. AO: Injectable oil solutions that are considered therapeutically equivalent to other pharmaceutically equivalent products. AT: Topical products that are considered therapeutically equivalent to other pharmaceutically equivalent products. BC: Controlled release formulations do not meet bioequivalence requirements. BD: Active ingredients and dosage forms with documented bioequivalence problems. BE: Enteric coating dosage formulations and delayed release oral dosage forms do not meet bioequivalence requirement. BN: Products in aerosol nebulizer drug delivery systems do not meet bioequivalence requirement. BP: Active ingredients and dosage forms with potential bioequivalence problems. BR: Suppositories or enemas that deliver drugs for systemic absorption do not meet bioequivalence requirement. BS: Products having standard deficiency; if the drug standards for an active ingredient in a particular dosage form are found by FDA to be deficient so as to prevent an FDA evaluation of either pharmaceutical or therapeutic equivalence, all drug products containing that active ingredient in that dosage form are coded BS. BT: Topical products with bioequivalence issues. BX: Drug products for which the data are insufficient to determine therapeutic equivalence.

An over-the-counter dispensing volume of Ipecac syrup should be restricted to: a. 30 cc b. 60 cc c. 90 cc d. 120 cc

Answer: (a) The over-the-counter dispensing volume of Ipecac syrup should be restricted to 30 cc, [21CFR201.308]. It is estimated that each year about 500,000 accidental poisonings occur in the United States and result in approximately 1,500 deaths, of which over 400 are children. In the emergency treatment of these poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical, since rapid treatment may be the difference between life and death. In view of the above recommendations, the Commissioner of Food and Drugs has determined that it is in the interest of the public health for ipecac syrup to be available for sale without prescription, provided that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and its label bears, in addition to other required label information, the following, in a prominent and conspicuous manner: 1. The container must contain the following label: "For emergency use to cause vomiting in poisoning. Before using, call a physician, the poison control center, or a hospital emergency room immediately for advice." 2. "Warning--Keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested." 3. Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age

Which of the following copies of a DEA 222 order form must the purchaser keep for his own record? I. Copy 3 II. Copy 2 III. Copy 1 a. I only b. I and II only c. II and III only d. All

Answer: (a) The purchaser must fill out all three copies of the DEA 222 form, [21CFR1305.13(d)]. He submits copies I and II of the DEA 222 form to the supplier and keeps copy III for his own record. The supplier records on the first and second copies the number of containers furnished on each item and the date on the containers that were shipped. The supplier keeps copy 1 for his own record and forwards copy 2 to the DEA.

The address printed on DEA 222 order forms for Rite Care Pharmacy is incorrect. In that case the Registrant: a. must return the form to the DEA to correct the error. b. should rewrite the correct address before ordering the drug. c. should not worry about the address. d. should place the correct address label before ordering the drug.

Answer: (a) The registrant must return DEA 222 forms to the DEA to correct the error [CFR1305.11(d)]. (a). DEA Forms 222 are issued in mailing envelopes containing either seven or fourteen forms, each form containing an original, duplicate, and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222, which will be furnished on any requisition unless additional forms are specifically requested and a reasonable need for such additional forms is shown. (b). Any person applying for a registration that would entitle him or her to obtain a DEA Form 222 may requisition the forms by so indicating on the application form; a DEA Form 222 will be supplied upon the registration of the applicant. Any person holding a registration entitling him or her to obtain a DEA Form 222 may requisition the forms for the first time by contacting any Division Office or the Registration Section of the Administration. Any person already holding a DEA Form 222 may requisition additional forms on DEA Form 222a, which is mailed to a registrant approximately 30 days after each shipment of DEA Forms 222 to that registrant, or by contacting any Division Office or the Registration Section of the Administration. All requisition forms (DEA Form 222a) must be submitted to the DEA Registration Section. (c). Each requisition must show the name, address, and registration number of the registrant and the number of books of DEA Forms 222 desired. Each requisition must be signed and dated by the same person who signed the most recent application for registration or for reregistration, or by any person authorized to obtain and execute DEA Forms 222 by a power of attorney under 1305.05. (d). DEA Forms 222 will be serially numbered and issued with the name, address, and registration number of the registrant, the authorized activity, and schedules of the registrant. This information cannot be altered or changed by the registrant; any errors must be corrected by the Registration Section of the Administration by returning the forms with notification of the error.

The safety of a new drug is most likely to be evaluated in: a. Phase I clinical trial. b. Phase II clinical trial. c. Phase III clinical trial. d. Phase IV clinical trial.

Answer: (a) The safety of a new drug is normally evaluated in phase I clinical trial. The therapeutic effectiveness of the new drug for which it is claimed to be effective is generally obtained by studying phase II clinical trial. The Phase III clinical trial generally helps evaluating the effectiveness and efficiency of new drug against the placebo.

A prescriber calls a pharmacist and asks about an off label use of Valproic acid. The information provides by the pharmacist in course of his professional practice is considered to be: a. Legal b. Illegal c. Severe violation of the law

Answer: (a) To prescribe and dispense drugs for their unapproved uses are not considered illegal by the FDA. However, the FDA would object if an off label use of the drug is used for the promotional purpose of the drug by the manufacturer.

For a schedule III or IV controlled substance, If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed. a. True b. False

Answer: (a) True, [21 CFR 1306.22 (d)]. (a). No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. (b). Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. (c). The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist for each refill. (5). The total number of refills for that prescription. (d). If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.

A controlled substance listed in Schedules II which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail. a. True b. False

Answer: (a) True, [21 CFR Section 1306.26]. A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail.

Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. a. True b. False

Answer: (a) True, [21CFR 1301.75]. (a). Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet. (b). Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. (c). Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access, except as authorized by §1317.80(d). (d). This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration. (e). Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription. a. True b. False

Answer: (a) True, [21CFR Section 1306.04]. (a). A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. (b). A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c). A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.

The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. a. True b. False

Answer: (a) True, [21CFR1301.76(b)]. The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. (a). The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. (b). The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors: (1). The actual quantity of controlled substances lost in relation to the type of business; (2). The specific controlled substances lost; (3). Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances; (4). A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, (5). Whether the specific controlled substances are likely candidates for diversion; (6). Local trends and other indicators of the diversion potential of the missing controlled substance.

A pharmacist may fill a physician's signed prescription for Alprazolam that is transmitted by the practitioner's agent to a pharmacy via facsimile. a. True b. False

Answer: (a) True, [21CFR Section 1306.21(a)]. A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner.

Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of Federal Law. The computers on which such records are maintained may be located at location other than the registered location. a. True b. False

Answer: (a) True, [21CFR1304.04(h)(5)]. Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of Federal Law. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the Administration or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled

If a purchaser ascertains that an unfilled DEA Form 222 has been lost, he or she must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222. a. True b. False

Answer: (a) True, [21CFR1305.16(a,b,c,d,e)]. (a). If a purchaser ascertains that an unfilled DEA Form 222 has been lost, he or she must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222. Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the DEA Form 222 first executed. A copy of the statement must be attached to Copies 1 and 2 of the second DEA Form 222 sent to the supplier. If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face "Not accepted" and return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement. (b). Whenever any used or unused DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost. (c). If the theft or loss includes any original DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers. (d). If an entire book of DEA Forms 222 is lost or stolen, and the purchaser is unable to state the serial numbers of the DEA Forms 222 in the book, the purchaser must report, in lieu of the numbers of the forms contained in the book, the date or approximate date of issuance. (e). If any unused DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located must immediately be notified.

Under CSA, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. a. True b. False

Answer: (a) True, [21CFR1306.12(a)(b)]. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: (i). Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; (ii). The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; (iii). The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; (iv). The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and (v). The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.

Under the Federal Pharmacy Law, if the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area. a. True b. False

Answer: (a) True, [21CFR1307.21]. (a). Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows: (1). If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area; or (2). If the person is not a registrant, he/she shall submit to the Special Agent in Charge a letter stating: (i). The name and address of the person; (ii). The name and quantity of each controlled substance to be disposed of; (iii). How the applicant obtained the substance, if known; and (iv). The name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant, if known. (b). The Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled substance in one of the following manners: (1). By transfer to person registered under the Act and authorized to possess the substance; (2). By delivery to an agent of the Administration or to the nearest office of the Administration; (3). By destruction in the presence of an agent of the Administration or other authorized person; or (4). By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons.

With the electronic prescribing of controlled substances, the DEA required contents of a prescription shall not be altered during transmission between the practitioner and pharmacy. a. True b. False

Answer: (a) True, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. The DEA-required contents of a prescription shall not be altered during transmission between the practitioner and pharmacy. However, this requirement only applies to the content (not the electronic format used to transmit the prescription). This requirement applies to actions by intermediaries. It does not apply to changes that occur after receipt at the pharmacy. Changes made by the pharmacy are governed by the same laws and regulations that apply to paper prescriptions.

Which of the following drugs is/are classified under the Pregnancy Category X? I. Cytotec II. Accutane III. Pravachol a. I only b. I and II only c. II and III only d. All

Answer: (d) The following drugs are classified under the Pregnancy Category-X. 1. Isotretinoin (Accutane) 2. HMG-COA inhibitors (e.g. Pravachol) 3. Misoprostol (Cytotec) 4. Finasteride (Proscar, Propecia) 5. Warfarin (Coumadin) 6. Alcohol

The State Pharmacy Board may suspend a pharmacist license if the pharmacist fails to repay a student loan. a. True b. False

Answer: (a) True. For purposes of this section, failing to repay a student loan issued or guaranteed by the state or the Federal Government in accordance with the terms of the loan or failing to comply with service scholarship obligations shall be considered a failure to perform a statutory or legal obligation, and the minimum disciplinary action imposed shall be a suspension of the license until new payment terms are agreed upon.

The partial supply on DEA 222 order forms must be filled within: a. 72 hours b. 10 days c. 48 hours d. 60 days

Answer: (d) The partial supply on DEA 222 order forms must be filled within 60 days from the issued date, [21CFR1305.13 (d)].

Which of the following reference book(s) provides a drug information in a lay language? I. USP DI Volume II II. The Orange Book III. The Red Book a. I only b. I and II only c. II and III only d. All

Answer: (a) USP DI Volume II provides a drug information in a lay language. This reference volume is deliberately prepared in simple language so that an average person can understand.

If RX Care Pharmacy compounds 1000 capsules of Tylenol No. 3 without following GMP guidelines, the compounded drug shall be classified as: a. Adulterated b. Misbranded

Answer: (a) When a pharmacy manufactures or compounds drugs without following GMP guidelines, the product is classified as Adulterated, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 501,351]. A drug shall be deemed to be adulterated: ____________________________________ (a). If it consists in whole or in part of any filthy, putrid, or decomposed substance. (b). If it has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (c). If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. (d). If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (e). It bears or contains, for purposes of coloring only, a color additive that is unsafe. (f). If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. (g). If it is a drug and any substance has been mixed or packed therewith to reduce its quality or strength or substituted wholly or in part thereof.

The post-marketing surveys for new drugs are generally conducted during: a. Phase I clinical trial. b. Phase II clinical trial. c. Phase III clinical trial. d. Phase IV clinical trial.

Answer: (d) The post marketing surveys for new drugs are generally conducted during phase IV clinical trial.

Under current CSA, can a practitioner write a prescription for controlled substances electronically? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/eapplications.htm]. DEA's rule, "Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule was published in the Federal Register Wednesday, March 31, 2010 and becomes effective on June 1, 2010.

Is it permissible to have a staff person in the practitioner's office complete all of the required information for a controlled substance prescription and then have the practitioner electronically sign and authorize the transmission of the prescription? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. Yes, however, if an agent of the practitioner enters information at the practitioner's direction prior to the practitioner reviewing and approving the information, the practitioner is responsible in the event the prescription does not conform in all essential respects to the law and regulations.

Can a distributor accept a DEA Form 222 if the size and strength of a product have been placed incorrectly on the form? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/faq/dea222.htm]. The DEA Form 222 is acceptable as long as there is no question as to what product has been ordered.

Can a distributor accept a DEA Form 222 that contains minor misspellings in the registrant's name, address, or drug name? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/faq/dea222.htm]. The DEA Form 222 is acceptable if the registrant's name or address contains minor misspellings. The registrant should request corrected official order forms and if necessary a corrected registration certificate from DEA. If the drug name has been misspelled and there is no question as to what product has been ordered then the DEA Form 222 is acceptable.

Can an LTCF store controlled substances in an emergency kit without being registered with the DEA? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/faq/general.htm#lt-2]. The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970, provided if the source from which an LTCF may obtain controlled substances for emergency kits must be a DEA registered hospital/clinic, pharmacy, or practitioner.

Can a prescription written for Alprazolam for a resident of an LTCF be faxed to a pharmacy? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/faq/general.htm] According to CSA, Schedules II-V controlled substance prescriptions written for a resident of an LTCF may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription.

Can a practitioner licensed under the CSA prescribe methadone for the treatment of pain? a. Yes b. No

Answer: (a) Yes, [http://www.deadiversion.usdoj.gov/faq/prescriptions.htm#rx-4] Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a registered practitioner acting in the usual course of professional practice. Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).

May a health care provider discuss a patient's health information over the phone with the patient's family, friends, or others involved in the patient's care or payment for care? a. Yes b. No

Answer: (a) Yes, [http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/provider_ffg.pdf]. Where a health care provider is allowed to share a patient's health information with a person, information may be shared face-to-face, over the phone, or in writing. Also, if a patient's family member, friend, or other person involved in the patient's care or payment for care calls a health care provider to ask about the patient's condition, HIPAA does NOT require the health care provider to obtain proof of who the person is before speaking with them. However, a health care provider may establish his or her own rules for verifying who is on the phone. HIPAA also allows health care providers to use professional judgment and experience to decide if it is in the patient's best interest to allow another person to pick up a prescription, medical supplies, X-rays, or other similar forms of information for the patient.

A prescription for Ativan issued on 01/01/2018 should not be filled after: a. 04/01/2018 b. 07/01/2018 c. 10/01/2018 d. 01/01/2019

Answer: (b) 07/01/2018, [21CFR1306.22(a)]. (a). No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. (b). Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. (c). The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist for each refill. (5). The total number of refills for that prescription. (d). If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.

What strength of OxyContin is most commonly abused or diverted? a. 20 mg b. 40 mg c. 80 mg d. 160 mg

Answer: (b) 40 mg, [http://www.deadiversion.usdoj.gov/drug_chem_info/oxycodone/oxycontin_faq.htm]. Law enforcement and forensic laboratory data indicate that their exhibits are primarily for the 40 mg tablets, although all strengths (10 mg, 20 mg, 40 mg, 80 mg, and 160 mg) have been encountered.

An individual is required to obtain which of the following certificates for electronic ordering of Schedule I and II controlled substances? a. POS b. CSOS c. DEA 222 Elite d. SIADH

Answer: (b) A CSOS Certificate is a digital identity issued by the DEA's CSOS Certification Authority (CSOS CA) that allows for electronic ordering for Schedule I and II (as well as III-V) controlled substances, [21CFR 1311]. A CSOS Certificate is the digital equivalent of the identification information contained on a DEA Form-222. CSOS Certificates are issued to individuals and are required for electronic ordering of Schedule I and II controlled substances. There are two types of CSOS Certificates: 1. CSOS Administrative Certificates are used to digitally sign communications with DEA as well as with other participants in the CSOS community. Administrative Certificates are issued only to CSOS Coordinators and are not valid for electronic ordering. 2. CSOS Signing Certificates are used for digitally signing controlled substance orders. Signing certificates are issued to approve Registrant and Power of Attorney applicants. Approved Coordinator applicants will only be issued a Signing certificate if he/she holds valid Power of Attorney for controlled substance ordering and has requested a Signing certificate on his/her CSOS Certificate Application. A separate CSOS Signing Certificate is required for each DEA Registrant number. In cases where a person represents multiple Registrants or DEA Registrant numbers, then multiple Certificates shall be issued. An outline of the procedure for ordering Schedule I and II controlled substances using an electronic filled DEA 222 order form: 1. An individual enrolls with DEA and, once approved, is issued a personal CSOS Certificate. 2. The purchaser creates an electronic 222 order using approved ordering software. The order is digitally signed using the purchaser's personal CSOS Certificate and then transmitted to the suppliers. The paper 222 is not required for electronic ordering. 3. The supplier receives the purchase order and verifies that the purchaser's certificate is valid with DEA. Additionally, the supplier validates the electronic order information just like it would a paper order. 4. The supplier completes the order and ships to the purchaser. Any communications regarding the order are sent electronically. 5. The order is reported by the supplier to DEA within two business days.

If we thoroughly mix 300 milligrams of Codeine powder with 3250 milligrams of Acetaminophen, and prepare 10 capsules, each capsule contains 355 mg of compounded mixture, the compounded capsules are classified as: a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (b) A Schedule III controlled substance, [21CFR1308.13(e)(2)]. 1. Any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below should be classified as a Schedule III controlled substance. "Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts." 2. In above example, each compounded capsule contains 30 milligrams of Codeine per dosage unit (300 mg/10 capsules), which is less than amount mentioned in the law (90 mg per dosage unit) and hence it should be classified as a Schedule III controlled drug.

What is a CSP stand for? a. Controlled Substances Productivity b. Cryptographic Service Provider c. Child-Serine Pharmacy Act d. FTC

Answer: (b) A cryptographic service provider, among many other things, creates the private key associated with the CSOS Certificate being retrieved from the DEA E-Commerce Web site, [http://www.deaecom.gov/qanda.html].

A pharmacy must register as a distributor if it distributes more than: a. 2 % of all controlled substances to another registrant within 1 year. b. 5 % of all controlled substances to another registrant within 1 year. c. 3 % of all controlled substances to another registrant within 1 year. d. 4 % of all controlled substances to another registrant within 1 year.

Answer: (b) A pharmacy must register as a distributor if it distributes more than 5 % of all controlled substances to another registrant within 1 year period [21CFR1307.11(a)(1),(2),(3),(4)]. A pharmacy registered to dispense controlled substances may distribute controlled substances even without being registered as a distributor provided that: I. The pharmacy or physician to which the controlled substance is distributed must be registered under the Act to dispense controlled substances. II. The distributing pharmacy must keep accurate record of distributing controlled substances including name, dosage form and quantity of the controlled substance distributed. It also requires the name, address and DEA registration number of the receiving pharmacy or physician. III. If the transferred controlled substance is either a Schedule I or II controlled drug, the transfer must be made on a DEA 222 order form. IV. The total number of controlled substances distributed by the pharmacy to another registrant must not exceed 5 % of all controlled substances dispensed by the pharmacy within a 12-month period.

Samples of prescription drugs received by a physician from medical representatives can be: a. Sold to a chain pharmacy store. b. Given to patients. c. Sold to a hospital pharmacy. d. Sold to another physician.

Answer: (b) According to the Prescription Drug Marketing Act of 1987, drug samples cannot be traded or purchased. Physicians may give drug samples to patients,[21CFR203.20]. The manufacturer or distributor of a drug may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made: (i). In response to a written request for drug samples made on a form which meets the requirements of subparagraph (B),and (ii). under a system which requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor. (B). A written request for a drug sample required by subparagraph (A)(i) shall contain-- (i). the name, address, professional designation, and signature of the practitioner making the request, (ii). the identity of the drug sample requested and the quantity requested, (iii). the name of the manufacturer of the drug sample requested, and (iv). the date of the request. (C). Each drug manufacturer or distributor which makes distributions by mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be maintained under this subparagraph shall be made available by the drug manufacturer or distributor to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable to drugs.

Before testing drugs on humans, the manufacturer must submit a(n): a. NDA to the FDA b. IND to the FDA c. ADR to the FDA d. CFR to the FDA

Answer: (b) An IND to the FDA, [21CFR Section 312]. 1. Before testing drugs on humans, the manufacturer must submit an IND (Investigational New Drug) application to the FDA. 2. After submitting the IND, the FDA has 30 days to decide whether to approve or disapprove the manufacturer's proposal. The safety of the drug at this time is normally decided by data provided by the manufacturer on animal testing. Once the manufacturer gets an approval from the FDA for human testing, the drug has to pass three phases before getting final approval for marketing. 3. Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. 4. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. 5. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.

Which of the following controlled drug(s) DEA Forms 222 must maintain separately from all other DEA Forms 222? I. Carfentanil II. Diprenorphine III. Buprenorphine a. I only b. I and II only c. II and III only d. All

Answer: (b) Carfentanil and Diprenorphine, [21CFR1305.17(d)]. 1. The supplier of carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant. 2. DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed DEA Form 222 and any attached statements or other related documents, at the registered location printed on the DEA Form 222.

The statement, "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", is required when dispensing: I. Schedule II controlled drugs. II. Schedule III controlled drugs. III. Schedule V controlled drugs. a. I only b. I and II only c. II and III only d. All

Answer: (b) Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed is required when dispensing Schedule II, III and IV controlled drugs. This cautionary label is not required when dispensing a Schedule V controlled substance or on the label of a controlled substance dispensed for use in clinical investigations which are "blind."

The records in a Schedule V (OTC) bound book should be maintained for at least: a. 6 months from the date of last transaction. b. 12 months from the date of last transaction. c. 1 year from the date of last transaction. d. 2 years from the date of last transaction.

Answer: (d) The records in Schedule V (OTC) bound book should be maintained for at least 2 years from the date of the last transactions, [21CFR1306.26 and 21CFR1304.04(a)].

A pharmacist receives a new prescription from a prescriber for compounding a cream that is commercially available. What shall pharmacist do? a. Fill the prescription. b. Do not fill the prescription.

Answer: (b) Do not fill the prescription, [FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding]. A pharmacist may not compound products that are commercially available, unless the Board/FDA has given prior approval to compound a commercially available product that is temporarily in short supply/unavailable. For parenteral products a commercially available product may be compounded if there are multiple companies that provide the mixture (ex. KCl premixed IV bags) or if the premix IV admixture is commercially available as well as the premixed IV bags (ex. Using a commercially available vial of medication to make an IV bag, even though there is a commercially available premixed IV bag).

Who can request to exempt a drug from the requirement of child resistant packaging? I. Patient II. Prescriber III. Pharmacist a. I only b. I and II only c. II and III only d. All

Answer: (b) Either a prescriber or patient or both can request to exempt a drug from the requirement of child resistant packaging, [The Poison Prevention Packaging Act, 15 U.S.C 1471-1474].

A Walgreen Pharmacy must renew its DEA registration to dispense controlled drugs every: a. 1 year b. 3 years c. 9 months d. 2 years

Answer: (b) Every pharmacy engaged in the dispensing of controlled substances must register with the DEA. The registration should be kept in the pharmacy, available for inspection. The registration must be renewed every three years, [21CFR1301.13(d)]. If the person/company owns more than one pharmacy, each pharmacy must be separately registered, [21CFR1301.12(a)].

How often shall FDA visit a drug manufacturer's premises to ensure that it meets current GMP guidelines? a. Every five years b. Every two years c. Every six months d. Every year

Answer: (b) Every two years FDA shall visit a drug manufacturer's premises to ensure that it meets current GMP guidelines.

Central fill pharmacies may prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from an individual practitioner. a. True b. False

Answer: (b) False, [21 Code of Federal Regulation 1306, Section 1306.11(d)(5)]. Central fill pharmacies shall not be authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.

The CSOS digital certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the DEA Certification Authority within 7 days of substantiation of the loss, theft, or compromise. a. True b. False

Answer: (b) False, [21CFR 1311.30]. The following persons are eligible to obtain a CSOS digital certificate from the DEA Certification Authority to sign electronic orders for controlled substances. (a). The person who signed the most recent DEA registration application or renewal application and a person authorized to sign a registration application. (b). A person granted power of attorney by a DEA registrant to sign orders for one or more schedules of controlled substances. A CSOS digital certificate issued by the DEA Certification Authority will authorize the certificate holder to sign orders for only those schedules of controlled substances covered by the registration under which the certificate is issued. Requirements for storing and using a private key for digitally signing orders: (a). Only the certificate holder may access or use his or her digital certificate and private key. (b). The certificate holder must provide FIPS-approved secure storage for the private key, as discussed by FIPS 140-2, 180-2, 186-2. (c). A certificate holder must ensure that no one else uses the private key. While the private key is activated, the certificate holder must prevent unauthorized use of that private key. (d). A certificate holder must not make back-up copies of the private key. (e). The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours (NOT 7 days) of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of Sec. 1311.25

The delivery of Morphine sulfate from Central fill pharmacy to a retail pharmacy must be accompanied with the properly filled DEA 222 order form. a. True b. False

Answer: (b) False, [21CFR1305.03]. Either a DEA Form 222 or its electronic equivalent is required for each distribution of a Schedule I or II controlled substance EXCEPT for the following: (a). Distributions to persons exempted from registration under Part 1301 of this chapter. (b). Exports from the United States that conform with the requirements of the Act. (c). Deliveries to a registered analytical laboratory or its agent approved by the DEA. (d). Delivery from a central fill pharmacy to a retail pharmacy. Central fill pharmacy: Central fill pharmacy means a pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user. Such central fill pharmacy shall be deemed "authorized" to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner.

Under CSA, it is okay to provide a DEA registration number on prescriptions written for non-controlled substances. a. True b. False

Answer: (b) False, [http://www.deadiversion.usdoj.gov/faq/general.htm]. 1. DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. 2. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. 3. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner's DEA registration number.

A surgeon who did emergency surgery on a patient told the patient's spouse about the patient's condition while the patient was unconscious. The act done by the physician is considered violating The HIPAA Privacy Rules. a. True b. False

Answer: (b) False, [http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/provider_ffg.pdf]. If the patient is not present or is incapacitated, a health care provider may share the patient's information with family, friends, or others as long as the health care provider determines, based on professional judgment that it is in the best interest of the patient. When someone other than a friend or family member is involved, the health care provider must be reasonably sure that the patient asked the person to be involved in his or her care or payment for care. The health care provider may discuss only the information that the person involved needs to know about the patient's care or payment. Here are few examples: 1. A surgeon who did emergency surgery on a patient may tell the patient's spouse about the patient's condition while the patient is unconscious. 2. A pharmacist may give a prescription to a patient's friend who the patient has sent to pick up the prescription. 3. A hospital may discuss a patient's bill with her adult son who calls the hospital with questions about charges to his mother's account. 4. A health care provider may give information regarding a patient's drug dosage to the patient's health aide who calls the provider with questions about the particular prescription. BUT: A nurse may not tell a patient's friend about a past medical problem that is unrelated to the patient's current condition. A health care provider is not required by HIPAA to share a patient's information when the patient is not present or is incapacitated, and can choose to wait until the patient has an opportunity to agree to the disclosure.

Hearing aids and exams for fitting a hearing aid for elderly (65 or above) is covered under Medicare Part B benefit. a. True b. False

Answer: (b) False. Items and services that Medicare (Part A and Part B) doesn't cover include, but aren't limited to, the following: 1. Acupuncture. 2. Chiropractic services. 3. Cosmetic surgery. 4. Custodial care, unless you also get skilled nursing care in a skilled nursing facility, at home, or as part of hospice care. 5. Deductibles, coinsurance, or copayments when you get certain health care services. People with limited income and resources may get help paying these costs. 6. Dental care and dentures. 7. Eye exams (routine), eye refractions (exam that measures how well you see at specific distances), and eyeglasses. 8. Foot care (routine), like cutting corns or calluses. 9. Hearing aids and exams for fitting a hearing aid. 10. Hearing tests that haven't been ordered by your doctor. 11. Laboratory tests (screening) with few exceptions. 12. Long-term care. 13. Orthopedic shoes (with few exceptions). 14. Physical exams (routine or yearly). Medicare will cover a one-time physical exam. 15. Prescription drugs (with few exceptions). 16. Shots to prevent illness. Part D must cover all commercially-available vaccines (like the shingles vaccine) except those covered by Part B. 17. Surgical procedures given in ambulatory surgical centers that aren't included on Medicare's list of ambulatory surgical center covered procedures. 18. Syringes or insulin. Insulin used with an insulin pump is covered by Part B. Syringes or insulin may be covered by Part D. 19. Travel (health care while you're traveling outside the United States).

Which of the following drugs is classified as a Schedule III drug? a. Fioricet b. Fiorinal c. Codeine d. Lorazepam

Answer: (b) Fiorinal (Butalbital with Aspirin) is classified as a Schedule III drug, [Section 811(g) (3) (A) of the Controlled Substances Act]. Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg. The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

Which of the following is/are TRUE about obtaining identity proofing for individual prescribing practitioners to allow them to prescribe electronically? I. Individual practitioners may obtain their two-factor authentication credential by applying to certain Federally approved credential service providers (CSPs). II. Individual practitioners may obtain their two-factor authentication credential by applying to certain Federally approved certification authorities (CAs). III. Only in person identity proofing will be acceptable. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. It is critical to the security of electronic prescribing of controlled substances that authentication credentials used to sign controlled substances prescriptions are issued only to individuals whose identity has been confirmed. Individual practitioners will be required to apply to certain Federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their two-factor authentication credential or digital certificates. The CSP or CA will be required to conduct identity proofing that meets National Institute of Standards and Technology Special Publication 800-63-1 Assurance Level 3. Both in person and remote identity proofing will be acceptable. Institutional practitioners will have the option to conduct in-person identity proofing in-house as part of their routine credentialing process.

Which of the following is/are correct filing method(s) for controlled substances? I. One file for CII, second file for III, IV and V and a third file for non-controlled substances. II. One file for CII and a second file for III, IV, V and non-controlled substances. III. One file for controlled and a second file for non-controlled substances. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR1304.04(h]. Each registered pharmacy shall maintain the inventories and records of controlled substances as follows: (1). Inventories and records of all controlled substances listed in Schedule I and II shall be maintained separately from all other records of the pharmacy. (2). Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a separate prescription file. (3). Inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy. (4). Paper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location either in a separate prescription file for Schedules III, IV, and V controlled substances only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs a computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived. (5). Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of part 1311 of this chapter. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the Administration or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled.

The partial filling of Schedule II controlled drugs is permitted for: I. A patient resides in an LTCF. II. A patient with a medical diagnosis documenting a terminal illness. III. A patient resides in the Medicare Certified Hospital. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR1306.13(b)]. 1. A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. 2. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. 3. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. 4. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. 5. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial dispensings later than 30 days after the prescription is written and no later than 72 hours in emergency situations. 21 U.S.C. § 829(f)(2).

Which of the following is/are FDA approved drugs for the treatment of narcotic addiction in a detoxification program? I. Methadone II. LAAM III. Percodan a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [http://www.deadiversion.usdoj.gov/drugreg/faq.htm#narc_treatment]. A practitioner who wants to use Schedule II narcotic drugs for maintenance and/or detoxification must obtain separate registration from DEA as a narcotic treatment program pursuant to the Narcotic Addict Treatment Act of 1974. This registration allows a practitioner to administer or dispense, but not prescribe, scheduled narcotic drugs that are approved by the United States Food and Drug Administration (FDA) for the treatment of narcotic addiction. Methadone and levo-alpha-acetylmethadol (LAAM) are the only scheduled narcotics approved by FDA for use in maintenance and detoxification treatment. If a practitioner plans to use any other narcotic drug for addiction treatment, prior authorization must be obtained from FDA through an Investigational New Drug Application. It should be noted that Buprenorphine, available under the brand name of Buprenex - a Schedule III controlled substance, is approved for the treatment of pain, it may not be prescribed or dispensed for use in narcotic addiction treatment. Instead, the FDA approved two high-dose schedule III formulations of sublingual Buprenorphine drug products (Suboxone and Subutex) for use in narcotic addiction treatment. Registration with DEA is contingent upon proper registration with the State Methadone Authority and the United States Department of Health and Human Services (HHS).

Which of the following drugs is/are recommended for disposal by flushing when take-back options are not readily available? I. Hydrocodone II. Sodium oxybate III. Clonazepam

Answer: (b) I and II only, [https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#Medicines_recommended]. A small number of medicines have specific instructions to immediately flush down the toilet when no longer needed and a take-back option is not readily available. These medicines may be especially harmful and, in some cases, fatal with just one dose if they are used by someone other than the person for whom they were prescribed. The list of such medications is as follows: 1. Benzhydrocodone/Acetaminophen (Apadaz) 2. Buprenorphine (Belbuca, Bunavail, Butrans, Suboxone, Subutex, Zubsolv) 3. Fentanyl (Abstral, Actiq, Duragesic, Fentora, Onsolis) 4. Diazepam (Diastat/Diastat AcuDial rectal gel) 5. Hydrocodone (Anexsia, Hysingla ER, Lortab, Norco, Reprexain, Vicodin, Vicoprofen, Zohydro ER) 6. Hydromorphone (Dilaudid, Exalgo) 7. Meperidine (Demerol) 8. Methadone (Dolophine, Methadose) 9. Methylphenidate (Daytrana transdermal patch system) 10. Morphine (Arymo ER, Embeda, Kadian, Morphabond ER, MS Contin , Avinza) 11. Oxycodone (Combunox, Oxaydo (formerly Oxecta), OxyContin, Percocet, Percodan, Roxicet, Roxicodone, Targiniq ER, Xartemis XR, Xtampza ER, Roxybond) 12. Oxymorphone (Opana, Opana ER) 13. Tapentadol (Nucynta, Nucynta ER) 14. Sodium Oxybate (Xyrem oral solution)

JD comes to a pharmacy and requests a transfer of a prescription for Alprazolam from another pharmacy. His patient profile shows that three eligible refills have been left on the prescription. If both pharmacies, transferring and receiving, electronically sharing a real-time, on-line database, how many times may the original prescription be transferred between pharmacies? a. One-time only b. Maximum three times c. As many times as needed until prescription expires d. Cannot be transferred

Answer: (b) Maximum three times, [21CFR Section 1306.25]. The one-time transfer of the original prescription information for a controlled substance listed in Schedules III, IV, or V, if any authorized refills remain, for the purpose of dispensing is permissible between pharmacies within six (6) months from the date the prescription was issued. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

A pharmacist who is reconstituting the Amoxicillin Suspension adds 75cc of distilled water to reconstitute the suspension. However, the label instruction on Amoxicillin bottle suggests to add 125cc. The resultant compounding shall be classified as: a. Adulterated b. Misbranded

Answer: (b) Misbranded, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 502,352]. A drug shall be classified as misbranded if: ____________________________________ (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

A 23 year old female wants to purchase Robitussin A/C with a valid identification without a prescription. What is the most the pharmacy may sell to her in any given 48-hour period? a. 30 CC b. 60 CC c. 120 CC d. 240 CC

Answer: (c) 120 cc, [21CFR1306.26(b)]. Under the Federal Pharmacy Law, not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance contains codeine (e.g. Robitussin A/C) nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period.

Under the Controlled Substances Act, is post-dating of multiple prescriptions allowed? a. Yes b. No

Answer: (b) No, [21CFR 1306.05(a), 21 CFR 1306.04(a) and http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm]. Federal regulations have always required that all prescriptions for controlled substances "be dated as of, and signed on, the day when issued.", [21 CFR 1306.05(a)]. Where a prescription contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. In addition, when filling any prescription for a controlled substance, a pharmacist who fills multiple prescriptions issued in accordance with this regulation has a corresponding responsibility to ensure that each sequential prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

An office used by a practitioner (who is registered at another location in the same State) where controlled substances are prescribed but neither administered nor dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained. Does this place of business require a separate controlled substance registration? a. Yes b. No

Answer: (b) No, [21CFR Section 1301.12]. A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. The following locations shall be deemed NOT to be places where controlled substances are manufactured, distributed, or dispensed: (1). A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register. (2). An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and (3). An office used by a practitioner (who is registered at another location in the same State or jurisdiction of the United States) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

A pharmacist receives a new verbal order for controlled substance from a licensed practitioner. The pharmacist has entered the verbal prescription order directly into electronic data system instead of writing it down on a new prescription blank. Is pharmacist meeting the requirement of Federal Pharmacy Law? a. Yes b. No

Answer: (b) No, [21CFR1306.11(d)(2) and 21CFR1306.21(c)]. Under the Code of Federal Regulations 1306.11(d)(2) and 1306.21(c), it has been stated: "A pharmacist may dispense a controlled substance upon receiving an oral authorization of a prescribing individual practitioner, provided that: (2). The prescription shall be immediately reduced to WRITING by the pharmacist and shall contain all information required in §1306.05, except for the signature of the prescribing individual practitioner. " Therefore, entering the oral prescription directly into electronic data system without first reduced to writing on the prescription blank does not meet the requirement of Federal law, and must be avoided by the pharmacist.

Can an individual return his/her controlled substance prescription medication to a pharmacy? a. Yes b. No

Answer: (b) No, [http://www.deadiversion.usdoj.gov/faq/general.htm]. 1. An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy. 2. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. 3. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient). 4. The CFR does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred. 5. An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. 6. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.

The pharmacist making an offer for a patient to ask questions is acting in accordance with the OBRA counseling act. a. Yes b. No

Answer: (b) No, [OBRA-90]. (a). The following can satisfy an offer: (1). A pharmacist counseling the patient. (2). A pharmacist intern/extern registered if (A). permitted by the pharmacist; and (B). the counseling by the pharmacist intern/extern is followed by a bona fide offer for the pharmacist to counsel the patient and if the patient or patient's representative desires such counseling. (3). A written notice containing the pharmacy's phone number and a bona fide offer when: (A). a patient is not present and has not authorized the giving of information to another; or (B). the drug or device is delivered by the United States Postal Service, parcel delivery, or hand delivery. The following cannot satisfy a counseling offer or requirement: (1). Making an offer for the patient to ask questions. (2). Any other method that serves to shift the responsibility from the pharmacist to the patient for initiating the counseling or for selecting the informational content of the counseling. (3). Relaying information through an intermediary, unless needed for translations, the hearing impaired, or other situation beyond the control of the pharmacist. (4). Using signs or other types of written notices or written information given to the patient with each drug dispensed. **"Offer" means a statement that is verbal or, only if necessary for an individual patient, nonverbal, for example, printed or written, that clearly informs the patient that a pharmacist is available, at the time the offer is made, to counsel the patient, including, but not limited to, giving information to or answering questions, or both, from the patient.**

Can an LTCF return a resident's unused controlled substance medication to a pharmacy? a. Yes b. No

Answer: (b) No, [http://www.deadiversion.usdoj.gov/faq/general.htm#lt-2]. 1. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., resident of an LTCF). 2. Most LTFCs are not licensed by their respective state to handle controlled substances and, therefore, are not registered with DEA. 3. LTCFs act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.

To change the packaging and labeling requirements of already marketed drugs, the manufacturer shall submit an: a. NDA b. ANDA c. SNDA d. IND

Answer: (c) Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).

The inventory for controlled substances should be taken at least: a. twice a year. b. once every two years. c. three times a year. d. every six months.

Answer: (b) Once every two years, [21CFR1304.11]. 1. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. 2. An inventory taken by use of an oral recording device must be promptly transcribed. 3. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. 4. A separate inventory shall be made for each registered location and each independent activity registered. 5. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory. 6. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory. 7. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

Physicians authorized to administer and dispense narcotic drugs for the treatment of detoxification are required to fill out which form(s)? a. FDA 483 b. FDA 2632 c. FDA 2633 d. FDA 482

Answer: (b) Physicians authorized to administer and dispense narcotic drugs for the treatment of detoxification are required to fill FDA 2632 form. a. Form FDA 2632: Application for Approval for Use of Narcotic Drugs in a Narcotic Addiction Treatment Program b. Form FDA 2633: Medical Responsibility Statement for Use of Narcotic Drugs in a Treatment Program c. Form FDA 2635: Consent to Treatment with an Approved Narcotic Drug d. Form FDA 2636: Hospital Request for Methadone Detoxification Treatment e. Form FDA 482: Notice of Inspection (sample) f. Form FDA 2438b: Routine Notice to Observe Patient Identifying Information g. Form FDA 483: Inspectional Observations

We have Roxanol (10 mg/5CC) 480 CC bottle. If we remove 25 CC from the bottle and dilute up to the 100 CC mark with distilled water, the resultant compounded solution is classified as: a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (b) Schedule III, [21CFR1308.13(e)(8)]. 1. We are removing 25 cc (50 mg Morphine) and diluting up to the 100 cc mark with distilled water which gives the final product a strength of 50 milligrams Morphine per 100 cc solution. It should be classified as a Schedule III controlled drug. [21CFR1308.13(e)(8): Not more than 50 milligrams of Morphine per 100 cc, or 100 grams of compounded product is classified as a schedule III controlled drug.]

Which of the following dosage forms of Secobarbital does not require a DEA 222 form? a. Capsule b. Suppository c. Injection d. Oral concentrate

Answer: (b) Secobarbital is classified as a Schedule II controlled drugs, [21CFR1305.03, 1308.12 and 1308.13]. A DEA Form 222 is required for each distribution of a Schedule I or II controlled substance. Schedule II controlled barbiturates such as Secobarbital, Pentobarbital and Amobarbital are classified as Schedule III controlled drugs when they are in suppository form or combine with any non-controlled substances such as aspirin or acetaminophen.

Which of the following is exempt from the requirement of PPPA? a. Metronidazole (500 mg) tablet b. Sublingual Isosorbide (10 mg) c. Niferex-150 capsule d. Erythromycin estolate (500 mg) tablet

Answer: (b) Sublingual Isosorbide (10 mg) is exempt from the requirement of PPPA. A list of drugs that is exempt from the requirement of PPPA. 1. Effervescent tablets containing aspirin, other than those intended for pediatric use, provided the dry tablet contains not more than 15 percent aspirin and have an oral LD-50 in rats of 5 grams or more per kilogram of body weight. 2. Unflavored aspirin-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 15.4 grains of aspirin per unit dose and that contain no other substance subject to the provisions of this section. 3. Sublingual dosage forms of nitroglycerin. 4. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less. 5. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 grams of the equivalent of erythromycin. 6. Cyclically administered oral contraceptives in manufacturers' mnemonic (memory-aid) dispenser packages that rely solely upon the activity of one or more progestogen or estrogen substances. 7. Anhydrous cholestyramine in powder form. 8. All unit dose forms of potassium supplements, including individually wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 milliequivalents of potassium per unit dose. 9. Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids and containing no other substances subject to this §1700.14(a)(10). 10. Betamethasone tablets packaged in manufacturers' dispenser packages, containing no more than 12.6 milligrams betamethasone. 11. Pancrelipase preparations in tablet, capsule, or powder form and containing no other substances subject to this §1700.14(a)(10). 12. Prednisone in tablet form, when dispensed in packages containing no more than 105 mg. of the drug, and containing no other substances subject to this §1700.14(a)(10). 13. Mebendazole in tablet form in packages containing not more than 600 mg. of the drug, and containing no other substance subject to the provisions of this section. 14. Methylprednisolone in tablet form in packages containing not more than 84 mg of the drug and containing no other substance subject to the provisions of this section. 15. Colestipol in powder form in packages containing not more than 5 grams of the drug and containing no other substance subject to the provisions of this section. 16. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin. 17. Conjugated Estrogens Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 32.0 mg of the drug and containing no other substances subject to this §1700.14(a)(10). 18. Norethindrone Acetate Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 50 mg of the drug and containing no other substances subject to this §1700.14(a)(10). 19. Medroxyprogesterone acetate tablets. 20. Sacrosidase (sucrase) preparations in a solution of glycerol and water. 21. Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances. 22. Colesevelam hydrochloride in powder form in packages containing not more than 3.75 grams of the drug. 23. Sevelamer carbonate in powder form in packages containing not more than 2.4 grams of the drug. 24. Effervescent tablets or granules containing acetaminophen, provided the dry tablet or granules contain less than 15 percent acetaminophen, the tablet or granules have an oral LD-50 of 5 grams or greater per kilogram of body weight, and the tablet or granules contain no other substance subject to the provisions of this section. 25. Unflavored acetaminophen-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 13 grains of acetaminophen per unit dose and that contain no other substance subject to this §1700.14(a).

Tamper-Resistant or Tamper-Evident packaging provides protection against: a. Accidental poisoning. b. Intentional contamination of OTC drugs. c. Brand name of manufacturer. d. Accidental breakage of containers.

Answer: (b) Tamper-Evident packaging provides protection against intentional contamination of over the counter drugs, [21CFR211.132]. Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the term "distinctive by design" means the packaging cannot be duplicated with commonly available materials or through commonly available processes. A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

Which of the following laws promotes the manufacturing of generic drugs? a. Orphan Drug Act b. Hatch-Waxman Act c. Kefauver-Harris Act d. Durham-Humphrey Act

Answer: (b) The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and Senator Orrin Hatch of Utah. The law allows generic manufacturers to submit an ANDA (Abbreviated New Drug Application) instead of filing an NDA (New Drug Application).

Which of the following laws differentiated prescription drugs and nonprescription drug for the first time? a. Food, Drug and Cosmetic Act of 1938 b. Durham-Humphrey Amendment of 1951 c. Kefauver-Harris's Amendment of 1962 d. Medical Device Amendment of 1976

Answer: (b) The Durham-Humphrey Amendment of 1951 laws first time drew a clearer legal distinction between prescription-only and OTC drugs.

The Poison Prevention Packaging Act is generally enforced by the: a. FDA b. CPSC c. DEA d. FTC

Answer: (b) The Poison Prevention Packaging Act is generally enforced by the CPSC (Consumer Product Safety Commission), [15 U.S.C 1471-1474]. The Unites States Poison Prevention Packaging Act (PPPA) of 1970 was enacted to prevent young children from accidentally ingesting hazardous substances ordinarily stored about the house. The law requires toxic, corrosive, or irritative substances to be packaged in such a way that it will be difficult for children less than 5 years to open them, yet not difficult for adults to open. The first product to fall under this law was aspirin, on August 8, 1972, with the law gradually encompassing more and more hazardous substances, including some prescriptions and over-the-counter medications. Essential in the law's success is not only preventing children from opening child-resistant containers but also permitting adults easy access to the medication. This may be especially difficult to achieve among, for example, elderly persons or those with severe arthritis. As a result, child-resistant packaging may be declined upon request at pharmacies, thus increasing the risk of childhood poisoning among, for example, children who visit their grandparents, who may not realize the need for such packaging when children are no longer present in the household.

Which of the following is the correct DEA number for Dr. Bridge, Robert? a. AB 3254767 b. BB 1244691 c. AR 1354789 d. MR 2489432

Answer: (b) The authenticity of the DEA number can be verified by following: 1. The first letter A or B normally indicates dispensing. 2. The second letter should be the first initial of the prescriber's last name. 3. Now add first, third and fifth numbers, which are 1 + 4 + 6 = 11. 4. Add second, fourth and sixth numbers and multiply the resultant sum by "2"; 2 + 4 + 9 = 15 x 2 = 30. 5. Add this sum to the first sum, 30 + 11 = 41, the right-most number of this sums (1) must be the ninth number of prescriber's DEA number, BB1244691.

Which of the following imprint is required on orally administered prescription drugs? a. The name of the distributor. b. The code that identifies a particular drug. c. The strength of medication. d. The name of the prescriber.

Answer: (b) The code that identifies a particular drug, [21CFR206.10]. (a). No drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature. (b). A solid oral dosage form drug product that does not meet the requirement for imprinting in paragraph (a) of this section and is not exempt from the requirement may be considered adulterated and misbranded and may be an unapproved new drug. (c). For purposes of this section, code imprint means any single letter or number or any combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product.

The distribution of drug samples is regulated by: a. Durham-Humphrey Amendment b. Prescription Drug Marketing Act c. Kefauver-Harris Amendment d. Food, Drug and Cosmetic Act

Answer: (b) The distribution of drug samples is regulated by the Prescription Drug Marketing Act (PDMA), [21CFR203.20]. 1. The Prescription Drug Marketing Act of 1987 — modified by the Prescription Drug Amendments of 1992 — establishes legal safeguards for human prescription drug marketing and distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent and expired prescription drugs. 2. Among other things, the PDMA prohibited, with certain exceptions, the sale, purchase or trade of any prescription drug that was purchased by a hospital or other health care entity. Wholesale distributors of drugs or retail pharmacies licensed under state law are not included in the term "entity." Regulations related to this section of the PDMA were issued in 1999, but FDA delayed the effective date on several occasions due to numerous concerns raised by various stakeholders.

Who may keep drug samples? I. Saint Agnes Hospital II. Dr. Bernard's office III. Rite-Aid Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (b) The hospital and prescriber offices can keep drug samples. The retail pharmacies, under the Prescription Drug Marketing Act cannot keep drug samples [21CFR203.20].

Which of the following drugs requires an exact count when taking inventory? a. Dalmane b. Concerta c. Halcion d. Tylenol No 3

Answer: (b) The inventory of Schedule II controlled drugs requires an exact count, [21CFR1304.11(e)(3)(i),(ii)]. Concerta (Methylphenidate) is a controlled II drug. Each person registered or authorized to dispense or conduct research with controlled substances shall conduct the inventory. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows: (i). If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or (ii). If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.

Which of the following should be replaced when refilling a prescription? I. The plastic container II. The plastic closure III. The glass container a. I only b. I and II only c. II and III only d. All

Answer: (b) The plastic container and closure must be replaced by the pharmacist when refilling the prescription, [The Poison Prevention Packaging Act, 15 U.S.C 1471-1474]. If the container is glass, the Consumer Product Safety Commission permits reuse of the glass container so long as it is dispensed with a new safety closure.

The Orange book is used to identify: a. Chemical names of drugs. b. Therapeutically equivalent products. c. Adverse effects of drugs. d. Drugs available in foreign countries.

Answer: (b) The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The Approved Drug Products list first appeared as a print publication in 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available. Did you ever wonder how the Orange Book got its nickname? When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?" Before long, The Orange Book had become a popular short title for this important publication.

Which of the following provides information about bioequivalency of two or more drug products? a. Drug Facts and Comparisons b. USP/DI Volume III c. Remington d. Goodman Gilman's Pharmacology

Answer: (b) USP/DI volume is available in three different volumes. It is published every year. A. USD/DI volume I contains information on: a. Indication. b. Mechanism and pharmacological action. c. Side effects and adverse reactions. d. Dosing information. e. Dosage forms. It is also known as "Drug Information For the Healthcare Professional". B. USP/DI volume II contains information on: a. General information about using medications properly. b. Discussion of commonly and not commonly used medications. It is also known as "Advice for the Patient Drug Information in Lay language". C. USP/DI volume III contains information on: a. Approved drug products with Therapeutic Equivalence Evaluation. b. USP/NF dispensing, requirements for labeling, packaging, storing and quality. It is also known as "Approved Drug Products and Legal Requirements".

A retail pharmacy that wants to collect unused controlled substances from a patient required to modify its current DEA registration to an: a. authorized reverse distributor b. authorized collector c. authorized destroyer d. authorized dea participant

Answer: (b) an authorized collector, [DEA September 2014 News Letter]. In September 2014, Drug Enforcement Administration (DEA) published its final rule, titled the Disposal of Controlled Substances, that allows some DEA registrants to modify their registration to become authorized collectors. Under the new rule, some DEA registrants, including retail pharmacies, hospitals/clinics with an on-site pharmacy, manufacturers, distributors, reverse distributors, and narcotic treatment programs, may modify their registration with DEA to become authorized collectors. The final rule implements the Secure and Responsible Drug Disposal Act of 2010, which authorized DEA to develop and implement regulations that would allow authorized entities other than law enforcement to collect unused and unwanted prescription drugs, including controlled substances (CS), for disposal purposes. Proper disposal of unused prescription medication is a key method of preventing and reducing prescription drug abuse. The final rule took effect on October 9, 2014.

Which of the following statements defines "Reverse Distributions"? a. It means a drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only. b. It means a non-narcotic drug or device that may be sold without a prescription and that is labeled and packaged in compliance with applicable state or federal law. c. It means the receipt of prescription drugs including controlled substances for the purposes of destroying the drugs or returning the drugs to their original manufacturers or distributors. d. It means distribution of prescription drugs to persons other than a consumer or patient.

Answer: (c) "Reverse distribution" means the receipt of prescription drugs including controlled substances for the purposes of destroying the drugs or returning the drugs to their original manufacturers or distributors.

An NPI number contains how many digits? a. 7 b. 5 c. 10 d. 12

Answer: (c) 10 digits. All pharmacists must have an individual NPI number by May 23, 2007. Applications to obtain an NPI began on May 23, 2005. The National Provider Identifier (NPI) number is a unique, government-issued, standard identification number for individual health care providers and provider organizations like clinics, hospitals, schools and group practices. The government has contracted with an external company for processing applications and developing these random 10-digit numbers for applicants. If one needs an NPI number he/she can apply at the NPPES website.

An emergency oral prescription for Schedule II controlled drugs must be delivered to the dispensing pharmacist by the prescribing individual practitioner within: a. 48 hours after an oral authorization. b. 72 hours after an oral authorization. c. 7 days after an oral authorization. d. 10 days after an oral authorization.

Answer: (c) 7 days after an oral authorization, [21CFR1306.11(d)(1-to-4)]. In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1). The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner); (2). The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in 1306.05, except for the signature of the prescribing individual practitioner; (3). If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (4). Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of 1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

A Double Blind study of a new drug is generally conducted in: a. Phase I trial. b. Phase II trial. c. Phase III trial. d. Phase IV trial.

Answer: (c) A Double Blind study of a new drug is generally conducted in phase III clinical trial. The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject. This 'blinding' is to prevent biases, since if a physician knew which patient was getting the study treatment and which patient was getting the placebo, he/she might be tempted to give the (presumably helpful) study drug to a patient who could more easily benefit from it. In addition, a physician might give extra care to only the patients who receive the placebos to compensate for their ineffectiveness. A form of double-blind study called a "double-dummy" design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.

In which of the following instances shall a dispensing of a drug be classified as misbranded? a. A tablet falls on a floor dispensed by a pharmacist. b. A spider is found in an original manufacturer container. c. A returned drug is mixed with the drug containing a different lot number. d. A drug is compounded without properly sanitizing the compounding area.

Answer: (c) A returned drug is mixed with the drug containing a different lot number, [Food, Drugs And Cosmetics 53-1-109]. The choices a, b and d are considered to be adulterated. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

When dispensing Schedule II controlled substance prescriptions; if computer system does not allow for only one prescription number to be used on a bill split between insurance and cash. Which of the following is/are TRUE? I. The prescription will need to be filled for the one amount. II. A pharmacist shall create a new handwritten amended prescription number to dispensing the additional amount. III. To fill the additional amount, another completed prescription order will need to be obtained for that amount from the prescribing practitioner. a. I only b. I and II only c. I and III only d. None of the above

Answer: (c) I and III only, [http://www.deadiversion.usdoj.gov]. A recent discussion with Drug Enforcement Administration (DEA) confirmed that pharmacists are advised to only use and record one prescription serial number (prescription number) when dispensing Schedule II controlled substance prescriptions. Therefore, if the computer system will not allow for only one prescription number to be used on a bill split between insurance and cash, the prescription will need to be filled for the one amount. To fill the additional amount, another completed prescription order will need to be obtained for that amount from the prescribing practitioner.

An individual practitioner employed by a hospital shall write which of the following on controlled substances prescriptions? I. A DEA number of an individual practitioner II. The registration number of the hospital III. The special internal code number assigned to the individual practitioner by the hospital a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only, [21 CFR 1301.22 (C)]. An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered him/herself, provided that: (1). Such dispensing, administering or prescribing is done in the usual course of his/her professional practice; (2). Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he/she is practicing; (3). The hospital or other institution by whom he/she is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction; (4). Such individual practitioner is acting only within the scope of his/her employment in the hospital or institution; (5). The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's DEA registration number, preceded by a hyphen (e.g., APO123456-10 or APO123456-A12); and (6). A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.

Which of the following agencies analyzes medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners? a. ASHP b. ACPE c. ISMP d. DRG

Answer: (c) ISMP (Institute for Safe Medication Practices) is an independent nonprofit agency that analyzes medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners. ISMP then makes appropriate contacts with companies and regulators, gathers expert opinion about prevention measures, and publishes its recommendations. To assist pharmacists in the process of minimizing the occurrence of medication errors, many state boards of pharmacy are contemplating or already requiring community pharmacies to have a continuous quality improvement program in place. Many of these state's regulations include the requirement of root cause analysis (RCA) in the case of sentinel events. The Joint Commission defines a sentinel event as an "unexpected occurrence involving death or serious physical or psychological injury or risk thereof," and recommends completing an RCA for all sentinel events for health care organizations in which they accredit. It is anticipated that RCA for sentinel events may be required as part of an accreditation program for community/ambulatory pharmacies. ASHP ACPE ISMP DRG

Explanation What is the difference between "night cabinet" and "emergency drug kit"? a. Night cabinets shall be used only at night when a pharmacist is off duty, whereas an emergency kit can be used any time of the day when an emergency arises. b. There is no difference between the two terms. c. When an institutional facility has an institutional pharmacy, a night cabinet shall be used in case of emergency in the absence of a pharmacist, whereas when an institutional facility does not have an institutional pharmacy, an emergency kit shall be used to obtain drugs in case of emergency. d. A night cabinet contains a numerical lock whereas an emergency drug kit contains a key lock.

Answer: (c) In the absence of a pharmacist, drugs for distribution to patients shall be stored in a locked cabinet ("night cabinet") or other enclosure constructed and located outside of the pharmacy area, to which only specifically authorized personnel may obtain access by key or combination. For an institutional facility that does not have an institutional pharmacy, drugs may be provided for use by authorized personnel by means of emergency kits located at the institutional facility.

Which of the following drug(s) is classified as a controlled substance? a. Cipro b. Vibramycin c. Lyrica d. Antara

Answer: (c) Lyrica (Pregabalin) is classified as a Schedule V controlled substance, [21CFR1308.15].

All of the following are Schedule I controlled drugs EXCEPT: a. Heroin b. LSD c. Demerol d. Marijuana

Answer: (c) Meperidine (Demerol) is a Schedule II controlled drug, [21CFR1308.11 and 21CFR1308.12]. Schedule I controlled substances have the highest potential for abuse.

Orphan drugs are defined as: a. Drugs used for terminally ill patients. b. Drugs imported from foreign countries. c. Drugs used to treat disease that affects very few people. d. Drugs administered by nasal routes.

Answer: (c) Orphan drugs are defined as drugs used to treat diseases that affect very few people. Orphan drug Act was issued in 1983. Prior to 1983, the manufacturers were not interested in developing orphan drugs due to their limited potential of profitability. Orphan Drug Act of 1983 provided various benefits and tax breaks to the manufacturers of orphan drugs. The act motivated manufacturers to develop more orphan drugs.

Which of the following is NOT a prospective DUR? a. Checking a patient profile for underutilization of drug before refilling. b. Checking for therapeutic duplication before dispensing. c. Reviewing a patient's profile after documenting a problem with the therapy. d. Checking for frequency of dosing at the time of dispensing.

Answer: (c) Reviewing a patient's profile after documenting a problem with the therapy is known as Retrospective DUR study, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. The other choices such as the checking for over or underutilization of drug before refilling, therapeutic duplication, or an interaction with the prescribed drug at the time of dispensing are known as Prospective DUR.

Who controls the Medicare? a. FTC b. PTC c. CMS d. CSA

Answer: (c) The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children's Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, and clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments. Medicare is Title XVIII of the Social Security Act of 1935. It provides health insurance for those over 65 years of age and for certain disabled individuals, regardless of age. Medicare is financed by a portion of the payroll taxes paid by workers and their employers. It also is financed in part by monthly premiums deducted from Social Security checks. Medicare is health insurance for the following: 1. People 65 or older. 2. People under 65 with certain disabilities. 3. People of any age with End-Stage Renal Disease (ESRD) (permanent kidney failure requiring dialysis or a kidney transplant). 4. People of any age suffering from amyotrophic lateral sclerosis (Lou Gehrig's disease).

Which of the following is responsible for an enforcement of the CSA? a. FDA b. FBI c. DEA d. AAPP

Answer: (c) The DEA is responsible for an enforcement of Controlled Substances Act (CSA).

A pharmacist is adding 1000 mg of pure codeine powder to 100 cc of Tylenol with Codeine Elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: a. Schedule V b. Schedule II c. Schedule III d. Schedule IV

Answer: (c) The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 grams (1000 mg + 240 mg), [21CFR1308.13(e)(2)]. It has been stated under CSA that if a mixture contains less than 1.8 grams of Codeine per 100 cc, it should be classified as a Schedule III controlled substance.

The product rated with "BC" is normally interpreted as: a. A drug has no bioequivalence problems. b. A topical drug with no known bioequivalence problems. c. A drug in an extended release dosage form with bioequivalence issues. d. A drug in parenteral dosage form with bioequivalence issues.

Answer: (c) The product rated with "BC" is normally interpreted as a drug in an extended release dosage form with bioequivalence issues.

The records of a Schedule V bound book should be inspected only by a(n): a. FDA officer b. DEA officer c. Authorized U.S. officer d. Director of the FBI

Answer: (c) The records of a Schedule V bound book should be inspected only by an Authorized U.S. Officer (by the Attorney General), [21 USC Sec. 827 01(a)(b)].

A filled DEA 222 order form must be kept available for an inspection for a period of at least: a. 1 year b. 4 years c. 2 years d. 6 months

Answer: (c) Two years, [21CFR1305.17(c)]. (a). The purchaser must retain Copy 3 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. (b). The supplier must retain Copy 1 of each DEA Form 222 that it has filled. (c). DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms 222, which may be kept elsewhere under 1305.12(e)), at the registered location printed on the DEA Form 222. (d). The supplier of carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant.

The unique generic name for a specific drug is generally given by the: a. FDA b. Manufacturer c. USAN Council d. FTC

Answer: (c) United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA). The goal of the USAN Council is to select simple, informative, and unique nonproprietary names (also called generic names) for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships. In addition to drugs, the USAN Council also provides names for contact lens polymers, agents for a gene and cell therapy, surgical materials, diagnostics, carriers, and substances used as an excipient. The USAN Council works in conjunction with the World Health Organization (WHO) International Nonproprietary Name (INN) Expert Committee and national nomenclature groups to standardize drug nomenclature and establish rules governing the classification of new substances.

The partial supply of Schedule II controlled drugs must be filled by pharmacists within: a. 24 hours of initial filling. b. 48 hours of initial filling. c. 72 hours of initial filling. d. 1 week of initial filling.

Answer: (c) Within 72 hours of initial filling, [21CFR1306.13(a)]. The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial dispensings later than 30 days after the prescription is written and no later than 72 hours in emergency situations. 21 U.S.C. § 829(f)(2).

A prescription for Buprenorphine prescribed for addiction requires which of the following on the prescription? a. DEA number b. NPI number c. X DEA number d. Buprenorphine Certification Number

Answer: (c) X DEA number is required, [http://www.nabp.net/news/nevada-news-buprenorphine-for-pain/]. Although Buprenorphine is not approved for use in pain, pharmacists are seeing an increasing number of prescriptions for this use. Rather than prescribed as a daily dose for addiction, it is usually given three to four times daily for pain. Buprenorphine prescribed for addiction requires the practitioner to have an "X" Drug Enforcement Administration (DEA) number, indicating special training in its use. It is legal for a pharmacist to fill a buprenorphine prescription for pain with the prescriber's regular DEA number just like all other Schedule III drugs. The pharmacist duty is to ensure that the prescription is indeed for the treatment of pain, which should hopefully be noted in the directions. Since buprenorphine can displace opioid agonists, the pharmacist should watch for interactions that may precipitate withdrawal.

A registrant must notify the Special Agent in Charge in his/her area: a. 48 hours before discontinuing the controlled substance business. b. 72 hours before discontinuing the controlled substance business. c. 7 days before discontinuing the controlled substance business. d. 14 days before discontinuing the controlled substance business.

Answer: (d) 14 days before discontinuing the controlled substance business, [21CFR1301.52] 1. Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his/her certificate of registration, and any unexecuted order forms in his/her possession, to the Registration Unit, Drug Enforcement Administration. 2. Any registrant desiring to discontinue business activities altogether or with respect to controlled substance (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information: (1). The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor); (2). The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee); (3). Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed); (4). Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indicated); and (5). The date on which the transfer of controlled substances will occur. (6). Unless the registrant-transferor is informed by the Special Agent in Charge, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his/her possession to the registrant-transferee.

Which of the following requires a PPI when dispensed? I. Accutane II. Lo-Ovral III. Premarin a. I only b. I and II only c. II and III only d. All

Answer: (d) A PPI (Patient Package Insert) is generally required when dispensing the following drugs [21CFR310, 501,515]: 1. Isotretinoin 2. Estrogen and progesterone containing products 3. Oral contraceptives

Which of the following is/are classified Schedule IV controlled drug(s)? I. Xanax II. Ambien III. Ultram a. I only b. I and II only c. II and III only d. All

Answer: (d) All, Schedule IV controlled substances have lower potential for abuse relative to Schedule III controlled drugs. The drugs in this class have a currently accepted medical use in treatment in the United States, [21CFR1308.14].

A pharmacist may refuse to fill a prescription for controlled substance if: I. The prescription is written for gamma-hydroxybutyric acid without the note on the face of the prescription the medical need of the patient. II. The prescriber's signature is missing. III. The prescription is written with a regular pencil. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR Section 1306.05(a) to (e)]. (a). All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. (b). A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued by the Administrator under Sec. 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of Sec. 1301.28(e) of this chapter. (c). Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. (d). A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. (e). Electronic prescriptions shall be created and signed using an application that meets the requirements of part 1311 of this chapter. (f). A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations

The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided which of the following condition(s) is/are met? I. The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription. II. The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription. III. The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription the date, quantity of refill, number of additional refills authorized, and his or her initials. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR 1306.22 (e)]. The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met: (1). The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription. (2). The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription. (3). The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription. (4). The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.

The prescriptions for which of the following cannot be transferred between pharmacies under any circumstances? I. MS-Contin II. Duragesic III. Sublimaze a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR 1308.12 and 21CFR 1306.25(a)]. The transfer of a prescription for a controlled substance listed in Schedule II between pharmacies is prohibited. Morphine sulfate (MS-Contin), Fentanyl (Duragesic) and Fentanyl citrate (Sublimaze) are Schedule II controlled drugs. The prescription for these substances cannot be transferred between pharmacies under any circumstances. The transfer of original prescription information for a controlled substance listed in Schedules III, IV or V for refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization. Transfers are subject to the following requirements: (1). The transfer must be communicated directly between two licensed pharmacists. (2). The transferring pharmacist must do the following: (i) Write the word "VOID" on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record. (ii). Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record. (iii). Record the date of the transfer and the name of the pharmacist transferring the information. (3). For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to 1306.21(a), the pharmacist receiving the transferred prescription information must write the word "transfer" on the face of the transferred prescription and reduce to writing all information required to be on a prescription pursuant to 1306.05 and include: (i). Date of issuance of original prescription. (ii). Original number of refills authorized on original prescription. (iii). Date of original dispensing. (iv). Number of valid refills remaining and date(s) and locations of previous refill(s). (v). Pharmacy's name, address, DEA registration number, and prescription number from which the prescription information was transferred. (vi). Name of pharmacist who transferred the prescription. (vii). Pharmacy's name, address, DEA registration number, and prescription number from which the prescription was originally filled.

Faxing a Schedule II controlled drug may serve as an original if: I. A prescription written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. II. A prescription written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. III. A prescription written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR1306.11 (e),(f) and (g)]. A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with 1304.04(h) of this chapter. 2. A prescription prepared in accordance with 1306.05 written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with 1304.04(h). 3. A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with 1304.04(h).

The labeling requirements do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized provided that: I. Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time. II. The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration. III. The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR1306.24(c)]. The labeling requirements do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized provided that: (1). Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time; (2). The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration; (3). The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V; and (4). The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

The pharmacy engagement in which of the following acts may consider by the FDA the violation of the new drug, adulteration, or misbranding provisions of the Act? I. Compounding very large quantities of particular drug before receiving valid prescriptions. II. Compounding drug products that are commercially available in the marketplace. III. Compounding drugs that were withdrawn or removed from the market for safety reasons. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding]. Generally, FDA will continue to defer to state authorities regarding less significant violations of the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states. However, when the scope and nature of a pharmacy's activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the pharmacy engages in any of the following acts: 1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions. Compounding very large quantities of particular drug before receiving valid prescriptions is considered as manufacturing. 2. Compounding drugs that were withdrawn or removed from the market for safety reasons. Appendix A provides a list of such drugs that will be updated in the future, as appropriate. 3. Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312. 4. Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility. 5. Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements. 6. Using commercial scale manufacturing or testing equipment for compounding drug products. 7. Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale. 8. Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient. 9. Failing to operate in conformance with applicable state law regulating the practice of pharmacy.

Prospective DUR means the part of the drug utilization review program that: I. is to occur before the drug is dispensed. II. is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. is to provide for the counseling of recipients about the proper use of drugs. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. Prospective DUR means the part of the drug utilization review program that: I. Is to occur before the drug is dispensed. II. Is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. Is to provide for the counseling of recipients about the proper use of drugs. Whereas Retrospective DUR means the part of the drug utilization review program that assesses or measures drug use based on an historical review of drug use data against predetermined and explicit criteria and standards that are developed on an ongoing basis with professional input.

Which of the following is/are benefit(s) of e-prescribing? I. The pharmacist can easily read the prescription, so there are fewer phone calls and faxes between a doctor and a pharmacy. II. Patients only have to make one trip to the pharmacy, instead of dropping off a prescription and picking it up later. III. Electronic prescriptions are easier to read than handwritten prescriptions. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.cms.hhs.gov/eprescribing/]. 1. E-prescribing or electronic prescribing is an electronic way for doctors to create prescriptions. E-prescribing is an easy way for patients to get safe prescriptions and save time and money. 2. When doctors e-prescribe, they don't have to write prescriptions on paper. Instead, they send electronic prescriptions directly to patients' pharmacy. Usually, all you need to do is go to your pharmacy and pick up the prescription. 3. Doctors have secure access to your prescription history, so they can prescribe drugs that won't interact with your other medications. 4. Electronic prescriptions are easier to read than handwritten prescriptions. This means there's less chance of you accidentally getting the wrong medication or dose. 5. Doctors can check which drugs your insurance covers, so they can try to prescribe a covered drug that costs you less. 6. You only have to make one trip to the pharmacy, instead of dropping off your prescription and picking it up later. In most cases, your prescription will be ready when you arrive, so you won't have to wait for the pharmacist to fill it. 7. The pharmacist can easily read the prescription, so there are fewer phone calls and faxes between your doctor and your pharmacy. This means you get your prescriptions sooner.

What should a pharmacist do if he/she receives a paper or oral prescription that indicates it was originally transmitted electronically to another pharmacy? I. The pharmacist must check with the other pharmacy to determine whether the prescription was received and dispensed. II. If the pharmacy received the original electronic prescription, but had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. III. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/pharmacies.htm]. The pharmacist must check with the other pharmacy to determine whether the prescription was received and dispensed. If the pharmacy received the original electronic prescription, but had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void.

A nursing home which provides extended health care to patients is classified as: a. HMO b. HCFA c. FTC d. LTCF

Answer: (d) The term Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients, [21CFR1300.01 Definitions-25]. A Skilled Nursing Facility is a nursing home that meets criteria for accreditation established by the sections of the Social Security Act that determine the basis for Medicaid and Medicare reimbursement for skilled nursing care. Skilled nursing care includes rehabilitation and various medical and nursing procedures. An Intermediate Care Facility (ICF) is a nursing home that is recognized only under Medicaid.

What information is/are required on a prescription for a controlled substance? I. Practitioner's name, address, and DEA registration number II. Manual signature of the prescriber III. Dosage form of the prescribed drug a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm]. A prescription for a controlled substance must include the following information: 1. Date of issue; 2. Patient's name and address; 3. Practitioner's name, address, and DEA registration number; 4. Drug name; 5. Drug strength; 6. Dosage form; 7. Quantity prescribed; 8. Directions for use; 9. Number of refills (if any) authorized; and 10. Manual signature of prescriber. A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation. Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations, a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days.

Under the Controlled Substances Act (CSA), what changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V? I. The dosage form of the prescribed controlled substance II. The strength of the prescribed controlled substance III. The quantity of the prescribed controlled substance a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm]. The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.

Medicaid provides health coverage to: I. The blind. II. The disabled. III. The medically indigent. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicaid is title XIX of the Social Security Act of 1935. It provides health care costs to medically indigent persons such as the blind, disabled, and aged. It is available only to certain low-income individuals and families who fit into an eligibility group that is recognized by federal and state laws. Medicaid does not pay money to patients; instead, it sends payments directly to health care providers. Depending on patients' state's rules, they may also be asked to pay a small part of the cost (co-payment) for some medical services. Medicaid is a state administered program and each state sets its own guidelines regarding eligibility and services.

Medicare Part B covers which of the following? I. Services or supplies that are needed for the diagnosis or treatment of medical condition and meet accepted standards of medical practice. II. Health care to prevent illness or detect illness at an early stage, when treatment is most likely to work best. III. It covers outpatient care. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicare Part B covers medically-necessary services like doctors' services, outpatient care, and other medical services or supplies that are needed for the diagnosis or treatment of medical condition and meet accepted standards of medical practice. It also covers preventive services—health care to prevent illness or detect illness at an early stage, when treatment is most likely to work best (for example, Pap tests, flu shots, and prostate cancer screenings). If one has Part B, he/she must pay a Part B premium each month. Most people will pay the standard premium amount. Social Security will contact some people who have to pay more depending on their income. If persons don't sign up for Part B when they are first eligible, they may have to pay a late enrollment penalty. Medicare Part B covers things like: 1. Clinical research 2. Ambulance services 3. Durable medical equipment 4. Mental health a. Inpatient b. Outpatient c. Partial hospitalization 5. Getting a second opinion before surgery 6. Limited outpatient prescription drugs

Which of the following is/are TRUE about Medicare Part C? I. It includes both Part A and Part B of Medicare. II. You usually pay a monthly premium and a copayment for covered services. III. Private insurance companies approved by Medicare provide this coverage. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicare Part C or Medicare Advantage Plan includes both Part A (Hospital Insurance) and Part B (Medical Insurance) of Medicare. A Medicare Advantage Plan (like an HMO or PPO) is another Medicare health plan choice you may have as part of Medicare. Medicare Advantage Plans, sometimes called "Part C" or "MA Plans," are offered by private companies approved by Medicare. If you join a Medicare Advantage Plan, the plan will provide all of your Part A (Hospital Insurance) and Part B (Medical Insurance) coverage. Medicare Advantage Plans may offer extra coverage, such as vision, hearing, dental, and/or health and wellness programs. Most include Medicare prescription drug coverage (Part D). Medicare pays a fixed amount for your care every month to the companies offering Medicare Advantage Plans. These companies must follow rules set by Medicare. However, each Medicare Advantage Plan can charge different out-of-pocket costs and have different rules for how you get services (like whether you need a referral to see a specialist or if you have to go to only doctors, facilities, or suppliers that belong to the plan for non-emergency or non-urgent care). These rules can change each year.

Medicare-Part A covers which of the following? I. Inpatient care in hospitals. II. Hospice care services. III. Home health care services. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicare covers certain medical services and supplies in hospitals, doctors' offices, and other health care settings. Services are either covered under Medicare Part A (Hospital Insurance) or Medicare Part B (Medical Insurance). Most people don't pay a Part A premium because they paid Medicare taxes while working. This is called "Premium-free Part A." A person can get premium-free Part A at 65 if: 1. He/she already gets retirement benefits from Social Security or the Railroad Retirement Board. 2. He/she is eligible to get Social Security or Railroad benefits but has not filed for them yet. 3. A person or his spouse had Medicare-covered government employment. If a person is under 65, he/she can get premium-free Part A if: 1. He/she got Social Security or Railroad Retirement Board disability benefits for 24 months. 2. He/she has End-Stage Renal Disease (ESRD) and meets certain requirements. In most cases, if a person chooses to buy Part A, he/she must also have Medicare Part B (Medical Insurance) and pay monthly premiums for both. Part A covers the following: ___________________________ 1. Hospital care 2. Skilled nursing facility care 3. Nursing home care (as long as *custodial care isn't the only care you need) 3. Hospice care. 4. Home health services. Custodial care: Non skilled personal care, like help with activities of daily living like bathing, dressing, eating, getting in or out of a bed or chair, moving around and using the bathroom. It may also include the kind of health-related care that most people do themselves, like using eye drops. In most cases, Medicare doesn't pay for custodial care.

Which of the following are TRUE about the Combat Methamphetamine Epidemic Act of 2005? I. Retail sales may not exceed 3.6 grams pseudoephedrine per day per purchaser, regardless of the number of transactions. II. Individuals are prohibited from purchasing more than 9 grams pseudoephedrine per 30-day period. III. All non-liquid forms (including gelcaps) of PSE products must be sold in blister packs with no more than two dosages or in unit-dose packets or pouches. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. On March 9, 2006, President George W. Bush signed into law the USA Patriot Act, Title VII, which includes the Combat Methamphetamine Epidemic Act of 2005. The federal law applies to all cough and cold products (including combination products) that contain the methamphetamine precursor chemicals ephedrine, pseudoephedrine, or phenylpropanolamine. 1. Retail sales may not exceed 3.6 grams pseudoephedrine per day per purchaser, regardless of the number of transactions. 2. Individuals are prohibited from purchasing more than 9 grams pseudoephedrine per 30-day period. 3. All non-liquid forms (including gelcaps) of pseudoephedrine products must be sold in blister packs with no more than two dosages or in unit-dose packets or pouches. 4. Mail-order companies may not sell more than 7.5 grams to a customer within a 30-day period. All pseudoephedrine products must be placed behind a counter (any counter, not necessarily the pharmacy counter) that is not accessible to purchasing consumers or in a locked display case that is located on the selling floor. Retailers must give the product directly to the purchaser; therefore, a retailer without a pharmacy may still sell the combination pseudoephedrine products from behind a counter or locked display case. Retailers must maintain a logbook of information on transactions involving pseudoephedrine products. The logbook may be maintained in either written or electronic form. The logbooks must capture the following information: a. Purchaser's signature; b. Purchaser's name and address; c. Date and time of sale; d. Name of product sold; and e. Quantity sold. Logbook requirements do not apply to purchases of single sales packages that contain no more than 60mg of pseudoephedrine. Each entry must be maintained for two years following the date of entry and the format may be written or electronic.

Which of the following is/are found in the PPI? I. Indication and usage. II. Adverse reactions and contraindications. III. Dosage and administration information. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. The PPI (Patient Package Insert) normally contains the following: a. Indications and usage of medication b. Pharmacodynamic and pharmacokinetic information c. Contraindication and adverse reactions d. Drug interaction e. Dosage and its administration information

The board may suspend, revoke, refuse to renew, or otherwise discipline any license or registration issued by it if the licensee or registrant: I. Has had his or her license to practice pharmacy in another state revoked or suspended. II. Has engaged in the practice of pharmacy while on inactive status. III. Has failed to notify the board of any discipline against his or her license in another state. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. The board may suspend, revoke, refuse to renew, or otherwise discipline any license or registration issued by it, after a hearing held in accordance with the provisions of this section, upon proof that the licensee or registrant: 1. Has had his or her license to practice pharmacy in another state revoked or suspended. 2. Has engaged in the practice of pharmacy while on inactive status. 3. Has failed to notify the board of any discipline against his or her license in another state.

The recent availability of Buprenorphine for an opioid addiction treatment has brought more optimism to the field of drug addiction because: I. Like Methadone, Buprenorphine is a replacement therapy. II. The risk of being diverted illegally is lower with Buprenorphine compared to Methadone. III. If it were injected instead of taken by mouth, it would result in to severe withdrawal symptoms and not a "high." a. I only b. I and II only c. II and III only d. All

Answer: (d) All. The recent availability of Buprenorphine for an opioid addiction treatment has brought more optimism to the field of drug addiction. Like Methadone, Buprenorphine is a replacement therapy. The risk of being diverted illegally is lower with Buprenorphine compared to Methadone. If it were injected by an abuser, rather than being taken by the mouth, it would result in to severe withdrawal symptoms and not a "high." This will discourage the opioid addict to use this drug parenterally.

Which of the following is required to synthesize the generic entity of patent expired drug? a. IND b. NDA c. SNDA d. ANDA

Answer: (d) An Abbreviated New Drug Application (ANDA) is normally required to synthesize generic entity of the patent expired drug. An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

Which of the following requires a manufacturer to imprint special identification codes on orally available solid dosage forms? a. JACHO b. FDCA c. HHA d. CFR

Answer: (d) CFR, [21CFR206.10]. According to Section 206.10 of Title 21 of CFR, no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature. The regulation changed that affects the pharmaceutical industry, pharmacy practice and daily pharmacist's activities has made available through two sources. I. Federal Register. II. CFR. The Federal Register is a daily publication that lists various Federal regulations, final regulations and government notices. The Code of Federal Regulations (CFR) is an annually revised compilation of final regulations.

Which of the following pregnancy categories shows the highest risk to the developing fetus? a. Category A b. Category B c. Category D d. Category X

Answer: (d) Category X includes drugs that are extremely contraindicated to use during pregnancy by pregnant women. Category A: Controlled studies show no risk to the developing fetus. Category B: No evidence of risk in humans. Category C: Risk cannot be ruled out. Category D: Positive evidence of risk. Category X: Contraindicated during pregnancy.

The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. This hard-copy printout shall contain all of the following information EXCEPT: a. patient name. b. quantity dispensed. c. patient's address. d. date of issuing.

Answer: (d) Date of issuing, [21CFR1306.22(f)(3)-to-(4)]. 1. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application. 2. If such an application provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. 3. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith). 4. This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. 5. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. 6. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill. 7. Any such computerized application shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). 8. Such a printout must include: a. name of the prescribing practitioner, b. name and address of the patient, c. quantity dispensed on each refill, d. date of dispensing (not issuing) for each refill, e. name or identification code of the dispensing pharmacist, and f. the number of the original prescription order. In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (e.g., postmark).

Which of the following missing information cannot be filled by a distributor on a DEA Form 222? a. Date of the form b. Size of the package c. Strength of the drug d. Last Line Completed

Answer: (d) Last Line Completed cannot be filled by a distributor in sections omitted by a registrant on a DEA Form 222, [http://www.deadiversion.usdoj.gov/faq/dea222.htm]. Date of the form: The distributor may place the date on the form. When possible, the date ascertained from the delivery document should be used as the issue date. The form is acceptable unless the ascertained date of issue is greater than 60 days from the date of receipt. Size of the package: The size of the package must be completed by the purchaser unless the product is only manufactured in one size. If more than one package size is manufactured and no package size is indicated, then the package size may not be added by the supplier. The line item with the missing package size must be voided by the supplier and the purchaser notified. Strength of the drug: If the product is only manufactured in one strength, then it is not necessary to indicate the strength in the section "Name of Drug". If the product is available in more than one strength, then the strength may not be added by the distributor. The line should be voided on the DEA Form 222 by the supplier and the purchaser notified. Last Line Completed: A distributor may not fill in the "Last Line Completed" area of the DEA Form 222. This section must be completed by the purchaser. If the purchaser enters an incorrect number, such as the total number of packages ordered instead of the last line completed, then the DEA Form 222 is not valid.

Under the Controlled Substances Act (CSA), what changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner? I. The dosage form of the drug II. The name of the controlled substance III. The quantity prescribed a. I only b. II only c. III only d. None of the above

Answer: (d) None of the above, [http://www.deadiversion.usdoj.gov/faq/general.htm and http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm]. On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed, and--in the case of multiple prescriptions under this Final Rule--the earliest date on which the prescription may be filled) may not be modified orally." The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.

Lomotil is classified as: a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (d) Schedule V controlled substances have lower potential for abuse compared to Schedule IV controlled substances. Schedule V controlled drugs normally include antitussive preparation contains codeine and antidiarrheal products. Many of schedule V controlled substances are available without a prescription; over the counter. [21CFR1308.15].

Which of the following laws requires that drugs marketed in the U.S. must be safe as well as effective? a. Food, Drug and Cosmetic Act of 1938 b. Prescription Drug Marketing Act of 1987 c. Durham-Humphrey Amendment of 1951 d. Kefauver-Harris Amendment of 1962

Answer: (d) The Kefauver-Harris amendment of 1962 requires that drugs marketed in the US must be safe as well as effective. Features of the Kefauver-Harris amendment: 1. It is also known as the Drug Efficacy Amendment. It was issued in 1962. 2. It requires that all the marketed drugs in the US must be safe as well as effective. 3. This amendment also provides authority to the FDA to regulate prescription drug advertisement. Features of the Food Drug and Cosmetic Act: 1. It is stated that new drugs marketed in the US must have been proven safe when used according to labeled direction. 2. It was issued in 1938. 3. It was the first law that required adequate direction for using drugs. 4. The law also states that labels must contain warnings about any habit forming drugs. 5. It was the first law that was applied to food, drugs, cosmetics and medical devices. 6. Drugs marketed prior to 1938 such as Digoxin, Levothyroxine, Phenobarbital and Nitroglycerine are exempt from this law and are known as "grand fathered" drugs. Feature of the Prescription Marketing Act: 1. It was issued in 1987. 2. It was issued to control the distribution of drug samples. 3. It restricts the health care providers and facilities from reselling the drug samples. Features of the Durham-Humphrey Amendment: 1. It was issued in 1951. 2. It was the first law that set up the difference between prescription drugs and OTC drugs. 3. The law also allowed health care providers to authorize oral prescriptions and refills. 4. The law also states that the manufacturer of prescription drugs must provide a warning on the label that indicates: "Federal law prohibits dispensing without a prescription." Features of the Medical Device Act: 1. It was issued in 1976. 2. The intention of this law is to protect the American public from dangerous and useless devices. 3. This law sets the requirement for medical devices which includes GMP standard manufacturing and premarket approval requirements. Features of the Orphan Drug Act: 1. It was passed in 1983. 2. The term orphan describes the class of drugs that are used to treat diseases which affect very few people. 3. The intention of this law is to encourage pharmaceutical manufacturers to develop and synthesize orphan drugs. Features of the Drug Price Competition and Patent Term Restoration Act of 1984: 1. It was passed in 1984. It is also known as Waxman Hatch Amendment. 2. This law exempts the generic manufacturer from the lengthy drug approval process. This encourages generic manufacturers to develop more generic entities. 3. Also, it increases the patent-term for newly developed drugs. This encourages the innovator drug manufactures to develop newer entities.

In which of the following situations is a PDR not required? a. A patient visits a physician in the physician's office and receives a prescription. The prescription is filled in a retail pharmacy. b. A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. c. A pharmacist fills a prescription for a patient who lives in a personal care home. d. A pharmacist fills a prescription for a patient who lives in a nursing home. a. a only b. b only c. c only d. d only

Answer: (d) The Prospective Drug Review (PDR) is required for retail or outpatient prescriptions, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. The PDR does not extend to the following: (1). An order for a drug for an inpatient of an institution. (2). A drug dispensed in an emergency room. (3). A drug dispensed by a medical practitioner. (4). A drug dispensed by a pharmacist to a medical practitioner who will administer it to a patient. The following are examples of situations in which a PDR is required: (1). A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. (2). A pharmacist fills a prescription for a patient who lives in a personal care home. (3). A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. (4). A patient is treated on a non-emergency basis in an outpatient clinic of a hospital and is given a prescription. (5). The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy. The following are examples of situations in which a PDR is not required: (1). A pharmacist fills a prescription for a patient in a nursing home. (2). A pharmacist in a hospital dispenses a drug that will be administered to a patient in the hospital. (3). A physician dispenses a drug to a patient being treated in the emergency room. (4). A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient.

If we add 6 capsules of Codeine Sulfate, each weighing 30 mg of pure Codeine powder, to 100 cc of plain distilled water, the resultant compounded solution is classified as: a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (d) The compounded Codeine solution that contains not more than 200 mg of Codeine per 100 cc of solution is classified as a Schedule V controlled substance. When this (Codeine) amount is greater than 200 mg/100 cc or less than 1.8 gm/100 cc, it is classified as a Schedule III controlled drug, [21CFR1308.13(e)(2) and 21CFR1308.15(c)(1)].

Which of the following represents a new therapeutic indication for an already marketed drug? a. Type I b. Type II c. Type IV d. Type VI

Answer: (d) Type VI or Type 6 indicates a new therapeutic indication for an already marketed drug. Below is the summary of classification: ________________________________ Type I: This indicates a new molecular structure of a drug that is not currently present in the U.S market. Type II: This indicates a new derivative of an already approved drug. For example, a new salt of an existing drug. Type III: This normally indicates a new formulation of an existing drug. Type IV: This indicates that a new product is the combination of one or more existing products. Type V: This indicates that the drug is manufactured by a new company. Type VI: This indicates a new therapeutic indication for an already marketed drug.

Under the current FDA guideline for a compounded prescription, the quantity of compounded products prepared by a pharmacy shall be limited to: a. 7-days b. 1-month c. 15-days d. Fill the current and refill requirements of the prescription.

Answer: (d) Under the current FDA guideline for a compounded prescription, the quantity of compounded products prepared by the pharmacy shall be limited to fill the current and refill requirements of the prescription.

All of the following are required on an OTC medication label EXCEPT: a. Inactive ingredients. b. Directions. c. Expiration date. d. NDC number.

nswer: (d) The following information is required on any OTC medication label, [21CFR201.2, 21CFR207.35, 21CFR201.6-201.63 and 21CFR201.1-201.55]: 1. Drug Facts - title 2. Active ingredient(s)-including amount in each dosage unit 3. Purpose - pharmacologic class 4. Use(s) - indications 5. Warnings 6. Do not use - absolute contraindications, when the product should not be used under any circumstances 7. Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms 8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions 9. When using this product - side effects that could occur and substances or activities to avoid 10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately 11. Pregnancy/breast-feeding warning 12. Keep out of reach of children/Accidental overdose warnings 13. Direction - dosage and when, how, or how often to take 14. Other information 15. Inactive ingredients 16. Questions? (Optional) - followed by telephone number 17. Lot number 18. Expiration date 19. Name and addresses of manufacturer or distributor The National Drug Code (NDC) number is requested but NOT required to appear on all drug labels (prescription as well as OTC) and in all drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be displayed as required in [21CFR207.35(b)(3)].

With the electronic prescribing of controlled substances, will a practitioner be allowed to simultaneously issue multiple prescriptions for multiple patients with a single signature? a. Yes b. No

Answer: (b) No, [http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/faq.htm]. In regards to electronic prescribing of controlled substances, a practitioner is not permitted to issue prescriptions for multiple patients with a single signature. However, a practitioner is allowed to sign multiple prescriptions for a single patient at one time. Each controlled substance prescription will have to be indicated as ready for signing, but a single execution of the two-factor authentication protocol can then sign all prescriptions for a given patient that the practitioner has indicated as being ready to be signed.

If RJ could not state the serial numbers of the lost DEA 222 order forms, he should: a. Provide a DEA registration number. b. Provide an approximate date of issuance of order forms. c. Not report to the DEA. d. Report to the local police office.

Answer: (b) RJ should provide an approximate date of issuance of DEA 222 order forms [21CFR1305.16(a,b,c,d,e)].

A duly licensed veterinarian, in good faith and in the course of his professional practice only, may prescribe a drug for use by a human being. a. True b. False

Answer: (b) False, [21CFR1306.04(a)]. A duly licensed veterinarian, in good faith and in the course of his professional practice only and not for use by a human being, may prescribe, administer and dispense regulated drugs and he may cause them to be administered for medical purposes only by an assistant or orderly or by the owner of the animal, under his direction and supervision.

In which of the following its publications, the FDA publishes listing of its biosimilar and interchangeable biological products? a. Orange Book b. Red Book c. Blue Book d. Purple Book

Answer: (d) Purple Book, [NABP News Letter January 2015]. FDA has released the "Purple Book," new documents listing biological products, including all biosimilar and interchangeable biological products licensed by FDA. The lists include the date a biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity, as defined under the Public Health Service Act. The Purple Book will also list whether a licensed biological product has been determined to be biosimilar to or interchangeable with a reference biological product. Separate lists for those biological products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are updated periodically.

Which of the following acts encourages manufacturers of generic drugs? a. Kefauver-Harris b. Durham-Humphrey c. Orphan Drug Act d. Waxman Hatch Act

Answer: (d) The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and Senator Orrin Hatch of Utah. Prior to this act, manufacturers of generic drugs have to go through the lengthy procedure to obtain an approval to market patent expired drugs. This law states that generic manufactures do not require submitting an NDA (New Drug Application) to FDA; rather, they can submit an ANDA (Abbreviated New Drug Application) to the FDA.

When should a pharmacist offer patient counseling? I. Upon a new prescription drug order. II. Upon refill of a prescription drug order. III. Once yearly on maintenance drugs. a. I only b. I and II only c. II and III only d. All

answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. A pharmacist should offer patient counseling on new prescription drug orders, refill orders and once yearly on maintenance drugs (maintenance medications are defined as any medication the patient has taken for one year or longer).