§360eee Definitions

Summary

Defines many key words used for tracking and moving prescription drugs so people know what each word means for the drug supply chain rules. Affiliate — a business related by control to another business. Authorized — having the proper registration or license and following required reporting rules, with different rules for manufacturers, repackers, wholesale distributors, third‑party logistics providers, and dispensers. Dispenser — a retail or hospital pharmacy or other person allowed to give out prescription drugs, and their affiliated warehouses, but not someone who only gives medicines for animals. Disposition — taking a product out of the drug distribution chain, for example by disposing of it, returning it for disposal, or keeping a sample for testing. Distribute/Distribution — selling, buying, trading, handling, storing, delivering, or receiving a product, but not giving a drug under a prescription or certain approved programs. Exclusive distributor — the wholesale distributor that bought the product directly from the maker and is the only one who sells that maker’s product next. Homogeneous case — a sealed case that holds only one product with one National Drug Code and one lot number. Illegitimate product — a product that credible evidence shows is counterfeit, diverted or stolen; intentionally adulterated so it could cause serious harm or death; the subject of a fraud; or otherwise appears unsafe and likely to cause serious harm or death. Licensed — having the required license for wholesale distributors, third‑party logistics providers, or dispensers. Manufacturer — the person who holds the approved application or license for the product, or who actually made it, and includes co‑license partners or affiliates that receive the product directly. Package — the smallest individual saleable unit the manufacturer or repacker makes for sale to a dispenser. Prescription drug — a drug for humans that requires a prescription. Product — a prescription drug in a finished form ready for a patient (like tablets or capsules), but for some parts of the law it does not include blood for transfusion, certain radioactive or imaging drugs regulated by the Nuclear Regulatory Commission or a State, certain intravenous products, medical gases, some homeopathic drugs sold under guidance, or drugs compounded under specific sections. Product identifier — a standard label that shows, both for people and machines, the standardized number, lot number, and expiration date. Quarantine — keeping a product separate and marked so it is not distributed. Repackager — a person or place that repacks or relabels a product for sale or distribution. Return — sending a product back to the authorized partner you bought it from or to a returns processor. Returns processor/Reverse logistics provider — a place that handles returned saleable or unsaleable products so they can be credited, returned to the maker, or disposed of. Specific patient need — moving a product from one pharmacy to another to fill a named patient’s prescription, not to restock for future use. Standardized numerical identifier — the National Drug Code for the product plus a unique serial number of up to 20 alphanumeric characters. Suspect product — a product that there is reason to believe might be counterfeit, diverted or stolen; intentionally adulterated; involved in fraud; or otherwise likely to cause serious harm or death. Third‑party logistics provider — an entity that stores or coordinates logistics for a product across state lines for a maker, distributor, or dispenser, but does not own the product or control its sale or final use. Trading partner — a maker, repacker, wholesale distributor, dispenser, or third‑party logistics provider who transfers or accepts direct ownership or possession of a product. Transaction — a change of ownership of a product, with many specific exceptions such as internal transfers within an affiliate, transfers among commonly controlled hospitals, emergency distributions, prescriptions filled, manufacturer samples, blood for transfusion, small office‑use transfers, certain sale or merger transfers, certain combination products and kits, certain IV solutions, medical gases, and some licensed products as listed. Transaction history — a paper or electronic record that shows transaction information for each prior transfer back to the manufacturer. Transaction information — basic facts about the product and transfer, including product name, strength and form, National Drug Code, container size and number, lot number, transaction date, shipment date if more than 24 hours after the transaction, and the business names and addresses of the seller and buyer. Transaction statement — a written or electronic statement from the seller saying they are authorized, received the product from an authorized party, received required transaction information and statement from the prior owner, did not knowingly ship a suspect or illegitimate product, had systems to verify products, did not knowingly give false information, and did not knowingly alter the transaction history. Verification/Verify — checking that the product identifier on a package or case matches the standardized number, lot, and expiration assigned by the manufacturer or repacker. Wholesale distributor — a person, other than a manufacturer, a co‑license partner, a third‑party logistics provider, or a repackager, who does wholesale distribution as defined elsewhere.