[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6255 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 6255

To require mail-order pharmacies to notify customers when generic drugs 
become available and to prevent mail-order pharmacies from substituting 
       drugs without the express authorization of the prescriber.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 29, 2010

 Ms. Shea-Porter introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To require mail-order pharmacies to notify customers when generic drugs 
become available and to prevent mail-order pharmacies from substituting 
       drugs without the express authorization of the prescriber.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. NOTIFICATION OF GENERIC DRUG AVAILABILITY AND REQUIREMENT OF 
              AUTHORIZATION FOR DRUG SUBSTITUTIONS.

    (a) Notification.--If a generic drug that is the pharmaceutical 
equivalent of a brand name drug becomes available, a mail-order 
pharmacy shall inform all customers for whom it receives prescriptions 
to dispense such brand name drug, that such a generic drug is 
available.
    (b) Authorized Substitution Only.--
            (1) Mail-order pharmacy requirements.--A mail-order 
        pharmacy may only dispense a generic drug in substitution for 
        brand name drug (or a brand name drug in substitution for a 
        generic drug) if the mail-order pharmacy--
                    (A) notifies the customer that the pharmacy will 
                request that the prescriber provide an authorization to 
                make such a substitution; and
                    (B) after providing such notification, obtains the 
                express written authorization of the prescriber of the 
                drug to make such a substitution.
            (2) Prescriber requirements.--If a prescriber provides an 
        authorization under paragraph (1)(B) to a mail-order pharmacy, 
        the prescriber shall provide notice to the customer of such 
        action.
    (c) Civil Monetary Penalties.--
            (1) In general.--The Secretary of Health and Human Services 
        may assess a civil monetary penalty against a mail-order 
        pharmacy in an amount not to exceed $500 for each violation, by 
        such pharmacy, of the requirements of--
                    (A) subsection (a) (relating to notice to 
                customers); or
                    (B) subsection (b)(1) (relating to obtaining 
                authorization from prescribers before making drug 
                substitutions).
            (2) Procedure and judicial review.--Subsections (b), (c), 
        and (d) of section 307 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 335b) apply to a civil monetary penalty under 
        paragraph (1) in the same manner that such subsections apply to 
        civil penalties under subsection (a) of such section 307.
    (d) Definitions.--For purposes of this section:
            (1) Brand name drug.--The term ``brand name drug'' means a 
        prescription drug for which an application is approved under 
        section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)), including an application referred to in section 
        505(b)(2) of such Act.
            (2) Generic drug.--The term ``generic drug'' means a 
        prescription drug that--
                    (A) has lost the patent protection that is provided 
                to a single manufacturer or multiple manufacturers; and
                    (B) is widely available from multiple 
                manufacturers.
            (3) Mail-order pharmacy.--The term ``mail-order pharmacy'' 
        means a pharmacy that--
                    (A) is State-licensed; and
                    (B) conducts its pharmaceutical business primarily 
                through mail services.
    (e) Preemption.--This section preempts the laws of any State to the 
extent that such State laws are inconsistent with this section.
    (f) Effective Date.--This section shall take effect on January 1, 
2011.
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