Rule 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 (department) 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 department's 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 stored according to the manufacturer's label conditions. They must be sold in their original container.Mont. Admin. r. 32.3.2301
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; AMD, 2024 MAR p. 2231, Eff. 9/21/2024AUTH: 81-2-102, 81-2-707, 81-20-101, MCA; IMP: 81-2-102, 81-2-707, 81-20-101, MCA