Pharmacy Law Flashcards
7 cards from real CPHT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacy Law flashcards as text
A patient requests their prescription records from the pharmacy. Under HIPAA, within how many days must the pharmacy respond?
Answer: 30 days
HIPAA requires covered entities to provide requested health records within 30 days, with a possible 30-day extension if needed.
Which federal regulation governs the safe disposal of controlled substances by patients at authorized collection sites?
Answer: DEA Drug Disposal Regulations (21 CFR 1317)
21 CFR Part 1317 establishes the DEA's rules for ultimate users and registrants to dispose of controlled substances through authorized collection methods.
Under the Poison Prevention Packaging Act (PPPA), which product is exempt from child-resistant packaging requirements?
Answer: Sublingual nitroglycerin tablets
Sublingual nitroglycerin tablets are specifically exempt from child-resistant packaging under PPPA due to the need for rapid emergency access.
What does 'therapeutic substitution' mean in pharmacy practice?
Answer: Dispensing a different drug in the same therapeutic class as prescribed
Therapeutic substitution involves dispensing a chemically different but pharmacologically similar drug, which generally requires prescriber authorization.
Which organization sets standards for drug purity, strength, and quality that have legal authority in the United States?
Answer: United States Pharmacopeia (USP)
USP standards are incorporated by reference into federal law through the FD&C Act, giving them legal enforceability in the US.
A pharmacy dispenses a non-controlled prescription with 3 refills. How long does the patient have to use those refills under most state and federal guidelines?
Answer: 1 year from the original date
Non-controlled prescriptions and their refills are generally valid for 1 year from the date originally written, though individual state laws vary.
Which act created the National Drug Code (NDC) numbering system for all commercially distributed drugs?
Answer: Drug Listing Act of 1972
The Drug Listing Act of 1972 required all commercially distributed drug products to register with the FDA using a unique National Drug Code.