21 CFR Ch. I (4–1–05 Edition)
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§ 250.102 21 CFR Ch. I (4–1–05 Edition) health, inhalers containing meth- any use other than management of an- amphetamine or methamphetamine gina pectoris, or that is represented to salts (d-desoxyephedrine, or dl-desoxy- be efficacious for any other purpose by ephedrine, or their salts), as well as reason of its containing such drug, will amphetamine inhalers should be re- be regarded by the Food and Drug Ad- stricted to prescription sale and should ministration as misbranded and subject be labeled with the statement ‘‘Rx to regulatory proceedings, unless such only.’’ recommendations are covered by the approval of a new-drug application [40 FR 14033, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002] based on a showing of safety and effec- tiveness. § 250.102 Drug preparations intended (d) Any such drug in long-acting dos- for human use containing certain age form is regarded as a new drug that ‘‘coronary vasodilators’’. requires an approved new-drug applica- (a)(1) The Food and Drug Administra- tion before marketing. tion finds that the following ‘‘coronary (e) Any of the drugs listed in para- vasodilators’’ are extensively regarded graph (a)(2) of this section is regarded by physicians as safe and useful as em- as a new drug that requires an ap- ployed under medical supervision for proved new-drug application. Articles the management of angina pectoris in for which new-drug approvals are now some patients: in effect should be covered by supple- mental new-drug applications as nec- Amyl nitrite. essary to provide for labeling revisions Erythrityl tetranitrate. consistent with this policy statement. Mannitol hexanitrate. Nitroglycerin. Potassium nitrite. §§ 250.103–250.104 [Reserved] Sodium nitrite. § 250.105 Gelsemium-containing prep- (2) Additionally, new-drug applica- arations regarded as prescription tions have been approved for products drugs. containing: It is the consensus of informed med- Inositol hexanitrate. ical opinion that the margin of safety Isosorbide dinitrate. between the therapeutic and toxic con- Octyl nitrite. centration of gelsemium is narrow and Pentaerythritol tetranitrate. it is difficult to predict the point at Triethanolamine trinitrate biphosphate which the dose will be toxic. Very (trolnitrate phosphate). small doses may cause toxic symptoms. (b) The Food and Drug Administra- It is therefore the view of the Food and tion also finds that there is neither Drug Administration that gelsemium substantial evidence of effectiveness is not a proper ingredient in any prod- nor a general recognition by qualified uct that is to be sold without prescrip- experts that such drugs are effective tion. Accordingly, any drug containing for any of the other purposes for which gelsemium will be regarded as mis- some such drugs are promoted to the branded under section 503(b)(4) of the medical profession in labeling and ad- Federal Food, Drug, and Cosmetic Act vertising. In particular, neither clin- if its label fails to bear in a prominent ical investigations nor clinical experi- and conspicuous fashion the statement ence justify any representations that ‘‘Rx only.’’ such drugs are effective in the manage- [40 FR 14033, Mar. 27, 1975, as amended at 67 ment of hypertension; in the manage- FR 4906, Feb. 1, 2002] ment of coronary insufficiency or coro- nary artery disease, except for their §§ 250.106–250.107 [Reserved] anginal manifestations; or in the man- agement of the post coronary state, ex- § 250.108 Potassium permanganate cept angina pectoris present after coro- preparations as prescription drugs. nary occlusion and myocardial infarc- (a) There have been a number of re- tion. ports in the medical literature of seri- (c) Any preparation containing such ous injuries to women resulting from drugs that is labeled or advertised for the misuse of potassium permanganate 156 VerDate Aug<04>2004 12:59 Apr 25, 2005 Jkt 205068 PO 00000 Frm 00166 Fmt 8010 Sfmt 8010 Y:\SGML\205068.XXX 205068.