(a) A nonresident pharmacy shall 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) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident pharmacies. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following:
(1) A detailed description of board activities related to the inspection and licensure of nonresident pharmacies.
(2) The status of proposed changes to federal law that are under serious consideration and that would govern compounding pharmacies, including legislation pending before the United States Congress, administrative rules, regulations, or orders under consideration by the federal Food and Drug Administration or other appropriate federal agency, and cases pending before the courts.
(3) If applicable, recommended modifications to the board’s statutory duties related to nonresident pharmacies as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public.
(e) 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.