CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR58.113]

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 F - Test and Control Articles

Sec. 58.113 Mixtures of articles with carriers.

(a) For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:

(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture.

(2) To determine the stability of the test and control articles in the mixture as required by the conditions of the study either:

(i) Before study initiation, or

(ii) Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture.

(b) [Reserved]

(c) Where any of the components of the test or control article carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.

[43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4, 1987]