§59-355.4. Substituting interchangeable biological products for
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prescribed biological products.
A. For the purposes of this section:
1. "Biological product" has the same meaning given to that term in 42 U.S.C., Section 262; and
2. "Interchangeable biological product" means a biological product that the U.S. Food and Drug Administration (FDA):
a. has licensed, and determined to meet the standards for
interchangeability pursuant to 42 U.S.C., Section
262(k)(4), or
b. has determined is therapeutically equivalent as set
forth in the latest edition of or supplement to the
United States Food and Drug Administration's
Approved Drug Products with Therapeutic Equivalence
Evaluations.
B. A pharmacist may substitute an interchangeable biological product for a prescribed biological product if:
1. The substituted product has been determined by FDA to be interchangeable, as defined in subsection A of this section, with the prescribed biological product;
2. The prescribing health care provider does not express a preference against substitution in writing, verbally or electronically; and
3. The pharmacy informs the patient of the substitution.
C. The dispensing pharmacist or the pharmacist's designee shall make an entry into an electronic records system of the specific product provided to the patient including the name of the product and the manufacturer. The communication shall be conveyed by making an entry through:
1. An interoperable electronic medical records system;
2. An electronic prescribing technology;
3. A pharmacy benefit management system; or
4. A pharmacy record.
D. Entry into an electronic records system as described in subsection C of this section is presumed to provide notice to the prescriber. If no electronic records system is in use by the pharmacy, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission or other prevailing means, except that communication shall not be required where:
1. There is no FDA-approved interchangeable biological product for the product prescribed; or
2. A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
E. The dispensing pharmacist or a prescriber shall not be:
1. Required to show proof that the prescriber has access to the record in any type of payment audit conducted by a payer or pharmacy benefit manager; or
2. Subject to disciplinary action or civil penalties for failure to ensure that the record is accessible or for failure to access the record.
F. The State Board of Pharmacy shall maintain a link on its Internet website to the current list of all biological products determined by the FDA to be interchangeable with a specific biological product.
G. Nothing in this section shall preclude existing approved brand and generic substitutions. Added by Laws 2021, c. 167, § 1, eff. Nov. 1, 2021.