Issue Date: January 1, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Allergenics, Blood Products, Allergens, Animal Feed, Combination Products, Current Good Manufacturing Practice (CGMP), Chemistry, Manufacturing, and Controls (CMC), Human Food Safety
Status: Draft
Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for Industry
This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples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) and its implementing regulation in Title 21 Code of Federal Regulations (CFR) section 2.10 (21 CFR 2.10). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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