MPJE Federal 5 — Questions and Answers
Question 1: Under the DEA's Disposal Regulations (21 CFR Part 1317), which of the following is an authorized method for ultimate users to dispose of unwanted controlled substances?
- Flushing medications down the toilet at home
- Returning medications to a DEA-authorized collector at a take-back location (Correct answer)
- Mailing medications to the prescriber for destruction
- Dropping medications in any hospital dumpster
Correct answer: Returning medications to a DEA-authorized collector at a take-back location
DEA-authorized collector take-back programs are the preferred lawful method for ultimate users to dispose of unwanted controlled substances.
Question 2: A pharmacy wishes to destroy returned controlled substances on-site. Which DEA form must be submitted to document the destruction of Schedule II substances?
- DEA Form 41 (Correct answer)
- DEA Form 106
- DEA Form 224
- DEA Form 363
Correct answer: DEA Form 41
DEA Form 41 (Registrant Record of Controlled Substances Destroyed) is used to document the on-site destruction of controlled substances by registrants.
Question 3: Under the Prescription Drug Marketing Act (PDMA), which of the following activities is prohibited?
- A manufacturer providing drug samples to licensed practitioners upon written request
- A wholesale distributor selling prescription drugs purchased from hospitals back into the retail market (Correct answer)
- A pharmacy transferring a prescription between its own chain locations
- A pharmacist accepting free product from a manufacturer for patient assistance
Correct answer: A wholesale distributor selling prescription drugs purchased from hospitals back into the retail market
The PDMA prohibits the sale of drug samples and the purchase of prescription drugs by hospitals for resale, to prevent drug diversion and counterfeiting.
Question 4: Under federal law, a pharmacist may dispense a controlled substance prescription only if it is issued for a 'legitimate medical purpose' by a practitioner acting in the 'usual course of professional practice.' Which landmark case reinforced pharmacist responsibility in this area?
- United States v. Moore (Correct answer)
- Gonzales v. Oregon
- United States v. Rybicki
- Chevron U.S.A. v. NRDC
Correct answer: United States v. Moore
United States v. Moore established that pharmacists have an independent corresponding responsibility to ensure controlled substance prescriptions serve a legitimate medical purpose.
Question 5: The Anabolic Steroid Control Act of 2004 placed anabolic steroids in which DEA schedule?
- Schedule II
- Schedule III (Correct answer)
- Schedule IV
- Schedule V
Correct answer: Schedule III
Anabolic steroids are classified as Schedule III controlled substances under the Anabolic Steroid Control Act of 2004.
Question 6: Under the Ryan Haight Online Pharmacy Consumer Protection Act, prescribing controlled substances via the internet without a valid in-person evaluation generally requires at least how many in-person medical evaluations by the prescribing practitioner?
- None if via telemedicine
- At least one (Correct answer)
- At least two
- Three within the prior 12 months
Correct answer: At least one
The Ryan Haight Act requires that a practitioner conduct at least one in-person medical evaluation before prescribing controlled substances via the internet, with limited telemedicine exceptions.
Question 7: Under the National Drug Code (NDC) numbering system, what do the three segments of an NDC number represent?
- Manufacturer, drug class, and dosage form
- Labeler, product, and package size (Correct answer)
- DEA schedule, therapeutic category, and lot number
- FDA approval number, active ingredient, and route of administration
Correct answer: Labeler, product, and package size
The NDC number is a 10- or 11-digit code where the three segments identify the labeler (manufacturer/distributor), the product (strength, dosage form, formulation), and the package size.
MPJE Federal 5
Under the DEA's Disposal Regulations (21 CFR Part 1317), which of the following is an authorized method for ultimate users to dispose of unwanted controlled substances?