2014 Indiana Code TITLE 16. HEALTH ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS CHAPTER 25. DRUGS: BIOSIMILAR BIOLOGICAL PRODUCTS
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IC 16-42-25
Chapter 25. Drugs: Biosimilar Biological Products
IC 16-42-25-1
"Biological product"
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.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-2
"Biosimilar"
Sec. 2. As used in this chapter, "biosimilar" refers to a biological
product that:
(1) has been licensed as a biosimilar product under 41 U.S.C.
262(k) or has been approved based on an application filed under
21 U.S.C. 355(b)(2); 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.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-3
"Interchangeable"
Sec. 3. As used in this chapter, "interchangeable" means:
(1) a determination by the federal Food and Drug
Administration that a biosimilar product may be substituted for
a reference biological product without the intervention of the
health care provider that prescribed the biological product; or
(2) concerning a biological product filed under 21 U.S.C.
355(b)(2), a product that is designated as therapeutically
equivalent by the federal Food and Drug Administration in the
Approved Drug Products with Therapeutic Equivalence
Evaluations.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-4
Substitution; conditions
Sec. 4. A pharmacist may substitute for a prescribed biological
product if the following conditions are met:
(1) The substitute 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.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-5
Records of dispensing biologic product; time frame; exception
Sec. 5. (a) Except as provided in subsection (b), in order to ensure
medical records are complete and accurate, a pharmacist shall, not
later than ten (10) calendar days after dispensing a biologic product,
record the name and manufacturer of the biologic product dispensed
using:
(1) an interoperable electronic health records system shared with
the prescribing practitioner, to the extent a system is in place
between the pharmacist and the practitioner; or
(2) if an electronic health records system is not in place between
the pharmacist and the prescribing practitioner, any prevailing
means available to communicate to the prescribing practitioner
the name and manufacturer of the biologic product dispensed.
(b) The pharmacist is not required to report to or communicate
with the prescribing practitioner under subsection (a)(2) if:
(1) there is no federal Food and Drug Administration approved
interchangeable biological product for the prescribed biological
product; or
(2) the refill prescription is not changed from the product
originally dispensed.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-6
Record retention; pharmacy; prescribing practitioner
Sec. 6. (a) The pharmacy shall retain a record in accordance with
IC 25-26-13-25(a) of the dispensed biological product.
(b) The prescribing practitioner shall retain a record in accordance
with IC 16-39-7-1 of the dispensed biological product.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-7
Link to current list of interchangeable biological products; rules
Sec. 7. (a) The Indiana board of pharmacy shall maintain a link on
the board's Internet web site to the current list of all biological
products determined by the United States Food and Drug
Administration to be interchangeable with a specific reference
biological product.
(b) The Indiana board of pharmacy may adopt rules under
IC 4-22-2 necessary to implement this chapter.
As added by P.L.96-2014, SEC.6.
IC 16-42-25-8
Compliance with prescription requirements
Sec. 8. A written or electronic prescription for a biological product
must comply with the requirements under IC 16-42-22-6.
As added by P.L.96-2014, SEC.6.
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