21 CFR 201.316 - Drugs with thyroid hormone activity for human use; required warning.

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There are 5 Updates appearing in the Federal Register for 21 CFR Part 201. View below or at eCFR (GPOAccess)
§ 201.316 Drugs with thyroid hormone activity for human use; required warning.

(a) Drugs with thyroid hormone activity have been promoted for, and continue to be dispensed and prescribed for, use in the treatment of obesity, although their safety and effectiveness for that use have never been established.

(b) Drugs for human use with thyroid hormone activity are misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless their labeling bears the following boxed warning at the beginning of the “Warnings” section:

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

[ 43 FR 22009, May 23, 1978]

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 201 after this date.

  • 2017-02-07; vol. 82 # 24 - Tuesday, February 7, 2017
    1. 82 FR 9501 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of effective date.
      The effective date of the rule amending 21 CFR Chapter I published at 82 FR 2193 on January 9, 2017 is delayed until March 21, 2017.
      21 CFR Parts 201, 801, and 1100

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.

  • 2017-02-07; vol. 82 # 24 - Tuesday, February 7, 2017
    1. 82 FR 9501 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of effective date.
      The effective date of the rule amending 21 CFR Chapter I published at 82 FR 2193 on January 9, 2017 is delayed until March 21, 2017.
      21 CFR Parts 201, 801, and 1100