Federal Drug Laws and Regulations
Federal Drug Laws and Regulations
This domain tests the federal statutes and FDA/DEA regulations that set the floor for drug approval, prescription status, labeling, packaging, marketing, and distribution. ND questions often ask which federal rule applies before a pharmacist may dispense, or how a federal requirement interacts with a stricter state rule.
Core rules
- FDCA: drugs must be approved under an NDA/ANDA or meet an OTC monograph; adulterated or misbranded drugs may not enter interstate commerce.
- Durham-Humphrey: creates the prescription-drug category; a legend drug requires a prescription except in specific practitioner or dispensing exceptions. Labels must carry "Rx only."
- Kefauver-Harris: requires substantial evidence of effectiveness and informed consent for investigational drugs.
- PPPA: child-resistant packaging for most oral prescription drugs; exemptions exist, including prescriber/patient requests, and non-CR packaging must still carry proper warning.
- CMEA: pseudoephedrine/ephedrine sales behind the counter, logbook, photo ID, 18+, 3.6 g/day and 9 g/30 days.
- DSCSA: interoperable tracing, verification, and authorized trading partners; pharmacies need policies for suspect product and recalls.
- REMS and Ryan Haight: special safety restrictions and telemedicine prescribing limits.
Worked example
A patient buys 20 tablets of 30 mg pseudoephedrine on Monday and returns Wednesday for another 20. Each purchase is 600 mg, so two purchases total 1,200 mg. That is under the 3.6 g daily limit and under the 9 g 30-day limit. The pharmacy must still record the sale, verify age/ID, and keep the product behind the counter. The trap is treating CMEA as a prescription requirement; it is a retail sales restriction.
Traps
- Assuming FDA approval alone authorizes dispensing without a prescription.
- Confusing OTC monograph drugs with NDA drugs.
- Forgetting PPPA exemptions and patient-requested non-CR packaging.
- Missing that federal law is a floor; ND may be stricter.