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SB-510 Pharmacies: compounding.(2017-2018)

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Date Published: 10/10/2017 09:00 PM

Senate Bill No. 510

An act to amend and renumber Sections 4127.8 and 4127.9 of, and to repeal Section 4127.7 of, the Business and Professions Code, relating to healing arts.

[ Approved by Governor  October 10, 2017. Filed with Secretary of State  October 10, 2017. ]


SB 510, Stone. Pharmacies: compounding.
Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. That law requires a pharmacy to compound sterile products from one or more nonsterile ingredients in prescribed environments.
This bill would repeal that compounding environment provision and make conforming renumbering changes to other provisions.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NO   Local Program: NO  

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


 Section 4127.7 of the Business and Professions Code is repealed.

SEC. 2.

 Section 4127.8 of the Business and Professions Code is amended and renumbered to read:

 The board may, at its discretion, issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (u) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license.

SEC. 3.

 Section 4127.9 of the Business and Professions Code is amended and renumbered to read:

 (a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in this state.
(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:
(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.