Federal Pharmacy Laws and Regulations
Federal framework
Federal questions reward a source-hierarchy approach: the Controlled Substances Act (CSA) and DEA regulations govern controlled substances; the Federal Food, Drug, and Cosmetic Act and Durham-Humphrey govern legend versus OTC status; and statutes such as OBRA '90, PPPA, and DSCSA add counseling, packaging, and tracing duties. Know the schedules and what changes by schedule: CII has no refills; CIII–CV may be refilled up to five times within six months of issue. A CII prescription may be oral in an emergency, but a written prescription must follow within seven days, or the pharmacist must notify DEA. Partial filling rules differ for CII versus CIII–CV. DEA registration is location-specific, and a registrant must have a power of attorney or CSOS access for Form 222 ordering. Inventory and records are generally kept two years and must be readily retrievable.
Traps include treating a prescriber's DEA number as proof of state authority, assuming a faxed CII is always valid, and missing the pharmacist's corresponding responsibility to resolve red flags. CMEA questions test behind-the-counter placement, logbook/ID rules, and the 3.6 g per day and 9 g per 30 days base limits for ephedrine/pseudoephedrine. DSCSA questions test transaction information and verification, not just storage.
Rule of thumb: identify the drug schedule first, then the prescription format, refill, recordkeeping, and counseling rules that attach. Worked example: a patient presents an oral CII for acute pain. The pharmacist may dispense only if the prescriber is authorized and the prescription is for a legitimate medical purpose; the pharmacist must obtain the written CII within seven days and document the emergency.