Drug Distribution, Inventory Control, Recordkeeping, and Recalls/Returns
Inventory and records
Controlled substance inventories are taken biennially (every two years) on any date chosen by the registrant, with the initial inventory taken at registration. Records of receipt, dispensing, and disposal must be maintained for at least two years, be readily retrievable, and be kept separately for Schedule II. Invoices and DEA 222 forms must be retained and reconciled against physical counts.
Distribution and pedigree
DSCSA requires transaction information, statements, and histories (TS/TH/TI) for product movement, verification of product identifiers at the package level for dispensing, and a process for suspect and illegitimate product: quarantine, investigate, notify trading partners and FDA. Pharmacies must be authorized trading partners.
Recalls
Recalls are classified by FDA (Class I, II, III). On notice, the pharmacy must identify affected stock, segregate it (quarantine), document the quantity on hand and disposition, notify patients when the recall requires it, and return only as directed by the manufacturer, wholesaler, or FDA instruction.
Returns and disposal
Non-controlled expired stock returns are governed by wholesaler policy and state law. Controlled substances cannot simply be shipped back to a wholesaler; they go to a reverse distributor, manufacturer, or via an authorized collector/disposal method with documentation. Never return a dispensed controlled substance to stock.
Traps
Questions that treat records as "three years," or that skip quarantine of recalled product, or that let a technician destroy controlled substances without witnesses and documentation. Also watch for pharmacy-to-pharmacy transfers treated as ordinary sales.
Rule of thumb
"Two years, two counts": keep records two years and be able to reconcile any drug from receipt to final disposition at any moment.