GroundRules
21 CFR 58.47: Facilities for handling test and control articles.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER A—GENERAL
- PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- Subpart C—Facilities
(a) As necessary to prevent contamination or mixups, there shall be separate areas for:
(1) Receipt and storage of the test and control articles.
(2) Mixing of the test and control articles with a carrier, e.g., feed.
(3) Storage of the test and control article mixtures.
(b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures.
Collected 2026-08-27T02:24:47Z. Source file · JSON