FDA Issues Draft Guidance for Identifying Trading Partners Under DSCSA – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Food and Drug Administration (FDA) issued a draft guidance to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply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). The draft guidance for industry, Identifying Trading Partners Under the Drug Supply Chain Security Act, also explains how to determine when certain statutory requirements will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 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. The agency is accepting either electronic or written comments on the draft guidance by October 20, 2017, which may be submitted using the instructions provided in the Federal Register notice.