Federal Pharmacy Laws and Regulations
CSA scheduling and DEA registration
The federal Controlled Substances Act places drugs in Schedules I-V. Schedule II prescriptions may not be refilled. Schedule III-IV prescriptions may be refilled up to five times within six months from the date written. Prescribers and dispensers need DEA registration, and electronic CII prescriptions require CSOS or an approved electronic prescription application. Pharmacists must verify DEA registration and exercise corresponding responsibility.
CII emergency and partial fills
An emergency oral CII order may be dispensed only for the emergency period; the prescriber must deliver a written prescription within seven days. If it is not received, the pharmacist must notify DEA. A CII may be partially filled when the pharmacist cannot supply the full quantity, with the remainder filled within 72 hours; if not, the pharmacist must notify the prescriber and no further quantity may be supplied. For long-term care patients and terminally ill patients, partial fills may extend up to 60 days.
Records, DSCSA, and pseudoephedrine
DEA Form 106 documents theft or significant loss; DEA Form 41 documents destruction. The Drug Supply Chain Security Act requires transaction documentation and verification of suspicious product. The Combat Methamphetamine Epidemic Act limits retail pseudoephedrine to 3.6 g per day and 9 g per 30 days, requires a logbook and photo ID, and restricts sales to adults.
Worked example
A prescriber telephones an emergency CII prescription for a patient with acute pain. The pharmacist may dispense a limited emergency quantity, documents the call, and requests a written prescription. The written prescription must arrive within seven days. If day seven passes without it, the pharmacist must notify DEA; the pharmacist cannot simply treat the oral order as a refillable prescription.
Traps
Refilling a CII; miscounting the six-month/five-refill rule for CIII-IV; missing the 72-hour or 60-day partial-fill limits; failing to use DEA Form 106 for loss; ignoring DSCSA verification; and selling pseudoephedrine without the logbook or over the daily/monthly limits.