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 ifbegin delete certain conditions are met, including, among other
conditions, the requirement that,end deletebegin insert 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,end insert for prescriptions filled prior to January 1, 2017, the pharmacybegin delete notify the prescriber or enter the appropriate information in a patient record system shared by the prescriber within 5 business days of the selectionend deletebegin insert 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 specifiedend insert.
The bill would prohibit a pharmacist frombegin delete substituting a biological product pursuant toend deletebegin insert
selecting a biosimilar that meets the requirements ofend insert these provisions unless thebegin delete biological productend deletebegin insert cost to the patient of the biosimilarend insert selectedbegin delete costs the patientend deletebegin insert isend insert the same or less than thebegin insert cost of theend insert 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 4073.5 is added to the Business and
2Professions Code, to read:
(a) A pharmacist filling a prescription order for a
4prescribed biological product may select a biosimilar only ifbegin delete allend delete
5begin insert both end insert of the following conditions are met:
6(1) The product selected as a biosimilar has been approved by
7the federal Food and Drug Administration (FDA) under the 351(k)
8pathway of the federal Public Health Service Act (42 U.S.C. Sec.
9262(k)) and has been determined to be interchangeable with the
10prescribed biological product.
P3 1(2) The
prescriber does not personally indicatebegin delete, either orally or “Do not substitute,” or words of
2in his or her own handwriting,end delete
3similar meaningbegin insert,end insert in the manner provided in subdivisionbegin delete (b)end deletebegin insert (c)end insert.
4(3) For prescriptions filled prior to January 1, 2017, the
5pharmacy notifies the prescriber or enters the appropriate
6information in a patient record system shared by the prescriber
7within five business days of the selection.
8(b) For prescriptions filled prior to January 1, 2017, the
9pharmacy shall, within five business days of the selection of a
10biological product or an interchangeable biosimilar, approved as
11provided in paragraph (1) of subdivision (a), notify the prescriber
12whether the prescription dispensed was a biological product or
13an interchangeable biosimilar, approved as provided in paragraph
14(1) of subdivision (a), or enter the information in a patient record
15system shared by the prescriber. No notification is required if the
16prescriber indicates “Do not substitute” in the manner provided
17in subdivision (c), if there is no FDA-approved interchangeable
18biosimilar pursuant to paragraph (1) of subdivision (a), or if a
19refill prescription is not changed from the product originally
20dispensed.
21(b)
end delete
22begin insert(c)end insert In no case shall a selection be made pursuant to this section
23if the prescriber personally indicates, either orally or in his or her
24own handwriting, “Do not substitute,” or words of similar meaning.
25Nothing in this subdivision shall prohibit a prescriber from
26checking a box on a prescription marked “Do not substitute,”
27provided that the prescriber personally initials the box or
28checkmark. To indicate that a selection shall not be made pursuant
29to this section for an electronic data transmission prescription as
30defined in subdivision (c) of Section 4040, a prescriber may
31indicate “Do not substitute,” or words of similar meaning, in the
32prescription as transmitted by electronic data, or may check a box
33marked on the prescription “Do not substitute.” In
either instance,
34it shall not be required that the prohibition on substitution be
35manually initialed by the prescriber.
36(c)
end delete
37begin insert(d)end insert Selection pursuant to this section is within the discretion of
38the pharmacist, except as provided in subdivisionbegin delete (b)end deletebegin insert (c)end insert. The
39pharmacist who selects the biosimilar to be dispensed pursuant to
40this section shall assume the same responsibility for substituting
P4 1the biosimilar as would be
incurred in filling a prescription for a
2biosimilar prescribed by name. There shall be no liability on the
3prescriber for an act or omission by a pharmacist in selecting,
4preparing, or dispensing a biological product pursuant to this
5section. In no case shall the pharmacistbegin delete substitute a biological begin insert
select a biosimilar that meets the
6product pursuant to this sectionend delete
7requirements of paragraph (1) of subdivision (a)end insert unless the
8begin delete biological product selected costs the patientend deletebegin insert cost to the patient of
9the biosimilar selected isend insert the same or less than thebegin insert cost of theend insert
10 prescribed biological product. Cost, as used in this subdivision, is
11defined to include any professional fee that may be charged by the
12pharmacist.
13(d)
end delete
14begin insert(e)end insert This section shall apply to all prescriptions, including those
15presented by or on behalf of persons receiving assistance from the
16federal government or pursuant to the Medi-Cal Act set forth in
17Chapter 7 (commencing with Section 14000) of Part 3 of Division
189 of the Welfare and Institutions Code.
19(e)
end delete
20begin insert(f)end insert When a selection is made pursuant to this section, the
21substitution of a biosimilar shall be communicated to the patient.
22(f)
end delete
23begin insert(g)end insert The board shall maintain on its public Internet Web site a
24link to the current list, if available, of biosimilar products
25determined by the FDA to be interchangeable, as provided in
26paragraph (1) of subdivision (a).
27(g)
end delete
28begin insert(h)end insert For purposes of this section, the following terms shall have
29the following meanings:
30(1) “Biological product,” “biosimilar,” and “interchangeable”
31have the
same meanings that apply to those terms under Section
32351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
33(2) “Prescription,” with respect to a biological product, means
34begin insert a prescription for end insert a product that is subject to Section 503(b) of
35the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
36(3) “351(k) pathway” refers to the licensure of a biological
37product as a biosimilar or an interchangeable biosimilar by the
38FDA pursuant to Section 351(k) of the federal Public Health
39Service Act.
40(h)
end delete
P5 1begin insert(i)end insert Nothing in this section prohibits the administration of
2immunizations, as permitted in Section 4052.
3(i)
end delete
4begin insert(j)end insert Nothing in this sectionbegin delete shall be interpreted to prohibitend delete
5begin insert prohibitsend insert a disability insurer or health care service plan from
6requiring prior authorization or imposing
other appropriate
7utilization controls in approving coverage for any biological
8product.
No reimbursement is required by this act pursuant to
10Section 6 of Article XIII B of the California Constitution because
11the only costs that may be incurred by a local agency or school
12district will be incurred because this act creates a new crime or
13infraction, eliminates a crime or infraction, or changes the penalty
14for a crime or infraction, within the meaning of Section 17556 of
15the Government Code, or changes the definition of a crime within
16the meaning of Section 6 of Article XIII B of the California
17Constitution.
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