Federal Drug Laws and Regulations: FDCA, CSA, DSCSA, and REMS
This domain tests the federal statutes that set the floor for drug approval, distribution, scheduling, and safety, and how pharmacy practice applies them. The MPJE expects you to distinguish FDA marketing rules from DEA controlled-substance rules and from state board rules that may be stricter.
Core federal rules
- FDCA: A new drug needs an approved NDA or ANDA; the Durham-Humphrey amendment creates prescription-only status; adulteration and misbranding prohibitions, cGMP, and postmarketing reporting apply. FDA approval does not authorize a controlled substance under state law.
- CSA: Drugs are placed in Schedules I–V; Schedule I has no accepted medical use. Registration, closed-system distribution, order forms, security, inventories, records, and theft/loss reporting are required. Federal rules are a minimum; states may be more restrictive.
- DSCSA: The prescription drug supply chain uses lot-level tracing, product verification, and serialization. Suspect or illegitimate product must be quarantined and investigated; transaction information must be exchanged.
- REMS: FDA can require ETASU such as prescriber certification, pharmacy certification, patient registry, or counseling. Dispensing may be prohibited unless requirements are met.
Worked example
A pharmacy receives a REMS drug and a DSCSA serialized package whose transaction data do not match. The technician should not dispense. The pharmacist quarantines the package, verifies the transaction information, and contacts the supplier; for the REMS drug, the pharmacist confirms the pharmacy and prescriber are certified before dispensing. The reasoning: DSCSA status and REMS status are separate gates, and both must be satisfied.
Traps
Assuming FDA approval settles scheduling; confusing prescription status with CSA schedule; treating DSCSA as optional; and dispensing a REMS drug without documenting required counseling or certification.