§ 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.