21 CFR § 58.107 - Test and control article handling.

---
identifier: "/us/cfr/t21/s58.107"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 58.107 - Test and control article handling."
title_number: 21
title_name: "Food and Drugs"
section_number: "58.107"
section_name: "Test and control article handling."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "58"
part_name: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "43 FR 60013, Dec. 22, 1978, unless otherwise noted."
cfr_part: "58"
---


# 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.