21 CFR 211.125 - Labeling issuance.

§ 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]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 211 after this date.

  • 2013-11-20; vol. 78 # 224 - Wednesday, November 20, 2013
    1. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; extension of comment period for the proposed rule and for its information collection provisions.
      The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section).
      21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211