Federal Pharmacy Law Test 1 - Section 1

FDA has made a new resource available for consumers and health care providers to help promote and educate individuals about how to safely dispose of unused opioids. This Toolkit is called: A. Safe Disposing Opioid B. Free Safe Opioid Disposal - Remove the Risk Outreach C. Opioid Abuse Deterrent D. FDA Safe Opioid Kit

Answer: (b) Free Safe Opioid Disposal - Remove the Risk Outreach, [www.nabp.pharmacy/initiatives/AWARxE]. FDA has made a new resource available for consumers and health care providers to help promote and educate individuals about how to safely dispose of unused opioids. The free Safe Opioid Disposal - Remove the Risk Outreach Toolkit includes video, radio, and print public service announcements, social media graphics and posts, fact sheets, drop-in content, and website badges that health care providers and other interested individuals and organizations can use to promote the message of opioid safety. The toolkit and its resources can be accessed on the Ensuring Safe Use of Medicine section of the FDA website.

Which of the following is a drug disposal company that provides a solution to eradicate the misuse of unused medications? A. OpioidRx B. RxAwareness C. RxCare D. DisposeRX

Answer: (d) DisposeRX. DisposeRx, Inc. is a drug disposal company that provides a solution to eradicate the misuse of unused medications. DisposeRx packets contain a blend of patented and proprietary solidifying materials that provide a safe solution for the disposal of unused or expired medications. When water and the DisposeRx powder are added to drugs in the prescription vial and shaken, the drugs are dissolved and then chemically and physically sequestered in a viscous polymer gel made from materials that are FDA approved for oral medications.

The partial supply on DEA 222 order forms must be filled within: A. 72 hours B. 10 days C. 48 hours D. 60 days

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

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

3 years for CT Answer: (c) Two years, [21CFR1305.17(c)]. (a). The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. (b). The supplier must retain the original 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 a copy 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 Thiafentanil, 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. (e). Electronic copies of DEA Forms 222 will be deemed to be maintained separately from all other records of the registrant, for the purposes of this section, if such copies are readily retrievable separately from all other records. Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.

When filling a prescription for Tylenol no. 3, the pharmacist may assign the maximum number of available refills: A. 5 times B. 10 times C. As needed D. 0 times

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

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.

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

DEA form 224a should be used for: A. Renewal of registration for dispensing controlled substances. B. New registration for dispensing controlled substances. C. Reporting theft or loss of controlled substances. D. None of the above.

Answer: (a) A DEA 224a form should be used for renewal of registration for dispensing controlled substances, [21CFR1301.13]. Below is the list of forms and their uses: __________________________________ 1. DEA 222: For purchase and transfer of Schedule I and II controlled substances. 2. DEA 224: New registration for Dispensing. 3. DEA 224A: Renewal of registration for Dispensing. 4. DEA 225: New registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 5. DEA 225A: Renewal of registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 6. DEA 363: New registration for Narcotic Treatment Program. 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 prescription for Vicodin can be refilled how many times? A. Cannot be refilled B. 5 times C. As Needed within 1-year D. Maximum 10 times

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

A father of 9 years old son comes to your pharmacy to pick up a prescription for Ritalin for his son. Upon conversation with a pharmacist; he requests the pharmacist to dispense Ritalin in two different vials - one for home and another one for his son's school. Which of the following is the most appropriate action by the pharmacist? A. Complies with the father's request. B. Explain him the law does not permit that. C. Call a physician and get two different Ritalin prescriptions. D. Ritalin cannot be self-administered by a minor.

Answer: (a) Complies with the father's request. 1. There is no federal or state law that prohibits the dispensing of medication into two different containers. In above circumstance, the dispensing pharmacist should print two labels for Ritalin. Put the medication in both dispensing containers and affix the printed label on each container. Hand write and change the quantity of drug on each dispensing label so that it accurately reflects the quantity present in each vial. 2. In most schools, such drugs are administered by a school nurse; therefore, the choice 'd' is not the right answer.

Which of the following is/are classified as Mid-Level practitioners? I. RN II. MD III. DDS A. I only B. I and II only C. II and III only D. All

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

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

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

Which of the following is required to order Schedule I and II controlled drugs? A. DEA 222 B. DEA 106 C. DEA 41 D. DEA 351

Answer: (a) Schedule I and II controlled drugs can be ordered by filling out a DEA 222 form, [21CFR1305.13]. (a). A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form. (b). A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and 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 the original DEA Form 222 for the supplier's files in accordance with §1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under §1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to [email protected]. The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy 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 its copy 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.

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

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

U.S. Health Coalition message: "Double Check, Don't Double Up" is in reference to which of the following? A. Acetaminophen B. Digoxin C. Levothyroxine D. Oxycodone

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

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

Answer: (a) The registrant must return DEA 222 forms to the DEA to correct the error [CFR1305.11(d)]. (a). DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown. (b). Any person with an active registration that is authorized to order schedule I and II controlled substances is entitled to obtain a DEA Form 222, which will be supplied at any time after the DEA registration is granted. Any person holding a registration authorizing the person to obtain a DEA Form 222 may requisition the forms through a DEA secured network connection or by contacting any Division Office or the Registration Section of the Administration through the customer service center. (c). Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired. (d). DEA Forms 222 will have an order form number and be 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; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration.

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

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

Medication-assisted treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a "whole-patient" approach to the treatment of substance use disorders. A. True B. False

Answer: (a) True, [Substance Abuse and Mental Health Services Administration (SAMHSA)]. Medication-assisted treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a "whole-patient" approach to the treatment of substance use disorders. MAT is primarily used for the treatment of addiction to opioids such as heroin and prescription pain relievers that contain opiates. The prescribed medication operates to normalize brain chemistry, block the euphoric effects of alcohol and opioids, relieve physiological cravings, and normalize body functions without the negative effects of the abused drug. Medications used in MAT are approved by Food and Drug Administration, and MAT programs are clinically driven and tailored to meet each patient's needs. Opioid treatment programs (OTPs) provide MAT for individuals diagnosed with an opioid use disorder. OTPs also provide a range of services to reduce, eliminate, or prevent the use of illicit drugs, potential criminal activity, and/or the spread of infectious disease. OTPs focus on improving the quality of life for those receiving treatment. The ultimate goal of MAT is full recovery, including the ability to live a self-directed life. This treatment approach has been shown to: a. Improve patient survival b. Increase retention in treatment c. Decrease illicit opiate use and other criminal activity among people with substance use disorders d. Increase patients' ability to gain and maintain employment e. Improve birth outcomes among women who have substance use disorders and are pregnant

A Universal Activity Number (UAN) is an identification assigned to each CPE activity developed and provided, or jointly provided, by an ACPE accredited provider. In following UAN example, what does 03 signify? UAN: 1234-0000-12-123-L03-P A. Live study B. Home study C. Topic designator D. Target audience

Answer: (c) Topic designator ACPE UAN NO: 1234-0000-12-123-L03-P 1. L indicates live CPE activity; H would indicate home study activity. 2. 03 is the topic designator for Law (all ACPE topic designators are listed below). 3. P indicates the activity's target audience is pharmacists; T would indicate pharmacy technicians. ACPE UAN Topic Designators 01 - Disease/Drug Therapy Related 02 - HIV/AIDS Therapy Related 03 - Law 04 - General Pharmacy Topics 05 - Patient Safety 06 - Immunizations 07 - Compounding

A prescription for Ativan issued on 01/01/2021 should not be filled after: A. 04/01/2021 B. 07/01/2021 C. 10/01/2021 D. 01/01/2022

Answer: (b) 07/01/2021, [21CFR1306.22(a)]. (a). No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. (b). Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. (c). The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist for each refill. (5). The total number of refills for that prescription. (d). If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.

_____________ is a comprehensive drug reporting system that monitors the flow of controlled substances (CS) from their point of manufacture through commercial distribution channels to the point of sale at the dispensing/retail level. A. FDACO B. ARCOS C. DEAXP D. FEDPMP

Answer: (b) Automation of Reports and Consolidated Orders System (ARCOS) Online Reporting System. Automation of Reports and Consolidated Orders System (ARCOS) Online Reporting System is a comprehensive drug reporting system that monitors the flow of controlled substances (CS) from their point of manufacture through commercial distribution channels to the point of sale at the dispensing/retail level. This newly added function will allow the more than 1,500 DEA-registered manufacturers and distributors to view the number of registrants who have sold a particular CS to a prospective customer in the last six months.

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

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

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

Answer: (b) I and II only, [21CFR1306.13(b)]. 1. A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. 2. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. 3. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. 4. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. 5. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial 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).

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

Answer: (b) Maximum three times, [21CFR Section 1306.25(a)]. The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

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

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

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.

DEA allows the reinstatement of an expired registration for ________ calendar month(s) after the expiration date. A. One B. Three C. Six D. Twelve

Answer: (b) One calendar month, [www .deadiversion.usdoj.gov/drugreg/index.html]. 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.

Who publishes guidance for treating opioid use disorder (OUD)? A. FDA B. SAMHSA C. CDC D. DEA

Answer: (b) SAMHSA, [www.samhsa.gov]. To help broaden health care professionals' understanding of medications that can be used to treat Americans with opioid use disorder (OUD), the Substance Abuse and Mental Health Services Administration (SAMHSA) offers guidance on clinical best practices in the February 2018 publication titled Treatment Improvement Protocol, Medications for Opioid Use Disorder. The publication reviews the use of the three Food and Drug Administration (FDA)- approved medications used to treat OUD - methadone, naltrexone, and buprenorphine - and other strategies and services needed to support recovery for people with OUD. Additionally, in February 2018, SAMHSA released the publication Clinical Guidance for Treating Pregnant and Parenting Women with Opioid Use Disorder and Their Infants, which offers standard approaches for health care professionals. This publication provides evidence-based treatment options, including pharmacotherapy with methadone, buprenorphine, and buprenorphine/naloxone, for pregnant women with OUD. The clinical guidance also helps health care professionals and patients determine the most clinically appropriate action for a particular situation and informs individualized treatment decisions. Both publications can be found in the Publications section of SAMHSA's website at www.samhsa.gov.

In collaboration with its pharmacy partners and several state pharmacy associations, _____________ developed a Pharmacy Toolkit to help pharmacists engage and educate patients about the safe use, storage, and disposal of pain medicines. A. FDA B. AASP C. AAOA D. ASHP

Answer: (c) Allied Against Opioid Abuse (AAOA), [https://againstopioidabuse.org/]. In collaboration with its pharmacy partners and several state pharmacy associations, Allied Against Opioid Abuse (AAOA) developed a Pharmacy Toolkit to help pharmacists engage and educate patients about the safe use, storage, and disposal of pain medicines. The AAOA Pharmacy Toolkit includes resources to help pharmacists raise awareness among patients about their rights, risks, and responsibilities associated with prescription opioids. These resources include: 1. a pharmacy display, 2. patient handout, 3. patient engagement guide, 4. tips for talking with patients and caregivers, 5. prescriber engagement guide, 6. safe storage and disposal training, and 7. social graphics. To learn more about the Pharmacy Toolkit and to obtain these resources, visit AAOA's website at https://againstopioidabuse.org.

All of the following are Schedule I controlled drugs EXCEPT: A. Heroin B. LSD C. Demerol D. Marijuana

Answer: (c) Meperidine (Demerol) is a Schedule II controlled drug, [21CFR1308.11 and 21CFR1308.12]. Schedule I controlled substances have the highest potential for abuse. List of Schedule I controlled drugs: _____________________________ Difenoxin (Lyspafen) Dihydromorphine Etorphine (except hydrochloride salt) Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

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

Answer: (c) The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 grams (1000 mg + 240 mg), [21CFR1308.13(e)(2)]. It has been stated under CSA that if a mixture contains less than 1.8 grams of Codeine per 100 cc, it should be classified as a Schedule III controlled substance. (1) Any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below: (i). Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. (ii). 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. (iii). Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts. (iv). Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (v). Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (vi). Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. A List of Schedule III controlled drugs:**Newly Added ______________________________ Amobarbital and noncontrolled active ingredients Amobarbital suppository dosage form Anabolic steroids Barbituric acid derivative Benzphetamine (Didrex, Inapetyl) Buprenorphine (Buprenex, Temgesic) Butabarbital (Butisol, Butibel) Butalbital (Fiorinal, Butalbital with aspirin) **Calcium, magnesium, potassium and sodium oxybate (Xywav) Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine) Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine) Dronabinol in sesame oil in soft gelatin capsule (Marinol) Ketamine (Ketalar) Lysergic acid Lysergic acid amide Methyltestosterone (Android, Oreton, Testred, Virilon) Nalorphine (Nalline) Nandrolone (Deca-Durabolin, Durabolin, Durabolin-50) Norethandrolone(Nilevar, Solevar) Opium combination product (Paregoric) **Perampanel (Fycompa) Pentobarbital and noncontrolled active ingredients Pentobarbital suppository dosage form Phendimetrazine (Bontril) Secobarbital and noncontrolled active ingredients Secobarbital suppository dosage form **Sodium oxybate (Xyrem) Testosterone (Android-T, Androlan, Depotest, Delatestryl) Thiopental (Pentothal)

The partial supply of Schedule II controlled drugs must be filled by pharmacists within: A. 24 hours of initial filling. B. 48 hours of initial filling. C. 72 hours of initial filling. D. 1 week of initial filling.

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

Answer: (d) All, Schedule IV controlled substances have lower potential for abuse relative to Schedule III controlled drugs. The drugs in this class have a currently accepted medical use in treatment in the United States, [21CFR1308.14]. List of Schedule IV controlled drugs:**Newly Added ______________________________ Alprazolam (Xanax) Barbital (Barbitone) Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol) Carisoprodol (Soma) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clonazepam (Klonopin, Clonopin) Clorazepate(Tranxene) Dexfenfluramine (Redux) Diazepam (Valium, Valrelease) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Estazolam (ProSom, Domnamid, Eurodin, Nuctalon) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Flurazepam (Dalmane) Fospropofol (Lusedra) **Lorcaserin (Belviq) Lorazepam (Ativan) Mazindol Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Midazolam (Versed) Modafinil (Provigil) Oxazepam (Serax, Serenid-D) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) **Phentermine + Topiramate (Qsymia) Prazepam (Centrax) Propofol (Diprivan) Propoxyphene dosage forms with other ingredients Quazepam (Doral, Dormalin) Sibutramine (Meridia) **Solriamfetol (Sunosi) **Suvorexant (Belsomra) Temazepam (Restoril) Tramadol (Ultram) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien) Zopiclone (Imovane) Eszopiclone (Lunesta)

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.

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

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

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

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

Lomotil is classified as: A. Schedule II controlled drug B. Schedule III controlled drug C. Schedule IV controlled drug D. Schedule V controlled drug

Answer: (d) Schedule V controlled substances have lower potential for abuse compared to Schedule IV controlled substances. Schedule V controlled drugs normally include antitussive preparation contains codeine and antidiarrheal products. Many of schedule V controlled substances are available without a prescription; over the counter. [21CFR1308.15]. List of Schedule V controlled drugs:**Newly Added ______________________________ 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 **Briviact - Brivaracetam **Xcopri - Cenobamate **Reyvow - Lasmiditan

_____________ means a prescription order written by a prescriber that is not specific to and does not identify a particular patient. A. Prescription designated for an office use B. Prescription order C. Chart order D. Standing order

Answer: (d) Standing order. "Standing order" means a prescription order written by a prescriber that is not specific to and does not identify a particular patient.

__________ has published a new guide for clinicians intended to provide guidelines for tapering or discontinuing long-term opioid use. A. FDA B. DEA C. PPS D. HHS

Answer: (d) The United States Department of Health and Human Services (HHS).

A nursing home which provides extended health care to patients is classified as: A. HMO B. HCFA C. FTC D. LTCF

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