This bill amends existing law to allow pharmacists to substitute one interchangeable biological product for another, provided that the substitution does not result in an increased cost to the patient. The definition of "interchangeable biological product" is expanded to include not only those products that the FDA has licensed and determined to be interchangeable under 42 U.S.C. section 262(k)(4), but also those that the FDA has determined to be therapeutically equivalent, as well as any biological product licensed under section 42 U.S.C. section 262(k) that the FDA has determined to be interchangeable with the referenced product. The bill also requires the board to maintain a link to the FDA's Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations on its website.

The bill outlines the procedures and conditions under which a pharmacist may substitute biological products, including the requirement to inform the patient and the prescriber when a substitution is made. It also specifies the method of communication that must be used to notify the prescriber of the specific product provided to the patient. Additionally, the bill mandates that the label of all dispensed biological products include the proper name and the manufacturer's name. The bill prohibits substitution if the prescriber indicates "medically necessary" to prevent it, and it also establishes the requirement for pharmacists to communicate the specific biological product dispensed to the prescriber within three business days. The act is set to take effect 60 days after its passage.

Statutes affected:
Introduced: 318:47-dd
As Amended by the House: 318:47-dd