Bill Text: CA SB671 | 2015-2016 | Regular Session | Chaptered
Bill Title: Pharmacy: biological product.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2015-10-06 - Chaptered by Secretary of State. Chapter 545, Statutes of 2015. [SB671 Detail]
Download: California-2015-SB671-Chaptered.html
BILL NUMBER: SB 671 CHAPTERED
BILL TEXT
CHAPTER 545
FILED WITH SECRETARY OF STATE OCTOBER 6, 2015
APPROVED BY GOVERNOR OCTOBER 6, 2015
PASSED THE SENATE AUGUST 31, 2015
PASSED THE ASSEMBLY AUGUST 27, 2015
AMENDED IN ASSEMBLY JULY 16, 2015
AMENDED IN ASSEMBLY JUNE 23, 2015
AMENDED IN SENATE MAY 5, 2015
AMENDED IN SENATE APRIL 14, 2015
INTRODUCED BY Senator Hill
FEBRUARY 27, 2015
An act to add Section 4073.5 to the Business and Professions Code,
relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 671, Hill. Pharmacy: biological product.
The Pharmacy Law governs the practice of pharmacy in this state,
including the permissible duties of licensed pharmacists. The
Pharmacy Law authorizes a pharmacist filling a prescription order for
a drug product prescribed by its trade or brand name to 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 knowing violation of the
Pharmacy Law is a misdemeanor.
This bill, except as specified, would authorize a pharmacist to
select an alternative biological product when filling a prescription
order for a prescribed biological product if the alternative
biological product is interchangeable, as defined, and the prescriber
does not personally indicate in a prescribed manner that a
substitution is not to be made. The bill would require a pharmacist
or a designee, within a specified period following the dispensing of
a biological product, to make an electronically accessible entry in a
described entry system of the specific biological product provided
to the patient. The bill would provide an alternate means of
communicating the name of the biological product dispensed to the
prescriber if the pharmacy does not have access to one or more of the
described entry systems. The bill would also require that the
substitution of a biological product be communicated to the patient.
The bill would prohibit a pharmacist from selecting an alternative
biological product that meets the requirements of these provisions
unless the cost to the patient of the alternative biological product
selected is the same or less than the cost of the prescribed
biological product. 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 biological products determined by the federal
Food and Drug Administration to be interchangeable.
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.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. 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 an alternative biological
product only if all of the following:
(1) The alternative biological product is interchangeable.
(2) The prescriber does not personally indicate "Do not
substitute," or words of similar meaning, in the manner provided in
subdivision (d).
(b) Within five days following the dispensing of a biological
product, a dispensing pharmacist or the pharmacists' designee shall
make an entry of the specific biological product provided to the
patient, including the name of the biological product and the
manufacturer. The communication shall be conveyed by making an entry
that can be electronically accessed by the prescriber through one or
more of the following electronic records systems:
(1) An interoperable electronic medical records system.
(2) An electronic prescribing technology.
(3) A pharmacy benefit management system.
(4) A pharmacy record.
(c) Entry into an electronic records system as described in
subdivision (b) is presumed to provide notice to the prescriber.
(d) If the pharmacy does not have access to one or more of the
entry systems in subdivision (b), the pharmacist or the pharmacist's
designee shall communicate the name of the biological product
dispensed to the prescriber using facsimile, telephone, electronic
transmission, or other prevailing means, except that communication
shall not be required in this instance to the prescriber when either
of the following apply:
(1) There is no interchangeable biological product approved by the
federal Food and Drug Administration for the product prescribed.
(2) A refill prescription is not changed from the product
dispensed on the prior filling of the prescription.
(e) 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.
(1) This subdivision shall not prohibit a prescriber from checking
a box on a prescription marked "Do not substitute," provided that
the prescriber personally initials the box or checkmark.
(2) 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 substitution be
manually initialed by the prescriber.
(f) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (e). A pharmacist
who selects an alternative biological product to be dispensed
pursuant to this section shall assume the same responsibility for
substituting the biological product as would be incurred in filling a
prescription for a biological product prescribed by name. 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
select a biological product that meets the requirements of
subdivision (a) unless the cost to the patient of the biological
product selected is the same or less than the cost of the prescribed
biological product. Cost, as used in this subdivision, includes any
professional fee that may be charged by the pharmacist.
(g) 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.
(h) When a selection is made pursuant to this section, the
substitution of a biological product shall be communicated to the
patient.
(i) The board shall maintain on its public Internet Web site a
link to the current list, if available, of biological products
determined by the federal Food and Drug Administration to be
interchangeable.
(j) For purposes of this section, the following terms shall have
the following meanings:
(1) "Biological product" has the same meaning that applies to that
term under Section 351 of the federal Public Health Service Act (42
U.S.C. Sec. 262(i)).
(2) "Interchangeable" means a biological product that the federal
Food and Drug Administration has determined meets the standards set
forth in Section 262(k)(4) of Title 42 of the United States Code, or
has been deemed therapeutically equivalent by the federal Food and
Drug Administration as set forth in the latest addition or supplement
of the Approved Drug Products with Therapeutic Equivalence
Evaluations.
(3) "Prescription," with respect to a biological product, means a
prescription for a product that is subject to Section 503(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k) This section shall not prohibit the administration of
immunizations, as permitted in Sections 4052 and 4052.8.
(l) This section shall not prohibit a disability insurer or health
care service plan from requiring prior authorization or imposing
other appropriate utilization controls in approving coverage for any
biological product.
SEC. 2. 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.
