1. (a) Purpose and applicability. The purpose of these sections is to implement the duties of the Department of State Health Services (department) under the Health and Safety Code (HSC), Chapter 486, relating to over-the-counter sales of ephedrine, pseudoephedrine, and norpseudoephedrine.

2. (b) Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. Unless otherwise specified, the terms have the meaning assigned by HSC, Chapters 481 and 486, or their common use meaning.

   1. (1) Business establishment--A retail distributor such as a grocery store; general merchandise store; drug store; or other entity or person, other than a licensed pharmacy, that engages in direct sales to end-user consumers. A distributor who engages in greater than 5% of gross annual sales of regulated products to other than end-user consumers must obtain a license as a wholesaler under HSC, Chapter 431, Subchapter I or Subchapter N.
   2. (2) Department--The Department of State Health Services.
   3. (3) Certificate of authority (COA)--A grant of authority to engage in over-the-counter sales of regulated products, issued by the department to a person under this subchapter.
   4. (4) Certificate of authority holder (COA holder)--A person that has been issued a certificate of authority by the department to engage in over-the-counter sales of regulated products.
   5. (5) Pharmacy--A person holding a current license to operate a pharmacy issued by the Texas State Board of Pharmacy (Board of Pharmacy) under Occupations Code, Chapter 560.
   6. (6) Record of sale--The paper or electronic documentation prepared and maintained in compliance with §230.15 of this title (relating to Records).
   7. (7) Regulated products--Any compound, mixture, or preparation containing any detectable amount of ephedrine, pseudoephedrine, or norpseudoephedrine, including its salts, optical isomers, and salts of optical isomers. The term does not include any compound, mixture, or preparation that is in liquid, liquid capsule, or liquid gel capsule form. A list of regulated products, by name and universal product code (UPC) or stock-keeping unit (SKU) identifiers, may be obtained from the Department of State Health Services, 1100 West 49th, Austin, Texas 78756.
   8. (8) Over-the-counter sale--The sale of not more than two packages or six grams of regulated products, in a single transaction to an individual.
3. (c) Persons who sell or distribute ephedrine, pseudoephedrine, norpseudoephedrine or phenylpropanolamine may be subject to additional federal statutes and regulations adopted thereunder.

Source Note:The provisions of this §230.11 adopted to be effective June 19, 2006, 31 TexReg 4863.