[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: 21CFR250.101]

[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. 250.101  Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    (a) Recurring reports of abuse and misuse of methamphetamine (also 
known as desoxyephedrine) inhalers show that they have a potentiality 
for harmful effect and that they should not be freely available to the 
public through over-the-counter sale. From complaints by law-enforcement 
officials, health officials, individual physicians, parents, and others 
as well as from Food and Drug Administration investigations, it is 
evident that the wicks from these inhalers are being removed and the 
methamphetamine they contain is being used as a substitute for 
amphetamine tablets. Amphetamine tablets and amphetamine inhalers have 
been restricted to prescription sale because of their potentiality for 
harm to the user.
    (b) It is the considered opinion of the Food and Drug Administration 
that, in order to adequately protect the public health, inhalers 
containing methamphetamine or methamphetamine salts (d-desoxyephedrine, 
or dl-desoxyephedrine, or their salts), as well as amphetamine inhalers 
should be restricted to prescription sale and should be labeled with the 
legend ``Caution: Federal law prohibits dispensing without 
prescription.''