21 CFR 201.18 - Drugs; significance of control numbers.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 201. View below or at eCFR (GPOAccess)
§ 201.18 Drugs; significance of control numbers.
The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.

Title 21 published on 2014-04-01.

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.

  • 2014-12-04; vol. 79 # 233 - Thursday, December 4, 2014
    1. 79 FR 72064 - Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2015. See section IV of this document for the implementation dates of this final rule.
      21 CFR Part 201

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2015-03-09; vol. 80 # 45 - Monday, March 9, 2015
    1. 80 FR 12364 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; extension of comment period.
      FDA is extending the comment period on the proposed rule published on December 18, 2014 (79 FR 75506). Submit either electronic or written comments by May 18, 2015.
      21 CFR Parts 201, 606, and 610