Cal. Bus. & Prof. Code § 4127
Sterile Drug Products
Redline — January 1, 2013 → current.View current text →
Current — January 1, 2017
As of January 1, 2013
(a) The board shall adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy.
(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 emergency 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 initially implement the provisions of this article that become operative on July 1, 2014. The initial adoption, amendment, or repeal of a regulation authorized by this section is deemed to address an emergency for purposes of Sections 11346.1 and 11346.6 of the Government Code, and the board is hereby exempted for that purpose from the requirements of subdivision (b) of Section 11346.1 of the Government Code. After the initial adoption, amendment, or repeal of an emergency regulation pursuant to this section, the board may request approval from the Office of Administrative Law to readopt the regulation as an emergency regulation pursuant to Section 11346.1 of the Government Code.
(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(c) This section shall become inoperative on July 1, 2014, and, as of January 1, 2015, is repealed, unless a later enacted statute, that becomes operative on or before January 1, 2015, deletes or extends the dates on which it becomes inoperative and is repealed.
(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).
Official source: California Legislative Information. Reproduced from public-domain California statutes; confirm against the official source for the current text. Not legal advice.