Federal Pharmacy Laws and Regulations
What the Federal Domain Tests
The federal portion tests the Controlled Substances Act (CSA), DEA registration and recordkeeping, FDA prescription drug requirements, HIPAA privacy, DSCSA product tracing, and Combat Methamphetamine Epidemic Act (CMEA) sales limits. Federal law sets a floor; states may be stricter, but a Kansas pharmacist must satisfy both.
Core Federal Rules
- DEA registration is required for each principal place of business where controlled substances are dispensed. A state license alone is not enough.
- Schedule II prescriptions may not be refilled. A prescriber may issue multiple Schedule II prescriptions for up to a 90-day supply with earliest-fill dates. Partial fills are limited: at patient or prescriber request, the remainder must generally be filled within 30 days; emergency oral Schedule II prescriptions require a written follow-up within 7 days.
- Schedule III–V prescriptions may be refilled up to five times within six months of issue.
- Schedule II records must be kept separately; a biennial inventory is required; theft or significant loss is reported to DEA, generally on Form 106.
- CMEA restricts OTC pseudoephedrine sales: 3.6 g per day, 9 g per 30 days, logbook, government ID, and age 18 or older.
- DSCSA requires transaction information, verification, and product serialization throughout the supply chain. HIPAA limits uses and disclosures to the minimum necessary for the purpose.
Worked Example
A patient presents a Schedule II oxycodone prescription for #30 and asks for only 10 tablets now because of cost. The pharmacist may partially fill 10 tablets and record the quantity. The remaining 20 may be dispensed within 30 days of the date written; after that, a new prescription is required. The pharmacist cannot treat the prescription as refillable, and cannot extend the remainder beyond the federal partial-fill window.
Traps That Cost Marks
Confusing DEA registration with state licensure; refilling a Schedule II; applying the six-month/five-refill rule to Schedule II; reporting theft only to local police and not DEA; and ignoring CMEA daily and 30-day limits.