21 CFR 201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

§ 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

(a) Digitalis and related cardiotonic drugs for human use in oral dosage forms 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) Digitalis and related cardiotonic drugs for human use in oral dosage forms 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:

Digitalis alone or with other drugs has been used in the treatment of obesity. This use of digoxin or other digitalis glycosides is unwarranted. Moreover, since they may cause potentially fatal arrhythmias or other adverse effects, the use of these drugs in the treatment of obesity is dangerous.

(c) This section does not apply to digoxin products for oral use, which shall be labeled according to the requirements of § 310.500 of this chapter.

[ 43 FR 22009, May 23, 1978]

Title 21 published on 09-Jun-2018 03:51

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

  • 2018-05-14; vol. 83 # 93 - Monday, May 14, 2018
    1. 83 FR 22224 - Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of partial withdrawal.
      As of May 14, 2018, FDA withdraws the proposed additions to §§ 343.3 and 343.10, and proposed revisions to §§ 343.20 and 343.50 published on August 21, 2002 (67 FR 54139).
      21 CFR Parts 201 and 343