Manufacturers, wholesalers or 3PLs? US FDA guidance looks to define supply chain roles
The DSCSA was signed into US law in November 2013, and includes a series of regulations and standards to track and trace drug products throughout the supply chain to help minimise the risk of falsified or contaminated medicine.
In the latest draft guidance on the subject, the US Food and Drug Administration (FDA) has laid down its definitions for trading partners in the supply chain in order to “assist industry and State and local governments in understanding the applicability of DSCSA requirements” and “help clarify for industry whether they are engaged in activities that require licensure and annual reporting.”
The definitions of trading partner activity as laid out in the guidance can be found below.
Among its aims, the guidance hopes to clear up confusion about how to determine whether a manufacturer is an authorised trading partner which the Agency says is related to the inclusion of entities that hold drug approvals, co-licensed partners, and their affiliates, rather than just an entity which owns an FDA-registered establishment that manufactures, prepares, propagates, compounds, or processes drugs in the United States, or that are offered for import into the United States.
As for an NDA-, BLA-, or ANDA-holder or co-licensed partner without its own manufacturing capabilities, the guidance says “such an entity would be an authorized trading partner without being registered under section 510 [of the Food, Drug & Cosmetic Act (FD&C Act)].”
The Agency invites comment from industry on the draft guidance by October 23, 2017.
Description of Activity
Manufactured the product.
Approved application holder, or co-licensed partner of the approved application holder who obtained the product directly from the application holder or person who manufactured the product.
Affiliate of manufacturer who obtained the product directly from the application holder or person who manufactured the product.
Owns or operates an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.
Engaged in distribution of a drug to, or receipt of a drug by, a person other than a consumer or patient, with certain exceptions.
Third Party Logistics (3PL) provider
Provides or coordinates warehousing or other logistics services with regard to a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.
Retail pharmacy, hospital pharmacy, or group of chain pharmacies under common ownership and control that do not act as a wholesale distributor.
Person authorized by law to dispense or administer prescription drugs.
Affiliated warehouses or distribution centers of a dispenser under common ownership and control that do not act as a wholesale distributor