[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR329.20]

[Page 206]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 329--HABIT-FORMING DRUGS--Table of Contents
 
                          Subpart C--Exemptions
 
Sec. 329.20  Exemption of certain habit-forming drugs from prescription requirements.


    The prescription-dispensing requirements of section 503(b)(1)(A) of 
the act are not necessary for the protection of the public health with 
respect to the following drugs subject to section 502(d):
    (a) The following exempt narcotic preparations:
    (1) Pharmaceutical preparations containing not more than 100 
milligrams of opium per 100 milliliters or per 100 grams.
    (2) Pharmaceutical preparations containing not more than 16.2 
milligrams (\1/4\ grain) morphine, or any of its salts, per 29.5729 
cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois 
ounce);
    (3) Pharmaceutical preparations containing not more than 64.8 
milligrams (1 grain) codeine, or any of its salts, per 29.5729 cubic 
centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois ounce);
    (4) Pharmaceutical preparations containing not more than 32.4 
milligrams (\1/2\ grain) dihydrocodeine, or any of its salts, per 
29.5729 cubic centimeters (1 fluid ounce) or per 28.3 grams (1 
avoirdupois ounce);
    (5) Pharmaceutical preparations containing not more than 16.2 
milligrams (\1/4\ grain) ethylmorphine, or any of its salts, per 29.5729 
cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois 
ounce);

Provided, That the preparations described in this paragraph contain one 
or more nonnarcotic active medicinal ingredients in sufficient 
proportion to confer upon the preparation valuable medicinal qualities 
other than those possessed by the narcotic drug alone.
    (b) Drugs containing chlorobutanol, intended for external use only.
    (c) Epinephrine solution, 1 percent, preserved with chlorobutanol 
and intended for use solely as a spray.
    (d) Combination drugs listed in part 329 as exempted from section 
511 of the act.

[39 FR 11736, Mar. 29, 1974, as amended at 55 FR 11581, Mar. 29, 1990]