SECTION 230.11. General Provisions

(a) Purpose and applicability. The purpose of this subchapter 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.

(b) Definitions. The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(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) Department--The Department of State Health Services.

(3) 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.

(4) Record of sale--The paper or electronic documentation prepared and maintained in compliance with §230.15 of this title (relating to Records).

(5) 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.

(6) Over-the-counter sale--The sale within any calendar day of no more than 3.6 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances; and within any 30-day period, no more than nine grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances to an individual.

(7) "Real-time electronic logging system"--A system intended to be used by law enforcement agencies and pharmacies or other business establishments that:

(A) is installed, operated, and maintained free of any one-time or recurring charge to the business establishment or to the state;

(B) is able to communicate in real-time with similar systems operated in other states and similar systems containing information submitted by more than one state;

(C) complies with the security policy of the Criminal Justice Information Services division of the Federal Bureau of Investigation;

(D) complies with information exchange standards adopted by the National Information Exchange Model;

(E) uses a mechanism to prevent the completion of a sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that would violate state or federal law regarding the purchase of a product containing those substances; and

(F) is equipped with an override of the mechanism described in subparagraph (E) of this paragraph that:

(i) may be activated by an employee of a business establishment; and

(ii) creates a record of each activation of the override.

(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; amended to be effective October 11, 2012, 37 TexReg 8032; amended to be effective June 7, 2018, 43 TexReg 3594