MPJE WA state federal law

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 information is/are TRUE ABOUT preserving DEA 222 forms? I. DEA Forms 222 must be maintained separately from all other records of the registrant. II. The purchaser must retain Copy 1 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. III. The supplier must retain Copy 3 of each DEA Form 222 that it has filled. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [21CFR1305.17]. (a). The purchaser must retain Copy 3 (not copy 1) 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 (not copy 3) 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 thiofentanyl, 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.

What will be the earliest date Dr. Naik may apply for re-registration if his DEA license expires on July 3, 2018? a. May 3, 2018 b. April 3, 2018 c. February 3, 2018 d. January 3, 2018

Answer: (a) May 3, 2018 (60 days in advance) would be the earliest date Dr. Naik may apply to renew his DEA license, [21CFR1301.13(b)]. 21CFR1301.13(b): Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration.

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.

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.

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.

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].

Under CSA, a prescription written for Alprazolam for "office stock" should only be filled by the pharmacist-in-charge. a. True b. False

Answer: (b) False, [21CFR1306.04(b)]. A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients, Therefore, a prescription written for office stock or "medical bag" use is not valid.

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,

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)].

RX-Care Pharmacy (Retail Pharmacy) has a contract with Correct Prescription Pharmacy (Central Fill Pharmacy) to fill prescriptions for RX Care Pharmacy. Which of the following shall be required on the dispensing container of Alprazolam? I. Name and address of RX-Care Pharmacy. II. A DEA registration number of Correct Prescription Pharmacy. III. Name and address of Correct Prescription Pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR1306.14(a),(b)]. (a). The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. (b). If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section.

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].

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.

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.

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.

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.

Which of the following is the most appropriate controlled substance registration number for a staff physician who is an employee of a hospital and authorized to prescribe controlled substances under the registration of the hospital? a. BB1244691 b. MB1244691 c. AB1244691-013 d. PB1244691

Answer: (c) AB1244691-013, [21CFR1301.22(c)(5)]. Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital or other institution, may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in which he or she is employed, in lieu of individual registration, provided that: 1. The dispensing, administering, or prescribing is in the usual course of professional practice. 2. The practitioner is authorized to do so by the state in which they practice. 3. The hospital or institution has verified that the practitioner is permitted to administer, dispense, or prescribe controlled substances within the state. 4. The practitioner acts only within the scope of employment in the hospital or institution. 5. The hospital or institution authorizes the practitioner to administer, dispense, or prescribe under its registration and assigns a specific internal code number for each practitioner. An example of a specific internal code number is depicted below: AB1244691 (Hospital DEA Registration Number)-013 (Physician's Hospital Code Number) Registrant type (first letter of DEA Number): 1. A, B or F: Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy 2. M: Mid-Level Practitioner (APN/CNP/PA/OD/ET,etc) 3. P or R: Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program

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). z

rphan 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.

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:

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 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.

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 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.

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.

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.

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.

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.

Which of the following contains codes for diseases, signs and symptoms and abnormal findings? a. NAREx b. Red Book c. Purple Book d. ICD-10

Answer: (d) ICD-10. ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. Work on ICD-10 began in 1983, in 1990 it was endorsed by the Forty-third World Health Assembly and was first used by member states in 1994. The code set in the base classification allows for more than 14,400 different codes and permits the tracking of many new diagnoses compared to ICD-9. Through the use of optional sub-classifications, the number of codes can be expanded to over 16,000. Some national editions expand the code set even further; ICD-10-CM, for example, has over 70,000 codes. The WHO provides detailed information about ICD online, and makes available a set of materials online, such as an ICD-10 online browser, ICD-10 Training, ICD-10 online training, ICD-10 online training support and study guide materials for download. The International version of ICD is the base classification for the national modifications of ICD. The adapted versions may differ in a number of ways.

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.

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 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.

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

a

LTCF

a nursing home retirement home mental care other facility or institution which provides extended health care to residents. extended health care giong nhu long term care, giong nhu nguoi gia chu yeu, bi benh gia, gan chet

Lomotil

class V, max dose sold is 48 does per 48 hours

DEA form

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.

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

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

60 days

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.

7 days 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.

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.

72 hours 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 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.

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.

U.S. Health Coalition message: "Double Check, Don't Double Up" is in reference to which of the following?

APAP because it's very common drug for cold and flu

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 .

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 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: ____________________________________

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.

A Home-Care Pharmacy compounds a stock solution that contains 30 grams of Codeine per 100 ml of distilled water. Does Home-Care Pharmacy require to obtain a manufacturing license under the Controlled Substances Act (CSA)? a. Yes b. No

Answer: (a) Yes, [21CFR 1301.13(e)(1)(iv)]. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II-V in a proportion not exceeding 20 % of the complete solution, compound or mixture without obtaining a manufacturer license. In the above question 30 grams of codeine are present in the final mixture (100 cc), which suggests a narcotic controlled substance proportion 30% of the compounded product. Therefore, Home-Care Pharmacy must obtain a manufacturing license before compounding the product.

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.

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.

Answer: (a) I is not true, [21CFR1306.11(d)(1-to-4)].

"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.

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".

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.

VR came to your pharmacy and said that he could only pay for 30 tablets of Ritalin. The remaining he would collect next week. The pharmacist may tell him: a. Okay, but call us before you come. b. We cannot dispense this prescription. c. You have to pay us in advance for the whole supply. d. No, you cannot do that.

Answer: (a) Okay, but call us before you come, [21CFR1306.13(b)]. 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).

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].

As a pharmacist you would like to buy drugs whose AAC are: a. Lower than their AWP. b. Greater than their AWP. c. Equal to their AWP. d. None of the above.

Answer: (a) Pharmacists always prefer to buy drugs whose AAC (Actual Acquisition Cost) are lower than their AWP (Average Wholesale Price). AAC is defined as the actual price pharmacists pay when purchasing drugs. AWP is defined as the published wholesale price for drugs. AWP is generally used to determine prices of prescription drugs. Pharmacists prefer to buy drugs at lower price than their AWP.

To prepare a unit dose, single dose, unit of issue package, customized patient medication package, or traditional dispensing system package for dispensing pursuant to an existing order is commonly defined as a(n): a. Repackage b. Prepackage c. Unit dose package d. Unit of issue package

Answer: (a) Repackage. Customized patient medication package: a package that contains two or more drugs per compartment. Prepackage: To prepare a drug in a container for dispensing, prior to the receipt of an order. Such packaging may be in a unit dose, single dose, or unit of issue package for use in a unit dose dispensing system, in a container suitable for a traditional dispensing system, or in a customized patient medication package. Repackage: To prepare a unit dose, single dose, unit of issue package, customized patient medication package, or traditional dispensing system package for dispensing pursuant to an existing order. Sealed unit dose container: A container that holds the drug in a hermetically sealed compartment to reduce the drug's exposure to moisture, air, and tampering until the time of administration. Traditional dispensing system: A drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages. Unit dose: A single dose of a drug in an individually sealed, labeled container ready for administration to a particular patient by the prescribed route at the prescribed time. Unit dose distribution system: A drug distribution system that is in a pharmacy outlet, hospital, or other healthcare facility and uses unit dose packages, or unit of issue packages, labeled in accordance with § 20:51:21:05 and preserves the identity of the drug until the time of administration. Unit dose package: An individual package that contains one single unit dose of a drug packaged by a manufacturer or a pharmacy and preserves the integrity and identity of the drug from the point of packaging to the point of administration. Unit of issue package: A package that provides multiple units of the same drug doses, each separated in a medication card or other specifically designed container.

A pharmacist adds 100mg pure codeine powder to 4 ounces of distilled water. Can the resultant mixture be sold over the counter by the pharmacist? a. Yes b. No

Answer: (a) Yes, [21CFR1308.15(c)(1) and [21CFR1306.26(a)-to-(e)]. Under section 1306.26(b), a pharmacist can sell no more than 120 milliliters or 4 ounces of solution containing any other controlled substance (e.g. codeine) to the same purchaser in any given 48-hour period without a prescription.

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).

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.

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.

The address printed on DEA 222 order forms for Rite Care Pharmacy is incorrect. In that case the Registrant:

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.

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.

A retail pharmacy may install and operate automated dispensing systems at long term care facilities. a. True b. False

Answer: (a) True, [21 CFR Section 1301.27]. (a). A retail pharmacy may install and operate automated dispensing systems at long term care facilities. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long-term care facility. (b). Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long-term care facility at which automated dispensing systems are located. If more than one registered retail pharmacy operates automated dispensing systems at the same long-term care facility, each retail pharmacy must maintain a registration at the long-term care facility. (c). A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for the dispensing of controlled substances at a long-term care facility is exempt from application fees for any such additional registrations.

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.

If a purchaser determines that an unfilled electronic DEA 222 order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order. a. True b. False

Answer: (a) True, [21CFR 1305.26]. (a). If a purchaser determines that an unfilled electronic DEA 222 order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order. (b). If the purchaser executes an order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them. (c). If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is "Not Accepted" and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement.

A prescription that is prepared by an agent of prescribing practitioner with the signature of the prescribing practitioner on the prepared prescription can be filled by a registered pharmacist. a. True b. False

Answer: (a) True, [21CFR Section 1306.05(f)]. 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. 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. 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.

Under the CSA, the transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing between two INTERNET PHARMACIES is allowed. a. True b. False

Answer: (a) True, [21CFR Section 1306.09(c)]. (a). No controlled substance that is a prescription drug may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. (b). In accordance with the Act, it is unlawful for any person to knowingly or intentionally fill a prescription for a controlled substance that was issued in a manner that constitutes dispensing by means of the Internet unless such person is a pharmacist who is acting in the usual course of his professional practice and is acting on behalf of a pharmacy whose registration has been modified under sections 1301.13 and 1301.19 of this chapter to authorize it to operate as an online pharmacy. (c). Any online pharmacy that participates in the transfer between pharmacies of prescription information must do so in accordance with the requirements of §§1306.15 and 1306.25 of this part.

Prescriptions for controlled substances listed in Schedule II may be transmitted from a retail pharmacy to a central fill pharmacy via facsimile. a. True b. False

Answer: (a) True, [21CFR Section 1306.15]. Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. The following requirements shall also apply: (a). Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must: (1). Write the words "CENTRAL FILL" on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal. For electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record. (2). Ensure that all information required to be on a prescription pursuant to Section 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information); (3). Maintain the original prescription for a period of two years from the date the prescription was filled; (4). Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery. (b). The central fill pharmacy receiving the transmitted prescription must: (1). Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription; (2). Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling of the prescription; (3). Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common or contract carrier).

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.

Dietary supplements containing ephedrine alkaloids are classified adulterated under the Federal Food, Drug, and Cosmetic Act. a. True b. False

Answer: (a) True, [21CFR119.1 and FFDC section 402(f)(1)(A)]. Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act.

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.

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 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.

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.

The recent Federal law prohibits the use of PRESCRIPTION opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years. a. True b. False

Answer: (a) True, [https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm]. In January 2018, Food and Drug Administration (FDA) announced that the agency is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. In addition, labeling for the medications will be updated with additional safety information for adult use. This update will include an expanded Boxed Warning notifying consumer about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

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.

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.

A practitioner's AUTHORIZED AGENT may transmit a valid Schedule II controlled substance prescription to a pharmacy via facsimile for patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII. a. True b. False

Answer: (a) True, [https://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies#h-8]. Because Schedule II controlled substances have the highest potential for abuse and the greatest likelihood of dependence among the pharmaceutical controlled substances (those in Schedules II-V), the CSA controls on Schedule II drugs are the most restrictive. The CSA requires that a Schedule II controlled substance be dispensed by a pharmacy only pursuant to a written prescription, except in emergency situations, and prohibits Schedule II prescriptions from being refilled. 21 U.S.C. 829(a). Thus, in most cases, a pharmacist must receive the original, manually signed paper prescription or an electronic prescription prior to dispensing a Schedule II controlled substance. 21 CFR 1306.11(a). DEA regulations specify two exceptions whereby a Schedule II controlled substance prescription sent by facsimile may serve as the original written prescription. A practitioner or a practitioner's AUTHORIZED AGENT may transmit a valid Schedule II controlled substance prescription to a pharmacy via facsimile for: (1). Patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or hospice programs which are licensed by the State (21 CFR 1306.11(g)); and (2). residents of LTCFs (21 CFR 1306.11(f)). The facsimile serves as the original written prescription and must be maintained by the pharmacy as such. An authorized agent of the prescribing practitioner may TRANSMIT the practitioner-signed prescription by facsimile on behalf of the practitioner.

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 use of a patient's own medication during or after admittance to a hospital should be discouraged as a general or routine practice. a. True b. False

Answer: (a) True. No drugs shall be administered to a patient except those provided through the pharmacy or as provided by written policies and procedures developed by the registered pharmacist-in-charge or, where applicable, the director of pharmaceutical services and approved by the Pharmacy and Therapeutics Committee. Although the use of a patient's own medications may be warranted in certain situations, it should be discouraged as a general or routine practice. If a patient's previously acquired medication is to be used, a written order to this effect shall be signed and dated by the patient's physician. Such medications shall be identified by the pharmacist as to contents and dispensing origin. Also, these medications shall be documented as part of the pharmacy's patient profile record system.

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

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 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

d

A unique number the purchaser assigns to track the order must be included on an DEA 222 electronic order for Schedule I and II controlled substances. The unique number shall consist of: a. 10 character long starting with 'NAP'. b. 18XLauren c. 9 character long ending with 'X' d. DEA222-12589525

Answer: (b) 18XLauren, [21CFR1305.21]. (a). To be valid, the purchaser must sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser's agent, by DEA as provided in part 1311 of this chapter. (b). The following data fields must be included on an electronic order for Schedule I and II controlled substances: (1). A unique number the purchaser assigns to track the order. The number must be in the following 9-character format: the last two digits of the year (e.g. 18), X, and six characters as selected by the purchaser (e.g. Lauren). (2). The purchaser's DEA registration number. (3). The name of the supplier. (4). The complete address of the supplier (may be completed by either the purchaser or the supplier). (5). The supplier's DEA registration number (may be completed by either the purchaser or the supplier). (6). The date the order is signed. (7). The name (including strength where appropriate) of the controlled substance product or the National Drug Code (NDC) number (the NDC number may be completed by either the purchaser or the supplier). (8). The quantity in a single package or container. (9). The number of packages or containers of each item ordered. (c). An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.

Which of the following helps customers to ensure the prescription drugs they order from online pharmacies are safe and legitimate? a. The web site shall have verified NABP X-NPI number. b. A .pharmacy domain is part of a website's address. c. The presence of DEA "Internet Verified Seal" on the home page of website. d. All of the above.

Answer: (b) A .pharmacy domain is part of a website's address, [www.safe.pharmacy/apply]. With only 4% of websites selling prescription drugs online following United States pharmacy laws and practice standards, consumers seeking medications online are faced with the daunting task of finding a safe site. To assist consumers and those legitimate pharmacies with an online presence, NABP has streamlined its website verification programs. As of September 1, 2017, NABP is only offering the .Pharmacy Verified Websites Program and the Verified Internet Pharmacy Practice Sites® (VIPPS®) program, providing an easy choice for safety-minded consumers and pharmacies alike. The .Pharmacy Program, which was launched in 2014, enables qualified pharmacies and pharmacy-related businesses to register a web address with the .pharmacy domain. A .pharmacy domain (pronounced "dot pharmacy") is part of a website's address like ".com" or ".biz": www.safe.pharmacy. It enables people to identify an online pharmacy or pharmacy-related website as safe and legitimate. Since .pharmacy is a verified domain, websites are evaluated against a set of safety standards before an applicant is approved to register the domain. In addition to showing patients that they operate a safe website, the .pharmacy domain allows pharmacies and related entities to advertise online through Google, Bing, and Yahoo! The .Pharmacy Program replaces the e-Advertiser Approval and Veterinary VIPPS® programs for those entities that are not eligible to apply for VIPPS but want to advertise with the search engines.

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.

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.

If we crush and add 10 tablets of Tylenol No. 3 to 100 ml distilled water. The resultant mixture should be classified as a: 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 drug, [21CFR1308.13(e)(1)(ii)]. According to CSA any material, compound, mixture, or preparation containing 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 shall be classified under Schedule III controlled substances. Each Tylenol No. 3 tablet contains 30mg of Codeine. The resultant mixture should contain 300mg of Codeine per 100ml of solution. Therefore it should be classified as a Schedule III controlled substance.

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

d

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

d

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.

A written prescription that contains the photocopy of the prescriber's signature is considered a valid prescription. a. True b. False

Answer: (b) False, [21 CFR Section 1306.15(d)]. Carbon or duplicate written prescriptions are not valid prescriptions. A written prescription must bear the original signature of the prescriber, not a copy or photo copy or stamp of the signature of the prescriber.

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)]. so sign not initial 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 pharmacy that has been issued a registration under Title 21 CFR Section 1301.13 shall request the NABP to modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. a. True b. False

Answer: (b) False, [21CFR1301.19(a)]. Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). (a). A pharmacy that has been issued a registration under §1301.13 may request that the Administrator (Not NABP) modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. The Administrator may deny an application for a modification of registration if the Administrator determines that the issuance of a modification would be inconsistent with the public interest. In determining the public interest, the Administrator will consider the factors listed in section 303(f) of the Act (21 U.S.C. 823(f)). (b). Each online pharmacy shall comply with the requirements of State law concerning licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense controlled substances by means of the Internet. (c). Application for a modified registration authorizing the dispensing of controlled substances by means of the Internet will be made by an online application process as specified in §1301.13 of this part. Subsequent online pharmacy registration renewals will be accomplished by an online process. (d). A pharmacy that seeks to discontinue its modification of registration authorizing it to dispense controlled substances by means of the Internet as an online pharmacy (but continue its business activity as a non-online pharmacy) shall so notify the Administrator by requesting to modify its registration to reflect the appropriate business activity.

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

all

Under the new Federal Pharmacy Law section 21CFR1306.05, the prescribing practitioner may delegate his or her signature authority to a physician's assistant. a. True b. False

Answer: (b) False, [21CFR1306.05(a)(f), 21CFR 1306.05(d), 21CFR 1306.05(e), 21 CFR 1311.140 and https://www.federalregister.gov/]. Controlled substance prescriptions are orders for medication to be dispensed to an ultimate user and are required to contain specific information including: Patient name, address, drug name and strength, quantity prescribed, directions for use, and the name, address and DEA number of the issuing practitioner, 21 CFR 1306.05(a). All prescriptions for controlled substances must be dated as of, and signed on, the day when issued. Paper prescriptions must be manually signed by the issuing practitioner in the same manner that the practitioner would sign a check or other legal document (21 CFR 1306.05(d)); electronic prescriptions for controlled substances must be signed in accordance with DEA regulations (21 CFR 1306.05(e), 21 CFR 1311.140). The regulations provide that 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.", 21 CFR 1306.05(f). Accordingly, an authorized agent may prepare a controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription and then provide the prescription to the practitioner to review. The authorized agent does not have the authority to make medical determinations. The practitioner must personally sign the prescription, whether manually or electronically. The prescribing practitioner CANNOT delegate his or her signature authority.

Any controlled drug prescription, including prescriptions for Schedule II drugs that are sent to a pharmacy via e-prescribing, may be forwarded to any other pharmacy if done through the use of an e-prescribing system. The Schedule II prescription could only be forwarded using e-prescribing to another pharmacy that shared the same computer system. a. True b. False

Answer: (b) False, [Electronic Prescriptions for Controlled Substances, https://www.deadiversion.usdoj.gov/ecomm/e_rx/]. Any controlled drug prescription, including prescriptions for Schedule II drugs that are sent to a pharmacy via e-prescribing, may be forwarded to any other pharmacy if done through the use of an e-prescribing system. Until now, the understanding has been that a Schedule II prescription could only be forwarded using e-prescribing to another pharmacy that shared the same computer system. That is no longer the case. According to Loren Miller, DEA's associate section chief of the Liaison and Policy Section of the agency's Diversion Control Division, "As posted in the preambles of the [notice of proposed rulemaking] and the [interim final rule], an unfilled original [electronic prescription for controlled substances] can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances."

According to DEA, on-hold unfilled controlled substance prescriptions cannot be transferred to another pharmacy. a. True b. False

Answer: (b) False, [https://www.deadiversion.usdoj.gov/ecomm/e_rx/]. There has been some confusion regarding the transfer or forwarding of a prescription that has been placed "on hold." The term "on hold" refers to the situation when a pharmacy receives a new prescription and does not immediately fill it. The new prescription is normally placed in a "hold" file or entered into the pharmacy's computer system. The prescription is not filled by the pharmacy until a later date requested by the patient or mandated by the prescriber. Some pharmacists believe that these on-hold prescriptions cannot be transferred to another pharmacy because the transfer rules only apply to refills. Drug Enforcement Administration (DEA) allows for an unfilled original electronic prescription for controlled substances (EPCS) to be forwarded from one retail pharmacy to another, including Schedule II controlled substances (CS) and therefore on-hold unfilled controlled substance prescriptions CAN be transferred to another pharmacy. DEA permits the transfer of original prescription information for a prescription refill in Schedules III, IV, and V on a one-time basis. The exception to this limit requires both pharmacies to share the same database and the transfer must be processed in real time.

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 acts emphasizes the security and safety of health related information? a. FTC b. HIPAA c. OBRA d. FDA Modernization Act

Answer: (b) HIPAA is known as the Health Insurance Portability and Accountability Act, [Public Law 104-191]. It emphasizes the security and safety of health-related information. It was issued in 1996. The major objectives of the HIPAA are: 1. To assure health insurance portability. This will help a person who has preexisting health conditions and wants to change jobs. Before the HIPPA, a person would think twice before changing jobs, if they had preexisting health conditions, because of insurance problems. 2. To prevent or reduce healthcare related fraud and abuse. 3. To ensure the safety and security of each patient's health related information. This will help to keep a patient's condition confidential. 4. To enforce the standard for health.

skilled nursing facility

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.

Which of the following statements is/are TRUE ABOUT the DEA registration renewal process? I. If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. II. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration. III. DEA allows the reinstatement of an expired registration for two calendar months after the expiration date.

Answer: (b) I and II are true, [ www.deadiversion.usdoj.gov/drugreg/index.html]. As of January 2017, Drug Enforcement Administration (DEA) will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration. In addition, DEA will retain its current policy and procedures with respect to renewal and reinstatement of registration. The policy is described below. 1. If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. 2. DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required. 3. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.

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 information about Plan-B One Step is/are TRUE? I. It is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. II. With Plan B One-Step, a patient has up to 72 hours to prevent a pregnancy. III. If a patient is 15 or older, Plan B One-Step is available ONLY through a prescription. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true. Plan B One-Step is a backup plan that helps prevent pregnancy after birth control failure. The sooner a patient takes an emergency contraception, the better it works. Plan B One-Step requires just one pill. Other emergency contraception requires two pills, 12 hours apart. With Plan B One-Step, a patient has up to 72 hours (3 days) to prevent a pregnancy. It is not the abortion pill and it isn't a substitute for routine birth control. Plan B is available to all Over-The-Counter without the prescription or presenting an id. A patient is required to take a single pill, as soon as possible within 72 hours, after an unprotected intercourse or a contraceptive failure.

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.

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).

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

b

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.

c

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.

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.

May a retail pharmacist allow to fill a prescription for Oxycontin that is transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment? a. Yes b. No

Answer: (b) No, [21CFR Section 1306.11]. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.

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.

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:

class III

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.

d

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 Observation

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)].

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 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.

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.

A pharmacist at Blue-Care Pharmacy receives a call from Red-Care Pharmacy requesting the purchase of 21 capsules of Cephalexin 500mg. Which of the following is TRUE? a. The pharmacist cannot sell the drug. b. The pharmacist can sell the drug as long as a record of the sale is maintained. c. The pharmacist can only sell an unopened, original container of the drug. d. The price charged to the pharmacy must be less than AWC of the drug

Answer: (b) The pharmacist can sell the drug as long as a record of the sale is maintained.

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.

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].

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 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.

Good Neighbor Care is a bulk manufacturer of Morphine Sulfate tablet. Its license for manufacturing controlled II drugs shall expire on 12/31/2018. What would be the earliest date the company can apply for re-registration? a. 10/31/2018 b. 07/31/2018 c. 08/31/2018 d. 05/31/2018

Answer: (c) 08/31/2018, [21CFR1301.13(b)]. The bulk manufacturer of controlled substance may apply to be reregistered no more than 120 days before the expiration date of their registration. Any person who is registered (controlled substances) may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II controlled substances or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration.

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.

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.

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.

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 statements is/are TRUE under the Controlled Substance Act? I. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription. II. Where a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V by conveying all the required prescription information to the practitioner's authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. III. In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy the practitioner's agent may transmit the practitioner-signed prescription to the pharmacy by facsimile. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR 1306.04(a); 1306.05(a), (f), 21 CFR 1306.11(a), 1306.11(f), 1306.11(g), and 1306.21(a), 21 CFR 1306.03(b), 1306.21(a)]. 1. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription. . 2. Where a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V by conveying all the required prescription information to the practitioner's authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. 3. In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy, the practitioner's agent may transmit the practitioner-signed prescription to the pharmacy by facsimile.

Which of the following is/are TRUE regarding importing or exporting controlled substances listed in schedule II, III, IV or V for a personal medical use? I. A United States resident may import into the United States no more than 50 dosage units combined of all such controlled substances in the individual's possession that were obtained abroad for personal medical use. II. The controlled substance is in the original container in which it was dispensed to the individual. III. The individual makes a declaration to an appropriate official of the Bureau of Customs and Border Protection stating that the controlled substance is possessed for his/her personal use.

Answer: (d) All, [21CFR 1301.26]. Any individual who has in his/her possession a controlled substance listed in schedules II, III, IV, or V, which he/she has lawfully obtained for his/her personal medical use, or for administration to an animal accompanying him/her, may enter or depart the United States with such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 952-955), provided the following conditions are met: (a). The controlled substance is in the original container in which it was dispensed to the individual; and (b). The individual makes a declaration to an appropriate official of the Bureau of Customs and Border Protection stating: (1). That the controlled substance is possessed for his/her personal use, or for an animal accompanying him/her; and (2). The trade or chemical name and the symbol designating the schedule of the controlled substance if it appears on the container label, or, if such name does not appear on the label, the name and address of the pharmacy or practitioner who dispensed the substance and the prescription number. (c) In addition to (and not in lieu of) the foregoing requirements of this section, a United States resident may import into the United States no more than 50 dosage units combined of all such controlled substances in the individual's possession that were obtained abroad for personal medical use. (For purposes of this section, a United States resident is a person whose residence (i.e., place of general abode-- meaning one's principal, actual dwelling place in fact, without regard to intent) is in the United States.) This 50 dosage unit limitation does not apply to controlled substances lawfully obtained in the United States pursuant to a prescription issued by a DEA registrant.

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 z

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.

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

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.

The requirements of labeling do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized provided that: I. Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time. II. The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration. III. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR Section 1306.14]. The requirements of labeling do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized provided that: 1. Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time; 2. The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration; 3. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II. 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.

No electronic DEA 222 order may be filled if: I. The order is not signed using a digital certificate issued by DEA. II. The digital certificate used had expired or had been revoked prior to signature. III. The purchaser's public key cannot validate the digital signature. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR1305.25]. (a) No electronic DEA 222 order may be filled if: (1). The required data fields have not been completed. (2). The order is not signed using a digital certificate issued by DEA. (3). The digital certificate used had expired or had been revoked prior to signature. (4). The purchaser's public key cannot validate the digital signature. (5). The validation of the order shows that the order is invalid for any reason. (b). If an order cannot be filled for any reason under this section, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph. (c). When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original order and the statement must be retained in accordance with §1305.27. (d). Neither a purchaser nor a supplier may correct a defective order; the purchaser must issue a new order for the order to be filled.

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.

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.

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.

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

d

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.

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

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:

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

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

A prescriber wishes to purchase acetaminophen with codeine 30 mg for "office use". Which of the following statements is TRUE? a. The prescriber must write a prescription labeling "Office Use Only". b. The prescriber must write a prescription for himself. c. The prescriber must complete a DEA Form 222. d. The prescriber shall order it directly from a supplier.

Answer: (d) The prescriber shall order it directly from a supplier, [21CFR1306.04(b)]. A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients. Therefore, a prescription written for office stock or "medical bag" use is not valid.

list of class 5 drugs under federal law

Codeine preparations - Not more than 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine). Difenoxin preparations - Not more than 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen). Dihydrocodeine preparations - Not more than 100 mg per 100 ml or 100 gm. Diphenoxylate preparations- Not more than 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen). Ethylmorphine preparations - Not more than 100 mg per 100 ml or 100 gm. Opium preparations - Not more than 100 mg per 100 ml or 100 gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.). Lyrica - Pregabalin Vimpat - Lacosamide Potiga - Ezogabine

Using the NARxCHECK, a pharmacist is receiving the scaled score of 650 for a particular patient. Which of the following statements based on this scaled score is TRUE? a. Very low risk for misuse. b. Low risk for misuse. c. Moderate risk for misuse. d. High risk for misuse.

NARXCHECK is an automatic prescription drug abuse assessment and management tool for health care providers. Once integrated into the facility's system, NARxCHECK automatically queries the state PMP database to generate a report that includes a score for three different drug classes: narcotics, sedatives, and stimulants. These three-digit scores (000-999) help practitioners to decide whether or not they need to review a patient history before prescribing additional medications. The score is easy to read using the following guidelines: 1. Less than 200 = Be confident - low risk for misuse. 2. 200 - 500 = Be curious - moderate risk for misuse. 3. Greater than 500 = Be cautious - higher risk for misuse.

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

d

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?

No 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.

DEA form 22

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.

Emergency oral communication of a valid Schedule II controlled substance prescription May BE delegated to an authorized agent. a. True b. False

The CSA contains an exception that allows a practitioner to issue oral prescriptions for Schedule II controlled substances in an emergency. An emergency for this purpose is defined by the Food and Drug Administration in 21 CFR 290.10. DEA regulations limit such an emergency oral prescription to the quantity necessary to treat the patient during the emergency period and require that it be followed up within 7 days by a practitioner-signed, written prescription to the dispensing pharmacy. Moreover, oral emergency prescriptions must immediately be reduced to writing by the pharmacist and must contain all the information ordinarily required in a prescription, except for the signature of the prescribing individual practitioner. If the prescribing individual practitioner is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a call back to the prescribing individual practitioner and/or other good faith efforts to ensure the practitioner's identity. Because the more specific requirement that the emergency Schedule II oral authorization must be from a registered individual practitioner supersedes the general rule that an employee or agent of the individual practitioner may communicate prescriptions to a pharmacist, the prescribing individual practitioner must PERSONALLY communicate the emergency oral prescription to the pharmacist. An agent may not call in an oral prescription for a Schedule II controlled substance on behalf of a practitioner even in an emergency circumstance.

Skilled Nursing Facility (SNF)

a facility that provides 24-hour room, board, and skilled nursing care and treatment to at least three residents. Skilled nursing care and treatment services are those performed by or under the supervision of a registered nurse for individuals requiring 24-hour-a-day care by licensed nursing personnel and under the direction of a licensed doctor. e.g Consider an elderly man who fell, causing broken bones, and ending up in the hospital. Once the immediate medical intervention is complete after a few days, that person no longer needs to be in the hospital, however still requires specialized rehabilitation and wound care services that they cannot receive at home.

Intermediate care facility ICF

a nursing home that is recognized only under Medicaid

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

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.

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?

no 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.

A 45-year-old patient comes to a pharmacy and presents a prescription for Ambien written by his podiatrist. A pharmacist shall: a. Not fill the prescription. b. Fill the prescription. c. Ask the patient to get a new prescription. d. Fill and dispense the prescription after filling a DEA 222 order form.

nswer: (a) A pharmacist shall not fill the prescription, [21CFR1306.04(a)]. For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order. A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill (Ambien) prescribed by a registered podiatrist.

If the registration of any purchaser is suspended or revoked for handling the controlled substances listed in Schedule I or II or both, the purchaser must return all unused DEA Forms 222 to the: I. Nearest office of the DEA II. HCFA III. State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

nswer: (a) I only, [21CFR Section 1305.18]. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the nearest office of the DEA.

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

nswer: (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.

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

nswer: (a) Phenobarbital is classified as a Schedule IV controlled drug, [21CFR1308.14].

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

nswer: (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.

A new cough syrup has been introduced in a market that contains Guaifenesin/Hydrocodone (100mg/10mg per 5ml). The syrup is available in 8 ounces glass bottle. What controlled schedule shall be assigned to this new cough syrup? a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

nswer: (a) The new syrup should be classified as a schedule II-controlled drug, [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. Therefore, the new cough syrup should be classified as a schedule II controlled substance.

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

nswer: (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.

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.

nswer: (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.

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

nswer: (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.

Drug Addiction Treatment Act-Waived qualifying physician assistants can prescribe and dispense the opioid maintenance drug buprenorphine from their offices. a. True b. False

nswer: (a) True, [Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder]. In January 2018, DEA announced a deregulatory measure that will make it easier for residents of underserved areas to receive treatment for opioid addiction. Nurse practitioners and physician assistants can now become Drug Addiction Treatment Act-Waived qualifying practitioners, which gives them authority to prescribe and dispense the opioid maintenance drug buprenorphine from their offices.

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

nswer: (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.

An individual practitioner who is an agent or employee of another practitioner registered to dispense controlled substances may, when acting in the normal course of business or employment, prescribe, administer or dispense controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices. a. True b. False

nswer: (b) False, [21CFR Section 1301.22(b)]. An individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, ADMINISTER or DISPENSE (other than by issuance of prescription-NO PRESCRIBING) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself.

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

nswer: (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 for a registrant who wants to change his/her address on the controlled substance certificate of registration? I. Any registrant may apply to change his/her name or address, by submitting a letter of request to the Registration Unit, Drug Enforcement Administration. II. The letter shall contain the registrant's name, address, and registration number as printed on the certificate of registration, and the new name or address as well as the signature of the registrant. III. The registration shall pay an appropriate modification fees to the DEA. a. I only b. I and II only c. II and III only d. All

nswer: (b) I and II are true, [21CFR Section 1301.51]. Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances or to change his/her name or address, by submitting a letter of request to the Registration Unit, Drug Enforcement Administration. The letter shall contain the registrant's name, address, and registration number as printed on the certificate of registration, and the substances and/or schedules to be added to his/ her registration or the new name or address and shall be signed in accordance with Sec. 1301.13(j). If the registrant is seeking to handle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, he/she shall attach three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate. No fee shall be required to be paid for the modification. The request for modification shall be handled in the same manner as an application for registration. If the modification in registration is approved, the Administrator shall issue a new certificate of registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration until expiration.

In which of the following situations can a pharmacist disclose patient information to a third party without the patient's consent? I. When a pharmacist is performing prospective DUR. II. To assist prescribers in obtaining a comprehensive drug history on a patient. III. When a patient's relative requests such information. a. I only b. I and II only c. II and III only d. All

nswer: (b) I and II only, [OBRA 90 and HIPAA]. A pharmacist may disclose patient information to a third party without the patient's consent in the following situations: 1. When a pharmacist is performing prospective DUR. 2. To assist prescribers in obtaining a comprehensive drug history on a patient. 3. To prevent abuse or misuse of any drug or device and the diversion of controlled substances. 4. Provide a medication therapy management program or a quality assurance program.

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

nswer: (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.

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

nswer: (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.

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

nswer: (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 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

nswer: (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.

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

nswer: (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 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.

nswer: (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.

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

nswer: (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.

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

nswer: (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.

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

nswer: (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 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

nswer: (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.

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

nswer: (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.

The pharmacist receives a telephone prescription for Alprazolam from a physician's assistant. Assuming that the dosage, quantity, and instructions are appropriate, and the prescription is reduced to writing, the pharmacist should: a. Not fill the prescription because a triplicate prescription is required. b. Not fill the prescription because a telephone prescription for Alprazolam is not valid. c. Fill the telephone prescription if the physician confirms all information with the pharmacist. d. It cannot be said since a prescriptive authority for controlled substances for a physician's assistant may vary a state to state.

nswer: (d) Under Federal Pharmacy Law and Controlled Substances Act, a prescriptive authority by mid-level practitioners is not well defined. For example, according to section 1306.03 (CFR): Persons entitled to issue prescriptions: _________________________________ (a). A prescription for a controlled substance may be issued only by an individual practitioner who is: (1). Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2). Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. (b). A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. Under Section 1300.01 (definition 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 controlled substances by the state in which they practice. Therefore, the prescriptive authority of mid-level practitioners is completely depending on states in which they practice.

A physician requesting Oxycodone for relieving a pain to treat one of hospitalized patients. A hospital pharmacy is currently out of stock of the requested drug. He asks a hospital pharmacist to borrow Oxycodone from another hospital. Which of the following is the most appropriate? a. The hospital pharmacist should borrow the requested medication from another hospital. b. The hospital pharmacist should tell the requesting physician that a schedule II-controlled substance can only be obtained from a wholesale distributor. c. The hospital pharmacist should suggest another pain reliever to the requesting physician. d. The hospital pharmacist should get Oxycodone from another hospital by executing a DEA 222 order form.

nswer: (d), [21CFR1305.03]. The hospital pharmacist should get Oxycodone from another hospital by using a DEA 222 order form. A DEA Form 222 is required for each distribution/transfer of a Schedule I or II controlled substance.

skilled nursing care

rehab various medical or nursing procedure, usually short term care between the hospital and home, to recover..... so mostly acute care and requires sepcialty