21 CFR 310.518 - Drug products containing iron or iron salts.

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There are 5 Updates appearing in the Federal Register for 21 CFR Part 310. View below or at eCFR (GPOAccess)
§ 310.518 Drug products containing iron or iron salts.
Drug products containing elemental iron or iron salts as an active ingredient in solid oral dosage form, e.g., tablets or capsules shall meet the following requirements:
(a) Labeling.
(1) The label of any drug in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement:
WARNING: Accidental overdose or iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
(2)
(i) The warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the information panel of the immediate container label.
(ii) If a drug product is packaged in unit-dose packaging, and if the immediate container bears labeling but not a label, the warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the immediate container labeling in a way that maximizes the likelihood that the warning is intact until all of the dosage units to which it applies are used.
(3) Where the immediate container is not the retail package, the warning statement required by paragraph (a)(1) of this section shall also appear prominently and conspicuously on the information panel of the retail package label.
(4) The warning statement shall appear on any labeling that contains warnings.
(5) The warning statement required by paragraph (a)(1) of this section shall be set off in a box by use of hairlines.
(b) The iron-containing inert tablets supplied in monthly packages of oral contraceptives are categorically exempt from the requirements of paragraph (a) of this section.
[68 FR 59715, Oct. 17, 2003]

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.

  • 2015-05-27; vol. 80 # 101 - Wednesday, May 27, 2015
    1. 80 FR 30151 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance date.
      Effective Date: This final rule is effective June 10, 2015. Compliance Date: The compliance date for the final rule published at 79 FR 33072 on June 10, 2014, is delayed until September 8, 2015.
      21 CFR Parts 310, 314, 329, and 600

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United States Code

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 310 after this date.

  • 2015-05-27; vol. 80 # 101 - Wednesday, May 27, 2015
    1. 80 FR 30151 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance date.
      Effective Date: This final rule is effective June 10, 2015. Compliance Date: The compliance date for the final rule published at 79 FR 33072 on June 10, 2014, is delayed until September 8, 2015.
      21 CFR Parts 310, 314, 329, and 600