I 111th CONGRESS 2d Session H. R. 6255 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.

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.