Federal Pharmacy Law and Rules
Scope of the federal domain
This domain tests the Controlled Substances Act, DEA registration and recordkeeping, federal prescription validity, and distribution rules that apply in Iowa pharmacies. Federal law sets a floor; Iowa Board rules can be stricter, and the MPJE expects you to apply both.
Core rules
- CII prescriptions have no refills. CIII–CV may be refilled up to five times within six months of issue.
- An emergency oral CII may be dispensed, but the prescriber must supply a written prescription within seven days.
- The prescriber must be DEA-registered and state-licensed. The pharmacist has corresponding responsibility to resolve red flags before dispensing.
- DEA registration renews every three years. Controlled substance records and inventories are generally kept two years, with a biennial inventory.
- DSCSA transaction information applies to prescription drug distribution; 503A/503B rules limit compounding and distribution.
Worked example
A patient presents a paper prescription for oxycodone 30 mg #60 with “refill x2.” The pharmacist cannot honor refills on a CII. She verifies the prescriber’s DEA and Iowa license, checks the Iowa PMP, confirms the quantity and directions are internally consistent, and dispenses one fill. She documents the red-flag review. If this had been an emergency oral CII, she could dispense it but must obtain the written prescription within seven days.
Traps that cost marks
Treating a CII refill as a clerical error; missing the seven-day written follow-up; accepting a DEA number without checking state authority; assuming federal rules override stricter Iowa PMP or labeling rules; ignoring corresponding responsibility when the patient pays cash or travels a long distance.