21 CFR § 226.80 - Packaging and labeling.

---
identifier: "/us/cfr/t21/s226.80"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 226.80 - Packaging and labeling."
title_number: 21
title_name: "Food and Drugs"
section_number: "226.80"
section_name: "Packaging and labeling."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "226"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 360b, 371, 374."
regulatory_source: "40 FR 14031, Mar. 27, 1975, unless otherwise noted."
cfr_part: "226"
---


# 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.