MISSISSIPPI LEGISLATURE
2015 Regular Session
To: Public Health and Human Services
By: Representative Howell
AN ACT TO CODIFY NEW SECTION 73-21-118, MISSISSIPPI CODE OF
1972, TO AUTHORIZE PHARMACISTS TO SUBSTITUTE INTERCHANGEABLE
BIOLOGICAL PRODUCTS FOR A PRESCRIBED PRODUCT UNDER CERTAIN CONDITIONS; AND FOR RELATED PURPOSES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. The following shall be codified as Section 73-21-118, Mississippi Code of 1972:
73-21-118. (1) As used in this section:
(a) "Biological product" or "biosimilar" means a biological product licensed by the United States Food and Drug Administration under 42 USCS Section 262(i)(2).
(b) "Interchangeable" means, in reference to a biological product, that the United States Food and Drug Administration had determined that a biological product meets the safety standards set forth in 42 USCS Section 262(k)(4) and may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
(c) "Prescription" means a product that is subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 USCS 353(b)).
(2) A pharmacist may substitute a prescription biosimilar product for a prescribed product only if:
(a) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed product for the specified indicated use;
(b) The prescriber has not expressly prohibited product selection in writing, verbally or electronically;
(c) The person presenting the prescription is notified and consents to the substitution;
(d) The pharmacist or the pharmacist's agent, within a reasonable time but not to exceed ten (10) days following the dispensing, records the name and manufacturer of the product dispensed in an interoperable health records system shared with the prescribing practitioner, to the extent that such a system is available, or if an interoperable electronic health records system is not available, communicates to the prescribing practitioner by facsimile, telephone, voicemail, email or other electronic means the name and the manufacturer of the biological product dispensed to the patient. No communication to the prescribing practitioner is required under this subsection where there is no interchangeable biological product for the prescribed biological product, or for a refill prescription that is not changed from the product originally dispensed; and
(e) The pharmacist and prescriber retain a written record of the biosimilar substitution for a period of no less than ten (10) years.
(3) The State Board of Pharmacy shall maintain on its public website a current list of biosimilar biological products determined to be interchangeable under subsection (2)(a) of this section.
SECTION 2. This act shall take effect and be in force from and after July 1, 2015.