Bill Text: IN SB0272 | 2013 | Regular Session | Engrossed
Bill Title: Prescription products.
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: (Enrolled - Dead) 2013-04-15 - Returned to the Senate with amendments [SB0272 Detail]
Download: Indiana-2013-SB0272-Engrossed.html
Citations Affected: IC 16-18; IC 16-42; noncode.
Synopsis: Prescription products. Allows a pharmacist to substitute an
interchangeable biosimilar product for a prescribed biological product
if certain conditions are met. Requires the board of pharmacy to
maintain an Internet web site that lists the biosimilar biological
products that are determined to be interchangeable. Allows the board
of pharmacy to adopt rules. Provides that a written or electronic
prescription for a biological product must comply with the existing
prescription form requirements. Requires, during the 2013 legislative
interim: (1) the division of mental health and addiction to provide the
health finance commission with specified information concerning
opioid treatment programs; and (2) the health finance commission to
study how Indiana law may affect the prescribing and substituting of
biosimilar biological products.
Effective: July 1, 2013.
(HOUSE SPONSORS _ CLERE, DAVISSON, CANDELARIA REARDON, SHACKLEFORD)
January 8, 2013, read first time and referred to Committee on Health and Provider
Services.
February 7, 2013, amended, reported favorably _ Do Pass.
February 12, 2013, read second time, amended, ordered engrossed.
February 13, 2013, engrossed.
February 14, 2013, returned to second reading.
February 21, 2013, re-read second time, amended, ordered engrossed.
February 22, 2013, re-engrossed.
February 25, 2013, read third time, passed. Yeas 50, nays 0.
March 4, 2013, read first time and referred to Committee on Public Health.
April 8, 2013, amended, reported _ Do Pass.
April 11, 2013, read second time, amended, ordered engrossed.
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in
Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or
A BILL FOR AN ACT to amend the Indiana Code concerning
human services.
IC 16-42-19-5.
(b) "Practitioner", for purposes of IC 16-41-14, has the meaning set
forth in IC 16-41-14-4.
(c) "Practitioner", for purposes of IC 16-42-21, has the meaning set
forth in IC 16-42-21-3.
(d) "Practitioner", for purposes of IC 16-42-22 and IC 16-42-25,
has the meaning set forth in IC 16-42-22-4.5.
(1) the practitioner must:
(A) sign on the line under which the words "May substitute" appear; or
(B) for an electronically transmitted prescription, electronically transmit the instruction "May substitute."; and
(2) the pharmacist must inform the customer of the substitution.
(b) This section does not authorize any substitution other than substitution of a generically equivalent drug product.
Chapter 25. Drugs: Biosimilar Biological Products
Sec. 1. As used in this chapter, "biological product" means:
(1) a virus;
(2) a therapeutic serum;
(3) a toxin;
(4) an antitoxin;
(5) a vaccine;
(6) blood;
(7) a blood component;
(8) a blood derivative;
(9) an allergenic product;
(10) a protein (except any chemically synthesized
polypeptide);
(11) a product analogous to a product described in
subdivisions (1) through (10);
(12) arsphenamine;
(13) an arsphenamine derivative; or
(14) any other trivalent organic arsenic compound;
applicable to the prevention, treatment, or cure of a disease or
condition for human beings.
Sec. 2. As used in this chapter, "biosimilar" means a biological
product that:
(1) has been licensed as a biosimilar product under 42 U.S.C.
262(k); and
(2) is highly similar to the reference product, with:
(A) no clinically meaningful differences between the
biological product and the reference product in terms of
safety, purity, and potency of the product; and
(B) only minor differences in clinically inactive
components.
Sec. 3. As used in this chapter, "interchangeable" means a
determination by the federal Food and Drug Administration that
a biosimilar product may be substituted for a reference product
without the intervention of the health care provider that prescribed
the biological product.
Sec. 4. As used in this chapter, "reference product" means the
single biological product licensed under 42 U.S.C. 262(a) against
which a biological product is evaluated in an application submitted
under 42 U.S.C. 262(k).
Sec. 5. A pharmacist may substitute a biosimilar product for a
prescribed biological product if the following conditions are met:
(1) The biosimilar product has been determined by the federal
Food and Drug Administration to be interchangeable with the
prescribed biological product.
(2) The prescribing practitioner has:
(A) for a written prescription, signed on the line under
which the words "May substitute." appear; or
(B) for an electronically transmitted prescription,
electronically transmitted the instruction "May
substitute.".
(3) The pharmacist has informed the customer of the
substitution.
(4) The pharmacist notifies the prescribing practitioner,
orally, in writing, or electronically, within five (5) calendar
days of the substitution. This subdivision expires July 1, 2017.
(5) The pharmacy and the prescribing practitioner retain a
written or electronic record of the interchangeable biosimilar
substitution for at least five (5) years.
Sec. 6. (a) The Indiana board of pharmacy shall maintain a
public Internet web site that contains a current list of biosimilar
biological products that the federal Food and Drug Administration
has determined to be interchangeable.
(b) The Indiana board of pharmacy may adopt rules under
IC 4-22-2 necessary to implement this chapter.
Sec. 7. A written or electronic prescription for a biological
product must comply with the requirements under IC 16-42-22-6.
(b) During the 2013 legislative interim, the commission shall study the following:
(1) The expansion of the INSPECT (as defined by IC 35-48-7-5.2) program, including:
(A) requiring real time reporting of collected information;
(B) studying the confidentiality issues concerning access to the INSPECT database;
(C) requiring health care practitioners who prescribe medications to report all legend drugs and the proper time frame to require the reporting; and
(D) having health care providers access information in the INSPECT database that would assist the health care practitioner in the treatment of patients.
(2) The use of methadone and opioids in treatment programs and clinic settings.
(c) Not later than September 1, 2013, the division of mental health and addiction shall provide the commission with the following information in writing:
(1) The number of patients served in Indiana opioid treatment programs certified under IC 12-23-18.
(2) The opioid treatment medications provided to patients, including the dosage.
(3) The drug testing protocol of Indiana opioid treatment programs.
(4) The number of opioid treatment program patients who have tested positive for other controlled substances during a drug test for a controlled substance provided under an opioid
treatment program.
(5) The number of opioid treatment program patients who are
subsequently determined to no longer need the assistance of
the opioid treatment program and released from treatment.
(6) Any other information requested by the commission or
that is determined by the division of mental health and
addiction to be relevant to the study described in this
SECTION.
(d) During the 2013 legislative interim, the commission shall
study how Indiana law may affect prescribing and substituting of
biosimilar biological products for other drugs.
(e) This SECTION expires December 31, 2013.
