21 CFR 211.125
Labeling issuance
21 CFR 211.125 is the regulation titled “Labeling issuance” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 4 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.125 most often, as written in the letters.
- 2 lettersYour firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a))
- 1 letterYour firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d))
- 1 letterYour firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188)
The regulation
Read the text of 21 CFR 211.125 (eCFR, as of Sep 1, 2026)
(a) Strict control shall be exercised over labeling issued for use in drug product labeling operations.
(b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records.
(c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 211.122(g)(2).
(d) All excess labeling bearing lot or control numbers shall be destroyed.
(e) Returned labeling shall be maintained and stored in a manner to prevent mixups and provide proper identification.
(f) Procedures shall be written describing in sufficient detail the control procedures employed for the issuance of labeling; such written procedures shall be followed.
[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993; 81 FR 81697, Nov. 18, 2016; 89 FR 51769, June 18, 2024]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.125.
- 21 CFR 211.22Responsibilities of quality control unit4 letters cite both
- 21 CFR 211.113Control of microbiological contamination3 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers2 letters cite both
- 21 CFR 201.115New drugs or new animal drugs2 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations2 letters cite both
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.125 that FDA posted most recently.
- DrugsView GenoGenix LLCcompounded sterile drug productsIssuedJan 20, 2026PostedMar 3, 2026
- DrugsView Wells Pharma of Houston, LLCCompounded sterile drug productsIssuedNov 7, 2025PostedNov 25, 2025
- DrugsView Uriel Pharmacy, Inc.Homeopathic Ampule Drug productsIssuedOct 21, 2025PostedNov 18, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.