Report Title:

Pseudoephedrine; Schedule V; Retail Sales; Recordkeeping

 

Description:

Establishes pseudoephedrine as a Schedule V controlled substance.  Authorizes and establishes requirements for sale of pseudoephedrine products by pharmacist or retailer, subject to exceptions for products in liquid, liquid capsule, and gel form.  (SD2)

 


THE SENATE

S.B. NO.

1100

TWENTY-THIRD LEGISLATURE, 2005

S.D. 2

STATE OF HAWAII

 

 

A BILL FOR AN ACT

 

 

relating to pseudoephedrine.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


     SECTION 1.  Chapter 329, Hawaii Revised Statutes, is amended by adding a new section to part III to be appropriately designated and to read as follows:

     "§329-    Sales of products, mixtures, or preparations containing pseudoephedrine.  (a)  Notwithstanding any other law to the contrary, a pharmacy or retailer may dispense, sell, or distribute without a prescription not more than three packages or not more than nine grams of any product, mixture, or preparation containing any detectable quantity of pseudoephedrine, its salts, optical isomers, or salts of optical isomers, as the only active ingredient or in combination with other active ingredients, provided the pharmacy or retailer complies with the following conditions:

     (1)  The product, mixture, or preparation is dispensed, sold, or distributed by a registered pharmacist, or a clerk or technician under the supervision or direction of a registered pharmacist; or

     (2)  The product, mixture, or preparation is dispensed, sold, or distributed by a clerk from an area not accessible by customers or the general public; or

     (3)  The product, mixture, or preparation is dispensed, sold, or distributed from a locked display case; and

     (4)  The pharmacy or retailer requires any person purchasing or otherwise acquiring any product, mixture, or preparation:

         (A)  To produce proper identification containing the photograph, printed name, and signature of the individual obtaining any product, mixture, or preparation containing pseudoephedrine; and

          (B)  To sign a written log, receipt, or other mechanism approved by the administrator, showing the date of the transaction, the name of the person, and the amount of the product, mixture, or preparation.

     (b)  No person shall purchase, receive, or otherwise acquire more than nine grams of any product, mixture, or preparation containing any detectable quantity of pseudoephedrine or its salts, optical isomers, or salts of optical isomers within any thirty-day period; provided that this limit shall not apply to any quantity of product, mixture, or preparation dispensed pursuant to a valid prescription.

     (c)  The sales restriction established in subsection (b), as it applies to products, mixtures, or preparations containing any detectable quantity of pseudoephedrine, its salts, optical isomers, or salts of optical isomers, shall not apply to any products, mixtures, or preparations that are in liquid, liquid capsule, or gel capsule form if pseudoephedrine is not the only active ingredient.

     (d)  The department, by rule, may exempt other products from this section if the administrator finds that the products are not used in the illegal manufacture of methamphetamine or other controlled substances.  A manufacturer of a drug product may apply for removal of the product from this section if the product is determined by the administrator to have been formulated in such a way as to effectively prevent the conversion of the active ingredient into methamphetamine."

     SECTION 2.  Section 329-22, Hawaii Revised Statutes, is amended by amending subsection (c) to read as follows:

     "(c)  Stimulants.  Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:

     (1)  Pyrovalerone[.]; and

     (2)  Pseudoephedrine, its salts, optical isomers, or salts of optical isomers."

     SECTION 3.  Section 329-64, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:

     "(a)  The requirements imposed by sections 329-62, 329-63, and 329-67 of this part shall not apply to any of the following:

     (1)  Any pharmacist or other authorized person who sells or furnishes a substance upon the prescription of a physician, dentist, podiatrist, or veterinarian;

     (2)  Any physician, dentist, podiatrist, or veterinarian who administers or furnishes a substance to patients;

     (3)  Any manufacturer or wholesaler licensed by the State who sells, transfers, or otherwise furnishes a substance to a licensed pharmacy, physician, dentist, podiatrist, or veterinarian; [and]

     (4)  Any sale, transfer, furnishing, or receipt of any drug which contains ephedrine, [pseudoephedrine, norpseudoephedrine,] or phenylpropanolamine and which is lawfully sold, transferred, or furnished over the counter without a prescription pursuant to the federal Food, Drug, and Cosmetic Act (21 United States Code Sec. 301 et seq.) or regulations adopted thereunder[.]; and

     (5)  Any "dietary supplement" as defined by the federal Food, Drug, and Cosmetic Act (21 United States Code Sec. 301) containing ephedrine alkaloids extracted from any species of Ephedra that meets all of the following criteria:

          (A)  It contains, per dosage unit or serving, not more than twenty-five milligrams of ephedrine alkaloids and its labeling does not suggest or recommend a total daily intake of more than one hundred milligrams of ephedrine alkaloids;

          (B)  It contains no hydrochloride or sulfate salts of ephedrine alkaloids;

          (C)  It is packaged with a prominent label securely affixed to each package that states all of the following:

              (i)  The amount in milligrams of ephedrine alkaloids in a dosage unit or serving;

             (ii)  The amount of the dietary supplement that constitutes a dosage unit or serving; and

            (iii)  The maximum recommended dosage of ephedrine alkaloids for a healthy adult human is not more than one hundred milligrams in a twenty-four hour period."

     SECTION 4.  This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun, before its effective date.

     SECTION 5.  Statutory material to be repealed is bracketed and stricken.  New statutory material is underscored.

     SECTION 6.  This Act shall take effect on July 1, 2015.