PTCE - Federal Requirements - Section 2.3

Apply federal requirements for receiving, storing, ordering, labelling, dispensing, returning, take-back programmes, loss or theft, and destruction of controlled substances.

Apply federal requirements governing the full lifecycle of controlled substances, from ordering via DEA Form 222 through receiving, storing, labelling, dispensing, and destruction, including biennial inventory and take-back programme obligations. Identify the documentation and reporting steps required at each stage, including loss or theft notification.

DEA Form 222Controlled substance inventoryTake-back programmeBiennial inventory

Practice question for this objective

Free sampleFederal Requirementshard

After a break-in, a pharmacy discovers that a quantity of Schedule II oxycodone is missing from the safe. A technician is asked which federal form is used to notify the DEA of this significant loss or theft. Which document serves that reporting function?

  • ADEA Form 222, because the same order form documents both incoming purchases and any unexplained shortfalls of Schedule II stock.
  • BDEA Form 224, the registration application, updated to reflect the reduced quantity of stock held.
  • CDEA Form 106, the report a registrant files to notify the DEA of a significant loss or theft of controlled substances. Correct
  • DDEA Form 41, the record completed when controlled substances are destroyed under witnessed conditions.
Identify DEA Form 106 as the federal report for notifying the DEA of significant loss or theft of controlled substances. Federal accountability rules require a registrant who discovers a significant loss or theft to document and report the event so the DEA can investigate diversion, and the Form 106 is the standardised instrument for that notification.

Why A is wrong: It is tempting because Form 222 tracks Schedule II movement, but it is an order form and does not serve as the loss or theft report.

Why B is wrong: Form 224 is the registration application and is unrelated to reporting losses, so using it to notify the DEA of theft is incorrect.

Why C is correct: Correct because the DEA Form 106 is the designated report for notifying the DEA of significant losses or thefts of controlled substances after discovery.

Why D is wrong: Form 41 documents destruction of controlled substances, not theft or unexplained loss, so it addresses a different stage of the lifecycle.

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