AB 1139, as introduced, Lowenthal. Prescriptions: biosimilar products.
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 by a specified federal entity, 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 filling a prescription order for a biological product subject to the Federal Food, Drug, and Cosmetic Act, as specified, to select a biosimilar product, as defined by federal statute, provided that product is deemed by the federal Food and Drug Administration (FDA) to be interchangeable with the prescribed product.
Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 4073 of the Business and Professions
2Code is amended to read:
(a) A pharmacist filling a prescription order for a drug
4product prescribed by its trade or brand name may select another
5drug product with the same active chemical ingredients of the same
6strength, quantity, and dosage form, and of the same generic drug
7name as determined by the United States Adopted Names (USAN)
8and accepted by the federal Food and Drug Administration (FDA),
9of those drug products having the same active chemical ingredients.
10(b) A pharmacist filling a prescription order for a biological
11product subject to Section 503(b) of the Federal Food, Drug, and
12Cosmetic Act (21 U.S.C. Sec. 353(b)), may select a biosimilar
13product, as
defined by Section 351 of the federal Public Health
14Service Act (42 U.S.C. Sec. 262), provided that product is deemed
15by the FDA to be interchangeable with the prescribed product.
16(b)
end delete
17begin insert(end insertbegin insertc)end insert 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 substitution be
30manually initialed by the prescriber.
31(c)
end delete
32begin insert(d)end insert Selection pursuant to this section is within the discretion of
33the pharmacist, except as provided in subdivisionbegin delete (b)end deletebegin insert
(c)end insert. The
34person who selects the drug product to be dispensed pursuant to
35this section shall assume the same responsibility for selecting the
36dispensed drug product as would be incurred in filling a
37prescription for a drug product prescribed by generic name. There
38shall be no liability on the prescriber for an act or omission by a
P3 1pharmacist in selecting, preparing, or dispensing a drug product
2pursuant to this section. In no case shall the pharmacist select a
3drug product pursuant to this section unless the drug product
4selected costs the patient less than the prescribed drug product.
5Cost, as used in this subdivision, is defined to include any
6professional fee that may be charged by the pharmacist.
7(d)
end delete
8begin insert(e)end insert This section shall apply to all prescriptions, including those
9presented by or on behalf of persons receiving assistance from the
10federal government or pursuant to the California Medical
11Assistance Program set forth in Chapter 7 (commencing with
12Section 14000) of Part 3 of Division 9 of the Welfare and
13Institutions Code.
14(e)
end delete
15begin insert(f)end insert When a substitution is made pursuant to this section, the use
16of the cost-saving drug product dispensed shall be communicated
17to the patient and the name of the dispensed drug product shall be
18indicated on the prescription label, except where the prescriber
19orders otherwise.
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