Pharmacy Law Flashcards

Which schedule includes drugs with no accepted medical use in the US and a high potential for abuse?

Answer: Schedule I

Schedule I substances (e.g., heroin, LSD, marijuana federally) have no currently accepted medical use, a lack of accepted safety, and high abuse potential.

A pharmacy technician who is authorized to call in a new prescription to another pharmacy for a Schedule III controlled substance must:

Answer: Only do so if allowed by the prescribing practitioner

Schedules III–V oral prescriptions may be communicated by an authorized agent of the practitioner (including a tech acting on the prescriber's behalf); the prescriber must authorize it.

Under federal law, what is the maximum number of refills allowed for a Schedule IV controlled substance?

Answer: Up to 5 refills within 6 months

Schedule IV controlled substances (e.g., benzodiazepines) may be refilled up to 5 times within 6 months of the date of issue.

The Poison Prevention Packaging Act (PPPA) requires child-resistant containers for most prescription drugs. Which patient can request a non-child-resistant container?

Answer: The patient or their caregiver

The PPPA allows the patient (or caregiver) to request non-child-resistant packaging, or the prescriber may request it on the patient's behalf.

Which amendment to the FD&C Act required drug manufacturers to prove both safety AND efficacy prior to approval?

Answer: Kefauver-Harris Amendment (1962)

The Kefauver-Harris Amendment (1962), passed after the thalidomide tragedy, required manufacturers to demonstrate both safety and efficacy through adequate clinical trials.

Which law created the framework for generic drug approval by establishing the Abbreviated New Drug Application (ANDA)?

Answer: Hatch-Waxman Act (1984)

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) established the ANDA pathway, allowing generics to prove bioequivalence rather than repeating full clinical trials.