(a)The following drug products containing ephedrine, its salts, optical isomers and salts of optical isomers shall be exempt from the application of Sections 312 and 313 of this Act if they:
(i)may lawfully be sold over-the-counter without a prescription under the Federal Food, Drug, and Cosmetic Act;
(ii)are labeled and marketed in a manner consistent with Section 341.76 of Title 21 of the Code of Federal Regulations;
(iii)are manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse; and (iv) are not marketed, advertised, or labeled for the indications of stimulation, mental alertness, weight loss, muscle enhancement, appetite control, or energy:
(1)Solid oral dosage forms, including soft gelatin caplets, which are formu
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(a) The following drug products containing ephedrine, its salts, optical isomers and salts of optical isomers shall be exempt from the application of Sections 312 and 313 of this Act if they: (i) may lawfully be sold over-the-counter without a prescription under the Federal Food, Drug, and Cosmetic Act; (ii) are labeled and marketed in a manner consistent with Section 341.76 of Title 21 of the Code of Federal Regulations; (iii) are manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse; and (iv) are not marketed, advertised, or labeled for the indications of stimulation, mental alertness, weight loss, muscle enhancement, appetite control, or energy: (1) Solid oral dosage forms, including soft gelatin caplets, which are formulated pursuant to 21 CFR 341 or its successor, and packaged in blister packs of not more than 2 tablets per blister. (2) Anorectal preparations containing not more than 5% ephedrine. (b) The marketing, advertising, or labeling of any product containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine, for the indications of stimulation, mental alertness, weight loss, appetite control, or energy, is prohibited. In determining compliance with this requirement the Department may consider the following factors: (1) The packaging of the drug product; (2) The name and labeling of the product; (3) The manner of distribution, advertising, and promotion of the product; (4) Verbal representations made concerning the product; (5) The duration, scope, and significance of misuse of the particular product. (c) A violation of this Section is a Class A misdemeanor. A second or subsequent violation of this Section is a Class 4 felony. (d) This Section does not apply to dietary supplements, herbs, or other natural products, including concentrates or extracts, which: (1) are not otherwise prohibited by law; and (2) may contain naturally occurring ephedrine, ephedrine alkaloids, or pseudoephedrine, or their salts, isomers, or salts of isomers, or a combination of these substances, that: (i) are contained in a matrix of organic material; and (ii) do not exceed 15% of the total weight of the natural product. (e) Nothing in this Section limits the scope or terms of the Methamphetamine Precursor Control Act. (f) This Section does not apply to the sale of any product dispensed or delivered by a practitioner or pharmacy according to a prescription issued by a prescriber authorized by this State or another state for a valid medical purpose and in the course of professional practice.