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.
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