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 14    b. 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 35    c.  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