BILL NUMBER: SB 671	INTRODUCED
	BILL TEXT


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.