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# FDA Supply Chain Regulations Due Soon: Attorneys
- URL: https://www.fdaweb.com/fda-supply-chain-regulations-due-soon-attorneys/
- Published: 2016-06-23T12:00:00.000Z
- Updated: 2026-09-14T21:11:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136027

FDA intends to issue its proposed regulations on the licensing of prescription drug wholesale distributors and third-party logistics providers by the end of this year, according to attorneys **Kevin Madagan** and **Rebecca Dittrich** (Reed Smith), writing online in a blog [post](https://www.lifescienceslegalupdate.com/2016/06/articles/regulatory-developments/hhs-agenda-signals-fdas-intent-to-issue-proposed-dscsa-in-december-2016/?ref=fdaweb.com). They base their prediction on information from an updated HHS 2016 regulatory agenda. “FDA was required to issue these regulations no later than two years following the law’s 11/2013 enactment,” they write. “However, that deadline passed on 11/27/15.”

They say that the Drug Supply Chain Security Act requires the agency to issue regulations that **(1)** update the federal standards governing state licensure of wholesale distributors; **(2)** establish federal standards governing state licensure of third-party logistics providers; and **(3)** create a federal system for licensing wholesale distributors and logistics providers.

Madagan and Dittrich raise several issues that they hope FDA will address in the regulations: 

- the extent to which federal licensing standards preempt state licensing requirements;
- how comprehensive and definitive the guidance to states will be on how to implement the new federal licensing standards;
- whether FDA will comment on logistic provider licensing in states that do not have their own licensing requirements, and where providers cannot yet benefit from federal licensing;
- the extent to which FDA will recognize inspection of wholesale distributors by independent accreditors such as VAWD (the National Association of Boards of Pharmacy’s Verified-Accredited Wholesale Distributors); and
- how the agency will specifically address independent accreditation of logistics providers.