---
kind: "section"
citation: "21 C.F.R. § 58.107"
title: "21"
number: "58.107"
heading: "Test and control article handling."
url: "https://uscodex.org/cfr/21/58.107"
---

# §58.107. Test and control article handling.


Procedures shall be established for a system for the handling of the test and control articles to ensure that:

- (a) **There is proper storage.**
- (b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
- (c) **Proper identification is maintained throughout the distribution process.**
- (d) **The receipt and distribution of each batch is documented.** Such documentation shall include the date and quantity of each batch distributed or returned.

## Notes

### Authority

Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.

### Source

Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.