Amended in Assembly June 23, 2015

Amended in Senate May 5, 2015

Amended in Senate April 14, 2015

Senate BillNo. 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 amended, Hill. Pharmacy: biological product.

The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists.begin delete Among other permitted acts,end deletebegin insert The Pharmacy Law authorizesend insert a pharmacist filling a prescription order for a drug product prescribed by its trade or brand namebegin delete is authorizedend delete 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. Abegin delete person who knowingly violatesend deletebegin insert knowing violation ofend insert the Pharmacy Law isbegin delete guilty of a misdemeanor, as specified.end deletebegin insert a misdemeanor.end insert

Thisbegin delete billend deletebegin insert bill, except as specified,end insert would authorize abegin delete pharmacist, in his or her discretion, except as specified,end deletebegin insert pharmacistend insert 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 indicatebegin delete “Do not substitute,” as specified.end deletebegin insert in a prescribed manner that a substitution is not to be made.end insert The bill wouldbegin delete alsoend delete require a pharmacistbegin delete or his or her designee when dispensing a biological product to communicate to the prescriberend deletebegin insert 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 ofend insert the specific biological product provided to thebegin delete patient, including the name of the product and the manufacturer, except as specified.end deletebegin insert 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. end insertbegin insertThe bill would also require that the substitution of a biological product be communicated to the patient.end insert 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. begin deleteThe bill would also require that the substitution of a biological product be communicated to the patient.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 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:

P2    1

SECTION 1.  

Section 4073.5 is added to the Business and
2Professions Code
, to read:

3

4073.5.  

(a) A pharmacist filling a prescription order for a
4prescribed biological product may select an alternative biological
5product only if all of the following:

6(1) The alternative biological product is interchangeable.

P3    1(2) The prescriber does not personally indicate “Do not
2substitute,” or words of similar meaning, in the manner provided
3in subdivisionbegin delete (c).end deletebegin insert (d).end insert

4(b) Within five days following the dispensing of a biological
5product, a dispensing pharmacist or the pharmacists’ designee
6shallbegin delete communicate to the prescriberend deletebegin insert make an entry ofend insert the specific
7biological product provided to the patient, including the name of
8the biological product and the manufacturer. The communication
9shall be conveyed by making an entrybegin delete into an interoperable
10electronic medical records system, through electronic prescribing
11technology, or a pharmacy record that is electronically accessible
12by the prescriber. Otherwise,end delete
begin insert that can be electronically accessed
13by the prescriber through:end insert

begin insert

14(1) An interoperable electronic medical records system,

end insert
begin insert

15(2) An electronic prescribing technology,

end insert
begin insert

16(3) A pharmacy benefit management system, or

end insert
begin insert

17(4) A pharmacy record.

end insert

18begin insert(c)end insertbegin insertend insertbegin insertEntry into an electronic records system as described in
19subdivision (b) is presumed to provide notice to the prescriber. If
20the pharmacy does not have access to one or more of the entry
21systems in subdivision (b),end insert
the pharmacist or the pharmacist’s
22designee shall communicate the name of the biological product
23dispensed to the prescriber using facsimile, telephone, electronic
24transmission, or other prevailing means, except that communication
25shall not be required in this instance to the prescriber when either
26of the following apply:

27(1) There is no interchangeable biological product approved by
28the federal Food and Drug Administration for the product
29prescribed.

30(2) A refill prescription is not changed from the product
31dispensed on the prior filling of the prescription.

begin delete

11 32(c)

end delete

33begin insert(d)end insert In no case shall a selection be made pursuant to this section
34if the prescriber personally indicates, either orally or in his or her
35own handwriting, “Do not substitute,” or words of similar meaning.

36(1) This subdivision shall not prohibit a prescriber from checking
37a box on a prescription marked “Do not substitute,” provided that
38the prescriber personally initials the box or checkmark.

39(2) To indicate that a selection shall not be made pursuant to
40this section for an electronic data transmission prescription, as
P4    1defined in subdivision (c) of Section 4040, a prescriber may
2indicate “Do not substitute,” or words of similar meaning, in the
3prescription as transmitted by electronic data, or may check a box
4marked on the prescription “Do not substitute.” In either instance,
5it shall not be required that the prohibition on substitution be
6manually initialed by the prescriber.

begin delete

25 7(d)

end delete

8begin insert(e)end insert Selection pursuant to this section is within the discretion of
9the pharmacist, except as provided in subdivisionbegin delete (c).end deletebegin insert (d).end insert A
10pharmacist who selects an alternative biological product to be
11dispensed pursuant to this section shall assume the same
12responsibility for substituting the biological product as would be
13incurred in filling a prescription for a biological product prescribed
14by name. There shall be no liability on the prescriber for an act or
15omission by a pharmacist in selecting, preparing, or dispensing a
16biological product pursuant to this section. In no case shall the
17pharmacist select a biological product that meets the requirements
18of subdivision (a) unless the cost to the patient of the biological
19product selected is the same or less than the cost of the prescribed
20biological product. Cost, as used in this subdivision, includes any
21professional fee that may be charged by the pharmacist.

begin delete

39 22(e)

end delete

23begin insert(f)end insert This section shall apply to all prescriptions, including those
24presented by or on behalf of persons receiving assistance from the
25federal government or pursuant to the Medi-Cal Act set forth in
26Chapter 7 (commencing with Section 14000) of Part 3 of Division
279 of the Welfare and Institutions Code.

begin delete

4 28(f)

end delete

29begin insert(g)end insert When a selection is made pursuant to this section, the
30substitution of a biological product shall be communicated to the
31patient.

begin delete

7 32(g)

end delete

33begin insert(h)end insert The board shall maintain on its public Internet Web site a
34link to the current list, if available, of biological products
35determined by the federal Food and Drug Administration to be
36interchangeable.

begin delete

12 37(h)

end delete

38begin insert(i)end insert For purposes of this section, the following terms shall have
39the following meanings:

P5    1(1) “Biological product” has the same meaning that applies to
2that term under Section 351 of the federal Public Health Service
3Act (42 U.S.C. Sec. 262(i)).

4(2) “Interchangeable” means a biological product that the federal
5Food and Drug Administration has determined meets the standards
6set forth in 42 U.S.C. Section 262(k)(4), or has been deemed
7therapeutically equivalent by the federal Food and Drug
8Administration as set forth in the latest addition or supplement of
9the Approved Drug Products with Therapeutic Equivalence
10Evaluations.

11(3) “Prescription,” with respect to a biological product, means
12a prescription for a product that is subject to Section 503(b) of the
13Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).

begin delete

27 14(i)

end delete

15begin insert(j)end insert This section shall not prohibit the administration of
16immunizations, as permitted in Sections 4052 and 4052.8.

begin delete

29 17(j)

end delete

18begin insert(k)end insert This section shall not prohibit a disability insurer or health
19care service plan from requiring prior authorization or imposing
20other appropriate utilization controls in approving coverage for
21any biological product.

22

SEC. 2.  

No reimbursement is required by this act pursuant to
23Section 6 of Article XIII B of the California Constitution because
24the only costs that may be incurred by a local agency or school
25district will be incurred because this act creates a new crime or
26infraction, eliminates a crime or infraction, or changes the penalty
27for a crime or infraction, within the meaning of Section 17556 of
28the Government Code, or changes the definition of a crime within
29the meaning of Section 6 of Article XIII B of the California
30Constitution.



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