GDP in the US: FDA Guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act

On 04 August 2023, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."

The new document finalizes the draft guidance of the same title that was issued on 09 May 2018. According to the FDA, "changes from the draft guidance to the final guidance include recommendations to authorized trading partners and other stakeholders for submitting a request, and what information to include for a waiver, exception, or exemption. The guidance also outlines situations in which the recipient of a waiver, exception, or exemption should notify the agency and affected entities."

Background

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013. It outlines steps to achieve electronic tracing of products at the package level to identify and trace certain prescription drugs.

An authorized trading partner or other stakeholder may request a waiver, exception, or exemption from certain requirements related to product tracing, product identifier, authorized trading partners, and verification in section 582 of the FD&C Act.

Content of the New Guidance

The new document includes a total of 11 pages. After an introduction and a background chapter, the two main parts deal on the one hand with the process for submitting waiver, exception, or exemption requests to the FDA and on the other hand the factors the FDA intends to consider when evaluating such requests. In addition, the document outlines the procedure the FDA intends to follow once every two years when reviewing and determining whether to renew a previously approved waiver, exception, or exemption.

Concerning requests to the FDA, the guideline describes the entities that may submit a request, and the information to include. The FDA recommends that requests should be submitted electronically. In this context, the appendix of the guideline gives the relevant details where to submit waiver, exception, and exemption requests and subsequent communications.

With respect to the review of requests, the guideline states that the FDA intends to evaluate each request on a case-by-case basis. "Once FDA has received and reviewed all relevant information and documentation to support a waiver, exception, or exemption request, FDA intends to notify the requesting trading partner or other stakeholder of the Agency’s determination to grant, deny, or take other appropriate action on the original request."

Further Information

The guidance document is available for download on the FDA website.

Since the DSCSA was enacted in 2013, the FDA has issued a couple of guidance and policy documents - as the overview "Drug Supply Chain Security Act Law and Policies" shows.