Bill Text: MS SB2731 | 2014 | Regular Session | Engrossed

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Bill Title: Substitution of interchangeable biological products by pharmacists; create study committee.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2014-03-04 - Died In Committee [SB2731 Detail]

Download: Mississippi-2014-SB2731-Engrossed.html

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MISSISSIPPI LEGISLATURE

2014 Regular Session

To: Public Health and Welfare

By: Senator(s) Kirby

Senate Bill 2731

(As Passed the Senate)

AN ACT TO ESTABLISH AN AD HOC COMMITTEE TO STUDY ISSUES RELATING TO 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.  (1)  As used in this section:

          (a)  "Biological product" has the meaning set forth in 42 USC Section 262(i)(1).

          (b)  "Biosimilar" means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 USC Section 262(i)(2) and also means a biological product approved based on an application filed under 21 USC Section 355(b)(2) that is highly similar to the prescribed biological product.

          (c)  "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, or with respect to a biological product filed under 21 USC Section 355(b)(2), means such product is designated therapeutically equivalent to the reference product by the Federal Food and Drug Administration in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

          (d)  "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)  There is hereby established an Ad Hoc Committee to Study Issues Relating to the Substitution of Interchangeable Biological Products for a Prescribed Product by a Pharmacist.

     (3)  The committee shall consist of eight (8) members as follows:

          (a)  The Chairman of the Senate Public Health and Welfare Committee and the Chairman of the House Public Health and Human Services Committee, who shall serve as Co-Chairmen;

          (b)  Three (3) members of the Senate appointed by the Lieutenant Governor;

          (c)  Three (3) members of the House of Representatives appointed by the Speaker of the House.

     (4)  The committee shall meet upon the call of the Co-Chairmen and shall organize for business.  The committee shall receive testimony information relating to the substitution of a prescription biosimilar product for a prescribed product, and the current list of biological products determined by the United States Food and Drug Administration to interchangeable and related information.

     (5)  Any necessary clerical and administrative assistance needed by the committee shall be provided by the State Board of Pharmacy.  The members of the committee shall be reimbursed for attending meetings in the same manner as legislative committees are reimbursed for out-of-session meetings.

     (6)  The committee shall develop and issue its report to the Legislature by January 1, 2015, with any recommendations for legislative action.  Upon the submission of its report, the committee shall be dissolved.

     SECTION 2.  This act shall take effect and be in force from and after July 1, 2014.