21 CFR 211.125: Labeling issuance
Requires manufacturers to tightly control labeling issued for drug batches, verify it against the master record, reconcile issued, used and returned quantities, destroy excess lot-numbered labels, store returns safely, and follow written procedures.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart G, Packaging and Labeling Control
2%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.125, from the 483s we hold.
Strict control is not exercised over labeling issued for use in drug product labeling operations.Most used
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.211.125(f)
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not evaluated and investigated.211.125(c)
Cited over time
483s citing 211.125, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.125
- Wells Pharma of Houston LLC · Houston, TexasStrict control is not exercised over labeling issued for use in drug product… Apr 13, 2026
- Lantheus Medical Imaging, Inc. · —Strict control is not exercised over labeling issued for use in drug product… Apr 9, 2026
- Neeyaan LLC · Cranbury, New JerseyStrict control is not exercised over labeling issued for use in drug product… Jan 27, 2026
- Hetero Labs Limited, Unit-EX · Narasapmam Village, IndiaYour firm failed to reconcile the quantities of identification labels issued, used,… Sep 26, 2025
- GenoGeni x · Boca Raton, FloridaStrict control is not exercised over labeling issued for use in drug product… Jul 18, 2025
The regulation text
§ 211.125 Labeling issuance.
(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]
Questions
What does 21 CFR 211.125 require?
Requires manufacturers to tightly control labeling issued for drug batches, verify it against the master record, reconcile issued, used and returned quantities, destroy excess lot-numbered labels, store returns safely, and follow written procedures.
How often is 211.125 cited in Form 483s?
It appears in about 2% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.125 observation?
The most common opening is: “Strict control is not exercised over labeling issued for use in drug product labeling operations.”
Which sections are cited alongside 211.125?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.100 (Written procedures; deviations), 211.67 (Equipment cleaning and maintenance).