Bill Text: MS HB1268 | 2014 | Regular Session | Introduced

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Bill Title: Pharmacists; may substitute prescription biosimilar product under certain conditions.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2014-02-04 - Died In Committee [HB1268 Detail]

Download: Mississippi-2014-HB1268-Introduced.html

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MISSISSIPPI LEGISLATURE

2014 Regular Session

To: Public Health and Human Services

By: Representative Howell

House Bill 1268

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.  (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 USCS Section 262(i) (2).

          (b)  "Interchangeable" means in reference to a biological product, that the Federal 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," 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 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 pharmacists agent, within a reasonable time but not to exceed ten (10) days following the dispensing, shall record the name and manufacturer of the product dispensed in an interoperable health records system shared with the prescribing practitioner, to the extent such a system is available, or, in the case that an interoperable electronic health records system is not in place, communicate to the prescribing practitioner by facsimile, telephone, voice mail, 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 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.