part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "F"
subpart_subject: "Production and Process Control System: Requirements for Quality Control"
section_number: "111.130"
section_subject: "What quality control operations are required for returned dietary supplements?"
cfr_reference: "21 CFR 111.130"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 100 to 169"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
Quality control operations for returned dietary supplements must include:
(a)Conducting any required material review and making any required disposition decision; including:
(1)Determining whether tests or examination are necessary to determine compliance with product specifications established in accordance with § 111.70(e); and
(2)Reviewing the results of any tests or examinations that are conducted to determine compliance with product specifications established in accordance with § 111.70(e);
(b)Approving or rejecting any salvage and redistribution of any returned dietary supplement;
(c)Approving or rejecting any reprocessing of any returned dietary supplement; and
(d)Determining whether the reprocessed dietary supplement meets product specifications and either approving for release, or rejecting, any returned dietary supplement that is reprocessed.