BILL NUMBER: SB 671	AMENDED
	BILL TEXT

	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, as amended, 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.
   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.
   (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:   through one or more of the following
electronic records systems: 
   (1) An interoperable electronic medical records  system,
  system. 
   (2) An electronic prescribing  technology,  
technology. 
   (3) A pharmacy benefit management  system, or 
 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.
 If 
    (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. 
   (d) 
   (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. 
   (e) 
    (f)  Selection pursuant to this section is within the
discretion of the pharmacist, except as provided in subdivision
 (d).   (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. 
   (f) 
    (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. 
   (g) 
    (h)  When a selection is made pursuant to this section,
the substitution of a biological product shall be communicated to the
patient. 
   (h) 
    (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. 
   (i) 
    (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  42 U.S.C.  Section  262(k)(4),
  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)).

   (j) 
    (k)  This section shall not prohibit the administration
of immunizations, as permitted in Sections 4052 and 4052.8. 
   (k) 
    (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.