CFR section
21 CFR 211.125(c): Labeling issuance
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart G-Packaging and Labeling Control
Key facts
| Citation | 21 CFR 211.125(c) |
|---|---|
| Section | Labeling issuance |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart G-Packaging and Labeling Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (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… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.