SB 598

  • California Senate Bill
  • 2013-2014 Regular Session
  • Introduced in Senate Feb 22, 2013
  • Passed Senate May 24, 2013
  • Passed Assembly Aug 26, 2013
  • Governor

Biosimilars.

Bill Subjects

Biosimilars.

Abstract

The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. Among other permitted acts, a pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined, as specified, of those drug products having the same active chemical ingredients. A person who knowingly violates the Pharmacy Law is guilty of a misdemeanor, as specified. This bill would authorize a pharmacist, in his or her discretion, except as specified, to select a biosimilar, as defined, when filling a prescription order for a prescribed biological product only if the product has been approved by the federal Food and Drug Administration, as specified, and the prescriber does not personally indicate "Do not substitute," as specified. The bill would also require, for prescriptions filled prior to January 1, 2017, the pharmacy to, within 5 business days of the selection of a biological product or an interchangeable biosimilar, notify the prescriber or enter in a patient record whether the prescription dispensed was a biological product or an interchangeable biosimilar, except as specified. The bill would prohibit a pharmacist from selecting a biosimilar that meets the requirements of these provisions unless the cost to the patient of the biosimilar selected is the same or less than the cost of the prescribed biological product. The bill would also require that the substitution of a biosimilar be communicated to the patient. Because a knowing violation of these requirements would be a misdemeanor, the bill would create new crimes, thereby imposing a state-mandated local program. The bill would also require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biosimilar products determined by the federal Food and Drug Administration to be interchangeable, as specified. 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 (3)

Votes


Actions


Feb 27, 2014

Senate

Consideration of Governor's veto stricken from file.

Oct 12, 2013

Senate

In Senate. Consideration of Governor's veto pending.

Senate

Vetoed by the Governor.

Sep 23, 2013

California State Legislature

Enrolled and presented to the Governor at 2 p.m.

Sep 04, 2013

Senate

Assembly amendments concurred in. (Ayes 30. Noes 2. Page 2132.) Ordered to engrossing and enrolling.

Aug 26, 2013

Assembly

Read third time. Passed. (Ayes 60. Noes 4. Page 2722.) Ordered to the Senate.

Senate

In Senate. Concurrence in Assembly amendments pending.

Aug 22, 2013

Assembly

Read second time. Ordered to third reading.

Aug 21, 2013

Assembly

From committee: Do pass. (Ayes 15. Noes 0.) (August 21).

Aug 14, 2013

Assembly

Hearing postponed by committee.

Aug 06, 2013

Assembly

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

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

Aug 05, 2013

Assembly

From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 14. Noes 2.) (July 2).

Jun 25, 2013

Assembly

From committee: Do pass and re-refer to Com. on HEALTH. (Ayes 12. Noes 0.) (June 25). Re-referred to Com. on HEALTH.

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

Jun 20, 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 17, 2013

Assembly

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

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

May 24, 2013

Assembly

In Assembly. Read first time. Held at Desk.

Senate

Read third time. Passed. (Ayes 29. Noes 4. Page 1044.) Ordered to the Assembly.

May 21, 2013

Senate

Read second time. Ordered to third reading.

May 20, 2013

Senate

From committee: Be placed on second reading file pursuant to Senate Rule 28.8.

May 10, 2013

Senate

Set for hearing May 20.

May 07, 2013

Senate

Hearing postponed by committee.

May 03, 2013

Senate

Set for hearing May 13.

May 02, 2013

Senate

From committee: Do pass and re-refer to Com. on APPR. (Ayes 6. Noes 1. Page 791.) (May 1). Re-referred to Com. on APPR.

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

Apr 23, 2013

Senate

Set for hearing May 1.

Apr 16, 2013

Senate

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

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

Apr 15, 2013

Senate

From committee: Do pass as amended and re-refer to Com. on HEALTH. (Ayes 10. Noes 0. Page 464.) (April 8).

Mar 21, 2013

Senate

Set for hearing April 8.

Mar 11, 2013

Senate

Referred to Coms. on B., P. & E.D. and HEALTH.

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

Feb 25, 2013

Senate

Read first time.

Feb 23, 2013

Senate

From printer. May be acted upon on or after March 25.

Feb 22, 2013

Senate

Introduced. To Com. on RLS. for assignment. To print.

Bill Text

Bill Text Versions Format
SB598 HTML
02/22/13 - Introduced PDF
04/16/13 - Amended Senate PDF
06/20/13 - Amended Assembly PDF
08/06/13 - Amended Assembly PDF
09/19/13 - Enrolled PDF

Related Documents

Document Format
No related documents.

Sources

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