2018 California Code
Business and Professions Code - BPC
DIVISION 2 - HEALING ARTS
CHAPTER 9 - Pharmacy
ARTICLE 7.5 - Sterile Drug Products
Section 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 not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.
(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.
(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.
(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:
(1) Reviews a current copy of the hospital satellite compounding pharmacy’s policies and procedures for sterile compounding.
(2) Reviews the hospital satellite compounding pharmacy’s completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.
(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.
(c) A hospital satellite compounding pharmacy shall do all of the following:
(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.
(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.
(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.
(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.
(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
(Added by Stats. 2017, Ch. 623, Sec. 2. (SB 351) Effective January 1, 2018.)
