PTCE Pharmacy Law and Regulations 3 — Questions and Answers
Question 1: Which federal law first required that prescription drugs be dispensed only with a valid prescription, separating them from OTC products?
- Pure Food and Drug Act of 1906
- Durham-Humphrey Amendment of 1951 (Correct answer)
- Kefauver-Harris Amendment of 1962
- Food, Drug, and Cosmetic Act of 1938
Correct answer: Durham-Humphrey Amendment of 1951
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:
- 30 days
- 60 days
- 90 days (Correct answer)
- 180 days
Correct 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.
Question 3: The term 'DAW-1' on a prescription means:
- Dispense as written — no generic substitution per prescriber (Correct answer)
- Dispense as written — patient requests brand
- Dispense generic equivalent as allowed
- Drug awaiting formulary approval
Correct 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.
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:
- 4 hours
- 12 hours (Correct answer)
- 24 hours
- 48 hours
Correct answer: 12 hours
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?
- DEA
- FDA
- OSHA itself (Correct answer)
- State Board of Pharmacy
Correct answer: OSHA itself
OSHA enforces its own hazardous drug handling regulations, including requirements for PPE and safe handling of antineoplastic agents in pharmacy settings.
Question 6: A pharmacist is on vacation and the pharmacy has only technicians present. Which action is legally permissible?
- Technicians may fill and counsel on new prescriptions
- Technicians may perform final verification of filled prescriptions
- Technicians may accept new verbal orders from physicians
- None of the above — the pharmacy must be closed (Correct answer)
Correct 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.
Question 7: The MedWatch program is administered by the FDA for the purpose of:
- Tracking controlled substance inventories
- Reporting serious adverse drug events and product problems (Correct answer)
- Certifying pharmacy technicians nationally
- Monitoring drug pricing and reimbursement
Correct 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.
PTCE Pharmacy Law and Regulations 3
Which federal law first required that prescription drugs be dispensed only with a valid prescription, separating them from OTC products?