1. Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.
2. Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which shall include 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 narcotic drugs alone:
a. Not more than two hundred milligrams of codeine per one hundred milliliters or per one hundred grams.
b. Not more than one hundred milligrams of dihydrocodeine per one hundred milliliters or per one hundred grams.
c. Not more than one hundred milligrams of ethylmorphine per one hundred milliliters or per one hundred grams.
d. Not more than two point five milligrams of diphenoxylate and not less than twenty-five micrograms of atropine sulfate per dosage unit.
e. Not more than one hundred milligrams of opium per one hundred milliliters or per one hundred grams.
f. Not more than point five milligram of difenoxin and not less than twenty-five micrograms of atropine sulfate per dosage unit.
3. Unless specifically excepted or listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs and their salts, as set forth below:
a. Buprenorphine.
4. Stimulants. Unless specifically excepted or listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of pyrovalerone, including its salts, isomers, and salts of isomers.
5. Ephedrine. Unless specifically excepted in paragraph "b" or listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substance, including its salts, optical isomers, and salts of such optical isomers:
a. Ephedrine.
b. The following drug products containing ephedrine, its salts, optical isomers, and salts of such optical isomers are excepted from this schedule, if they may lawfully be sold over the counter without a prescription under the federal Food, Drug and Cosmetic Act; are labeled and marketed in a manner consistent with the pertinent over-the-counter tentative final or final monograph; are manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse; and are not marketed, advertised, or labeled for the indication of stimulation, mental alertness, weight loss, muscle enhancement, appetite control, or energy:
(1) Solid oral dosage forms, including soft gelatin capsules, that combine active ingredients in the following range for each dosage unit of not less than twelve and five- tenths milligrams but not more than twenty-five milligrams of ephedrine and not less than four hundred milligrams of guaifenesin packaged in blister packs of not more than two tablets per blister.
(2) Anorectal preparations containing less than five percent ephedrine.
[C73, 75, 77, 79, 81, § 204.212]
84 Acts, ch 1013, § 12; 85 Acts, ch 86, § 6; 89 Acts, ch 109, § 4
C93, § 124.212
94 Acts, ch 1009, §16, 17; 97 Acts, ch 77, § 1
Referred to in § 124.201, 124.202, 124.303
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