Maine § 1808. - Sale, distribution and use of certain biologics

§ 1808.. Sale, distribution and use of certain biologics

A biological product capable of eliciting an immunological response offered for use in the treatment or prevention of diseases of domestic animals may not be produced, sold, distributed, imported or used within the State, or imported into the State for sale, distribution or use unless approval and written permission has first been obtained from the commissioner. The commissioner has the right to refuse permission for distribution, sale, importation or use of any such product within the State, and may require reporting of sale, distribution, importation or use of any such product within the State, if permission is granted.   [PL 2001, c. 572, §37 (AMD).]

An antigen used for diagnostic purposes in domestic animals may not be produced in or shipped into the State without the approval of the commissioner.   [PL 2001, c. 572, §37 (AMD).]

A person except a licensed veterinarian may not offer for sale or distribution, within the State, any biological product containing living organisms or viruses offered for use in the treatment or prevention of diseases of domestic animals, without first obtaining a permit to act as a salesperson or distributor from the department.   [PL 2001, c. 572, §37 (AMD).]

The commissioner shall, in a manner consistent with the Maine Administrative Procedure Act, adopt rules as to refrigeration, handling, shipping, disposing of outdated material and sale of such products.   [PL 2001, c. 572, §37 (AMD).]

Failure to comply with this section or section 1807, or the rules adopted pursuant thereto, is grounds for revocation of any permit granted pursuant to these sections.   [PL 2003, c. 510, Pt. A, §4 (AMD).]