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
Universal Citation: 25 TX Admin Code ยง 230.11
Current through Reg. 49, No. 38; September 20, 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.
(c) Persons who sell or distribute ephedrine, pseudoephedrine, norpseudoephedrine or phenylpropanolamine may be subject to additional federal statutes and regulations adopted thereunder.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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