BILL NUMBER: SB 598 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 20, 2013
AMENDED IN SENATE APRIL 16, 2013
INTRODUCED BY Senator Hill
( Coauthors: Assembly Members
Gorell and Mullin )
FEBRUARY 22, 2013
An act to add Sections 4052.55 and Section
4073.5 to the Business and Professions Code, relating to
pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 598, as amended, Hill. Biosimilars.
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
certain conditions are met, including, among other conditions, the
requirements requirement that, for
prescriptions filled prior to January 1, 2017, the pharmacy notify
the prescriber or enter the appropriate information in a patient
record system shared by the prescriber within 5 business days of the
selection and retain a written record of the biosimilar
selection for a period of at least 3 years . The bill would
prohibit a pharmacist from substituting a biological product
pursuant to these provisions unless the biological product selected
costs the patient the same or less than 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.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4052.55 is added to the
Business and Professions Code, to read:
4052.55. (a) In addition to the authority allowed under Section
4073.5, a pharmacist filling a prescription order for a prescribed
biological product may select a biosimilar only if all of the
following conditions are met:
(1) The product selected as a biosimilar has been approved by the
federal Food and Drug Administration (FDA) under the 351(k) pathway
of the federal Public Health Service Act (42 U.S.C. Sec. 262(k)) and
has been determined to be interchangeable with the prescribed
biological product.
(2) The prescriber does not personally indicate, either orally or
in his or her own handwriting, "Do not substitute," or words of
similar meaning, pursuant to subdivision (b).
(3) For prescriptions filled prior to January 1, 2017, the
pharmacy notifies the prescriber or enters the appropriate
information in a patient record system shared by the prescriber
within five business days of the selection.
(4) For prescriptions filled prior to January 1, 2017, the
pharmacy retains a written record of the biosimilar selection for a
period of at least three years.
(b) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or
her own handwriting, "Do not substitute," or words of similar
meaning. Nothing in this subdivision shall prohibit a prescriber from
checking a box on a prescription marked "Do not substitute" if the
prescriber personally initials the box or checkmark.
(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The
pharmacist who selects the biosimilar to be dispensed pursuant to
this section shall assume the same responsibility for substituting
the dispensed biosimilar as would be incurred in filling a
prescription for a biosimilar using the prescribed form of
medication. There shall be no liability on the prescriber for an act
or omission by a pharmacist in selecting, preparing, or dispensing a
drug product pursuant to this section.
(d) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from the
federal government or pursuant to the Medi-Cal Act set forth in
Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of
the Welfare and Institutions Code.
(e) When a selection is made pursuant to this section, the
substitution of a biosimilar shall be communicated to the patient.
(f) The board shall maintain on its public Internet Web site a
link to the current list, if available, of biosimilar products
determined by the FDA to be interchangeable, as provided in paragraph
(1) of subdivision (a).
(g) For purposes of this section, the following terms shall have
the following meanings:
(1) "Biological product," "biosimilar," and "interchangeable" have
the same meanings that apply to those terms under Section 351 of the
federal Public Health Service Act (42 U.S.C. Sec. 262).
(2) "Prescription," with respect to a biological product, means a
product that is subject to Section 503(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(3) "351(k) pathway" refers to the licensure of a biological
product as a biosimilar or an interchangeable biosimilar by the FDA
pursuant to Section 351(k) of the federal Public Health Service Act
(42 U.S.C. Sec. 262(k)).
(h) Nothing in this section prohibits the administration of
immunizations, as permitted in Section 4052.
SEC. 2. SECTION 1. Section 4073.5 is
added to the Business and Professions Code, to read:
4073.5. (a) A pharmacist filling a prescription order for a
prescribed biological product may select a biosimilar only if all of
the following conditions are met:
(1) The product selected as a biosimilar has been approved by the
federal Food and Drug Administration (FDA) under the 351(k) pathway
of the federal Public Health Service Act (42 U.S.C. Sec. 262(k)) and
has been determined to be interchangeable with the prescribed
biological product.
(2) The prescriber does not personally indicate, either orally or
in his or her own handwriting, "Do not substitute," or words of
similar meaning in the manner provided in subdivision (b).
(3) For prescriptions filled prior to January 1, 2017, the
pharmacy notifies the prescriber or enters the appropriate
information in a patient record system shared by the prescriber
within five business days of the selection.
(4) For prescriptions filled prior to January 1, 2017, the
pharmacy retains a written record of the biosimilar selection for a
period of at least three years.
(b) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or
her own handwriting, "Do not substitute," or words of similar
meaning. Nothing in this subdivision shall prohibit a prescriber from
checking a box on a prescription marked "Do not substitute,"
provided that the prescriber personally initials the box or
checkmark. To indicate that a selection shall not be made pursuant to
this section for an electronic data transmission prescription as
defined in subdivision (c) of Section 4040, a prescriber may indicate
"Do not substitute," or words of similar meaning, in the
prescription as transmitted by electronic data, or may check a box
marked on the prescription "Do not substitute." In either instance,
it shall not be required that the prohibition on selection
substitution be manually initialed by the
prescriber.
(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The
pharmacist who selects the biosimilar to be dispensed pursuant to
this section shall assume the same responsibility for substituting
the dispensed biological product biosimilar
as would be incurred in filling a prescription for a biosimilar
using the prescribed form of medication
prescribed by name . There shall be no liability on the
prescriber for an act or omission by a pharmacist in selecting,
preparing, or dispensing a biological product pursuant to this
section. In no case shall the pharmacist substitute a biological
product pursuant to this section unless the biological product
selected costs the patient the same or less than the
prescribed biological product. Cost, as used in this subdivision, is
defined to include any professional fee that may be charged by the
pharmacist.
(d) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from the
federal government or pursuant to the Medi-Cal Act set forth in
Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of
the Welfare and Institutions Code.
(e) When a selection is made pursuant to this section, the
substitution of a biosimilar shall be communicated to the
patient. patient.
(f) The board shall maintain on its public Internet Web site a
link to the current list, if available, of biosimilar products
determined by the FDA to be interchangeable, as provided in paragraph
(1) of subdivision (a).
(g) For purposes of this section, the following terms shall have
the following meanings:
(1) "Biological product," "biosimilar," and "interchangeable" have
the same meanings that apply to those terms under Section 351 of the
federal Public Health Service Act (42 U.S.C. Sec. 262).
(2) "Prescription," with respect to a biological product, means a
product that is subject to Section 503(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(3) "351(k) pathway" refers to the licensure of a biological
product as a biosimilar or an interchangeable biosimilar by the FDA
pursuant to Section 351(k) of the federal Public Health Service Act.
(h) Nothing in this section prohibits the administration of
immunizations, as permitted in Section 4052.
(i) Nothing in this section shall be interpreted to prohibit a
disability insurer or health care service plan from requiring prior
authorization or imposing other appropriate utilization controls in
approving coverage for any biological product.
SEC. 3. SEC. 2. No reimbursement is
required by this act pursuant to Section 6 of Article XIII B of the
California Constitution because the only costs that may be incurred
by a local agency or school district will be incurred because this
act creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction, within
the meaning of Section 17556 of the Government Code, or changes the
definition of a crime within the meaning of Section 6 of Article XIII
B of the California Constitution.