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80 Cards in this Set
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In 1997, the Food and Drug Administration Modernization Act changed the labeling requirement for legend drugs, thereby authorizing the use of the "Rx Only" symbol. Prior to this change, the label was required to read as follows: |
Caution: Federal law prohibits dispensing without a prescription.
More information on labeling requirements can be found in 21 USC 353. |
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Dr. Ann Thomas is a hospitalist at ABC Hospital. Because she is an employee of the hospital and does not have her own practice, she issues prescriptions for controlled substances using the hospital’s DEA number and prescription forms, to which is added her hospital internal code number. In addition to placing the internal code number on the prescription, she must stamp, type, or handprint her name on each prescription for a controlled substance that she issues. |
True
The applicable DEA regulation is 21 CFR 1306.05. |
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A pharmacy registration must be renewed A.annually. B.biennially. C.every 3 years. D.every 5 years. E.every 10 years. |
IL law has pharmacy registration expiring automatically on March 31st of every even # year C. q 3 years per federal law The applicable section of the DEA Pharmacist's Manual is Section III. |
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Which of the following amendments to the federal Food, Drug, and Cosmetic Act created the legal distinction between legend (prescription) and nonlegend (nonprescription) drug products? A. Kefauver-Harris B. Durham-Humphrey C. Waxman-Hatch D. Dingell-Williams E. Rogers-Williams |
durham-humphrey
Enacted in 1951, the Durham-Humphrey Amendment to the federal Food, Drug, and Cosmetic Act created the distinction between legend (prescription) and nonlegend (nonprescription) drugs. The amendment created this distinction by exempting certain drugs (legend drugs) from the “adequate directions for use” labeling requirement. After the amendment, legend drugs could be sold only by a pharmacy or other authorized dispenser pursuant to a prescription and could be dispensed in a container with a label that included directions for use. To distinguish legend from nonlegend drugs, the amendment required a commercial container of a legend drug to carry on the label the statement “Caution: Federal law prohibits dispensing without a prescription.” This language was known as the “federal legend” and is the reason prescription drugs are also referred to as legend drugs. This statement was replaced with the “Rx Only” symbol by enactment of the Food and Drug Administration Modernization Act in 1997. |
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According to federal law, a prescription for a schedule III, IV, or V controlled substance may be transferred between pharmacies that are not electronically sharing a real-time, online database for a maximum of how many times? |
One time The applicable DEA regulation is 21 CFR 1306.25. |
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A unit of a drug that is not intended to be sold and is intended to promote the sale of the drug is referred to as which of the following terms? |
drug sample The applicable section of the federal FDCA is 21 USC 353. |
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t/f To ensure safe use, the FDA may require that pharmacies, practitioners, or health care settings that dispense such drugs are specially certified and that the opportunity to obtain such certification is available to any willing provider from a frontier area. |
true The statement is true, and the applicable section of the federal FDCA is 21 USC 355-1. |
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A medical device, classified as a humanitarian use device, may be granted an exemption from proving effectiveness if the device is designed to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States. |
True The statement is true, and the applicable section of the federal FDCA is 21 USC 360i. For more information on humanitarian use devices, see the FDA's Device Approvals and Clearances page (http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htm). |
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According to the federal FDCA, the following definition applies to which term? "Any drug, the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." |
new drug The applicable section of the federal FDCA is 21 USC 321. |
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Which DEA form does a pharmacy use to register as a chemical distributor, thereby allowing the pharmacy to engage in the wholesale distribution of bulk quantities of SLCPs?
A. DEA Form 41 B. DEA Form 106 C. DEA Form 222 D. DEA Form 224 E. DEA Form 510 |
Form 510 Answer choice A is for inventory of drugs submitted, answer choice B is for theft or loss of controlled substances, answer choice C is for purchase or transfer of schedule II controlled substances, and answer choice D is for new application for registration. SLCP refers to a schedule listed chemical product. The applicable section of the DEA Pharmacist's Manual is Section III. |
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According to the Ryan Haight Act of 2008, online pharmacies are required to report their dispensing of controlled substances to the DEA. How often are those reports required? A. Weekly B. Monthly C. Quarterly D. Annually E. Biennially |
Monthly The applicable section of the DEA Pharmacist's Manual is Section XI. |
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Which of the following DEA registration numbers is correct for Tillara Lucht, MD? A. AT8213468 B. AL8212468 C. BL8212465 D. TL8212465 E. FL8212462
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INCORRECT. The answer is C. The applicable section of the DEA Pharmacist's Manual is Section IX. |
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You work for a chain of pharmacies that can access a real time, online database. How many times may you transfer a prescription for a schedule III pain medication within the chain? A. You may not transfer a prescription for a controlled substance. B. You may transfer a prescription for a controlled substance only once. C. You may transfer a prescription for a controlled substance up to the maximum refills permitted by law and by the prescriber's authorization. D. In this circumstance, you may transfer a prescription for a controlled substance 5 times. E. You may transfer a prescription for a controlled substance as many times as the patient wants within the first 12 months.
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The answer is C. |
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ou have just completed your biennial inventory of controlled substances. According to federal law, you must submit a copy of the inventory A. to the state board of pharmacy. B. to the state branch of the DEA. C. to the DEA regional office. D. to the DEA in Washington, D.C. E. to no one; there is no requirement to submit a copy of the inventory to the DEA. |
e. to no one The applicable section of the DEA Pharmacist's Manual is Section VII. |
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According to the federal FDCA, the following definition applies to which term? "A listed drug that is marketed, sold, or distributed directly or indirectly to a retail class of trade under a different labeling, packaging, product code, labeler code, trade name, or trade mark than the listed drug." |
authorized generic drug |
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What is the term applied to all written, printed, or graphic matter accompanying any drug article? |
labeling The definition of labeling is found in 21 USC 321. |
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T/F According to the Consumer Product Safety Commission publication Poison Prevention: A Guide for Healthcare Professionals regarding child-resistant packaging requirements, a pharmacist is permitted to dispense all of a patient’s prescriptions in nonspecial packaging pursuant to a “blanket waiver” issued by the patient, but it is a prudent practice for the pharmacist to periodically check with the patient to ensure that nonspecial packaging continues to be the preferred packaging. |
Truuu |
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With respect to over-the-counter drug packaging, a package having one or more indicators or barriers to entry that, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred is which of the following?
A. Tamper-proof packaging B. Tamper-resistant packaging C. Tamper-evident packaging D. Tamper-protected packaging |
c. tamper evident packaging |
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A federal government practitioner is exempt from registration with the DEA if his or her _______ is provided on the prescription. A. Branch of military B. Service identification number (if military) C. Social security number (if a public health service employee) D.All of the above E. B and C only |
D. all of the above The applicable section of the DEA Pharmacist's Manual is Section IX. |
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You break 3 ampules of morphine sulfate. You clean the area and dispose of the glass and any recoverable controlled substance according to DEA requirements. When the disposal occurs, which form should you use to report this event? |
DEA Form 41
The breakage or spillage of controlled substances does not constitute a "loss" of controlled substances and must be reported on DEA Form 41 (Registrants Inventory of Drugs Surrendered), not DEA Form 106 (Theft or Loss of Controlled Substances). None of the other forms listed apply to the situation in question. The applicable section of the DEA Pharmacist's Manual is Section V. |
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t/f A pharmacy may dispense a prescription that contains the words “for office use” in place of a patient’s name and address when the prescription has been issued by a practitioner seeking to purchase controlled substances for administration to patients while in the practitioner’s office. |
False |
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Which of the following DEA registration numbers would be issued to a nurse practitioner named Robert McDonald? A. AR3614511 B. BR3614511 C. AM3614511 D. FM3614511 E. MM3614511 |
Correct. The answer is E.
EXPLANATION: |
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A pharmacist sells a schedule V controlled substance without a prescription in a state where such a sale is allowed. What information is required to be in the logbook recording this sale? A. The name and address of the purchaser B. The purchaser's date of birth C. The name or initials of the pharmacist who dispensed the substance to the purchaser D. All of the above E. A and C only |
E. A, C The applicable section of the DEA Pharmacist's Manual is Section X. |
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A practitioner is allowed to issue multiple prescriptions for a schedule II controlled substance provided that which of the following conditions is met? A. The patient is authorized to receive, at most, a 90-day supply. B. Refills are written on the first prescription issued. C. Each prescription is issued on a separate prescription blank. D. Each prescription is written electronically. E. A and C only |
Correct. The answer is E. |
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Which of the following items is required to be on a pharmacy's biennial inventory of controlled substances? A. The date of the inventory B. The signature of the person conducting the inventory C. The time of the inventory (whether the inventory was taken at the beginning or close of business) D. All of the above E. A and C only |
The answer is E. (You answered d.)
EXPLANATION: |
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T/F With respect to pharmaceutical controlled substances, the DEA's responsibility is twofold: to prevent diversion and abuse while ensuring that an adequate and uninterrupted supply of the substance is available to meet the United States' legitimate medical, scientific, and research needs. |
True The statement is true, according to the preface of the Drug Enforcement Administration (DEA) Pharmacist's Manual. |
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Which of the following is the official DEA form that is the actual Certificate of Registration that must be conspicuously displayed at a pharmacy or other location registered with the DEA? A. DEA Form 111 B. DEA Form 222 C. DEA Form 223 D. DEA Form 224 E. DEA Form 224a |
C. DEA 223 DEA Form 223 is the DEA Certificate of Registration that must be displayed at the registrant’s location. DEA Form 111 is not a real DEA form. DEA Form 222 is used to order schedule II controlled substances. DEA Form 224 is the application form for a new DEA Certificate of Registration. DEA Form 224a is the renewal application form that DEA mails to registrants approximately 60 days prior to the expiration of a DEA Certificate of Registration. The applicable DEA regulation is 21 CFR 1301.13. |
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The Combat Methamphetamine Epidemic Act of 2005 places limits on the sale of nonprescription drugs containing pseudoephedrine, ephedrine, and phenylpropanolamine. Which of the following limits is accurate? A. 3.6 g per sale, with purchases limited to 9 g per 30 day period B. 3.6 g per day, with purchases limited to 9 g per 7 day period C. 3.6 g per product per sale, with purchases limited to 9 g per 30 day period D. 3.6 g per day, with purchases limited to 9 g per 30 day period E. 3.6 g of pseudoephedrine per sale, 4.2 g of ephedrine per sale, and 6.3 g of phenylpropanolamine per sale, with purchases limited to 9 g per 30 day period |
-Federal law is D. 3.6g/d, 9g per 30 day period -IL law is 360mg per day, 7500mg within 30 days The applicable section of the DEA Pharmacist's Manual is Section XIV. |
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A pharmaceutical manufacturer has inadvertently omitted the quantity of drug used in producing a label for his new tablet formulation. Using such a label would render the drug product A. adulterated. B. counterfeit. C. dangerous. D. homeopathic. E. misbranded. |
E. misbranded |
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DEA Form 106 is used to report the theft or loss of a controlled substance, and it requires one to provide A. the name and address of the reporting pharmacy. B. the type of theft (e.g., armed robbery). C. the name and telephone number of the local police department (if it was notified). D. All of the above E. A and C only |
D. all of the the above The applicable section of the DEA Pharmacist's Manual is Section V. |
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According to federal law, what information is required on the label for a controlled substance prescription? A. The date of filling B. The name of the patient C. The phone number of the dispensing pharmacy D. All of the above E. A and B only |
E. A & B -also requires
IL also requires drug name, dosage, quanitty Federal requries statement on C2-C4: 'Fed law prohibits the transfer of this drug to any person other than the patient for whom it was Rx'd' |
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On Saturday, a patient presents you the second of three prescriptions that were issued as multiple prescriptions for a schedule II controlled substance. The patient says that she wants to fill the prescription on Saturday because the “do not fill by” date on the prescription is the next day, which is a Sunday, and your pharmacy is not open on Sunday. Because your pharmacy is closed on Sunday, the applicable DEA regulation allows you to dispense the prescription on Saturday prior to the “do not fill by” date. A. True B. False |
The answer is B. EXPLANATION: |
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Your pharmacy sent several expired vials of meperidine to a registered reverse distributor for destruction. Which of the following statements is correct concerning this transaction? A. The reverse distributor issued DEA Form 222 and DEA Form 41. B. The pharmacy issued DEA Form 222, and the reverse distributor issued DEA Form 41. C. The pharmacy issued DEA Form 222 and DEA Form 41. D. The reverse distributor issued DEA Form 222, and the pharmacy issued DEA Form 41. E. None of the above is correct. |
A. The reverse distributor must issue to the DEA both an official order form (DEA Form 222) and a DEA Form 41 (Registrants Inventory of Drugs Surrendered). The applicable section of the DEA Pharmacist's Manual is Section IV. |
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According to federal law, pharmacies have two options for filing prescription records. Which of the following prescriptions would be filed separately from the others, in both systems? A. Acetaminophen with codeine B.Atenolol C.Carisoprodol D.Diazepam E. Meperidine |
E. Paper prescriptions for schedule II controlled substances dispensed are filed separately from other paper prescriptions whether a pharmacy is using two separate files or three separate files for its system. Meperidine is the only schedule II controlled substance listed. Therefore, answer choice E is correct. The applicable section of the DEA Pharmacist's Manual is Section VI. |
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Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances for maintenance and detoxification treatment must obtain a separate DEA registration as a narcotic treatment program. Which of the following forms is required for this registration? A. DEA Form 41 B. DEA Form 222 C. DEA Form 363 D.DEA Form 510 E. DEA Form 690 |
The answer is C. (You answered d.)
EXPLANATION: |
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A written prescription presented to a pharmacy to cover an oral prescription for a schedule II controlled substance issued in an emergency situation must have which of the following statements written on its face? A. Authorization for Emergency Prescribing B. Authorization for Emergency Prescription C. Authorization for Emergency Situation D. Authorization for Emergency Dispensing |
D. authorization for emergency dispening with no artifical supply limit |
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According to the DEA, all of the following may indicate a forged prescription except A. the prescriber's handwriting is too legible. B. the directions are written in full with no abbreviations. C. the quantities, directions, or dosages differ from usual medical usage. D.the prescription is not dated. E. the prescription appears to be photocopied. |
The answer is D. (You answered a.) The applicable section of the DEA Pharmacist's Manual is Appendix D. |
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what are changes on a C2 Rx a Rph can make? |
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In 2012, the DEA for the first time scheduled carisoprodol as a controlled substance. When a drug not previously listed as a controlled substance is scheduled, when must it be counted in the controlled substances inventory? A. All new bottles ordered as of the effective date of scheduling must be inventoried. B. All quantities of the drug on hand as of the effective date of scheduling must be inventoried. C. All quantities of the drug on hand during the next biennial inventory must be inventoried. D. All quantities of the drug on hand within 30 days of the effective date of scheduling must be inventoried. E. The quantity of drug on hand during the next biennial inventory must be estimated. |
B. All quantities of the drug on hand as of the effective date of scheduling must be inventoried.
The applicable section of the DEA Pharmacist's Manual is Section VII. |
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Which of the following people may issue a prescription for a schedule II controlled substance? A. A physician authorized by state law to prescribe controlled substances B. A physician assistant working in a federal prison C. A veterinarian registered with the DEA D. All of the above E. A and C only
Correct. The answer is D. |
D. all of the above The applicable section of the DEA Pharmacist's Manual is Section IX. |
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Which of the following health care practitioners is allowed to compound? A. A licensed pharmacist in a state-licensed pharmacy B. A licensed pharmacist in a federal facility C. A licensed physician D. All of the above E. A and B only |
D. all of the above The applicable section of the federal FDCA is 21 USC 353a. |
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A physician writes a prescription for 100 tablets of hydromorphone 4 mg. She notes on the prescription that the patient is terminally ill. How long does the pharmacist have to dispense in partial quantities up to the 100 tablets ordered?
A. The pharmacist must dispense all of the tablets at once. B. The pharmacist must complete the dispensing within 72 hours. C. The pharmacist may partially fill the prescription for 30 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed). D. The pharmacist may partially fill the prescription for 60 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed). E. The pharmacist may partially fill the prescription for 90 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed). |
D. A prescription for a schedule II controlled substance written for a patient with a terminal illness may be filled in partial quantities to include individual dosage units. Such prescriptions are valid up to 60 days after the issue date. The applicable section of the DEA Pharmacist's Manual is Section X. |
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When can the facsimile of a prescription for a schedule II controlled substance serve as the original prescription? A. When the prescription is for a narcotic to be compounded for direct administration to a patient via injection B. When a patient is a resident of a long-term care facility C. When a patient is enrolled in a hospice care program D.All of the above E. B and C only |
D. all of the above Home Infusion, hospice, and LTC, federal and IL allow the fax to serve as the original
but if home infusion pharmacy is dispesning a solid/liquid/po/IV dosage form to be inj by the patient, the original writtten Rx is still required |
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As required by the Combat Methamphetamine Epidemic Act of 2005, pharmacies that sell over-the-counter products containing pseudoephedrine must A. be licensed by the DEA. B. be registered with the DEA. C. be self-certified with the DEA. D. be a licensed pharmacy. E. have a wholesale distributor permit. |
C. self certified with DEA -In IL, must have a sign log of purchaser's name and address, date and time of transcaction, brand, product name, and quanity of PSE/EPH -keep confidential and mainted for at least 2 years |
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In addition to obtaining a separate DEA registration as a narcotic treatment program (using DEA Form 363), opioid addiction treatment programs must also be approved and certified by A. the Department of Justice. B. the Center for Substance Abuse Treatment. C. Homeland Security. D.the Food and Drug Administration. E. the Centers for Disease Control and Prevention. |
B. center for substance abuse tx |
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A patient has a prescription for 20 tablets of alprazolam 1 mg, 1 tid prn for anxiety, with 5 refills. She wants to pick up 10 tablets every week. Which of the following statements is correct? A. The patient will receive a total of only 60 tablets (10 at the first filling, plus 10 more at each subsequent refill). B. The patient will receive 10 tablets a week up to the 120 tablets originally prescribed if no dispensing occurs beyond 6 months from the date on which the prescription was issued. C. The patient may receive only 5 refills, and she must receive 20 tablets each time. D. The patient may refill this prescription only once per month. E. The prescription may be filled only 6 times. |
B. |
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To protect the public, the United States Department of Health and Human Services requires the disclosure of material facts relating to any drug subject to an abbreviated drug application. Knowingly failing to disclose this information could cost an individual up to how much money in civil penalties? A. $250 B. $2,500 C. $25,000 D. $250,000 E. $2,500,000 |
D. 250000 |
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T/F You manage a pharmaceutical warehouse where schedule II controlled substances are sold to pharmacies. You receive a DEA Form 222 from a pharmacy ordering 10 bottles of 100 count oxycodone/acetaminophen 5/325 mg. It is acceptable for you to send 1 bottle of 1,000 count of the same drug and strength. |
True The applicable section of the DEA Pharmacist's Manual is Section VIII. |
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T/F The person granted power of attorney to obtain and execute a DEA Form 222 must be a registrant with the DEA. |
The statement is false. Pharmacists can execute a DEA Form 222, but they do not have to be registrants. Moreover, there is no requirement that the person granted power of attorney be a health care practitioner. A pharmacy can grant power of attorney to any individual, whether or not the individual is located at the registered location. The applicable section of the DEA Pharmacist's Manual is Section VIII |
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When requesting a drug sample, a prescriber must provide which of the following items? A. A list of patients who will receive the samples B. A list of the diagnoses for which the samples will be used C. The prescriber's actual signature D. A statement confirming that the prescriber will not sell these samples E. All of the above |
c. The prescriber's actual signature The applicable section of the federal FDCA is 21 USC 353. |
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A disciplinary action by the DEA against a registrant is initiated by which of the following? A. An indictment B. A notice of hearing and charges C. An order to show cause D.A presentment E. A complaint |
C. an order to show cause |
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Pharmacists may remove the labeling of a “commercial” or “stock” container of a prescription drug, without violating the federal Food, Drug, and Cosmetic Act prohibition against removing the labeling of a prescription drug, when selling the drug A. on the prescription of a licensed prescriber. B. to another pharmacy. C. to a licensed prescriber. D. to a licensed hospital. E. to a licensed nursing home facility.
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The answer is A. (You answered b.)
The U.S. Food, Drug, and Cosmetic Act at 21 U.S.C. 331 prohibits “alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.” However, 21 U.S.C. 353 of the act exempts from the labeling requirements the dispensing of a prescription drug as long as the label contains the information required in 21 U.S.C. 353. |
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Who has access to logbook information relating to sales of SLCPs? A. FDA site inspectors B. National Institutes of Health grantees C. State boards of medicine D. Persons facilitating a product recall E. County health boards |
D. SLCPs stands for scheduled listed chemical products. The applicable section of the DEA Pharmacist's Manual is Section XIV. |
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The U.S. Food, Drug, and Cosmetic Act requires that both human use and animal use prescription drugs have the symbol “Rx Only” on the label of the commercial container in which the drugs are packaged. A. True B. False |
B. false Human use prescription drugs are required to have the “Rx Only” symbol on the label. Veterinary use (animal use) prescription drugs are required to have the federal legend “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian” on the label. The applicable section of the U.S. Code (U.S.C.) is found at 21 U.S.C. 353. |
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“[A] pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user” is the definition of which of the following? A. Central fill pharmacy B. Substitute pharmacy C. Replacement pharmacy D.Transfer pharmacy E. Virtual pharmacy |
a. central fill pharmacy |
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The only person who may grant and issue a power of attorney to sign the DEA order form for purchasing schedule II controlled substances is the person who signed the last application for registration or reregistration. A. True B. False |
true |
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Your pharmacy discovers a significant loss of Lortab (acetaminophen and hydrocodone). The pharmacy must notify the DEA A. on the day of the discovery. B. within 1 business day of the discovery. C. within 3 business days of the discovery. D. within 7 business days of the discovery. E. within 30 business days of the discovery. |
B. A pharmacy must report, in writing to the local DEA Diversion Field Office, a significant loss of a drug product within 1 business day of the discovery. The applicable section of the DEA Pharmacist's Manual is Section V.
then they must fill out a DEA 106 form (no timeline) to properly document the circumstances of theft or significant loss |
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With respect to compounding, a pharmacist may not A. compound based on a history of prescribing from a licensed prescriber. B. compound in response to an oral prescription. C. compound a product that has been removed from the market D. compound a dose of a commercially available product in an emergency. E. compound a dose of a commercially available product in response to a drug shortage. |
C. a product that has been removed from market |
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Under the "Five Percent Rule," a pharmacy registered to dispense controlled substances to another registrant may do so without registering as a distributor as long as the amount of controlled substances distributed does not exceed 5% of the A. total number of dosage units of all controlled substances dispensed by the pharmacy during a calendar year. B. dosage units on hand at the time of the dispensation to the other registrant. C. total dollars spent on controlled substances in one month. D. individual controlled substances ordered in that month. E. total weight (mg) of controlled substances on hand at the time of the sale. |
A. The applicable section of the DEA Pharmacist's Manual is Section XIII. |
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A manufacturer produces a drug that must be mixed prior to dispensing. This mixing is considered compounding. A. True B. False |
The statement is false. The applicable section of the federal FDCA is 21 USC 353a, which states that compounding "does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling." |
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Under federal law, a controlled substance may be dispensed without a prescription provided that A. dispensing is done by a pharmacist. B. a maximum of 100 tablets is dispensed. C. the purchaser is 21 years old. D. the sale is reported to the DEA prescription drug monitoring program. E. A and C only |
Federal law says A,
-but IL law says purchaser must provide 2 positive forms of ID required showing that purchasers is 21yo along with recording signature of purchaser, certification of no purchases within 96 hrs, time of sale and signature of pharmD
The applicable section of the DEA Pharmacist's Manual is Section X. |
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Your pharmacy has transferred controlled substances to another DEA registrant. How long do you need to keep the record of transfer? A. 1 year B. 2 years C. 3 years D.5 years E. 10 years |
2 years |
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The term dietary supplement means a product (other than tobacco) intended to supplement the diet that bears or contains which of the following dietary ingredients? A. An amino acid B. An herb or other botanical C. A mineral D. A vitamin E. All of the above |
E. all of the above |
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For a retail pharmacy to transmit a prescription electronically to a central fill pharmacy, which of the following must happen? A. The retail pharmacy must ensure that all information required to be on a prescription is transmitted to the central fill pharmacy. B. The retail pharmacy must write "CENTRAL FILL" on the face of the prescription. C. The retail pharmacy must maintain the original prescription for a period of 2 years from the date the prescription was last refilled. D. All of the above E. None of the above |
D. all the above The applicable section of the DEA Pharmacist's Manual is Section XII. |
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In 2007, the U.S. Congress passed two acts relating to children, the Best Pharmaceuticals for Children Act of 2007 and the Pediatric Research Equity Act of 2007. A. True B. False |
true |
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A narcotic drug that contains a non-narcotic active medicinal ingredient and is a schedule V controlled substance is defined as any compound that does not have more than A. 200 mg of codeine per 100 mL of product. B. 100 mg of dihydrocodeine per 100 mL of product. C. 100 mg of opium per 100 g of product. D. All of the above E. A and B only |
d. all the above
rickerts packet says C5 of hydrocodone must be <= 10mg/100mL OR 100g |
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Which of the following terms is defined as any adverse event associated with the use of a drug in humans, whether or not the event is considered drug related? A. Adverse drug experience B. Drug reaction C. Drug safety issue D. Drug side effect E. Drug toxicity |
D. adverse drug experience |
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A college or school of pharmacy may obtain and use tax-free alcohol for scientific, medicinal, and mechanical purposes, such as teaching students proper pharmaceutical compounding techniques. A. True B. False |
true |
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If a drug and its container are so made, formed, or filled as to be misleading, that drug shall be deemed to be A. adulterated. B. counterfeit. C. dangerous. D.misbranded. E. a pesticide. |
D. misbranded |
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You are a DEA registrant, and you have an interest in "medical marijuana," which currently is a schedule I controlled substance. What are the restrictions on the use of a schedule I controlled substance? A. It cannot be administered for medical use. B. It cannot be dispensed for medical use. C. It cannot be prescribed for medical use. D. All of the above E. A and B only |
D. all the above |
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In 1938, the U.S. Congress passed the federal Food, Drug, and Cosmetic Act. This law was preceded by which of the following laws? A. The Pure Food and Drug Act B. The Durham–Humphrey Amendment C. The Kefauver–Harris Amendment D. The Prescription Drug Marketing Act E. The Dietary Supplement Health and Education Act |
The Pure Food and Drug Act was passed in 1906. Answer choices B and C are incorrect because they are amendments to the federal FDCA of 1938 (the Durham–Humphrey Amendment was passed in 1951, and the Kefauver–Harris Amendment was passed in 1962). Answer choices D and E are incorrect because they did not precede the federal FDCA (the Prescription Drug Marketing Act was passed in 1987, and the Dietary Supplement Health and Education Act was passed in 1994). |
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You have received a shipment of zolpidem. You must keep an invoice or packing slip on which you record A. the date the drug was received. B. the dosage form of drug products received. C. the number of commercial containers ordered and received. D. All of the above E. A and C only
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D |
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The labeling for all over-the-counter drug products that are intended for systemic absorption, unless specifically exempted, shall contain a general warning under the heading "Warning" as follows: " ask a health professional before use." In addition to the written warning, a symbol that conveys the intent of the warning may be used in labeling. This labeling policy applies to all of the following drug types except
A. drugs intended to benefit the fetus during pregnancy. B. drugs labeled exclusively for pediatric use. C. drugs intended to benefit a nursing infant. D. All of the above E. A and C only |
D. all the above |
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You discover that there has been a clerical error in your perpetual inventory of fentanyl. You must report this error on a DEA Form 106. A. True B. False |
The statement is false. Miscounts or adjustments to inventory involving clerical errors should be noted on a separate log at the pharmacy manager's discretion. The applicable section of the DEA Pharmacist's Manual is Section V. |
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According to the federal FDCA, the term rare disease or condition means any disease or condition affecting A. fewer than 10,000 people in the United States. B. fewer than 100,000 people worldwide. C. fewer than 200,000 people in the United States. D. fewer than 1 million people worldwide. E. fewer than 2 million people worldwide. |
C |
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The DEA requires pharmacies to report a significant loss of controlled substances. Which of the following factors should be considered when determining if a loss is significant? A. The actual quantity of controlled substances lost in relation to the type of business B. A pattern of losses over a specific time period and whether those losses appear to be random C. The specific controlled substances lost and whether those controlled substances are likely candidates for diversion D. Local trends and other indicators of the missing controlled substances' diversion potential E. All of the above |
e |
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A physician assistant who practices in a facility owned by an Indian tribe can use his social security number to write prescriptions for controlled substances at a local emergency room where he moonlights in lieu of obtaining DEA registration. A. True B. False |
The statement is false. The requirement of DEA registration is waived only when prescribing in the course of duty as a federal employee. The applicable section of the DEA Pharmacist's Manual is Section IX. |
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The pharmacy where you practice is open on Sunday. At 1:00 p.m. on Sunday, you receive a telephone call from an oral surgeon who tells you that she performed significant oral surgery on a patient on the preceding Friday. She prescribed hydrocodone in combination with acetaminophen for pain management. However, she just spoke with the patient and learned that the medication was not controlling the pain. She now wants to issue an emergency oral prescription for the schedule II controlled substance oxycodone in combination with acetaminophen. For you to dispense this prescription, a legitimate emergency situation must exist. Which of the following is not one of the three conditions that must be satisfied to have a legitimate emergency situation? A. Immediate administration of the controlled substance is necessary for proper treatment of the patient. B. The patient has used a schedule III or IV controlled substance for at least 72 hours prior to the oral emergency prescription order for a schedule II controlled substance, but the schedule III or IV controlled substance has been ineffective. C. No appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under schedule II of the Controlled Substances Act. D. It is not reasonably possible for the prescribing practitioner to present a written prescription to the person dispensing the substance, prior to the dispensing. |
B. The applicable U.S. Food and Drug Administration (FDA) regulation is found in the Code of Federal Regulations (CFR) at 21 CFR 290.10. First, although this question addresses dispensing of controlled substances, the applicable regulation is in the FDA regulations and not the U.S. Drug Enforcement Agency (DEA) regulations. Second, because the individual items are joined by the conjunction “and” in the regulation, the three remaining items must be present simultaneously to have a legitimate emergency situation. |
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Which of the following items is not required on a written prescription for a controlled substance? A. The patient's full name B. The patient's address C. The prescriber's phone number D. The quantity prescribed E. The dosage form (e.g., tablet or capsule) |
c. prescribers phone # |
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On the over-the-counter label for Benadryl (diphenhydramine), what would be listed under the heading "Purpose"? A. Antihistamine B. Sneezing and allergies C. May cause drowsiness D. Keep out of the reach of children. E. No such heading exists on an OTC label. |
a. antihistamine |
