CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—DRUGS: GENERAL (parts 200 to 299) > PART 201—LABELING > SUBPART G—Specific Labeling Requirements for Specific Drug Products (§201.300 to §201.326) > 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:
(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.

Code of Federal Regulations

[43 FR 22009, May 23, 1978]