§ 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]
How BatchGlow handles this
A product's labeling comes from its QA-approved product bill of materials, and when a formula gets a new approved version, the kit bills of materials that print it are flagged for review.
What it asks for, in plain words
- 21 CFR 211.125
- Labeling issued for a batch is strictly controlled and examined against the master or batch record. Quantities issued, used and returned are reconciled, and a discrepancy outside preset limits is investigated. Excess labeling bearing a lot number is destroyed, and written issuance procedures are followed.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.