---
kind: "section"
citation: "21 C.F.R. § 111.83"
title: "21"
number: "111.83"
heading: "What are the requirements for reserve samples?"
url: "https://uscodex.org/cfr/21/111.83"
---

# §111.83. What are the requirements for reserve samples?

- (a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute.
- (b) **The reserve samples must—**
  - (1) Be held 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 it is distributed for packaging and labeling elsewhere;
  - (2) Be identified with the batch, lot, or control number;
  - (3) Be retained 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 sample, for use in appropriate investigations; and
  - (4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.

## 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.