---
kind: "section"
citation: "21 C.F.R. § 111.465"
title: "21"
number: "111.465"
heading: "What requirements apply to holding reserve samples of dietary supplements?"
url: "https://uscodex.org/cfr/21/111.465"
---

# §111.465. What requirements apply to holding reserve samples of dietary supplements?

- (a) You must hold reserve samples of dietary supplements in a manner that protects against contamination and deterioration. This includes:
  - (1) Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions; and
  - (2) Using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distribute the dietary supplement for packaging and labeling elsewhere.
- (b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations.

## 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.