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Beginning December 31, 2016, pharmacists in Arizona will be allowed to substitute an interchangeable biological product for a prescribed biological product if certain conditions are met, including if the prescribing physician does not indicate an intent to prevent substitution with such product on the prescription.
Under the new law, a pharmacist may make the substitution if US Food and Drug Administration (FDA) has determined the substituted product is an interchangeable biological product. In addition, the pharmacy is required to inform the patient of the substitution. The pharmacist (or pharmacist’s designee) is also required to make an entry of the specific product dispensed to the patient in an interoperable electronic medical records system that is accessible to the prescriber within five business days after dispensing a biological product.
The pharmacist may communicate to the prescriber which biological product was dispensed using fax, telephone, or other means. The communication must include the name of the product and the manufacturer. The pharmacist is also required to place on the container the name of the biological product dispensed followed by the words “interchangeable biological product for” followed by the brand or trade name of the product that is being replaced by the interchangeable biological product.
The law also states that the Arizona State Board of Pharmacy is required to maintain a link on its website to the current list of each biological product determined by FDA to be an interchangeable biological product. House Bill 2310 was signed into law by Governor Doug Ducey on May 17, 2016, and is effective beginning on December 31, 2016.