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| Public Act 104-0252 | ||||
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AN ACT concerning criminal law. | ||||
Be it enacted by the People of the State of Illinois, | ||||
represented in the General Assembly: | ||||
Section 5. The Illinois Controlled Substances Act is | ||||
amended by changing Section 216 as follows: | ||||
(720 ILCS 570/216) | ||||
Sec. 216. Ephedrine. | ||||
(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. | ||
(Source: P.A. 103-881, eff. 1-1-25.) | ||