California 2013-2014 Regular Session Status: Enacted

SB 294 — Sterile drug products.

Last action — Chaptered by Secretary of State. Chapter 565, Statutes of 2013.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. ✓
    Passed Senate
  4. ✓
    Passed Assembly
  5. ✓
    To Executive
  6. 6
    Enacted

This bill has been enacted into law. Introduced February 15, 2013. Enacted.

Prognosis

Likely to advance 70% · moderate confidence

Where this bill stands today.

Odds of enactment

High

How often bills like it became law.

  • Enacted

    Current position in the legislative process.

  • 1 sponsor

    1 primary, 0 co-sponsors signed on.

  • 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

Action History

  1. Chaptered by Secretary of State. Chapter 565, Statutes of 2013.

  2. Approved by the Governor.

  3. Enrolled and presented to the Governor at 7 p.m.

  4. Assembly amendments concurred in. (Ayes 36. Noes 0. Page 2286.) Ordered to engrossing and enrolling.

  5. In Senate. Concurrence in Assembly amendments pending.

  6. Read third time. Passed. (Ayes 65. Noes 9. Page 3016.) Ordered to the Senate.

  7. Read second time. Ordered to third reading.

  8. Read second time and amended. Ordered to second reading.

  9. From committee: Do pass as amended. (Ayes 13. Noes 0.) (August 30).

  10. Set, first hearing. Referred to APPR. suspense file.

  11. From committee with author's amendments. Read second time and amended. Re-referred to Com. on APPR.

  12. From committee: Do pass and re-refer to Com. on APPR. (Ayes 17. Noes 2.) (August 13). Re-referred to Com. on APPR.

  13. From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH.

  14. Read second time and amended. Re-referred to Com. on HEALTH.

  15. From committee: Do pass as amended and re-refer to Com. on HEALTH. (Ayes 10. Noes 3.) (July 2).

  16. From committee with author's amendments. Read second time and amended. Re-referred to Com. on B.,P. & C.P.

  17. Referred to Coms. on B.,P. & C.P. and HEALTH.

  18. In Assembly. Read first time. Held at Desk.

  19. Read third time. Passed. (Ayes 39. Noes 0. Page 1165.) Ordered to the Assembly.

  20. Read second time and amended. Ordered to third reading.

  21. From committee: Do pass as amended. (Ayes 7. Noes 0. Page 1010.) (May 23).

  22. Set for hearing May 23.

  23. Placed on APPR. suspense file.

  24. Set for hearing April 22.

  25. Set, first hearing. Hearing canceled at the request of author.

  26. Set for hearing April 15.

  27. 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.

  28. Set for hearing April 1.

  29. Referred to Com. on B., P. & E.D.

  30. From printer. May be acted upon on or after March 21.

  31. 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.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Votes

Passed 36 Yea · 0 Nay · 3 Other
Party YeaNayPresentNot Voting
Unaffiliated 33003
Democratic 3000
Total 36003
% 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

Official roll call →

Passed 65 Yea · 9 Nay · 4 Other
Party YeaNayPresentNot Voting
Unaffiliated 61604
Democratic 4000
Republican 0300
Total 65904
% 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

Official roll call →

Do pass as amended.

Passed 13 Yea · 0 Nay · 4 Other
Party YeaNayPresentNot Voting
Unaffiliated 12004
Democratic 1000
Total 13004
% 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

Official roll call →

Passed 17 Yea · 2 Nay
Party YeaNayPresentNot Voting
Unaffiliated 16200
Democratic 1000
Total 17200
% 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

Official roll call →

3rd Reading

Passed 39 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 36000
Democratic 3000
Total 39000
% 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

Official roll call →

Do pass as amended.

Passed 7 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 6000
Democratic 1000
Total 7000
% 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

Official roll call →

Subjects

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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?
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