§201.317. Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
21 C.F.R. § 201.317
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.
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:
This section does not apply to digoxin products for oral use.
Notes, amendments, and revision history
Amendments
[43 FR 22009, May 23, 1978, as amended at 85 FR 72907, Nov. 16, 2020]
Authority
Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
Amendments
[43 FR 22009, May 23, 1978, as amended at 85 FR 72907, Nov. 16, 2020]