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.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 25. Drugs: Biosimilar Biological Products
16-42-25-1. "Biological Product"
16-42-25-4. Substitution; Conditions
16-42-25-5. Records of Dispensing Biologic Product; Time Frame; Exception
16-42-25-6. Record Retention; Pharmacy; Prescribing Practitioner
16-42-25-7. Link to Current List of Interchangeable Biological Products; Rules