CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 510Introduced by Senator StoneFebruary 16, 2017 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. LEGISLATIVE COUNSEL'S DIGESTSB 510, as introduced, 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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4127.7 of the Business and Professions Code is repealed.4127.7.A pharmacy shall compound sterile products from one or more nonsterile ingredients in one of the following environments:(a)An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.(b)An ISO class 5 cleanroom.(c)A barrier isolator that provides an ISO class 5 environment for compounding.SEC. 2. Section 4127.8 of the Business and Professions Code is amended and renumbered to read:4127.8.4127.7 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 licenseholders 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:4127.9.4127.8 (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.
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 510Introduced by Senator StoneFebruary 16, 2017 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. LEGISLATIVE COUNSEL'S DIGESTSB 510, as introduced, 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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Senate Bill No. 510
Introduced by Senator StoneFebruary 16, 2017
Introduced by Senator Stone
February 16, 2017
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.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 510, as introduced, 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.
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.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 4127.7 of the Business and Professions Code is repealed.4127.7.A pharmacy shall compound sterile products from one or more nonsterile ingredients in one of the following environments:(a)An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.(b)An ISO class 5 cleanroom.(c)A barrier isolator that provides an ISO class 5 environment for compounding.SEC. 2. Section 4127.8 of the Business and Professions Code is amended and renumbered to read:4127.8.4127.7 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 licenseholders 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:4127.9.4127.8 (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.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 4127.7 of the Business and Professions Code is repealed.4127.7.A pharmacy shall compound sterile products from one or more nonsterile ingredients in one of the following environments:(a)An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.(b)An ISO class 5 cleanroom.(c)A barrier isolator that provides an ISO class 5 environment for compounding.
SECTION 1. Section 4127.7 of the Business and Professions Code is repealed.
### SECTION 1.
4127.7.A pharmacy shall compound sterile products from one or more nonsterile ingredients in one of the following environments:(a)An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.(b)An ISO class 5 cleanroom.(c)A barrier isolator that provides an ISO class 5 environment for compounding.
A pharmacy shall compound sterile products from one or more nonsterile ingredients in one of the following environments:
(a)An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
(b)An ISO class 5 cleanroom.
(c)A barrier isolator that provides an ISO class 5 environment for compounding.
SEC. 2. Section 4127.8 of the Business and Professions Code is amended and renumbered to read:4127.8.4127.7 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 licenseholders 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. 2. Section 4127.8 of the Business and Professions Code is amended and renumbered to read:
### SEC. 2.
4127.8.4127.7 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 licenseholders 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.
4127.8.4127.7 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 licenseholders 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.
4127.8.4127.7 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 licenseholders 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.
4127.8.4127.7 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 licenseholders 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:4127.9.4127.8 (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.
SEC. 3. Section 4127.9 of the Business and Professions Code is amended and renumbered to read:
### SEC. 3.
4127.9.4127.8 (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.
4127.9.4127.8 (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.
4127.9.4127.8 (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.
4127.9.4127.8 (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.