Sterile drug products.
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SB 294 — Sterile drug products.
Last action — Chaptered by Secretary of State. Chapter 565, Statutes of 2013.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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✓Passed Senate
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✓Passed Assembly
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✓To Executive
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6Enacted
This bill has been enacted into law. Introduced February 15, 2013. Enacted.
Prognosis
Where this bill stands today.
Odds of enactment
HighHow often bills like it became law.
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Enacted
Current position in the legislative process.
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1 sponsor
1 primary, 0 co-sponsors signed on.
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Cleared a recorded vote
Passed 9 recorded votes so far.
Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.
Summary
(1) 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 requires the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime. This bill, commencing July 1, 2014, would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill, commencing July 1, 2014, would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. The bill would require the board to adopt regulations to implement these provisions, and, on and after July 1, 2014, to review formal revisions to specified national standards relating to the compounding of sterile preparations to determine whether amendments to those regulations are necessary, as specified. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program. (2) Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products. This bill, commencing July 1, 2014, would establish the fee for the issuance or renewal of a nonresident sterile compounding pharmacy license in the amount of $780 and would require the applicant to deposit a reasonable amount, as determined by the board, necessary to cover the board's estimated cost of performing an inspection of the nonresident pharmacy location, as specified. (3) The bill would also require the board to report to the Legislature, on or before January 1, 2018, regarding the regulation of nonresident pharmacies, including, among other things, a detailed description of board activities related to the inspection and licensure of nonresident pharmacies. (4) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.
Bill Text
- Chaptered 10/04/13 - Chaptered Current pdf October 04, 2013
- Enrolled 09/11/13 - Enrolled pdf September 11, 2013
- Amended 09/03/13 - Amended Assembly pdf September 03, 2013
- Amended 08/15/13 - Amended Assembly pdf August 15, 2013
- Amended 08/05/13 - Amended Assembly pdf August 05, 2013
- Amended 07/03/13 - Amended Assembly pdf July 03, 2013
- Amended 06/24/13 - Amended Assembly pdf June 24, 2013
- Amended 05/28/13 - Amended Senate pdf May 28, 2013
- Introduced 02/15/13 - Introduced pdf February 15, 2013
- SB294 View text html
Action History
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Chaptered by Secretary of State. Chapter 565, Statutes of 2013.
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Approved by the Governor.
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Enrolled and presented to the Governor at 7 p.m.
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Assembly amendments concurred in. (Ayes 36. Noes 0. Page 2286.) Ordered to engrossing and enrolling.
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In Senate. Concurrence in Assembly amendments pending.
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Read third time. Passed. (Ayes 65. Noes 9. Page 3016.) Ordered to the Senate.
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Read second time. Ordered to third reading.
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Read second time and amended. Ordered to second reading.
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From committee: Do pass as amended. (Ayes 13. Noes 0.) (August 30).
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Set, first hearing. Referred to APPR. suspense file.
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From committee with author's amendments. Read second time and amended. Re-referred to Com. on APPR.
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From committee: Do pass and re-refer to Com. on APPR. (Ayes 17. Noes 2.) (August 13). Re-referred to Com. on APPR.
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From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH.
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Read second time and amended. Re-referred to Com. on HEALTH.
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From committee: Do pass as amended and re-refer to Com. on HEALTH. (Ayes 10. Noes 3.) (July 2).
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From committee with author's amendments. Read second time and amended. Re-referred to Com. on B.,P. & C.P.
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Referred to Coms. on B.,P. & C.P. and HEALTH.
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In Assembly. Read first time. Held at Desk.
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Read third time. Passed. (Ayes 39. Noes 0. Page 1165.) Ordered to the Assembly.
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Read second time and amended. Ordered to third reading.
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From committee: Do pass as amended. (Ayes 7. Noes 0. Page 1010.) (May 23).
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Set for hearing May 23.
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Placed on APPR. suspense file.
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Set for hearing April 22.
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Set, first hearing. Hearing canceled at the request of author.
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Set for hearing April 15.
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From committee: Do pass and re-refer to Com. on APPR. (Ayes 10. Noes 0. Page 388.) (April 1). Re-referred to Com. on APPR.
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Set for hearing April 1.
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Referred to Com. on B., P. & E.D.
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From printer. May be acted upon on or after March 21.
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Introduced. Read first time. To Com. on RLS. for assignment. To print.
Sponsors
- Emmerson · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 121 not signed on · 3 voted No
Sponsors (1)
- Emmerson
Co-sponsors (0)
None.
Not signed on (121)
121 members have not signed on to this bill.
Show all 121 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Votes
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 33 | 0 | 0 | 3 |
| Democratic | 3 | 0 | 0 | 0 |
| Total | 36 | 0 | 0 | 3 |
| % of votes cast | 92% | 0% | 0% | 8% |
How each member voted (39)
| Member | Party | Vote |
|---|---|---|
| Anderson | — | Yea |
| Beall | — | Yea |
| Hill | — | Yea |
| Huff | — | Yea |
| Lara | — | Yea |
| Walters | — | Not Voting |
| Emmerson | — | Yea |
| Correa | — | Yea |
| Evans | — | Yea |
| DeSaulnier | — | Yea |
| Wright | — | Yea |
| Wyland | — | Yea |
| Cannella | — | Yea |
| De León | — | Yea |
| Corbett | — | Yea |
| Galgiani | — | Yea |
| Block | — | Yea |
| Hernandez | — | Yea |
| Hueso | — | Yea |
| Knight | — | Yea |
| Leno | — | Yea |
| Lieu | — | Yea |
| Liu | — | Yea |
| Monning | — | Yea |
| Nielsen | — | Yea |
| Pavley | — | Not Voting |
| Roth | — | Yea |
| Steinberg | — | Yea |
| Torres | — | Yea |
| Vidak | — | Yea |
| Wolk | — | Yea |
| Fuller | — | Yea |
| Yee | — | Yea |
| Hancock | — | Not Voting |
| Beth Gaines | — | Yea |
| Bill Berryhill | — | Yea |
| Calderon, Lisa | Democratic | Yea |
| Jackson, Corey A. | Democratic | Yea |
| Padilla, Stephen C. | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 61 | 6 | 0 | 4 |
| Democratic | 4 | 0 | 0 | 0 |
| Republican | 0 | 3 | 0 | 0 |
| Total | 65 | 9 | 0 | 4 |
| % of votes cast | 83% | 12% | 0% | 5% |
How each member voted (78)
| Member | Party | Vote |
|---|---|---|
| Achadjian | — | Yea |
| Alejo | — | Yea |
| Ammiano | — | Yea |
| Bradford | — | Yea |
| Brown | — | Yea |
| Buchanan | — | Yea |
| Holden | — | Yea |
| Levine | — | Yea |
| Logue | — | Yea |
| Maienschein | — | Nay |
| Mansoor | — | Yea |
| Nestande | — | Yea |
| Rendon | — | Yea |
| Skinner | — | Yea |
| Wagner | — | Yea |
| Wieckowski | — | Yea |
| Wilk | — | Nay |
| Chesbro | — | Yea |
| Chávez | — | Yea |
| Pan | — | Yea |
| Gomez | — | Yea |
| Gorell | — | Yea |
| Hall | — | Yea |
| Harkey | — | Yea |
| Linder | — | Yea |
| Medina | — | Yea |
| Lowenthal | — | Yea |
| Garcia | — | Yea |
| Gray | — | Yea |
| Atkins | — | Yea |
| Fong | — | Yea |
| Mitchell | — | Yea |
| Bonilla | — | Yea |
| Bloom | — | Yea |
| Daly | — | Yea |
| Nazarian | — | Yea |
| Olsen | — | Yea |
| Quirk | — | Yea |
| Jones-Sawyer | — | Yea |
| Mullin | — | Yea |
| Perea | — | Yea |
| Bocanegra | — | Yea |
| Williams | — | Yea |
| Campos | — | Yea |
| Cooley | — | Yea |
| Dickinson | — | Yea |
| John A. Pérez | — | Yea |
| Salas | — | Yea |
| Ting | — | Yea |
| Weber | — | Yea |
| Chau | — | Yea |
| Allen | — | Nay |
| Melendez | — | Not Voting |
| Morrell | — | Nay |
| Bigelow | — | Nay |
| Conway | — | Not Voting |
| Waldron | — | Not Voting |
| Eggman | — | Yea |
| Donnelly | — | Nay |
| Fox | — | Not Voting |
| Frazier | — | Yea |
| Gatto | — | Yea |
| Yamada | — | Yea |
| Gordon | — | Yea |
| Hagman | — | Yea |
| Beth Gaines | — | Yea |
| Jim Patterson | — | Yea |
| Lorena Gonzalez | — | Yea |
| Mark Stone | — | Yea |
| Roger Hernández | — | Yea |
| V. Manuel Pérez | — | Yea |
| Bonta, Mia | Democratic | Yea |
| Calderon, Lisa | Democratic | Yea |
| Muratsuchi, Al | Democratic | Yea |
| Quirk-Silva, Sharon | Democratic | Yea |
| Dahle, Megan | Republican | Nay |
| Grove, Shannon | Republican | Nay |
| Jones, Brian W. | Republican | Nay |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 12 | 0 | 0 | 4 |
| Democratic | 1 | 0 | 0 | 0 |
| Total | 13 | 0 | 0 | 4 |
| % of votes cast | 76% | 0% | 0% | 24% |
How each member voted (17)
| Member | Party | Vote |
|---|---|---|
| Bigelow | — | Not Voting |
| Bradford | — | Yea |
| Harkey | — | Not Voting |
| Quirk | — | Yea |
| Campos | — | Yea |
| Gatto | — | Yea |
| Gomez | — | Yea |
| Hall | — | Yea |
| Bocanegra | — | Yea |
| Holden | — | Yea |
| Linder | — | Yea |
| Donnelly | — | Not Voting |
| Eggman | — | Yea |
| Pan | — | Yea |
| Wagner | — | Not Voting |
| Weber | — | Yea |
| Calderon, Lisa | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 16 | 2 | 0 | 0 |
| Democratic | 1 | 0 | 0 | 0 |
| Total | 17 | 2 | 0 | 0 |
| % of votes cast | 89% | 11% | 0% | 0% |
How each member voted (19)
| Member | Party | Vote |
|---|---|---|
| Ammiano | — | Yea |
| Maienschein | — | Nay |
| Mansoor | — | Yea |
| Pan | — | Yea |
| Chesbro | — | Yea |
| Logue | — | Yea |
| Bonilla | — | Yea |
| Mitchell | — | Yea |
| Lowenthal | — | Yea |
| Nazarian | — | Yea |
| Nestande | — | Yea |
| Wagner | — | Yea |
| Wieckowski | — | Yea |
| Atkins | — | Yea |
| Wilk | — | Nay |
| Gomez | — | Yea |
| Roger Hernández | — | Yea |
| V. Manuel Pérez | — | Yea |
| Bonta, Mia | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 10 | 2 | 0 | 0 |
| Republican | 0 | 1 | 0 | 0 |
| Total | 10 | 3 | 0 | 0 |
| % of votes cast | 77% | 23% | 0% | 0% |
How each member voted (13)
| Member | Party | Vote |
|---|---|---|
| Skinner | — | Yea |
| Gordon | — | Yea |
| Hagman | — | Yea |
| Bocanegra | — | Yea |
| Holden | — | Yea |
| Campos | — | Yea |
| Eggman | — | Yea |
| Maienschein | — | Nay |
| Mullin | — | Yea |
| Ting | — | Yea |
| Wilk | — | Nay |
| Dickinson | — | Yea |
| Jones, Brian W. | Republican | Nay |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 36 | 0 | 0 | 0 |
| Democratic | 3 | 0 | 0 | 0 |
| Total | 39 | 0 | 0 | 0 |
| % of votes cast | 100% | 0% | 0% | 0% |
How each member voted (39)
| Member | Party | Vote |
|---|---|---|
| Anderson | — | Yea |
| Block | — | Yea |
| Hill | — | Yea |
| Hueso | — | Yea |
| Huff | — | Yea |
| Knight | — | Yea |
| Liu | — | Yea |
| Roth | — | Yea |
| Walters | — | Yea |
| Wright | — | Yea |
| Cannella | — | Yea |
| Corbett | — | Yea |
| Emmerson | — | Yea |
| Correa | — | Yea |
| Evans | — | Yea |
| Hernandez | — | Yea |
| Beall | — | Yea |
| Leno | — | Yea |
| Lieu | — | Yea |
| Nielsen | — | Yea |
| Steinberg | — | Yea |
| Torres | — | Yea |
| De León | — | Yea |
| Hancock | — | Yea |
| Lara | — | Yea |
| Price | — | Yea |
| Wyland | — | Yea |
| Monning | — | Yea |
| Pavley | — | Yea |
| Wolk | — | Yea |
| DeSaulnier | — | Yea |
| Fuller | — | Yea |
| Galgiani | — | Yea |
| Yee | — | Yea |
| Beth Gaines | — | Yea |
| Bill Berryhill | — | Yea |
| Calderon, Lisa | Democratic | Yea |
| Jackson, Corey A. | Democratic | Yea |
| Padilla, Stephen C. | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 6 | 0 | 0 | 0 |
| Democratic | 1 | 0 | 0 | 0 |
| Total | 7 | 0 | 0 | 0 |
| % of votes cast | 100% | 0% | 0% | 0% |
How each member voted (7)
| Member | Party | Vote |
|---|---|---|
| Hill | — | Yea |
| Walters | — | Yea |
| Lara | — | Yea |
| De León | — | Yea |
| Steinberg | — | Yea |
| Beth Gaines | — | Yea |
| Padilla, Stephen C. | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Democratic | 1 | 0 | 0 | 0 |
| Unaffiliated | 6 | 0 | 0 | 0 |
| Total | 7 | 0 | 0 | 0 |
| % of votes cast | 100% | 0% | 0% | 0% |
How each member voted (7)
| Member | Party | Vote |
|---|---|---|
| Hill | — | Yea |
| De León | — | Yea |
| Lara | — | Yea |
| Steinberg | — | Yea |
| Walters | — | Yea |
| Beth Gaines | — | Yea |
| Padilla, Stephen C. | Democratic | Yea |
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 9 | 0 | 0 | 0 |
| Democratic | 1 | 0 | 0 | 0 |
| Total | 10 | 0 | 0 | 0 |
| % of votes cast | 100% | 0% | 0% | 0% |
How each member voted (10)
| Member | Party | Vote |
|---|---|---|
| Block | — | Yea |
| Hill | — | Yea |
| Emmerson | — | Yea |
| Wyland | — | Yea |
| Hernandez | — | Yea |
| Corbett | — | Yea |
| Price | — | Yea |
| Galgiani | — | Yea |
| Yee | — | Yea |
| Padilla, Stephen C. | Democratic | Yea |
Subjects
Frequently asked questions
- What does SB 294 do?
- (1) 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 requires the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime. This bill, commencing July 1, 2014, would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill, commencing July 1, 2014, would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. The bill would require the board to adopt regulations to implement these provisions, and, on and after July 1, 2014, to review formal revisions to specified national standards relating to the compounding of sterile preparations to determine whether amendments to those regulations are necessary, as specified. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program. (2) Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products. This bill, commencing July 1, 2014, would establish the fee for the issuance or renewal of a nonresident sterile compounding pharmacy license in the amount of $780 and would require the applicant to deposit a reasonable amount, as determined by the board, necessary to cover the board's estimated cost of performing an inspection of the nonresident pharmacy location, as specified. (3) The bill would also require the board to report to the Legislature, on or before January 1, 2018, regarding the regulation of nonresident pharmacies, including, among other things, a detailed description of board activities related to the inspection and licensure of nonresident pharmacies. (4) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.
- Who sponsors SB 294?
- SB 294 is sponsored by Emmerson.
- What is the current status of SB 294?
- This bill has been enacted into law. Introduced February 15, 2013. Enacted.
- Where can I track SB 294?
- Track SB 294 free on One Click Politics — get push/email alerts when it moves.
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