House File 638 HOUSE FILE BY COMMITTEE ON PUBLIC SAFETY (SUCCESSOR TO HSB 273) Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act relating to ephedrine and pseudoephedrine, and making 2 penalties applicable. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 3084HV 80 5 jm/sh/8 PAG LIN 1 1 Section 1. Section 124.212, subsection 5, Code 2003, is 1 2 amended to read as follows: 1 3 5. EPHEDRINE. Unless specifically excepted in paragraph 1 4"b" or"c", or listed in another schedule, any material, 1 5 compound, mixture, or preparation which contains any quantity 1 6 of the following substance, including its salts, optical 1 7 isomers, and salts of such optical isomers: 1 8 a. Ephedrine. 1 9 b. Any dietary supplement product that is not otherwise 1 10 prohibited by any other law and is a naturally occurring 1 11 ephedrine alkaloid or associated salts, isomers, salts of 1 12 isomers, or a combination of these substances that are 1 13 contained in a matrix of organic material. 1 14b.c. The following drug products containing ephedrine, 1 15 its salts, optical isomers, and salts of such optical isomers 1 16 are excepted from this schedule if they may lawfully be sold 1 17 over the counter without a prescription under the federal 1 18 Food, Drug and Cosmetic Act; are labeled and marketed in a 1 19 manner consistent with the pertinent over=the=counter 1 20 tentative final or final monograph; are manufactured and 1 21 distributed for legitimate medicinal use in a manner that 1 22 reduces or eliminates the likelihood of abuse; and are not 1 23 marketed, advertised, or labeled for the indication of 1 24 stimulation, mental alertness, weight loss, muscle 1 25 enhancement, appetite control, or energy: 1 26 (1) Solid oral dosage forms, including soft gelatin 1 27 capsules, that combine active ingredients in the following 1 28 range for each dosage unit of not less than twelve and five= 1 29 tenths milligrams but not more than twenty=five milligrams of 1 30 ephedrine and not less than four hundred milligrams of 1 31 guaifenesin packaged in blister packs of not more than two 1 32 tablets per blister. 1 33 (2) Anorectal preparations containing less than five 1 34 percent ephedrine. 1 35c. A dietary supplement is also excepted from this 2 1 schedule if the dietary supplement is not otherwise prohibited 2 2 by any other law and is a naturally occurring ephedrine 2 3 alkaloid or associated salts, isomers, salts of isomers, or a 2 4 combination of these substances that are contained in a matrix 2 5 of organic material and do not exceed fifteen percent of the 2 6 total weight of the natural product.2 7 Sec. 2. NEW SECTION. 126.23A PSEUDOEPHEDRINE. 2 8 1. Beginning July 1, 2003, a retailer shall not sell or 2 9 offer for sale pseudoephedrine in a single ingredient form 2 10 through the use of a self=service display. 2 11 2. A retailer that violates this section commits a simple 2 12 misdemeanor, punishable as a scheduled violation under section 2 13 805.8C, subsection 4. 2 14 3. As used in this section, "retailer" means any business 2 15 or enterprise that sells or offers for sale pseudoephedrine to 2 16 the general public. 2 17 4. As used in this section, "self=service display" means 2 18 any manner of product display, placement, or storage which a 2 19 person purchasing pseudoephedrine may take possession of the 2 20 product, prior to purchase, without assistance from the 2 21 retailer or an employee of the retailer, in removing the 2 22 pseudoephedrine from a restricted access location. 2 23 Sec. 3. Section 805.8C, Code 2003, is amended by adding 2 24 the following new subsection: 2 25 NEW SUBSECTION. 4. RETAILER VIOLATION. For a violation 2 26 of section 126.23A, the scheduled fine for a retailer is one 2 27 hundred dollars. 2 28 EXPLANATION 2 29 This bill relates to ephedrine and making pseudoephedrine a 2 30 controlled substance. 2 31 The bill provides that any dietary supplement containing 2 32 any naturally occurring ephedrine becomes a schedule V 2 33 controlled substance. "Dietary supplement" is generally 2 34 defined under the bill to mean a naturally occurring ephedrine 2 35 alkoid or associated salts, isomers, salts of isomers, or a 3 1 combination of these substances that are contained in a matrix 3 2 of organic material. 3 3 Iowa administrative code rule 657=10.31 establishes the 3 4 rules for dispensing a schedule V controlled substance. The 3 5 rule further limits the amount and frequency of purchase, 3 6 requires the purchaser be at least 18 years of age, and 3 7 requires presentation of identification and a signature before 3 8 purchase. A schedule V controlled substance does not require 3 9 a prescription but is not to be distributed other than for a 3 10 medical purpose. The distribution of a schedule V substance 3 11 is regulated by pharmacists, and scheduled V substances must 3 12 be kept off public access shelves. 3 13 Any criminal offense related to a schedule V controlled 3 14 substance is punishable as an aggravated misdemeanor pursuant 3 15 to Code section 124.401(1)(d). 3 16 The bill provides that beginning July 1, 2003, a retailer 3 17 shall not sell or offer for sale pseudoephedrine in a single 3 18 ingredient form through the use of a self=service display. 3 19 The bill defines "self=service display" to mean any product 3 20 display which a person purchasing the product may take 3 21 possession of the product without assistance from the 3 22 retailer. 3 23 A retailer who displays pseudoephedrine in a single 3 24 ingredient form by using a self=service display commits a 3 25 simple misdemeanor punishable by a scheduled fine of $100. 3 26 LSB 3084HV 80 3 27 jm/sh/8