MISSISSIPPI LEGISLATURE

2013 Regular Session

To: Public Health and Human Services

By: Representative Moak

House Bill 1387

AN ACT TO CREATE NEW SECTION 73-21-118, MISSISSIPPI CODE OF 1972, TO AUTHORIZE THE SUBSTITUTION OF INTERCHANGEABLE BIOLOGICAL PRODUCTS FOR A PRESCRIBED PRODUCT BY A PHARMACIST UNDER CERTAIN CIRCUMSTANCES; 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," "biosimilar," "interchangeable," have the meanings that apply to * * *such those terms under Section 351 of the Public Health Service Act (42 USC Section 262).

          (b)  "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 Section 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 five (5) business days by facsimile, telephone, voice mail, e-mail, or other electronic means; 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 * * *pursuant to under subsection (2)(a) of this section.

     SECTION 2.  This act shall take effect and be in force from and after July 1, 2013.