On August 24, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a notice [Docket No. FDA-2017-D-1956] announcing the availability of a draft guidance for industry entitled ‘‘Identifying Trading Partners Under the Drug Supply Chain Security Act’’ (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of “private-label distributors” of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.
Although comments on any guidance may be filed at any time, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 23, 2017.