Biologic substitution rules approved

Pharmacists are allowed to substitute biological products with FDA-approved interchangeable biologics under a bill given final approval May 3.

Sen. John Kuehn
Sen. John Kuehn

Biologics include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood components and allergenic products used to treat or cure human diseases. An FDA-approved interchangeable biological product is one that the FDA has determined to be therapeutically equivalent to a prescribed product.

Under LB481, introduced by Heartwell Sen. John Kuehn, a pharmacist who receives a prescription for a biological product and chooses to dispense an interchangeable biological for the prescribed product must advise the patient or the patient’s caregiver that drug product selection has occurred.

Within three business days after dispensing a biological product, the dispensing pharmacist or the pharmacist’s designee is required to make an entry of the specific product provided to the patient, including the product name and manufacturer.

The bill also requires the state Department of Health and Human Services to maintain a link on its website to the current list of all biological products that the FDA has determined to be interchangeable biological products.

LB481 passed on a 47-0 vote.

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