Regulatory Compliance Flashcards
7 cards from real CCP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance flashcards as text
Under USP , which beyond-use date (BUD) category applies to a compounded sterile preparation made under non-sterile conditions with immediate use?
Answer: Immediate use (1 hour)
USP allows immediate-use CSPs prepared non-aseptically to be administered within 1 hour of preparation.
A consultant pharmacist is asked about the legal basis for mandating medication therapy management (MTM) services for Medicare Part D beneficiaries. Which law applies?
Answer: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
The Medicare Modernization Act of 2003 (MMA) created Medicare Part D and required MTM programs for eligible beneficiaries.
Which federal regulation prohibits a pharmacist from dispensing a drug not approved under an NDA or ANDA without a valid exemption?
Answer: 21 CFR Part 314 (New Drug Applications)
21 CFR Part 314 governs the NDA/ANDA approval process; dispensing unapproved drugs violates the FDCA unless an exemption applies.
Which schedule requires a new written prescription for each refill, with no refills permitted?
Answer: Schedule II
Schedule II controlled substances cannot be refilled; a new prescription is required for each dispensing.
A long-term care pharmacist wants to verify a nursing facility's compliance with federal pharmacy regulations. Which CMS survey tool is primarily used?
Answer: CMS Form 2567 (Statement of Deficiencies)
CMS Form 2567 documents deficiencies found during nursing facility surveys and is the primary compliance verification tool.
The Ryan Haight Online Pharmacy Consumer Protection Act primarily regulates which activity?
Answer: Online prescribing and dispensing of controlled substances
The Ryan Haight Act requires at least one in-person medical evaluation before prescribing controlled substances via the internet.
Under HIPAA, which term describes the minimum amount of patient information necessary to accomplish the intended purpose?
Answer: Minimum necessary standard
The minimum necessary standard requires covered entities to limit PHI use and disclosure to what is needed for the specific purpose.