[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.100]

[Page 176-177]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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

[[Page 177]]

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 statement ``Rx only.''
    (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.

[40 FR 14033, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]