Federal Pharmacy Law
What this domain tests
Federal pharmacy law on the MPJE tests the FDCA, Controlled Substances Act (CSA), DEA regulations, HIPAA, DSCSA, REMS, PPPA, and federal compounding rules. Questions often turn on a federal minimum that a state may make stricter.
Core federal rules
- FDCA: A drug must have FDA approval for its labeled use before interstate distribution; pharmacists handle prescription labeling, adulteration/misbranding, and REMS requirements.
- CSA scheduling: CI has no accepted medical use; CII–V have accepted medical use with abuse potential. Registration is site-specific; each principal place of business needs its own DEA registration, renewed every three years.
- CII orders and records: Use DEA Form 222 or CSOS for CII purchases. Keep biennial inventories and records; report theft or significant loss to DEA in writing within one business day of discovery (Form 106).
- Prescription rules: CII prescriptions cannot be refilled. CIII–V may be refilled up to five times within six months of issue. A CII may be partially filled in limited circumstances; know the difference between a partial fill due to insufficient stock and one requested by the patient or prescriber.
- DSCSA: Verify transaction information and serialized product; know the exemptions and the verification response requirements.
Worked example
A prescription reads 'oxycodone 5 mg #90, refills: 2.' The refills are invalid because oxycodone is CII. If the prescription is otherwise valid, dispense no more than 90 tablets and do not refill it; contact the prescriber for a new prescription for any additional supply. Also follow Maine’s PMP and quantity rules, which can be stricter.
Traps
Treating DEA registration as portable between locations; refilling a CII because a state law seems to allow it; using Form 222 for CIII–V; missing the one-business-day loss report; assuming HIPAA requires written consent for treatment, payment, or operations.