Senate BillNo. 587


Introduced by Senator Stone

February 26, 2015


An act to amend Section 4127.1 of the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

SB 587, as introduced, Stone. Pharmacy: compounding.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. The law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board, and prohibits the board from issuing or renewing that license until the board has, among other things, reviewed a current copy of the pharmacy’s procedures and policies for sterile compounding.

This bill would make a nonsubstantive change to that licensing provision.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

P1    1

SECTION 1.  

Section 4127.1 of the Business and Professions
2Code
, as added by Section 5 of Chapter 565 of the Statutes of
32013, is amended to read:

4

4127.1.  

(a) A pharmacy shall not compound sterile drug
5products unless the pharmacy has obtained a sterile compounding
6pharmacy license from the board pursuant to this section. The
7license shall be renewed annually and is not transferable.

P2    1(b) A license to compound sterile drug products shall be issued
2only to a location that is licensed as a pharmacy and shall be issued
3only to the owner of the pharmacy licensed at that location.

4(c) A license to compound sterile drug products shall not be
5issued or renewed until the location is inspected by the board and
6found in compliance with this article and regulations adopted by
7the board.

8(d) A license to compound sterile drug products shall not be
9issued or renewed until the board does all of the following:

10(1) Reviews a current copy of the pharmacy’sbegin delete policies andend delete
11 proceduresbegin insert and policiesend insert for sterile compounding.

12(2) Reviews the pharmacy’s completed self-assessment form
13required by Section 1735.2 of Title 16 of the California Code of
14Regulations.

15(3) Is provided with copies of all inspection reports conducted
16of the pharmacy’s premises, and any reports from a private
17accrediting agency, conducted in the prior 12 months documenting
18the pharmacy’s operations.

19(4) Receives a list of all sterile medications compounded by the
20pharmacy since the last license renewal.

21(e) A pharmacy licensed pursuant to this section shall do all of
22the following:

23(1) Provide to the board a copy of any disciplinary or other
24action taken by another state within 10 days of the action.

25(2) Notify the board within 10 days of the suspension of any
26accreditation held by the pharmacy.

27(3) Provide to the board, within 12 hours, any recall notice
28issued by the pharmacy for sterile drug products it has
29compounded.

30(f) Adverse effects reported or potentially attributable to a
31pharmacy’s sterile drug product shall be reported to the board
32within 12 hours and immediately reported to the MedWatch
33program of the federal Food and Drug Administration.

34(g) The reconstitution of a sterile powder shall not require a
35license pursuant to this section if both of the following
36requirements are met:

37(1) The sterile powder was obtained from a manufacturer.

38(2) The drug is reconstituted for administration to patients by
39a health care professional licensed to administer drugs by injection
40pursuant to this division.

P3    1(h) This section shall become operative on July 1, 2014.



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