PTCB Federal Pharmacy Law 1 — Questions and Answers
Question 1: Which federal law established the current drug scheduling system in the US?
- Durham-Humphrey Amendment
- Kefauver-Harris Amendment
- Controlled Substances Act (Correct answer)
- OBRA '90
Correct answer: Controlled Substances Act
The Controlled Substances Act of 1970 established the five-schedule classification system for controlled drugs.
Question 2: How long must pharmacies keep Schedule II prescription records?
- 1 year
- 2 years (Correct answer)
- 5 years
- 7 years
Correct answer: 2 years
Federal law requires Schedule II controlled substance records to be maintained for a minimum of 2 years.
Question 3: Which law requires pharmacists to offer counseling to Medicaid patients?
- HIPAA
- OBRA '90 (Correct answer)
- Kefauver-Harris Act
- Durham-Humphrey Amendment
Correct answer: OBRA '90
OBRA '90 (Omnibus Budget Reconciliation Act) mandated prospective drug use review and patient counseling for Medicaid patients.
Question 4: What does HIPAA primarily protect?
- Drug pricing
- Patient health information (Correct answer)
- Pharmacy licensing
- Drug manufacturing standards
Correct answer: Patient health information
HIPAA (Health Insurance Portability and Accountability Act) establishes national standards for protecting patients' private health information.
Question 5: A DEA Form 222 is required for ordering which type of drugs?
- Schedule III–V only
- Schedule II only (Correct answer)
- All controlled substances
- All prescription drugs
Correct answer: Schedule II only
DEA Form 222 (or the electronic CSOS equivalent) is required for ordering Schedule II controlled substances.
Question 6: Which amendment to the Federal Food, Drug, and Cosmetic Act distinguished legend from OTC drugs?
- Kefauver-Harris Amendment
- Durham-Humphrey Amendment (Correct answer)
- Drug Price Competition Act
- DSHEA
Correct answer: Durham-Humphrey Amendment
The Durham-Humphrey Amendment of 1951 defined which drugs require a prescription (legend drugs) and which can be sold OTC.
PTCB Federal Pharmacy Law 1
Which federal law established the current drug scheduling system in the US?