California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 9 — PharmacyArticle 2 — DefinitionsSection 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).

Notes

Defines an “outsourcing facility” as a facility located at one United States address that compounds sterile and nonsterile drugs, is federally registered as an outsourcing facility, does business within or into California, and is licensed by the board as an outsourcing facility. All four stated conditions must be met.

Use as reference

Lexinter.net | California Code, Business and Professions Code - BPC § 4034 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-9/article-2/section-4034

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