California Business and Professions Code

§ 4129.1

BPC § 4129.1 Effective Jan 1, 2017Div. 2 · Ch. 9 · Art. 7.7

Statute text

(a)An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable.

(b)An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities.

(c)An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board.

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Legislative history

Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.