[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR290.2]

[Page 158]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 290--CONTROLLED DRUGS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 290.2  Exemption from prescription requirements.

    The prescription-dispensing requirements of section 503(b)(1) of the 
Federal Food, Drug, and Cosmetic Act are not necessary for the 
protection of the public health with respect to a compound, mixture, or 
preparation containing not more than 200 milligrams of codeine per 100 
milliliters or per 100 grams that also includes one or more nonnarcotic 
active medicinal ingredients in sufficient proportion to confer upon the 
compound, mixture, or preparation valuable medicinal qualities other 
than those possessed by codeine alone.

[67 FR 4907, Feb. 1, 2002]