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, thebegin delete requirementsend deletebegin insert requirementend insert 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 selectionbegin delete and retain a written record of the biosimilar selection for a period of at least 3 yearsend delete. The bill would prohibit a pharmacist from substituting a biological product pursuant to these provisions unless the biological product selected costs the patientbegin insert the same orend insert 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 4052.55 is added to the Business and
2Professions Code, to read:
(a) In addition to the authority allowed under Section
44073.5, a pharmacist filling a prescription order for a prescribed
5biological product may select a biosimilar only if all of the
6following conditions are met:
7(1) The product selected as a biosimilar has been approved by
8the federal Food and Drug Administration (FDA) under the 351(k)
9pathway of the federal Public Health Service Act (42 U.S.C. Sec.
10262(k)) and has been determined to be interchangeable with the
11prescribed biological product.
12(2) The prescriber does not personally indicate, either orally or
13in his or her own handwriting, “Do not substitute,”
or words of
14similar meaning, pursuant to subdivision (b).
15(3) For prescriptions filled prior to January 1, 2017, the
16pharmacy notifies the prescriber or enters the appropriate
17information in a patient record system shared by the prescriber
18within five business days of the selection.
P3 1(4) For prescriptions filled prior to January 1, 2017, the
2pharmacy retains a written record of the biosimilar selection for a
3period of at least three
years.
4(b) In no case shall a selection be made pursuant to this section
5if the prescriber personally indicates, either orally or in his or her
6own handwriting, “Do not substitute,” or words of similar meaning.
7Nothing in this subdivision shall prohibit a prescriber from
8checking a box on a prescription marked “Do not substitute” if the
9prescriber personally initials the box or checkmark.
10(c) Selection pursuant to this section is within the discretion of
11the pharmacist, except as provided in subdivision (b). The
12pharmacist who selects the biosimilar to be dispensed pursuant to
13this section shall assume the same responsibility for substituting
14the dispensed biosimilar as would be incurred in filling a
15prescription for a biosimilar using the prescribed form of
16medication. There
shall be no liability on the prescriber for an act
17or omission by a pharmacist in selecting, preparing, or dispensing
18a drug product pursuant to this section.
19(d) This section shall apply to all prescriptions, including those
20presented by or on behalf of persons receiving assistance from the
21federal government or pursuant to the Medi-Cal Act set forth in
22Chapter 7 (commencing with Section 14000) of Part 3 of Division
239 of the Welfare and Institutions Code.
24(e) When a selection is made pursuant to this section, the
25substitution of a biosimilar shall be communicated to the patient.
26(f) The board shall maintain on its public Internet Web site a
27link to the current list, if available, of biosimilar products
28determined by the FDA to be interchangeable, as provided in
29paragraph (1) of subdivision (a).
30(g) For purposes of this section, the following terms shall have
31the following meanings:
32(1) “Biological product,” “biosimilar,” and “interchangeable”
33have the same meanings that apply to those terms under Section
34351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
35(2) “Prescription,” with respect to a biological product, means
36a product that is subject to Section 503(b) of the Federal Food,
37Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
38(3) “351(k) pathway” refers to the licensure of a biological
39product as a biosimilar or an interchangeable biosimilar by the
P4 1FDA pursuant to Section 351(k) of the federal Public Health
2Service Act (42 U.S.C. Sec. 262(k)).
3(h) Nothing in this section prohibits the administration of
4immunizations, as permitted in Section 4052.
Section 4073.5 is added to the Business and
7Professions Code, to read:
(a) A pharmacist filling a prescription order for a
9prescribed biological product may select a biosimilar only if all
10of the following conditions are met:
11(1) The product selected as a biosimilar has been approved by
12the federal Food and Drug Administration (FDA) under the 351(k)
13pathway of the federal Public Health Service Act (42 U.S.C. Sec.
14262(k)) and has been determined to be interchangeable with the
15prescribed biological product.
16(2) The prescriber does not personally indicate, either orally or
17in his or her own handwriting, “Do not substitute,” or words of
18similar meaning in the manner provided in
subdivision (b).
19(3) For prescriptions filled prior to January 1, 2017, the
20pharmacy notifies the prescriber or enters the appropriate
21information in a patient record system shared by the prescriber
22within five business days of the selection.
23(4) For prescriptions filled prior to January 1, 2017, the
24pharmacy retains a written record of the biosimilar selection for a
25period of at least three years.
26(b) In no case shall a selection be made pursuant to this section
27if the prescriber personally indicates, either orally or in his or her
28own handwriting, “Do not substitute,” or
words of similar meaning.
29Nothing in this subdivision shall prohibit a prescriber from
30checking a box on a prescription marked “Do not substitute,”
31provided that the prescriber personally initials the box or
32checkmark. To indicate that a selection shall not be made pursuant
33to this section for an electronic data transmission prescription as
34defined in subdivision (c) of Section 4040, a prescriber may
35indicate “Do not substitute,” or words of similar meaning, in the
36prescription as transmitted by electronic data, or may check a box
37marked on the prescription “Do not substitute.” In either instance,
38it shall not be required that the prohibition onbegin delete selectionend deletebegin insert substitutionend insert
39 be manually initialed by the prescriber.
P5 1(c) Selection pursuant to this section is within the discretion of
2the pharmacist, except as provided in subdivision (b). The
3pharmacist who selects the biosimilar to be dispensed pursuant to
4this section shall assume the same responsibility for substituting
5thebegin delete dispensed biological productend deletebegin insert biosimilarend insert as would be incurred
6in filling a prescription for a biosimilarbegin delete using the prescribed form begin insert prescribed by nameend insert. There shall be no liability on
7of medicationend delete
8the prescriber for an act or omission by a
pharmacist in selecting,
9preparing, or dispensing a biological product pursuant to this
10section. In no case shall the pharmacist substitute a biological
11product pursuant to this section unless the biological product
12selected costs the patientbegin insert the same orend insert less than the prescribed
13biological product. Cost, as used in this subdivision, is defined to
14include any professional fee that may be charged by the pharmacist.
15(d) This section shall apply to all prescriptions, including those
16presented by or on behalf of persons receiving assistance from the
17federal government or pursuant to the Medi-Cal Act set forth in
18Chapter 7 (commencing with Section 14000) of Part 3 of Division
199 of the Welfare and Institutions Code.
20(e) When a selection is made pursuant to this section, the
21substitution of a biosimilar shall be communicated to thebegin delete patient.end delete
22begin insert patient.end insert
23(f) 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) For purposes of this section, the following terms shall have
28the following meanings:
29(1) “Biological product,” “biosimilar,” and “interchangeable”
30have the same meanings that
apply to those terms under Section
31351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
32(2) “Prescription,” with respect to a biological product, means
33a product that is subject to Section 503(b) of the Federal Food,
34Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
35(3) “351(k) pathway” refers to the licensure of a biological
36product as a biosimilar or an interchangeable biosimilar by the
37FDA pursuant to Section 351(k) of the federal Public Health
38Service Act.
39(h) Nothing in this section prohibits the administration of
40immunizations, as permitted in Section 4052.
P6 1(i) Nothing
in this section shall be interpreted to prohibit a
2disability insurer or health care service plan from requiring prior
3authorization or imposing other appropriate utilization controls
4in approving coverage for any biological product.
No reimbursement is required by this act pursuant to
7Section 6 of Article XIII B of the California Constitution because
8the only costs that may be incurred by a local agency or school
9district will be incurred because this act creates a new crime or
10infraction, eliminates a crime or infraction, or changes the penalty
11for a crime or infraction, within the meaning of Section 17556 of
12the Government Code, or changes the definition of a crime within
13the meaning of Section 6 of Article XIII B of the California
14Constitution.
O
97