Senate Bill No. 671

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, as introduced, Hill. Pharmacy: biological product.

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 is authorized 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 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 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 “Do not substitute,” as specified. The bill would also require a pharmacist or his or her designee when dispensing a biological product to communicate to the prescriber the specific biological product provided to the patient, including the name of the product and the manufacturer, except as specified. 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. The bill would also require that the substitution of a biological product 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 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.

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 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, as
defined in paragraph (2) of subdivision (h).

(2) The prescriber does not personally indicate “Do not
substitute,” or words of similar meaning, in the manner provided
in subdivision (c).

(b) Within a reasonable time following the dispensing of a
biological product, a dispensing pharmacist or the pharmacists’
designee shall communicate to the prescriber 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 into an interoperable electronic
medical records system, through electronic prescribing technology,
or a pharmacy record that is electronically accessible by the
prescriber. Otherwise, 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 FDA-approved interchangeable biological
product, as defined in subdivision (h), for the product prescribed.

(2) A refill prescription is not changed from the product
dispensed on the prior filling of the prescription.

(c) 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.

(d) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (c). A pharmacist
who selects the 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.

(e) 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.

(f) When a selection is made pursuant to this section, the
substitution of a biological product shall be communicated to the
patient.

(g) The board shall maintain on its public Internet Web site a
link to the current list, if available, of biological products
determined by the FDA to be interchangeable, as defined in
paragraph (2) of subdivision (h).

(h) 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 FDA
has determined meets the standards set forth in 42 U.S.C. Section
262(k)(4), or has been deemed therapeutically equivalent by the
FDA 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 503B of the
federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).

(i) This section shall not prohibit the administration of
immunizations, as permitted in Section 4052.

(j) 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.