---
kind: "section"
citation: "21 C.F.R. § 111.90"
title: "21"
number: "111.90"
heading: "What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?"
url: "https://uscodex.org/cfr/21/111.90"
---

# §111.90. What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?

- (a) You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless:
  - (1) Quality control personnel conduct a material review and make a disposition decision to approve the reprocessing, treatment, or in-process adjustment; and
  - (2) The reprocessing, treatment, or in-process adjustment is permitted by [§ 111.77](/cfr/21/111.77.md);
- (b) You must not reprocess any dietary supplement or treat or provide an in-process adjustment to a component to make it suitable for use in the manufacture of a dietary supplement, unless:
  - (1) Quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approves the reprocessing, treatment, or in-process adjustment; and
  - (2) The reprocessing, treatment or in-process adjustment is permitted by [§ 111.77](/cfr/21/111.77.md);
- (c) Any batch of dietary supplement that is reprocessed, that contains components that you have treated, or to which you have made in-process adjustments to make them suitable for use in the manufacture of the dietary supplement must be approved by quality control personnel and comply with [§ 111.123(b)](/cfr/21/111.123.md?p=b) before releasing 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.