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

§ 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 10-May-2017 03:43

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

  • 2017-05-18; vol. 82 # 95 - Thursday, May 18, 2017
    1. 82 FR 22741 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; extension of comment period.
      FDA is extending the comment period on the document delaying the effective date and seeking comment on the final rule published March 20, 2017 (82 FR 14319). Submit either electronic or written comments by July 18, 2017. For additional information on the comment date, see ADDRESSES and SUPPLEMENTARY INFORMATION .
      21 CFR Parts 201, 801, and 1100