Food and Drug Administration, HHS § 250.102 Food and Drugs received reports of the sale because of their potentiality for abuse of this drug by those who do not harm to the user. require it for medical purposes. Addi- (b) It is the considered opinion of the tionally, comment included a great Food and Drug Administration that, in deal of concern expressed by individual order to adequately protect the public physicians, medical associations, phar- health, inhalers containing meth- maceutical associations, manufactur- amphetamine or methamphetamine ers, and State and local health authori- salts (d-desoxyephedrine, or dl-desoxy- ties. Based on the information avail- ephedrine, or their salts), as well as able, it is the opinion of the Commis- amphetamine inhalers should be re- sioner of Food and Drugs, concurred in stricted to prescription sale and should by the Food and Drug Administration be labeled with the statement ‘‘Rx Medical Advisory Board, that amyl ni- only.’’ trite inhalant is a drug with a poten- tiality for harmful effect and that it [40 FR 14033, Mar. 27, 1975, as amended at 67 should be removed from over-the- FR 4906, Feb. 1, 2002] counter status and restricted to sale on § 250.102 Drug preparations intended the prescription of a practitioner li- for human use containing certain censed by law to administer such drug. ‘‘coronary vasodilators’’. (b) Therefore, amyl nitrite inhalant will be regarded as misbranded unless (a)(1) The Food and Drug Administra- the labeling on or within the package tion finds that the following ‘‘coronary from which the drug is to be dispensed vasodilators’’ are extensively regarded bears adequate information for its safe by physicians as safe and useful as em- and effective use by physicians, in ac- ployed under medical supervision for cordance with § 201.100(c) of this chap- the management of angina pectoris in ter, and its label bears the statement some patients: ‘‘Rx only.’’ Amyl nitrite. (c) Regulatory proceedings may be Erythrityl tetranitrate. initiated with regard to the interstate Mannitol hexanitrate. shipment of amyl nitrite inhalant that Nitroglycerin. is labeled, advertised, or dispensed con- Potassium nitrite. trary to this statement of policy if Sodium nitrite. such act occurs after July 1, 1969. (2) Additionally, new-drug applica- [40 FR 14033, Mar. 27, 1975, as amended at 67 tions have been approved for products FR 4906, Feb. 1, 2002] containing: § 250.101 Amphetamine and meth- Inositol hexanitrate. amphetamine inhalers regarded as Isosorbide dinitrate. prescription drugs. Octyl nitrite. Pentaerythritol tetranitrate. (a) Recurring reports of abuse and Triethanolamine trinitrate biphosphate misuse of methamphetamine (also (trolnitrate phosphate). known as desoxyephedrine) inhalers show that they have a potentiality for (b) The Food and Drug Administra- harmful effect and that they should tion also finds that there is neither not be freely available to the public substantial evidence of effectiveness through over-the-counter sale. From nor a general recognition by qualified complaints by law-enforcement offi- experts that such drugs are effective cials, health officials, individual physi- for any of the other purposes for which cians, parents, and others as well as some such drugs are promoted to the from Food and Drug Administration in- medical profession in labeling and ad- vestigations, it is evident that the vertising. In particular, neither clin- wicks from these inhalers are being re- ical investigations nor clinical experi- moved and the methamphetamine they ence justify any representations that contain is being used as a substitute such drugs are effective in the manage- for amphetamine tablets. Amphet- ment of hypertension; in the manage- amine tablets and amphetamine inhal- ment of coronary insufficiency or coro- ers have been restricted to prescription nary artery disease, except for their 187 VerDate Mar<15>2010 13:10 May 12, 2011 Jkt 223068 PO 00000 Frm 00197 Fmt 8010 Sfmt 8010 Y:\SGML\223068.XXX 223068 WReier-Aviles on DSKGBLS3C1PROD with CFR.