§360eee Definitions

Summary

Defines key words used to track and control prescription drugs so people know who can handle, move, and report drugs and how to treat suspicious or unsafe products. Affiliate: a business related to another by control. Authorized: having the required federal registration or state license to act as a maker, repacker, wholesaler, third‑party logistics provider, or dispenser. Dispenser: a pharmacy or other person allowed to give or administer prescription drugs (not those who only dispense animal products). Disposition: removing a product from the drug supply chain, like disposal, return for disposal, or holding a sample for testing. Distribute/Distribution: selling, buying, delivering, handling, storing, or receiving a product (does not mean filling a prescription). Exclusive distributor: the single wholesale distributor who bought directly from the manufacturer and only supplies the next sellers. Homogeneous case: a sealed case with only one product NDC and one lot. Illegitimate product: a product shown by credible evidence to be counterfeit, diverted, stolen, intentionally dangerously altered, part of a fraud, or otherwise unfit and likely to cause serious harm or death. Licensed: having the required license for wholesalers, third‑party logistics providers, or dispensers. Manufacturer: the person who holds an approved application or license for the product, or who made it, or a co‑licensee or affiliate who receives it directly. Package: the smallest individual saleable unit made by a manufacturer or repackager intended to be sold to a dispenser. Prescription drug: a drug for human use that requires a prescription. Product: a finished prescription drug ready for patient use (capsules, tablets, certain lyophilized products), with specific listed exclusions such as blood for transfusion, certain radioactive or imaging drugs, some IV products, medical gases, certain homeopathic items, and certain compounded drugs. Product identifier: a standard label that shows the standardized numerical identifier, lot number, and expiration date in human‑readable and machine‑readable form. Quarantine: storing or identifying a product to keep it from being distributed. Repackager: a person or place that repacks or relabels product or packages for resale or distribution. Return: giving product back to the immediate seller or to a returns processor or reverse logistics provider. Returns processor/reverse logistics provider: a business that handles returned products to process them for credit or dispose of them. Specific patient need: moving product from one pharmacy to another to fill a prescription for a named patient (not for restocking). Standardized numerical identifier: the product’s NDC plus a unique serial number of up to 20 characters that identifies each package or homogeneous case. Suspect product: a product for which there is reason to believe it might be counterfeit, diverted, stolen, intentionally dangerous, part of a fraud, or otherwise unfit and likely to cause serious harm or death. Third‑party logistics provider: an entity that warehouses or coordinates logistics across state lines for others but does not take ownership or decide sales or disposition. Trading partner: a maker, repackager, wholesaler, dispenser, or third‑party logistics provider who directly transfers ownership or possession of a product. Transaction: a change of ownership of a product; many specific exceptions apply (for example, intracompany transfers, transfers among commonly controlled hospitals, certain public‑health emergency uses but not routine shortages, prescription dispensing, samples, blood for transfusion, small practitioner office use, certain charity transfers, transfers in sales/mergers with required record transfer, certain approved combination products and kits under conditions, specified IV solutions, medical gases, and some licensed biological products). Transaction history: a paper or electronic record showing prior transactions back to the manufacturer. Transaction information: product name, strength and form, NDC, container size and count, lot number, transaction date, shipment date if more than 24 hours later, and the business names and addresses of the seller and buyer. Transaction statement: a paper or electronic statement by the party transferring ownership that they are authorized, received the product from an authorized source, got required transaction information and prior statements, did not knowingly ship a suspect or illegitimate product, had systems to verify products, did not knowingly provide false information, and did not knowingly alter the transaction history. Verification/Verify: checking that the product identifier matches the manufacturer’s assigned identifier, lot number, and expiration date. Wholesale distributor: a person engaged in wholesale distribution who is not a manufacturer, co‑licensee, third‑party logistics provider, or repackager.