Current through Reg. 49, No. 38; September 20, 2024
(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:
(A) brucellosis;
(B) equine infectious anemia;
(C) equine viral arteritis;
(D) hog cholera;
(E) laryngotracheitis;
(F) Mycoplasma gallisepticum (MG);
(G) paratuberculosis;
(H) pseudorabies;
(I) tuberculosis;
(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.
