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

21 CFR 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.

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 C—DRUGS: GENERAL
PART 226—CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
Subpart D—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.

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

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