Federal Pharmacy Law and Regulations
What this domain tests
Federal law sets the floor for dispensing in every Nevada pharmacy. The NV MPJE tests legend-drug status, prescription validity, refills, labeling, recordkeeping, compounding, and drug-supply-chain rules. Nevada may be stricter, but it cannot authorize what federal law prohibits.
Core rules
- Prescription validity. A prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The pharmacist has a duty to resolve red flags before dispensing.
- Refills. Schedule II has no refills. Schedule III–V may be refilled up to five times or within six months of issue, whichever comes first.
- Emergency CII. An oral CII may be filled only in a bona fide emergency; the prescriber must provide a written prescription within seven days, or the pharmacist must notify DEA.
- Labeling and records. Federal rules require pharmacy name and address, Rx number, date, patient name, prescriber, directions, and cautionary statements. Controlled-substance records are kept two years; a biennial inventory is required.
- Compounding. 503A compounding is patient-specific and uses bulk drug substances from the FDA list; 503B outsourcing facilities are subject to cGMP.
- DSCSA and REMS. Verify trading partners and product serialization; follow REMS restrictions before dispensing.
Worked example
A prescriber writes “Hydrocodone/APAP 5/325, #30, refill 6 times.” Hydrocodone combination products are Schedule II, so there are no refills at all. The pharmacist may dispense the original 30 but cannot honor any refill. If the drug were CIII–V, the pharmacist could allow five refills or six months, whichever comes first.
Traps
Do not apply state leniency to federal refill limits; do not accept “PRN” as a refill on a CII; do not forget the seven-day written follow-up for emergency CII; do not confuse DEA Form 222 with an ordinary prescription.