Description
This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples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.
Scope & Applicability
Product Classes
8articles used for food or drink for man or other animals
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Subject to sampling requirements under 702(b).; Cosmetic means articles intended to be rubbed, poured, sprinkled, or sprayed on the human body
A dietary supplement is deemed to be food under section 201(ff)
Legal classification of substances not GRAS and requiring approval.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The general category of products this guidance applies to.
Example of product not requiring a 702(b) portion
Stakeholders
6ORA office that may be consulted regarding sample portions.
Person whose actions may cause a product to be deemed adulterated
Officials who may collect official samples.
HHS officer or employee who collects an official sample
The individual to whom the request for a 702(b) portion can be addressed.
FDA office that may be consulted regarding requests for sample portions.
Regulatory Context
Attributes
1Condition under which FDA is authorized to destroy a sample.