[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.100]

[Page 150]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS--Table of Contents
 
      Subpart B--New Drug or Prescription Status of Specific Drugs
 
Sec. 250.100  Amyl nitrite inhalant as a prescription drug for human use.


    (a) Amyl nitrite inhalant has been available over-the-counter for 
emergency use by the patient in the management of angina pectoris for a 
number of years. As a result of a proposed policy statement published 
August 25, 1967 (32 FR 12404), the Commissioner of Food and Drugs 
received reports of the abuse of this drug by those who do not require 
it for medical purposes. Additionally, comment included a great deal of 
concern expressed by individual physicians, medical associations, 
pharmaceutical associations, manufacturers, and State and local health 
authorities. Based on the information available, it is the opinion of 
the Commissioner of Food and Drugs, concurred in by the Food and Drug 
Administration Medical Advisory Board, that amyl nitrite inhalant is a 
drug with a potentiality for harmful effect and that it should be 
removed from over-the-counter status and restricted to sale on the 
prescription of a practitioner licensed by law to administer such drug.
    (b) Therefore, amyl nitrite inhalant will be regarded as misbranded 
unless the labeling on or within the package from which the drug is to 
be dispensed bears adequate information for its safe and effective use 
by physicians, in accordance with Sec. 201.100(c) of this chapter, and 
its label bears the legend ``Caution: Federal law prohibits dispensing 
without prescription.''
    (c) Regulatory proceedings may be initiated with regard to the 
interstate shipment of amyl nitrite inhalant that is labeled, 
advertised, or dispensed contrary to this statement of policy if such 
act occurs after July 1, 1969.