CFR - Code of Federal Regulations Title 21

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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 4]

[CITE: 21CFR226]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL

PART 226 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

Subpart D - Packaging and Labeling

Sec. 226.80 Packaging and labeling.

(a) Packaging and labeling operations shall be adequately controlled:

(1) To assure that only those Type A medicated article(s) that have met the specifications established in the master-formula records shall be distributed.

(2) To prevent mixups during the packaging and labeling operations.

(3) To assure that correct labeling is employed for each Type A medicated article(s).

(4) To identify Type A medicated article(s) with lot or control numbers that permit determination of the history of the manufacture and control of the batch of Type A medicated article(s).

(b) Packaging and labeling operations shall provide:

(1) For storage of labeling in a manner to avoid mixups.

(2) For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.

(3) For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).

(c) Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.

Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.