BILL NUMBER: SB 598 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 4, 2013
PASSED THE ASSEMBLY AUGUST 26, 2013
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, 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 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.
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 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 "Do not
substitute," or words of similar meaning, in the manner provided in
subdivision (c).
(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.
(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.
(d) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (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 select a biosimilar that
meets the requirements of paragraph (1) of subdivision (a) unless the
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.
(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.
(f) When a selection is made pursuant to this section, the
substitution of a biosimilar shall be communicated to the patient.
(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).
(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.
(i) Nothing in this section prohibits the administration of
immunizations, as permitted in Section 4052.
(j) Nothing in this section 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.