Drug Distribution, Recordkeeping, and Inventory Management
The distribution chain
Drugs move from manufacturer to licensed wholesale distributor to pharmacy. Missouri licenses wholesale distributors and requires transaction documentation showing chain of custody, with DSCSA requirements at the federal level. Purchasing from an unlicensed source is itself a violation even if the product is genuine. Records must let any package be traced backward and forward.
What to keep and for how long
Prescription files, purchase and disposition records for controlled substances, inventories, 222 forms/CSOS records, and powers of attorney. Federal rule: controlled substance records two years, kept separately for CII or readily retrievable. Non-controlled purchase invoices prove legitimate acquisition. Prescription records must be retrievable and reproducible; electronic systems need audit trails, backups, and signature capture.
Inventory and loss control
Initial, biennial, change-of-PIC, and closing inventories. A perpetual count for CII is best practice even where not mandated. Reconcile receipts against dispensing to catch diversion early; unexplained shrinkage may be a significant loss requiring Form 106 unless theft is suspected (then Form 41).
Returns, recalls, destruction
Dispensed prescriptions cannot be returned to stock. Undispensed, unopened stock may be returned under policy; controlled substances go to a reverse distributor or are destroyed on site with two witnesses. Recalls must be executed and documented, including patient-level notification for Class I recalls.
Traps: treating invoices as a substitute for controlled substance disposition records; destroying outdated CII without documentation; returning dispensed product to stock.