Amended in Senate April 16, 2013

Senate Bill No. 598

Introduced by Senator Hill

February 22, 2013

An act to add Sections 4052.55 and 4073.5 to the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

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 begin insert , including, among other conditions, the requirements 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 selection and retain a written record of the biosimilar selection for a period of at least 3 years end insert . 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 begin delete and that the full name and manufacturer of the biosimilar be indicated on the prescription label end delete . 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 1.  

Section 4052.55 is added to the Business and
Professions Code, to read:

4052.55.  

(a) In addition to the authority allowed under Section
4073.5, a pharmacist filling a prescription order for a prescribed
biological product may select a biosimilar only if all 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, either orally or
in his or her own handwriting, “Do not substitute,” or words of
similar meaning, pursuant to subdivision (b).

(3)  begin delete The pharmacist end delete begin insert For prescriptions filled prior to January 1,
2017, the pharmacy end insert notifies the prescriber or enters the appropriate
information in a patient record system shared by the prescriber
within five business days of the selection.

(4)  begin delete The end delete begin insert For prescriptions filled prior to January 1, 2017, the end insert
pharmacy retains a written record of the biosimilar selection for a
period of at least three years.

(b) 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” if the
prescriber personally initials the box or checkmark.

(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The
pharmacist who selects the biosimilar to be dispensed pursuant to
this section shall assume the same responsibility for substituting
the dispensed biosimilar as would be incurred in filling a
prescription for a biosimilar using the prescribed form of
medication. There shall be no liability on the prescriber for an act
or omission by a pharmacist in selecting, preparing, or dispensing
a drug product pursuant to this section.

(d) 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.

(e) When a selection is made pursuant to this section, the
substitution of a biosimilar shall be communicated to the patient begin delete and the full name and manufacturer of the dispensed biosimilar
shall be indicated on the prescription label, unless where the
prescriber orders otherwise end delete .

(f) 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).

(g) 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 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 (42 U.S.C. Sec. 262(k)).

(h) Nothing in this section prohibits the administration of
immunizations, as permitted in Section 4052.

SEC. 2.  

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 all
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, either orally or
in his or her own handwriting, “Do not substitute,” or words of
similar meaning in the manner provided in subdivision (b).

(3)  begin delete The pharmacist end delete begin insert For prescriptions filled prior to January 1,
2017, the pharmacy end insert notifies the prescriber or enters the appropriate
information in a patient record system shared by the prescriber
within five business days of the selection.

(4)  begin delete The end delete begin insert For prescriptions filled prior to January 1, 2017, the end insert
pharmacy retains a written record of the biosimilar selection for a
period of at least three years.

(b) 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 selection be manually
initialed by the prescriber.

(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The
pharmacist who selects the biosimilar to be dispensed pursuant to
this section shall assume the same responsibility for substituting
the dispensed biological product as would be incurred in filling a
prescription for a biosimilar using the prescribed form of
medication. 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 substitute a biological product pursuant to this section
unless the biological product selected costs the patient less than
the prescribed biological product. Cost, as used in this subdivision,
is defined to include any professional fee that may be charged by
the pharmacist.

(d) 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.

(e) When a selection is made pursuant to this section, the
substitution of a biosimilar shall be communicated to the patient
begin delete and the full name and manufacturer of the dispensed biosimilar
shall be indicated on the prescription label, unless where the
prescriber orders otherwise end delete .

(f) 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).

(g) 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 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.

(h) Nothing in this section prohibits the administration of
immunizations, as permitted in Section 4052.

SEC. 3.  

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.