Drug Distribution, Inventory, and Recordkeeping
Controlled substance paperwork
DEA requires every registrant to take a biennial inventory - an exact count for Schedule II and an exact count or, for sealed containers exceeding 1,000 units, a recorded estimate for III–V - on any date within two years of the previous one, retained with records for two years. Schedule II purchases use DEA Form 222 or CSOS, and a power of attorney lets an agent sign. Invoices and dispensing records must be readily retrievable, with Schedule II records kept separate from III–V. Theft or significant loss is reported on DEA Form 106; destruction is documented through Form 41 or a reverse distributor's records.
Virginia additions
Virginia requires dispensers to report to the PMP within the interval set by Board regulation, sets retention periods for prescription files, and regulates behind-the-counter pseudoephedrine sales with photo identification, a logbook, and the federal gram limits. Legend drug returns, recalls, and expiration-date handling all require documentation.
Traps
- Reporting a loss only internally, or waiting until an inspection.
- Treating a return-to-stock of a controlled substance as an invisible adjustment.
- Confusing DSCSA transaction documentation with a DEA 222.
Worked example
Rule of thumb: if you cannot reconstruct the drug's journey from receipt to dispenser on paper, the record is deficient. A pharmacy that received 1,000 tablets, dispensed 700, destroyed 50, and has 240 on the shelf has 10 units unaccounted for - investigate, and report if the loss is significant.