---
kind: "section"
citation: "21 C.F.R. § 111.127"
title: "21"
number: "111.127"
heading: "What quality control operations are required for packaging and labeling operations?"
url: "https://uscodex.org/cfr/21/111.127"
---

# §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)](/cfr/21/111.70.md?p=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)](/cfr/21/111.70.md?p=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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.