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Rule Title: CONTROL OF BIOLOGICS
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Department: LIVESTOCK, DEPARTMENT OF
Chapter: DISEASE CONTROL
Subchapter: Control of Biologics
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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32.3.2301    CONTROL OF BIOLOGICS

(1) In this sub-chapter "biologic" means a medicinal preparation made from living organisms and their products. It includes but is not limited to serums, vaccines, antigens, and antitoxins.

(2) No biologic may be brought into the state without a permit from the department of livestock as required by 81-2-703 , MCA. A long term permit may be granted upon request.

(3) No person may manufacture for sale, or sell, or offer for sale for use in the state of Montana, any biological product intended for diagnostic, immunizing or therapeutic purposes in animals unless such product is approved by and manufactured under a license issued by the U.S. department of agriculture, or unless upon specific permission in writing by the Montana department of livestock, animal health division.

(4) The distribution, sale or use of viable anthrax vaccines is prohibited except by permit from the state veterinarian of Montana.

(5) The sale of any rabies biologic except to a licensed veterinarian or public health agency is prohibited.

(6) All serums, viruses and vaccines sold or offered for sale in the state of Montana for use in domestic animals shall be kept in a dark place at a temperature of not more than 45F, and not less than 35F, until such time as they are sold, and shall not be sold after their expiration date. They must be sold in their original container.

History: Sec. 81-2-102, 81-20-101, MCA; IMP, Sec. 81-2-102, 81-20-101, MCA; Eff. 12/31/72; AMD, Eff. 11/4/75; AMD, 1980 MAR p. 1083, Eff. 3/28/80; AMD, 1984 MAR p. 267, Eff. 1/27/84; AMD, 1996 MAR p. 2300, Eff. 8/23/96.


 

 
MAR Notices Effective From Effective To History Notes
8/23/1996 Current History: Sec. 81-2-102, 81-20-101, MCA; IMP, Sec. 81-2-102, 81-20-101, MCA; Eff. 12/31/72; AMD, Eff. 11/4/75; AMD, 1980 MAR p. 1083, Eff. 3/28/80; AMD, 1984 MAR p. 267, Eff. 1/27/84; AMD, 1996 MAR p. 2300, Eff. 8/23/96.
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