SB 598, as introduced, 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. The bill would prohibit a pharmacist from substituting a biological product pursuant to these provisions unless the biological product selected costs the patient less than the prescribed biological product. The bill would also require that the substitution of a biosimilar be communicated to the patient and that the full name and manufacturer of the biosimilar be indicated on the prescription label. 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) The pharmacist notifies the prescriber or enters the
16appropriate information in a patient record system shared by the
17prescriber within five business days of the selection.
18(4) The pharmacy retains a written record of the biosimilar
19selection for a period of at least three years.
20(b) In no case shall a selection be made pursuant to this section
21if the prescriber personally indicates, either orally or in his or her
22own handwriting, “Do not substitute,” or words of similar meaning.
23Nothing in this subdivision shall prohibit a prescriber from
24checking a box on a prescription marked “Do not substitute” if the
25prescriber personally initials the box or checkmark.
P3 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
5the dispensed biosimilar as would be incurred in filling a
6prescription for a biosimilar using the prescribed form of
7medication. There shall be no liability on the prescriber for an act
8or omission by a pharmacist in selecting, preparing, or dispensing
9a drug product pursuant to this section.
10(d) This section shall apply to all prescriptions, including those
11presented by or on behalf of persons receiving assistance from the
12federal government or pursuant to the Medi-Cal Act set forth in
13Chapter 7 (commencing with Section 14000) of Part 3 of Division
149 of the Welfare and Institutions Code.
15(e) When a selection is made pursuant to this section, the
16substitution of a biosimilar shall be communicated to the patient
17and
the full name and manufacturer of the dispensed biosimilar
18shall be indicated on the prescription label, unless where the
19prescriber orders otherwise.
20(f) The board shall maintain on its public Internet Web site a
21link to the current list, if available, of biosimilar products
22determined by the FDA to be interchangeable, as provided in
23paragraph (1) of subdivision (a).
24(g) For purposes of this section, the following terms shall have
25the following meanings:
26(1) “Biological product,” “biosimilar,” and “interchangeable”
27have the same meanings that apply to those terms under Section
28351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
29(2) “Prescription,” with respect to a biological product, means
30a product that is subject to Section 503(b) of
the Federal Food,
31Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
32(3) “351(k) pathway” refers to the licensure of a biological
33product as a biosimilar or an interchangeable biosimilar by the
34FDA pursuant to Section 351(k) of the federal Public Health
35Service Act (42 U.S.C. Sec. 262(k)).
36(h) Nothing in this section prohibits the administration of
37immunizations, as permitted in Section 4052.
Section 4073.5 is added to the Business and Professions
39Code, to read:
(a) A pharmacist filling a prescription order for a
2prescribed biological product may select a biosimilar only if all
3of the following conditions are met:
4(1) The product selected as a biosimilar has been approved by
5the federal Food and Drug Administration (FDA) under the 351(k)
6pathway of the federal Public Health Service Act (42 U.S.C. Sec.
7262(k)) and has been determined to be interchangeable with the
8prescribed biological product.
9(2) The prescriber does not personally indicate, either orally or
10in his or her own handwriting, “Do not substitute,” or words of
11similar meaning in the manner provided in subdivision (b).
12(3) The pharmacist notifies the prescriber or enters the
13appropriate information in a patient record system shared by the
14prescriber within five business days of the selection.
15(4) The pharmacy retains a written record of the biosimilar
16selection for a period of at least three years.
17(b) In no case shall a selection be made pursuant to this section
18if the prescriber personally indicates, either orally or in his or her
19own handwriting, “Do not substitute,” or words of similar meaning.
20Nothing in this subdivision shall prohibit a prescriber from
21checking a box on a prescription marked “Do not substitute,”
22provided that the prescriber personally initials the box or
23checkmark. To indicate that a selection shall not be made pursuant
24to this section for an electronic data transmission prescription as
25defined in subdivision (c) of Section 4040, a prescriber may
26indicate “Do
not substitute,” or words of similar meaning, in the
27prescription as transmitted by electronic data, or may check a box
28marked on the prescription “Do not substitute.” In either instance,
29it shall not be required that the prohibition on selection be manually
30initialed by the prescriber.
31(c) Selection pursuant to this section is within the discretion of
32the pharmacist, except as provided in subdivision (b). The
33pharmacist who selects the biosimilar to be dispensed pursuant to
34this section shall assume the same responsibility for substituting
35the dispensed biological product as would be incurred in filling a
36prescription for a biosimilar using the prescribed form of
37medication. There shall be no liability on the prescriber for an act
38or omission by a pharmacist in selecting, preparing, or dispensing
39a biological product pursuant to this section. In no case shall the
40pharmacist substitute a biological product pursuant to this section
P5 1unless the
biological product selected costs the patient less than
2the prescribed biological product. Cost, as used in this subdivision,
3is defined to include any professional fee that may be charged by
4the pharmacist.
5(d) This section shall apply to all prescriptions, including those
6presented by or on behalf of persons receiving assistance from the
7federal government or pursuant to the Medi-Cal Act set forth in
8Chapter 7 (commencing with Section 14000) of Part 3 of Division
99 of the Welfare and Institutions Code.
10(e) When a selection is made pursuant to this section, the
11substitution of a biosimilar shall be communicated to the patient
12and the full name and manufacturer of the dispensed biosimilar
13shall be indicated on the prescription label, unless where the
14prescriber orders otherwise.
15(f) The board shall maintain on its
public Internet Web site a
16link to the current list, if available, of biosimilar products
17determined by the FDA to be interchangeable, as provided in
18paragraph (1) of subdivision (a).
19(g) For purposes of this section, the following terms shall have
20the following meanings:
21(1) “Biological product,” “biosimilar,” and “interchangeable”
22have the same meanings that apply to those terms under Section
23351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
24(2) “Prescription,” with respect to a biological product, means
25a product that is subject to Section 503(b) of the Federal Food,
26Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
27(3) “351(k) pathway” refers to the licensure of a biological
28product as a biosimilar or an interchangeable biosimilar by
the
29FDA pursuant to Section 351(k) of the federal Public Health
30Service Act.
31(h) Nothing in this section prohibits the administration of
32immunizations, as permitted in Section 4052.
No reimbursement is required by this act pursuant to
34Section 6 of Article XIII B of the California Constitution because
35the only costs that may be incurred by a local agency or school
36 district will be incurred because this act creates a new crime or
37infraction, eliminates a crime or infraction, or changes the penalty
38for a crime or infraction, within the meaning of Section 17556 of
39the Government Code, or changes the definition of a crime within
P6 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
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