21 CFR § 211.134 - Drug product inspection.

---
identifier: "/us/cfr/t21/s211.134"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 211.134 - Drug product inspection."
title_number: 21
title_name: "Food and Drugs"
section_number: "211.134"
section_name: "Drug product inspection."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "211"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS"
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. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264."
regulatory_source: "43 FR 45077, Sept. 29, 1978, unless otherwise noted."
cfr_part: "211"
---


# 211.134 Drug product inspection.

(a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.

(b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.

(c) Results of these examinations shall be recorded in the batch production or control records.