Ala. Admin. Code r. 420-4-4-.09

Current through Register Vol. 43, No. 1, October 31, 2024

Section 420-4-4-.09 - Extra-Label Use Of Animal Rabies Vaccines

Extra-label use of rabies vaccines may be considered under the following conditions:

(a) The United States Department of Agriculture regulations and the Food and Drug Administration regulations and guidelines for pharmaceuticals shall be followed relative to the extra-label use of animal rabies vaccines. Notations of extra-label use in domestic animals must also be entered on the animal's veterinary medical record.

(b) Animal rabies vaccines licensed for use in other species may be used in domestic animals when there is a demonstrated need for the product, provided there is evidence that some efficacy can be expected.

(c) Parenteral vaccination of captive native wildlife species shall not be allowed because the period of viral shedding, the clinical syndrome, and the efficacy of vaccines are not established.

(d) Zoos, research institutions, and exotic exhibitors licensed under the United States Department of Agriculture Animal Welfare Act may establish rabies vaccination programs under the supervision of the Department in an attempt to protect valuable animals. These programs should not be in lieu of appropriate quarantine and isolation measures that protect humans.

(e) Due to some uncertainties of the immunologic response to vaccination, the infective period of viral shedding, and the clinical course of disease in hybrid-cross animals, such animals involved in exposures to humans shall be considered for euthanasia on a case-by-case basis by the Department with due consideration given to the species, the circumstances of the exposure, and the epidemiology of rabies in the area.

Ala. Admin. Code r. 420-4-4-.09

New Rule: Filed September 19, 1997; effective October 24, 1997; operative November 4, 1997. Repealed and New Rule: Filed November 18, 2009; effective December 23, 2009.

Rule .07 was renumbered to .09 as per certification filed November 18, 2009.

Authors: William B. Johnston, D.V.M., Dee Jones, D.V.M.

Statutory Authority:Code of Ala. 1975, §§ 3-7A-1, et seq., 22-2-2(6).