Citations Affected: IC 16-42.
Synopsis: Biosimilar biological products. Provides that a biological
product that is substituted under the biosimilar biological products
requirements is not subject to the generic drug substitution
requirements. Allows a pharmacist to substitute a biosimilar product
for a prescribed biological product if certain conditions are met.
Requires the board of pharmacy to maintain a web site that lists the
biosimilar biological products that are determined to be
interchangeable. Allows the board of pharmacy to adopt rules. Provides
for disciplinary action for violations by a pharmacist.
Effective: July 1, 2013.
January 17, 2013, read first time and referred to Committee on Public Health.
A BILL FOR AN ACT to amend the Indiana Code concerning
JULY 1, 2013]:
Chapter 25. Drugs: Biosimilar Biological Products
Sec. 1. This chapter applies to a prescription for a biological product that is subject to 21 U.S.C. 353(b).
Sec. 2. The definitions set forth in 42 U.S.C. 262(i) apply to this chapter.
Sec. 3. 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 for the specified indicated use.
(2) The prescribing physician has not indicated on the prescription that a substitution is not permitted.
(3) The patient or the patient's authorized representative provides written consent for the substitution.
(4) The pharmacist notifies the physician, in writing or electronically, within twenty-four (24) hours of the substitution.
(5) The pharmacy and the prescribing physician retain a written or electronic record of the biosimilar substitution for at least five (5) years.
Sec. 4. (a) The Indiana board of pharmacy shall maintain a public 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. 5. A pharmacist who violates this chapter is subject to disciplinary action under IC 25-1-9.