Emergency Sections An agency may adopt a new or amended section or repeal an existing section on an emergency basis if it determines that such action is necessary for the public health, safety, or welfare of this state. The section may become effective immediately upon filing with the Texas Register, or on a stated date less than 20 days after filing, for no more than 120 days. The emergency action is renewable once for no more than 60 days. Symbology in amended emergency sections. New language added to an existing section is indicated by the use of bold text. [Brackets] indicate deletion of existing material within a section. TITLE 25. Health Services Part I. Texas Department of Health Chapter 229. Food and Drug Licensing of Wholesale Distributors of Drugs-Including Good Manufacturing Practices 25 TAC sec.229.252 The Texas Department of Health (department) adopts on emergency basis an amendment to sec.229.252, concerning licensing fee and procedures/licensing of wolesale distributors of drugs-including good manufacturing practices. The section will enable the department to license and regulate wholesale drug distributors of compressed medical gases at a reduced fee. This amendment will not include those distributors of compressed medical gas who also transfill cylinders because these facilities require more inspectional time for operations testing and record review. A reduced fee is also established for small volume businesses that function as wholesale drug distributors at a median level. The majority of medical gas transfillers will be included in this category. Any place of business that is registered with the United States Food and Drug Administration as a manufacturer of compressed medical gases will be required to license with the department. This amendment is also being proposed for permanent adoption in this issue of the Texas Register. The amendment is adopted on an emergency basis because failure of these facilities to license and provide medical gas to incapacitated or nonambulatory patients would adversely affect the lives and health of these individuals. The amendment is adopted on an emergency basis under Texas Health and Safety Code, sec.431.241, which provides the Department with the authority to adopt necessary regulations pursuant to the enforcement of this chapter; and Texas Civil Statutes, Article 6252-13a, sec.5, which provide the board with authority to adopt emergency rules; and sec.12.001, which provide the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health and the commissioner of health. sec.229.252. Licensing Fee and Procedures. (a) License fee. All wholesale distributors of drugs who sell drugs in Texas shall obtain a license annually on or before September 1 with the Texas Department of Health (department) and shall pay a licensing fee for each wholesale distribution place of business operated as follows: (1) $150 per distributor engaged in distribution only of compressed medical gases (no transfilling operations) having a gross annual volume of $0- $20,000; (2) $250 per wholesale distributor having a gross annual volume of $0- $199,999.99 (includes medical gas transfillers); (3) [(1)]$500 per wholesale distributor having a gross annual volume of $200,000.00
    [$0]-$19,999,999.99; (4) [(2)]$750 per wholesale distributor having a gross annual volume greater than or equal to $20 million; and (5) [(3)]$750 per out-of-state wholesale distributor, unless an audited statement is provided which demonstrates a gross annual volume of less than $20 million which would require a licensing fee of $500. (b)-(h) (No change.) Issued in Austin, Texas, on January 1, 1988. TRD-9213199 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: September 29, 1992 Expiration date: January 27, 1993 For further information, please call: (512) 458-7248