July 6 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” 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). The revised draft guidance explains how to determine when certain statutory requirements will apply to entities that are considered trading partners in the drug supply chain. It also discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers. Additionally, the revised draft guidance discusses the distribution of drugs for emergency medical reasons, office use, non-human research purposes, and research purposes in humans under an investigational new drug application. This guidance revises the August 2017 draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.”
Submit either electronic or written comments on the draft guidance by September 6, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
FDA is announcing the availability of a revised draft guidance for industry entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The DSCSA (Title II of Pub. L. 113-54) establishes new requirements to develop and enhance drug distribution security by 2023. It does this, in part, by defining different types of entities in the drug supply chain as trading partners (manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers). Among other things, the DSCSA requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers meet the applicable requirements for being “authorized trading partners.”
In addition, the DSCSA outlines requirements for specific trading partners, including drug product tracing, verification, and licensure requirements (where applicable). This revised draft guidance describes the activities and requirements for entities that are considered to be a manufacturer, repackager, wholesale drug distributor, third-party logistics provider, and/or dispenser and therefore considered a trading partner under the DSCSA. This guidance revises the draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act” that was published on August 24, 2017 (82 FR 40159).
In response to public comments received and policy considerations, FDA has added or revised its current thinking on the status of some entities as trading partners, including private-label distributors, salvagers, and returns processors and reverse logistics providers. The Agency has also provided clarification on certain drug distribution scenarios, including distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application. FDA also addresses the interpretation of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act, which discusses third-party logistics providers licensure status prior to the effective date of the forthcoming regulations establishing licensure standards.
Draft industry guidance:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/identifying-trading-partners-under-drug-supply-chain-security-act
FRN:
https://www.federalregister.gov/d/2022-14345