(a) Each licensee shall designate a person(s) to make all official contacts with Animal and Plant Health Inspection Service on matters pertaining to the preparation of biological products under the Virus-Serum-Toxin Act. The licensee shall file three copies of biographical summary with Animal and Plant Health Inspection Service for such designated person and for each person responsible for any phase of preparation of a biological product.

(b) All personnel employed in the preparation of biological products at a licensed establishment shall be competent in good laboratory techniques through education or training, or both, so as to consistently prepare high quality products.

(c) All biological products prepared at licensed establishments shall be prepared and handled with due sanitary precautions. Good sanitary measures shall be practiced at all times by all personnel involved in such preparation and handling of biological products.

(1) The clothing worn by persons while preparing biological products shall be clean. All persons, immediately before entering laboratory rooms of a licensed establishment, shall change their outer clothing or effectively cover the same with gowns or other satisfactory clean garments.

(2) Unsanitary practices such as, but not limited to, eating, smoking, or expectorating on the floors or otherwise creating a nuisance in any room, compartment, or place in which biological products are prepared, handled, or stored at licensed establishments are prohibited.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991]