21 U.S.C. § 360eee — Definitions

In this part: (1) “Affiliate” — Two business entities are affiliates of each other if either one controls, or has the power to control, the other, or if a third party controls, or has the power to control, both of them. (2) “Authorized” means: (A) for a manufacturer or repackager, having a valid registration under section 360; (B) for a wholesale distributor, having a valid state license, or a license under section 360eee–2, in line with section 360eee–1(a)(6), and meeting the licensure reporting rules in section 353(e); (C) for a third-party logistics provider, having a valid state license, or a license under section 360eee–3(a)(1), in line with section 360eee–1(a)(7), and meeting the reporting rules in section 360eee–3(b); and (D) for a dispenser, having a valid state license. (3) “Dispenser” (A) means a retail pharmacy, a hospital pharmacy, a group of commonly owned chain pharmacies that don't act as a wholesale distributor, or anyone else legally allowed to dispense or give prescription drugs — including their affiliated warehouses or distribution centers under common ownership that also don't act as a wholesale distributor. (B) It does not include someone who only dispenses products for use in animals under section 360b(a)(5). (4) “Disposition”, for a product an entity possesses or controls, means removing that product from the drug supply chain — which can include disposing of it, returning it for disposal, or other proper handling, such as keeping a sample for further examination or lab analysis by a manufacturer or a regulatory or law enforcement agency. (5) “Distribute” or “distribution” means selling, buying, trading, delivering, handling, storing, or receiving a product. It does not include dispensing a product under a valid prescription under section 353(b)(1), or dispensing a product approved under section 360b(b). (6) “Exclusive distributor” means the wholesale distributor that bought the product directly from the manufacturer and is the only one distributing that manufacturer's product onward to a repackager, another wholesale distributor, or a dispenser. (7) “Homogeneous case” means a sealed case holding only product that has a single National Drug Code number, all from a single lot. (8) “Illegitimate product” means a product that credible evidence shows: (A) is counterfeit, diverted, or stolen; (B) has been intentionally adulterated in a way that would cause serious adverse health consequences or death to people; (C) is part of a fraudulent transaction; or (D) otherwise appears unfit for distribution in a way that would reasonably likely cause serious adverse health consequences or death to people. (9) “Licensed” means: (A) for a wholesale distributor, having a valid license under section 353(e) or section 360eee–1(a)(6), whichever applies; (B) for a third-party logistics provider, having a valid license under section 360eee–3(a) or section 360eee–1(a)(7), whichever applies; and (C) for a dispenser, having a valid state license. (10) “Manufacturer”, for a given product, means: (A) whoever holds the application approved under section 355, or the license issued under section 262 of title 42, for that product, or, if it isn't covered by an approved application or license, whoever actually manufactured it; (B) a co-licensed partner of that person, if the partner gets the product directly from that person or from someone described in (A) or (C); or (C) an affiliate of a person in (A) or (B), if the affiliate gets the product directly from that person or from someone in (A) or (B). (11) “Package” (A) means the smallest individual saleable unit of a product that a manufacturer or repackager distributes, meant by the manufacturer for eventual sale to the dispenser. (B) An “individual saleable unit” is the smallest container of the product that the manufacturer or repackager puts into commerce, meant for individual sale to a dispenser. (12) “Prescription drug” means a drug for human use that's subject to section 353(b)(1). (13) “Product” means a prescription drug in its finished dosage form, ready to give to a patient without substantial further manufacturing, such as capsules, tablets, or freeze-dried products before they're mixed. But for section 360eee–1 specifically, “product” does not include: blood or blood components meant for transfusion; radioactive drugs or radioactive biological products regulated by the Nuclear Regulatory Commission or by a state under an agreement with that Commission; imaging drugs; certain intravenous products described in paragraph (24)(B)(xiv), (xv), or (xvi); any medical gas as defined in section 360ddd; homeopathic drugs marketed under applicable FDA guidance; or a drug compounded under section 353a or 353b. (14) “Product identifier” means a standardized graphic that shows, both in human-readable form and on a machine-readable data carrier meeting a widely recognized international standard, the product's standardized numerical identifier, lot number, and expiration date. (15) “Quarantine” means storing or marking a product to keep it from being distributed or transferred, either in a clearly identified, physically separate area or through other procedures used for that purpose. (16) “Repackager” means someone who owns or runs an establishment that repacks and relabels a product or package for (A) further sale, or (B) distribution without any further sale happening. (17) “Return” means giving a product back to the authorized trading partner it was bought or received from, or to a returns processor or reverse logistics provider for handling. (18) “Returns processor” or “reverse logistics provider” means someone who owns or runs an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner, so it can be credited to the purchaser, manufacturer, or seller, or disposed of so it's never distributed again. (19) “Specific patient need” means moving a product from one pharmacy to another to fill a prescription for a particular, identified patient. It does not include moving a product between pharmacies just to build up or refill stock in case of a possible future need. (20) “Standardized numerical identifier” means a set of numbers or characters that uniquely identifies each package or homogeneous case, made up of the National Drug Code for that specific product, including its particular package type, combined with a unique alphanumeric serial number of up to 20 characters. (21) “Suspect product” means a product there's reason to believe: (A) might be counterfeit, diverted, or stolen; (B) might have been intentionally adulterated in a way that would cause serious adverse health consequences or death to people; (C) might be part of a fraudulent transaction; or (D) otherwise appears unfit for distribution in a way that would cause serious adverse health consequences or death to people. (22) “Third-party logistics provider” means an entity that provides or arranges warehousing or other logistics services for a product in interstate commerce, on behalf of a manufacturer, wholesale distributor, or dispenser, without ever taking ownership of the product or being responsible for directing its sale or disposal. (23) “Trading partner” means: (A) a manufacturer, repackager, wholesale distributor, or dispenser that directly accepts or transfers ownership of a product to or from another manufacturer, repackager, wholesale distributor, or dispenser; or (B) a third-party logistics provider that directly accepts or transfers possession of a product to or from a manufacturer, repackager, wholesale distributor, or dispenser. (24) “Transaction” (A) generally means transferring a product between people in a way that changes who owns it. (B) But “transaction” does not include: (i) moving a product within a company, between affiliates or within one manufacturer; (ii) moving a product among hospitals or other health care entities under common control; (iii) moving a product for emergency medical reasons, including a declared public health emergency — except that an ordinary drug shortage not caused by such an emergency does not count; (iv) dispensing a product under a valid prescription under section 353(b)(1); (v) a manufacturer or licensed wholesale distributor giving out product samples under section 353(d); (vi) distributing blood or blood components meant for transfusion; (vii) a licensed retail pharmacy giving small amounts of a product to a licensed practitioner for office use; (viii) a charitable organization under section 501(c)(3) of title 26 selling, buying, or trading a drug with its own nonprofit affiliate, to the extent otherwise legally allowed; (ix) distributing a product because a pharmacy or wholesale distributor was sold or merged — though the required records for the product must still transfer to the new owner; (x) dispensing a product approved under section 360b(c); (xi) moving products to or from a facility licensed by the Nuclear Regulatory Commission or by a state under an agreement with that Commission; (xii) certain combination products that don't need separate drug approval or licensing — such as a product combining a device with one or more other regulated components (like a drug and device) made as a single item; two or more separate products packaged together as a unit, combining a drug and device, or a device and a biological product; or two or more finished medical devices plus one or more drugs or biologics packaged together as a “medical convenience kit” described in clause (xiii); (xiii) distributing a “medical convenience kit” — a collection of finished medical devices, possibly including a drug or biological product, assembled purely for the buyer's or user's convenience — as long as: (I) it's assembled at a facility registered with the FDA as a device manufacturer under section 360(b)(2); (II) it contains no controlled substance under the Comprehensive Drug Abuse Prevention and Control Act of 1970; (III) if it includes a drug, the kit's maker bought that drug directly from the drug's manufacturer, or from a wholesale distributor that bought it directly from the manufacturer, and didn't alter the drug's original container or label; and (IV) that included drug is one of a specific list: an intravenous fluid-and-electrolyte replenisher, a product for maintaining water-and-mineral balance, a product for irrigation or reconstitution, an anesthetic, an anticoagulant, a vasopressor, or a sympathomimetic; (xiv) distributing an intravenous product formulated to replenish fluids, electrolytes such as sodium, chloride, and potassium, or calories such as dextrose and amino acids; (xv) distributing an intravenous product used to maintain the body's water-and-mineral balance, such as dialysis solutions; (xvi) distributing a product meant for irrigation, or sterile water meant for irrigation or injection; (xvii) distributing a medical gas as defined in section 360ddd; or (xviii) distributing or selling a licensed biological product under section 262 of title 42 that also meets the definition of a device under section 321(h). (25) “Transaction history” means a paper or electronic statement listing the transaction information for every earlier transaction involving the product, going all the way back to the manufacturer. (26) “Transaction information” means: (A) the product's proprietary and/or established name; (B) its strength and dosage form; (C) its National Drug Code number; (D) the container size; (E) the number of containers; (F) the lot number; (G) the date of the transaction; (H) the date of shipment, if that's more than 24 hours after the transaction date; (I) the business name and address of whoever is transferring ownership; and (J) the business name and address of whoever is receiving it. (27) “Transaction statement” means a paper or electronic statement, from the entity transferring ownership in a transaction, certifying that it: (A) is authorized as the Drug Supply Chain Security Act requires; (B) received the product from someone who was also authorized as that Act requires; (C) received the required transaction information and transaction statement from the prior owner, as section 360eee–1 requires; (D) did not knowingly ship a suspect or illegitimate product; (E) had systems and processes in place to meet the verification requirements of section 360eee–1; (F) did not knowingly provide false transaction information; and (G) did not knowingly alter the transaction history. (28) “Verification” or “verify” means checking whether the product identifier on, or printed on, a package or homogeneous case actually matches the standardized numerical identifier, lot number, and expiration date that the manufacturer or repackager assigned to that product, following section 360eee–1. (29) “Wholesale distributor” means a person — other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager — engaged in wholesale distribution, as defined in section 353(e)(4).