SB 294

  • California Senate Bill
  • 2013-2014 Regular Session
  • Introduced in Senate Feb 15, 2013
  • Passed Senate May 29, 2013
  • Passed Assembly Sep 09, 2013
  • Signed by Governor Oct 04, 2013

Sterile drug products.

Bill Subjects

Sterile Drug Products.

Abstract

(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 Sponsors (1)

Votes


Actions


Oct 04, 2013

California State Legislature

Approved by the Governor.

California State Legislature

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

Sep 12, 2013

California State Legislature

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

Sep 10, 2013

Senate

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

Sep 09, 2013

Senate

In Senate. Concurrence in Assembly amendments pending.

Assembly

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

Sep 04, 2013

Assembly

Read second time. Ordered to third reading.

Sep 03, 2013

Assembly

Read second time and amended. Ordered to second reading.

Aug 30, 2013

Assembly

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

Aug 21, 2013

Assembly

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

  • Referral-Committee
APPR. suspense file. APPR

Aug 15, 2013

Assembly

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

  • Committee-Passage
  • Amendment-Passage
  • Reading-2
  • Reading-1
  • Referral-Committee
Com. on APPR.

Aug 14, 2013

Assembly

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

  • Committee-Passage-Favorable
  • Referral-Committee
  • Committee-Passage
Com. on APPR.

Aug 05, 2013

Assembly

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

  • Committee-Passage
  • Amendment-Passage
  • Reading-2
  • Reading-1
  • Referral-Committee
Com. on HEALTH.

Jul 03, 2013

Assembly

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

  • Amendment-Passage
  • Reading-2
  • Reading-1
  • Referral-Committee
Com. on HEALTH.

Jul 02, 2013

Assembly

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

Jun 24, 2013

Assembly

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

  • Committee-Passage
  • Amendment-Passage
  • Reading-2
  • Reading-1
  • Referral-Committee
Com. on B.,P. & C.P.

Jun 14, 2013

Assembly

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

  • Referral-Committee
Coms. on B.,P. & C.P. and HEALTH.

May 30, 2013

Assembly

In Assembly. Read first time. Held at Desk.

May 29, 2013

Senate

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

May 28, 2013

Senate

Read second time and amended. Ordered to third reading.

May 24, 2013

Senate

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

May 17, 2013

Senate

Set for hearing May 23.

Apr 22, 2013

Senate

Placed on APPR. suspense file.

Apr 12, 2013

Senate

Set for hearing April 22.

Apr 09, 2013

Senate

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

Apr 05, 2013

Senate

Set for hearing April 15.

Apr 02, 2013

Senate

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.

  • Committee-Passage-Favorable
  • Referral-Committee
  • Committee-Passage
Com. on APPR.

Mar 19, 2013

Senate

Set for hearing April 1.

Feb 28, 2013

Senate

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

  • Referral-Committee
Com. on B., P. & E.D.

Feb 19, 2013

Senate

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

Feb 15, 2013

Senate

Introduced. Read first time. To Com. on RLS. for assignment. To print.

Bill Text

Bill Text Versions Format
SB294 HTML
02/15/13 - Introduced PDF
05/28/13 - Amended Senate PDF
06/24/13 - Amended Assembly PDF
07/03/13 - Amended Assembly PDF
08/05/13 - Amended Assembly PDF
08/15/13 - Amended Assembly PDF
09/03/13 - Amended Assembly PDF
09/11/13 - Enrolled PDF
10/04/13 - Chaptered PDF

Related Documents

Document Format
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Sources

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