ASSEMBLY, No. 2718

 

STATE OF NEW JERSEY

 

211th LEGISLATURE

 

INTRODUCED MAY 6, 2004

 

 

Sponsored by:

Assemblyman ANTHONY CHIAPPONE

District 31 (Hudson)

 

 

 

 

SYNOPSIS

    Requires that pharmacists provide certain prescription drug information to consumers.

 

CURRENT VERSION OF TEXT

    As introduced.

 


An Act concerning information about prescription drugs and supplementing P.L.2003, c.280 (C.45:14-40 et seq.).

 

    Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

    1. a. The New Jersey State Board of Pharmacy shall prescribe, by regulation, requirements to be adopted by each pharmacy practice site with regard to notifying consumers, when a generic drug product is dispensed, about the characteristics of that drug product, other than its active ingredient, which differ from the brand-name drug product for which it is being substituted and may be important in the therapy of a particular patient.

    b. For the purpose of subsection a. of this section, the board shall direct each pharmacy practice site to provide written information to the person to whom a generic drug product is dispensed, at the time that the product is dispensed and on a form and in a manner as prescribed by the board, about any of the following characteristics that may differentiate that product from the drug product for which it is being substituted: its shape; scoring configuration; release mechanisms; packaging; excipients, including, but not limited to, colors, flavors and preservatives; expiration date or time; and labeling.

    c. The provisions of subsection a. of this section shall not apply when a prescription drug is dispensed on the premises of a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) for inpatient use.

 

    2. The New Jersey State Board of Pharmacy, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations to effectuate the purposes of this act.

 

    3. This act shall take effect on the 180th day after enactment, except that the New Jersey State Board of Pharmacy may take such anticipatory administrative action in advance as shall be necessary for the implementation of the act.

 

STATEMENT

 

    This bill requires the New Jersey State Board of Pharmacy to prescribe, by regulation, requirements to be adopted by each pharmacy practice site with regard to notifying consumers, when a generic drug product is dispensed, about the characteristics of that drug product, other than its active ingredient, which differ from the brand-name drug product for which it is being substituted and may be important in the therapy of a particular patient.

    Specifically, the board is to direct each pharmacy practice site to provide written information to the person to whom a generic drug product is dispensed, at the time that the product is dispensed and on a form and in a manner as prescribed by the board, about any of the following characteristics that may differentiate that product from the drug product for which it is being substituted: its shape; scoring configuration; release mechanisms; packaging; excipients, including, but not limited to, colors, flavors and preservatives; expiration date or time; and labeling.

    The provisions of the bill would not apply when a prescription drug is dispensed on the premises of a licensed health care facility for inpatient use.

    The bill directs the board, pursuant to the "Administrative Procedure Act" (N.J.S.A.52:14B-1 et seq.), to adopt rules and regulations to effectuate the purposes of the bill.

    The bill takes effect on the 180th day after enactment, but authorizes the board to take anticipatory administrative action in advance as necessary for its implementation.