21 CFR § 111.127 - What quality control operations are required for packaging and labeling operations?
---
identifier: "/us/cfr/t21/s111.127"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.127 - What quality control operations are required for packaging and labeling operations?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.127"
section_name: "What quality control operations are required for packaging and labeling operations?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---
# 111.127 What quality control operations are required for packaging and labeling operations?
Quality control operations for packaging and labeling operations must include:
(a) Reviewing the results of any visual examination and documentation to ensure that specifications established under § 111.70(f) are met for all products that you receive for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier);
(b) Approving, and releasing from quarantine, all products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) before they are used for packaging or labeling;
(c) Reviewing and approving all records for packaging and label operations;
(d) Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);
(e) Conducting any required material review and making any required disposition decision;
(f) Approving or rejecting any repackaging of a packaged dietary supplement;
(g) Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and
(h) Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.