499.033 Ephedrine; prescription required.—Ephedrine is declared to be a prescription drug.
(1) Except as provided in subsection (2), any product that contains any quantity of ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine may be dispensed only upon the prescription of a duly licensed practitioner authorized by the laws of the state to prescribe prescription drugs.
(2) A product containing ephedrine described in paragraphs (a)-(e) is exempt from subsection (1) if it may lawfully be sold over the counter without a prescription under the federal act; is labeled and marketed in a manner consistent with the pertinent United States Food and Drug Administration Over-the-Counter Tentative Final or Final Monograph; and is manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse, when considered in the context with: the package sizes and the manner of packaging of the drug product; the name and labeling of the product; the manner of distribution, advertising, and promotion of the product; the duration, scope, health significance, and societal cost of abuse of the particular product; the need to provide medically important ephedrine-containing therapies to the public for United States Food and Drug Administration approved indications on an unrestricted, over-the-counter basis; and other facts as may be relevant to and consistent with public health and safety.
(a) Solid oral dosage forms that combine active ingredients in the following ranges for each dosage unit:
