What is a 702(b) Portion?

Recommendation

5-7 December 2023

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The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled Collecting and Providing 702(b) Portions of FDA Official Samples. The 10-page document is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act).

Definition

According to the draft guidance, "FDA uses the term 702(b) portion to refer to the part of FDA’s official sample of a food, drug, or cosmetic that FDA is required to provide to the owner, upon request under section 702(b) of the FD&C Act. FDA will collect and provide a 702(b) portion in accordance with 702(b) of the FD&C Act and its implementing regulation in 21 CFR 2.10."

Content of the Document

In the document, the following ten questions are answered:

• When must FDA collect a 702(b) portion?
• What are the exceptions to 702(b) portion collection?
• When FDA receives a food, drug, or cosmetic as part of a consumer complaint, should FDA collect a 702(b) portion?
• Does FDA collect the 702(b) portion as a separate subsample?
• When must FDA provide a 702(b) portion?
• If FDA is required to provide a 702(b) portion, how much should FDA provide?
• If FDA collected one or more separate subsamples as the 702(b) portion, but the owner requests a portion of the subsample FDA used for the sample analysis, should FDA provide the portion the owner requested?
• How long should a 702(b) portion be retained?
• Can FDA use 702(b) portions of a sample for research purposes?
• How should the owner request a 702(b) portion?

The PDF-Version of the draft guidance is available following this link.

Submitting Comments

Online or written comments on any guidance can be submitted at any time. However, to ensure that the FDA considers the remarks on this draft guidance before beginning to work on the final version of the guidance, comments should be submitted until February 22, 2022.