PTCE Pharmacy Law and Regulations 3

Question 1

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

Accepted Answer

Durham-Humphrey Amendment of 1951

Answer

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

Question 2

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:

Accepted Answer

90 days

Answer

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.

Question 3

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

Accepted Answer

Dispense as written — no generic substitution per prescriber

Answer

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

Question 4

Under USP <797>, a low-risk compounded sterile preparation with no more than 12 hours storage at room temperature must be used within:

Accepted Answer

12 hours

Answer

USP <797> allows low-risk CSPs stored at controlled room temperature to have a BUD of up to 12 hours.

Question 5

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

Accepted Answer

OSHA itself

Answer

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

(PTCE) Pharmacy Technician Certification Exam Practice Test

(PTCE) Pharmacy Technician Certification Exam Practice Test

PTCE Pharmacy Law and Regulations 3