California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 9 — PharmacyArticle 7.5 — Sterile Drug ProductsSection 4127
(a) A pharmacy that compounds sterile drug products shall possess a sterile compounding pharmacy license as provided in this article.
(b) The board shall 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.
(c) The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivision (b).
Notes
Requires a pharmacy compounding sterile drug products to hold a sterile compounding pharmacy license and requires the board to adopt implementing regulations under the Administrative Procedure Act. The board must review each formal revision to USP-NF General Chapter 797 concerning sterile preparations no later than 90 days after the revision becomes official to determine whether its regulations need amendment.
Use as reference
Lexinter.net | California Code, Business and Professions Code - BPC § 4127 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-9/article-7-5/section-4127