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
Under the Drug Supply Chain Security Act (DSCSA), what is the primary goal for pharmacy compliance by November 2024?
Answer: Unit-level drug tracing using interoperable electronic systems
The DSCSA's 2024 implementation deadline requires pharmacies and trading partners to exchange serialized, unit-level drug tracing data electronically.
Which DEA registration form must a pharmacy complete to order Schedule II controlled substances?
Answer: DEA Form 222 or CSOS electronic equivalent
DEA Form 222 (or its electronic equivalent via CSOS) is required for ordering Schedule I and II controlled substances from a distributor.
A prescriber verbally orders a Schedule II controlled substance for a hospitalized patient. When must the pharmacy receive the written or electronic prescription?
Answer: Within 7 days of the verbal order
In emergency situations, a Schedule II may be dispensed on a verbal order, but the pharmacy must receive the written or e-prescription within 7 days.
Under HIPAA's minimum necessary standard, what should a pharmacy technician do when accessing patient records?
Answer: Access only the information needed to complete the specific task
The minimum necessary standard requires workforce members to access only the PHI needed to perform their specific job function.
Which law requires manufacturers to include a Medication Guide with certain high-risk prescription drugs?
Answer: FDA Regulations under 21 CFR Part 208
21 CFR Part 208 requires Medication Guides for drugs that FDA determines pose serious risk if used incorrectly, ensuring patients receive specific written safety information.
What is the legal requirement for a pharmacy technician who discovers a dispensing error made by another technician?
Answer: Immediately report the error to the pharmacist for evaluation
Any discovered dispensing error must be immediately escalated to the supervising pharmacist, who is legally responsible for evaluating patient safety and required reporting.
Which federal act specifically regulates the marketing and distribution of biological products, including vaccines?
Answer: Public Health Service Act (PHSA)
The Public Health Service Act authorizes FDA regulation of biological products such as vaccines, blood products, and gene therapies.