“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).