Mich. Admin. Code R. 287.703 - Importation, distribution, and use of veterinary biologicals

Rule 3.

(1) Any person, agency, or company that desires to import into this state or to distribute intrastate, for experimental or field trial use, any veterinary biological that is not conditionally or unconditionally licensed by the USDA shall request and obtain permission from the director to do so.

(2) All of the following information is required when requesting permission to distribute, in this state, veterinary biologicals which are conditionally or unconditionally licensed by the USDA or which have import permits for distribution and sale issued by the USDA.

(a) A copy of the current USDA license.

(b) Any restrictions set forth by the USDA.

(c) A complete product name--generic and trade.

(d) Product information, including directions for use.

(e) Slaughter withdrawal times, if applicable.

(3) Veterinary biologicals for experimental or field trial purposes shall be shipped only to veterinarians. Veterinary biologicals for experimental or field trial purposes shall be used only by the veterinarians to whom the product is shipped or by individuals who are under the direct supervision of the veterinarians to whom the product is shipped.

(4) A report of each requested shipment shall be made to the department by the person, agency, or company consigning, shipping, or transporting veterinary biologicals for experimental or field trial purposes into or within this state. The report shall be filed with the department within 5 working days of the shipment. The report shall contain all of the following information:

(a) The quantity consigned, shipped, or transported.

(b) The expiration date of the product.

(c) The complete name of the veterinary biological.

(d) The name and address of the recipient veterinarian.

(5) Any person, agency, or company that requests permission to import or distribute intrastate a veterinary biological to be administered for experimental or field trial purposes to animals owned by the public shall submit, to the department, a written statement which shall be given to the owner of the animals before the administration, prescription, or distribution of the veterinary biological and which states both of the following:

(a) That the veterinary biological to be administered, prescribed, or dispensed to an animal or animals is an experimental or field trial veterinary biological.

(b) That the veterinary biological has not been approved by the USDA or the department for unconditional distribution or use.

(6) Any person, agency, or company that requests permission to import or distribute intrastate a veterinary biological for experimental or field trial purposes shall not hold the department responsible for any liability or injury to humans or animals or for loss of any animals.

(7) Any person, agency, or company that requests permission to import or distribute intrastate a veterinary biological for experimental or field trial purposes shall report any adverse reactions to the department within 5 working days.

(8) Determination of distribution of veterinary biologicals for experimental or field trial purposes shall be based upon, but not limited to, the following criteria:

(a) Need for the product by the animal industry.

(b) Safety of the product for the target animal species.

(c) Safety of the product for the person or persons who administer the biological.

(d) Safety of the human food chain when the veterinary biological is used in food-producing animals.

(9) The director may limit the distribution of a veterinary biological for experimental or field trial purposes to certain geographical areas within this state and for specific time periods.

(10) The director may at any time revoke permission to distribute veterinary biologicals for experimental or field trial purposes.

Notes

Mich. Admin. Code R. 287.703

1994 AACS