Louisiana § RS 40:962.1 - Ephedrine products

§ RS 40:962.1. Ephedrine products

            A. Except as provided in Subsection B of this Section, 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.

            B. The following products containing ephedrine shall be exempt from the provisions of Subsection A of this Section provided that such product may lawfully be sold over the counter without a prescription under the federal Food, Drug, and Cosmetic Act, is labeled and marketed in a manner consistent with the pertinent OTC 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: 

            (1) Solid oral dosage forms (including soft gelatin caplets) that combine active ingredients in the following ranges for each dosage unit:

            (a) Theophylline (100-130 mg), Ephedrine (12.56-24 mg).

            (b) Theophylline (60-100 mg), Ephedrine (12.5-24 mg), Guaifenesin (200-400 mg).

            (c) Ephedrine (12.5-25 mg), Guaifenesin (200-400 mg).

            (d) Phenobarbital (not greater than 8 mg) in combination with ingredients of Subparagraph (a) or (b) of this Paragraph.

            (2) Liquid oral dosage forms that combine active ingredients in the following ranges for each (5 ml) dose:

            (a) Theophylline (not greater than 45 mg), Ephedrine (not greater than 36 mg), Guaifenesin (not greater than 100 mg), Phenobarbital (not greater than 12 mg).

            (b) Phenylephephrine (not greater than 5 mg), Ephedrine (not greater than 5 mg), chlorpheniramine (not greater than 2 mg), dextromethorphan (not greater than 10 mg), ammonium C1 (not greater than 40 mg), ipecac fluid extract (not greater than 0.005 ml).

            (3) Anorectal preparations containing less than five percent ephedrine.

            (4) Any liquid compound, mixture, or preparation containing one-half percent or less of ephedrine.

            C. The marketing, advertising, or labeling of any nonprescription product containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine for the indication of stimulation, mental alertness, weight loss, appetite control, or energy is prohibited. The Louisiana Department of Health, office of public health is authorized to adopt rules and regulations in accordance with the Administrative Procedure Act to exempt other nonprescription products from the prohibition contained herein. Such rules and regulations shall require a distributor or manufacturer seeking an exemption from the prohibition contained herein to clearly demonstrate that the nonprescription product is intended for use for a valid medicinal purpose and that the marketing of that product does not encourage, promote, or abet the abuse or misuse of ephedrine. In addition, such rules and regulations shall include the following factors for purposes of determining whether or not such an exemption should be granted:

            (1) The packing of the 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 abuse or misuse of the particular product.

            D. Whoever violates any provision of this Section shall be fined not more than one thousand dollars or imprisoned for not more than six months, or both.

            E. Notwithstanding any provision of law to the contrary, unless listed in another schedule, 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 is a Schedule V controlled dangerous substance and shall be dispensed, sold, or distributed only in accordance with the provisions of R.S. 40:1049.1 et seq. Such products shall be exempt from the reporting for Schedule V drugs as provided for in R.S. 40:1001 et seq.

            Acts 1995, No. 1253, §1, eff. Jan. 1, 1996; Acts 2009, No. 314, §1; Acts 2018, No. 206, §4.