Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 230 - SPECIFIC ADDITIONAL REQUIREMENTS FOR DRUGS › Subchapter B - LIMITATIONS ON SALES OF PRODUCTS CONTAINING EPHEDRINE, PSEUDOEPHEDRINE, AND NORPSEUDOEPHEDRINE › Section 230.11 - General Provisions

Current through Reg. 49, No. 28; July 12, 2024
(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.