Drugs

FDA Supply Chain Regulations Due Soon: Attorneys

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. 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.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome