BILL NUMBER: SB 598 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 6, 2013
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 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 requirement that, 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 notify the
prescriber or enter the appropriate information in a patient record
system shared by the prescriber within 5 business days of the
selection 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
substituting a biological product pursuant to
selecting a biosimilar that meets the requirements of
these provisions unless the biological product
cost to the patient of the biosimilar selected
costs the patient 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.
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 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 both 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) (c) .
(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.
(b) For prescriptions filled prior to January 1, 2017, the
pharmacy shall, within five business days of the selection of a
biological product or an interchangeable biosimilar, approved as
provided in paragraph (1) of subdivision (a), notify the prescriber
whether the prescription dispensed was a biological product or an
interchangeable biosimilar, approved as provided in paragraph (1) of
subdivision (a), or enter the information in a patient record system
shared by the prescriber. No notification is required if the
prescriber indicates "Do not substitute" in the manner provided in
subdivision (c), if there is no FDA-approved interchangeable
biosimilar pursuant to paragraph (1) of subdivision (a), or if a
refill prescription is not changed from the product originally
dispensed.
(b)
(c) 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
substitution be manually initialed by the prescriber.
(c)
(d) Selection pursuant to this section is within the
discretion of the pharmacist, except as provided in subdivision
(b) (c) . The pharmacist who selects
the biosimilar to be dispensed pursuant to this section shall assume
the same responsibility for substituting the biosimilar as would be
incurred in filling a prescription for a biosimilar 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 select a biosimilar that meets the
requirements of paragraph (1) of subdivision (a) unless the
biological product selected costs the patient
cost to the patient of the biosimilar selected is the same or
less than the cost of 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)
(e) 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)
(f) When a selection is made pursuant to this section,
the substitution of a biosimilar shall be communicated to the
patient.
(f)
(g) 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)
(h) 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 prescription for 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)
(i) Nothing in this section prohibits the administration
of immunizations, as permitted in Section 4052.
(i)
(j) Nothing in this section shall be
interpreted to prohibit prohibits 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. 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.