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, […]
4127.1. (a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable. (b) A license to compound sterile drug products shall be issued only to a location that is licensed as a […]
4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be transferable. (a) A hospital satellite compounding pharmacy license shall […]
4127.2. (a) A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A license to compound sterile drug products shall be issued only to a location that […]
4127.3. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist […]
4127.4. Notwithstanding any other provision of law, a violation of this article, or regulations adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to two thousand five hundred dollars ($2,500) per occurrence pursuant to a citation issued by the board. (Added by Stats. 2001, Ch. 827, […]
4127.6. This article shall become operative upon the allocation of positions to the board for the implementation of the provisions of this article in the annual Budget Act. (Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Note: The condition in this section for operation of Article 7.5 (comm. with Section 4127), […]
4127.7. The board may, at its discretion, issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (u) of […]
4127.8. (a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of […]
