AB 2605, as introduced, Bonilla. Pharmacy: sterile drug products.
The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. Existing law, until July 1, 2014, prohibits a nonresident pharmacy from compounding injectable sterile drug products for shipment into the state without a license issued by the board, and specifies the information the board is required to receive before issuing the license. Existing law, commencing July 1, 2014, expands that provision to apply to nonresident pharmacies that compound any sterile drug products, and specifies different information the board is required to receive before issuing the license.
This bill would, with regard to the provisions that become inoperative July 1, 2014, prohibit the board from issuing a license to a nonresident pharmacy until the board receives any other information the board deems necessary.
Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 4127.2 of the Business and Professions
2Code is amended to read:
(a) A nonresident pharmacy shall not compound
4injectable sterile drug products for shipment into the State of
5California without a license issued by the board pursuant to this
6section. The license shall be renewed annually and shall not be
7transferable.
8(b) A license to compound injectable sterile drug productsbegin delete may begin insert shallend insert be issuedbegin insert onlyend insert for a location that is licensed as a
9onlyend delete
10nonresident pharmacy. Furthermore, the license to
compound
11injectable sterile drug productsbegin delete may onlyend deletebegin insert
shallend insert be issuedbegin insert onlyend insert to
12the owner of the nonresident pharmacy license at that location. A
13license to compound injectable sterile drug productsbegin delete mayend deletebegin insert shallend insert not
14be issued or renewed until the board receives the following from
15the nonresident pharmacy:
16(1) A copy of an inspection report issued by the pharmacy’s
17licensing agency, or a report from a private accrediting agency
18approved by the board, in the prior 12 months documenting the
19pharmacy’s compliance with board regulations regarding the
20compounding of injectable sterile drug products.
21(2) A copy
of the nonresident pharmacy’s proposed policies
22and procedures for sterile compounding.
23(3) Any other documentation the board deems necessary.
end insert
24(c) Nonresident pharmacies operated by entities that are licensed
25as a hospital, home health agency, or a skilled nursing facility and
26have current accreditation from the Joint Commission on
27Accreditation of Healthcare Organizations, or other private
28accreditation agencies approved by the board, are exempt from
29the requirement to obtain a license pursuant to this section.
30(d) On or before January 1, 2018, the board shall provide a
31report to the Legislature regarding the regulation of nonresident
32pharmacies. The report shall be submitted to the Legislature in the
33manner
required pursuant to Section 9795 of the Government
34Code. At a minimum, the report shall address all of the following:
35(1) A detailed description of board activities related to the
36inspection and licensure of nonresident pharmacies.
37(2) The status of proposed changes to federal law that are under
38serious consideration and that would govern compounding
P3 1pharmacies, including legislation pending before the United States
2Congress, administrative rules, regulations, or orders under
3consideration by the federal Food and Drug Administration or
4other appropriate federal agency, and cases pending before the
5courts.
6(3) If applicable, recommended modifications to the board’s
7statutory duties related to nonresident pharmacies as a result of
8changes to federal law or any additional modifications necessary
9to protect the health
and safety of the public.
10(e) This section shall become inoperative on July 1, 2014, and,
11as of January 1, 2015, is repealed, unless a later enacted statute,
12that becomes operative on or before January 1, 2015, deletes or
13extends the dates on which it becomes inoperative and is repealed.
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