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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 58.107: Test and control article handling.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER A—GENERAL
  4. PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
  5. Subpart F—Test and Control Articles

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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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