Cal. Code Regs. Tit. 17, § 972 - Containers and Labeling

(a) No biological product either for human or animal use shall be distributed except in the original final container bearing the original label of the manufacturer; provided, however, that a licensed laboratory may purchase products from other producers likewise licensed by the State, and repack and relabel such products in smaller containers; provided, there are no changes, substitutions or additions in the product or the label, and further provided, that all such repacked biological products shall bear on the label the name of the manufacturer as well as the name of the distributor together with a statement that the product has been repacked. All such repacked products are subject to the requirements of Sections 1600 to 1621, inclusive, Health and Safety Code, and are not exempted from inspection and license by the department.

(b) The labels of all biologic products on the containers for general distribution shall show the name of the product, the lot number that will identify the lot or batch in the record of the manufacturer, the expiration date, and the name of the manufacturer. The expiration date shall be based on a period of duration approved by the department.

(c) The labels on all bottles and individual packages of bacterial vaccines (bacterins) shall give the correct name of the organism concerned and mixed bacterins shall give the names of each organism according to the classification of Bergey in the mixture and the proportion that each organism represents in the mixture. The concentration may be expressed in number per mil or in terms of a turbidity standard acceptable to the department.

(d) The labels on products requiring refrigeration or maintenance of uniform temperatures to avoid deterioration, shall specify the temperature range within which the product shall be maintained.

(e) To prevent accidental use, all stocks of labels and advertising not accepted by the department shall be destroyed.

Notes

Cal. Code Regs. Tit. 17, § 972

1. Repealer of subsection (e) and relettering of subsection (f) to (e) filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 34).