Receiving, Returns, and Recalls
Receiving, Returns, and Recalls
Receiving is a control point, not a formality. Compare the shipment to the purchase order and packing slip, count units, inspect packaging, verify expiration dates are sufficiently distant per policy, and confirm the cold chain with the shipping data logger before signing. Discrepancies are logged as OS&D (over, short, damaged) and resolved with a credit memo or replacement under a return authorization (RGA).
Controlled substances deserve a pharmacist's signature, a documented count, and separate handling; CII orders arrive via CSOS or DEA Form 222.
Returns divide into returnable stock (unopened, non-refrigerated, inside the vendor's window, properly authorized) and non-returnable or special-handling items. Expired or unusable controlled substances go to a reverse distributor, with destruction documented on DEA Form 41; theft or significant loss is reported on DEA Form 106.
Recall notices come from the FDA or the manufacturer and are classified by hazard: Class I - reasonable probability of serious adverse health consequences or death; Class II - temporary or medically reversible harm; Class III - unlikely to cause harm. On notice, quarantine the lot immediately (physically and in the system), document the action, complete the recall response form, and retrieve product already dispensed.
Worked example: a Class I recall of a lot dispensed to 12 patients - pull and segregate remaining stock the same day, identify the 12 patients from dispensing records, notify patients and prescribers, and return product as directed.
Traps: downgrading a serious-harm recall to Class II; returning expired CIIs to stock or the regular trash instead of a reverse distributor; accepting a shipment with a broken cold-chain indicator.