MISSISSIPPI LEGISLATURE
2014 Regular Session
To: Public Health and Welfare
By: Senator(s) Kirby
AN ACT TO CODIFY SECTION 73-21-118, MISSISSIPPI CODE OF 1972, TO PROVIDE FOR THE SUBSTITUTION OF INTERCHANGEABLE BIOLOGICAL PRODUCTS FOR A PRESCRIBED PRODUCT BY A PHARMACIST; 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. Biosimilars, substitution of interchangeable biological products. (1) As used in this section:
(a) "Biological product" and "biosimilar" means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 USC Section 262(i)(2).
(b) "Interchangeable" means in reference to a biological product, that the Federal Food and Drug Administration has determined that a biological product meets the safety standards set forth in 42 USC 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," with respect to this section, means such a product that is subject to Section 503(b) of the Federal, Food, Drug, and Cosmetic Act (21 USC 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 pharmacist's agent notifies the prescriber or the prescriber's agent of the substitution within ten (10) business days by facsimile, telephone, voice mail, e-mail, or other electronic means; or
(e) The pharmacist or pharmacist's agent records the name and manufacturer of the product dispensed to the patient in an interoperable electronic health records system shared with the prescribing practitioner, to the extent that such a system is available.
(f) 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 pursuant to subsection (2)(a) of this section.
SECTION 2. This act shall take effect and be in force from and after July 1, 2014.