Pharmacy Law and Regulations Flashcards

Which federal law first required that prescription drugs be dispensed only with a valid prescription, separating them from OTC products?

Answer: Durham-Humphrey Amendment of 1951

The Durham-Humphrey Amendment of 1951 established the legal distinction between prescription and over-the-counter drugs.

A patient requests a 90-day supply of a Schedule III medication. The maximum days' supply a pharmacy can dispense on a single written prescription is:

Answer: 90 days

Schedule III and IV prescriptions may be dispensed for up to a 90-day supply per fill and refilled up to 5 times within 6 months.

The term 'DAW-1' on a prescription means:

Answer: Dispense as written — no generic substitution per prescriber

DAW-1 (Dispense As Written code 1) indicates the prescriber mandates the brand-name product and no generic substitution is permitted.

Under USP , a low-risk compounded sterile preparation with no more than 12 hours storage at room temperature must be used within:

Answer: 12 hours

USP allows low-risk CSPs stored at controlled room temperature to have a BUD of up to 12 hours.

Which agency enforces the Occupational Safety and Health Administration (OSHA) hazardous drug handling standards in pharmacies?

Answer: OSHA itself

OSHA enforces its own hazardous drug handling regulations, including requirements for PPE and safe handling of antineoplastic agents in pharmacy settings.

A pharmacist is on vacation and the pharmacy has only technicians present. Which action is legally permissible?

Answer: None of the above — the pharmacy must be closed

A licensed pharmacist must be present for dispensing, final verification, and counseling; a pharmacy cannot legally operate with only technicians.

The MedWatch program is administered by the FDA for the purpose of:

Answer: Reporting serious adverse drug events and product problems

MedWatch is the FDA's safety reporting program for healthcare professionals and consumers to report adverse drug reactions and product defects.