21 CFR 211.125 - Labeling issuance.

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There are 3 Updates appearing in the Federal Register for 21 CFR Part 211. View below or at eCFR (GPOAccess)
§ 211.125 Labeling issuance.
Link to an amendment published at 81 FR 81697, November 18, 2016.

(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]

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United States Code

Title 21 published on 2015-12-03

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

  • 2016-11-18; vol. 81 # 223 - Friday, November 18, 2016
    1. 81 FR 81685 - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule.
      21 CFR Parts 201 and 211

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-11-18; vol. 81 # 223 - Friday, November 18, 2016
    1. 81 FR 81685 - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule.
      21 CFR Parts 201 and 211