“Outsourcing facility” means a facility that meets all of the following:

(a) Is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs.

Terms Used In California Business and Professions Code 4034

  • board: means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or registration authorizing a person to engage in a business or profession. See California Business and Professions Code 31

(b) Has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353b).

(c) Is doing business within or into California.

(d) Is licensed with the board as an outsourcing facility pursuant to Article 7.7 (commencing with Section 4129).

(Added by Stats. 2016, Ch. 484, Sec. 15. (SB 1193) Effective January 1, 2017.)