StacksVerified U.S. regulatory reference

21 CFR §111.127

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
Quality control operations for packaging and labeling operations must include:
  1. (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);
  2. (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;
  3. (c)Reviewing and approving all records for packaging and label operations;
  4. (d)Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);
  5. (e)Conducting any required material review and making any required disposition decision;
  6. (f)Approving or rejecting any repackaging of a packaged dietary supplement;
  7. (g)Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and
  8. (h)Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.