The US Food and Drug Administration (FDA) issued a draft guidance to identify trading partners under the Drug Supply Chain Security Act. The industry and trade sector will now need to respond with comments before October end.
Under DSCSA identifies five types of entities in the prescription drug supply chain: manufacturers, re-packagers, dispensers, wholesale distributors, and third party logistic players.
DSCSA restricts access to the distribution system for prescription drug products by requiring trading partners of manufacturers, wholesale distributors, dispensers, and repackagers meet the applicable requirements for being authorized trading partners.
Now to be considered as an authorized trading partner, a manufacturer or repackager must have a valid registration in accordance with section 510 of the FD&C Act and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.
To be considered an authorized trading partner, a wholesale distributor must have a valid license under State law and comply with the licensure reporting requirements. Similarly, to be considered an authorized trading partner, a third party logistic player must have a valid license.
A dispenser must have a valid license under State law and accept or transfer direct 132 ownership of a product from or to a manufacturer, re-packager, wholesale distributor, or dispenser. DSCSA also establishes new licensure and reporting requirements for wholesale distributors and third-party logistics providers.
Section 503(e) of the FD&C Act establishes licensure requirements and adds reporting requirements for wholesale drug distributors. Specifically, section 503(e)(1) prohibits a person from engaging in wholesale distribution of prescription drugs in any State unless such person is licensed by the State from which the drug is distributed.
Furthermore, under certain circumstances, such person must also be licensed by the State into which the drug is distributed. Section 503(e)(2) of the FD&C Act requires wholesale drug distributors to report certain information to FDA on an annual basis, including State licensure information for each license, the name and address of each licensed facility, and any significant disciplinary actions taken by a State or the Federal government.
DSCSA adds section 584 to the FD&C Act; the section sets forth requirements for licensure and reporting by third party logistic facilities. Specifically, section 584(a) prohibits a third party logistics in any State from conducting activities unless each facility is licensed from which the drug is distributed. Furthermore, under certain circumstances, the third party logistics must also be licensed by the State into which the drug is distributed. Section 584(b) of the FD&C Act requires 3PL facilities to report certain information to FDA, including State licensure information for each facility and the name and address of each facility.