Section 4127.2.

(a) A nonresident pharmacy may not compound injectable sterile drug products for shipment into the State of California without a 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 injectable sterile drug products may only be issued for a location that is licensed as a nonresident pharmacy. Furthermore, the license to compound injectable sterile drug products may only be issued to the owner of the nonresident pharmacy license at that location. A license to compound injectable sterile drug products may not be issued or renewed until the board receives the following from the nonresident pharmacy:

(1) A copy of an inspection report issued by the pharmacy's licensing agency, or a report from a private accrediting agency approved by the board, in the prior 12 months documenting the pharmacy's compliance with board regulations regarding the compounding of injectable sterile drug products.

(2) A copy of the nonresident pharmacy's proposed policies and procedures for sterile compounding.

(c) Nonresident pharmacies operated by entities that are licensed as a hospital, home health agency, or a skilled nursing facility and have current accreditation from the Joint Commission on Accreditation of Healthcare Organizations, or other private accreditation agencies approved by the board, are exempt from the requirement to obtain a license pursuant to this section.

(d) This section shall become effective on the earlier of July 1, 2003, or the effective date of regulations adopted by the board pursuant to Section 4127.

(Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Section operative July 1, 2003, or sooner, pursuant to subd. (f).)