Regulatory Compliance and Controlled Substances
The controlled-substance framework
Know the schedules by abuse potential and accepted medical use: CII has high abuse potential and no refills; CIII–V may be refilled up to five times within six months of the issue date. DEA forms are heavily tested: Form 222 (or CSOS) for ordering CII; Form 41 for destruction; Form 106 for theft or significant loss; Form 224 for registration; Form 363 for CSOS. A biennial inventory is required, and records are kept two years. A power of attorney lets an agent sign CII orders.
CII partial fills: the balance must be supplied within 30 days, or 60 days for long-term care residents and terminally ill patients. Emergency oral CII orders require a written prescription within seven days. Red flags-cash payment, early refills, long distances, a pattern of lost prescriptions-trigger verification, not accusation. Check the PDMP per state rules. DSCSA requires transaction information and tracing for prescription drugs.
Traps
Questions bait you with 'CII may have up to five refills' (false) or mix Form 106 and Form 41. State law may be stricter than federal; follow the stricter rule. Never alter a CII prescription without prescriber authorization.
Worked example
A patient receives 40 of 90 oxycodone tablets. The remaining 50 must be dispensed within 30 days; document the partial fill and notify the prescriber if the balance is not picked up.