Drug Distribution, Inventory, and Recordkeeping
Everything that moves gets a record
Distribution law separates dispensing (to a patient under a prescription) from wholesale distribution. Alabama licenses drug wholesalers, including out-of-state distributors serving Alabama, and DSCSA imposes national tracing: transaction information, history, and statements; verification of suspect product; and licensure verification of trading partners. A pharmacy that transfers product outside normal channels may be functioning as a distributor.
Inventory and records: maintain purchase and dispensing records; retain controlled substance records for two years federally and per Alabama rule for other records; conduct an initial inventory and biennial inventories thereafter; segregate and document expired, recalled, or damaged drugs; follow recall instructions (quarantine, return, destroy) and document. Returns go only to licensed entities with credit documentation; CII returns require a reverse distributor. Sample and donated drugs have special handling.
Security: locked, limited-access storage, alarm and access control, and employee screening. On closure or change of ownership, notify the Board, transfer or destroy drugs per rule, and preserve records.
Traps: assuming invoices alone satisfy CII receipt documentation (a 222/CSOS record is separate); returning expired stock without documentation; treating a recall email as sufficient action; missing theft-reporting timelines.
Rule of thumb: for every unit, be able to answer where it came from, where it went, and who signed for it.