Section 34.2 - General Requirements(a) Importation. Veterinary biologics produced under a regular license issued by the USDA, APHIS, VS may be imported into the State of Texas, however, prior to initial importation of any licensed veterinary biologic for sale, use, or distribution within the state, written approval of the executive director is required. The executive director may allow the importation of unlicensed or conditionally licensed veterinary biologics when it is determined necessary for the protection of humans or domestic animals or for research purposes.(b) Restriction of biologics for disease control.(1) Rabies vaccines shall be sold, distributed, and administered as prescribed by Chapter RSA 826, Health and Safety Code, and rules adopted by the Texas Board of Health.(2) All veterinary biologics used to control or diagnose any of the following diseases listed in subparagraphs (A)-(K) of this paragraph are restricted: (B) equine infectious anemia;(C) equine viral arteritis;(F) Mycoplasma gallisepticum (MG);(J) vesicular stomatitis.(3) Restricted veterinary biologics may be purchased, administered, or otherwise used under the following conditions listed in subparagraphs (A)-(C) of this paragraph. (A) Laryngotracheitis (LT) chick embryo origin vaccine may be used upon tentative or confirmed diagnosis by a recognized laboratory and pursuant to a written agreement between the commission and the flock owners in a designated area.(B) Mycoplasma gallisepticum (MG) attenuated vaccine may be used upon confirmed diagnosis by a recognized laboratory, and where a written permit for its use has been issued by the commission. MG vaccine may be used without restriction following approval outlined in subsection (a) of this section.(C) Other restricted veterinary biologics may be purchased, administered, or otherwise used: (i) under the direct supervision of licensed veterinarians;(ii) by employees of the commission or USDA;(iii) by research agencies or laboratories as authorized by the commission;(iv) in emergency disease control programs as authorized by the commission; or(v) for other limited purposes authorized by the commission and not likely to pose a threat to public health or to the health of animals.(c) Solicitation of information. The commission may solicit information and recommendations on the following topics listed in paragraphs (1)-(4) of this subsection prior to approving a veterinary biologic for sale, use, or distribution within the state: (1) known effectiveness of the biologic;(2) to what extent the disease for which the veterinary biologic is used or intended to be used is present in this state;(3) degree of isolation of the affected animals and area; and(4) any other factor which may constitute a hazard to animal or public health in this state.(d) Reporting. Any person using a veterinary biologic shall report to the commission any suspected or actual disease outbreak or adverse reaction that occurs in connection with use of the veterinary biologic.(e) Petition for review. Any person or entity may petition the commission for a review of the sale and distribution of a veterinary biologic.(f) Appeal. Any person or other entity that receives an adverse decision by the executive director on a request to sell, distribute, or use veterinary biologics in this state may appeal such decision pursuant to the provisions of the Administrative Procedure Act.4 Tex. Admin. Code § 34.2
The provisions of this §34.2 adopted to be effective December 18, 1992, 17 TexReg 8287; amended to be effective March 21, 1999, 24 TexReg 1767