I 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. NOTIFICATION OF GENERIC DRUG AVAIL-
ABILITY AND REQUIREMENT OF AUTHORIZA-
TION 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 cus-
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tomers 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 phar-
macy will request that the prescriber provide an 
authorization to make such a substitution; and 
(B) after providing such notification, ob-
tains the express written authorization of the 
prescriber of the drug to make such a substi-
tution. 
(2) PRESCRIBER
REQUIREMENTS.—If a pre-
scriber 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— 
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(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.—Sub-
sections (b), (c), and (d) of section 307 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
335b) apply to a civil monetary penalty under para-
graph (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 sec-
tion 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 
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