The Drug Supply Chain Security Act (DSCSA) includes any party involved in the manufacturing, distribution, and sales of prescription drugs. Prescription drugs are defined by the law as:
"a drug for human use that because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measure necessary to its use, is not safe for use except under the supervision of a practitioner licensed by the law to administer such drug."
Below is a detailed breakdown of the different types of trading partners:
Manufacturers: A person (or co-licensed partner or affiliate) that holds an application approved under section 505 of the law or a license issued under section 351 of the Public Health Service Act for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product. Generally, includes a NDA Holder - (New Drug Application); ANDA Holder - (Abbreviated New Drug Application) or BLA Holder - (Biologic License Application).
Repackagers: A company that repacks and re-labels a product or a package for sale or for distribution. This also includes in-house repackaging departments within hospital networks.
Dispensers: A company that dispenses drugs directly to human patients, such as a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.
Wholesale Distributors: An organization or company that engages in wholesale distribution of prescription drugs.
Third-Party Logistic Provider (3PL): An entity that provides or coordinates warehousing or other logistics services of a product on behalf of other organizations but does not take ownership and disposition of the product.
Trading Partner: A manufacturer, repackager, wholesale distributor, or dispenser who accepts direct ownership of a prescription drug. Additionally, 3PLs who accept direct possession but not ownership of the product are identified as a second type of Trading Partner.
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