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:
- (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.