4034. “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.
(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. Sec. 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.)
Structure California Code