California Business and Professions Code

§ 4129

BPC § 4129 Effective Jan 1, 2022Div. 2 · Ch. 9 · Art. 7.7

Statute text

(a)A facility registered as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution within or into California.

(b)A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location.

(c)The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article.

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Legislative history

Amended by Stats. 2021, Ch. 629, Sec. 20. (AB 1533) Effective January 1, 2022.