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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. NOTIFICATION OF GENERIC DRUG AVAIL4 ABILITY AND REQUIREMENT OF AUTHORIZA5 TION FOR DRUG SUBSTITUTIONS. 

6 (a) NOTIFICATION.—If a generic drug that is the 

7 pharmaceutical equivalent of a brand name drug becomes 

8 available, a mail-order pharmacy shall inform all cusVerDate Mar 15 2010 04:15 Oct 08, 2010 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6255.IH H6255

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1 tomers for whom it receives prescriptions to dispense such 

2 brand name drug, that such a generic drug is available. 

3 (b) AUTHORIZED SUBSTITUTION ONLY.— 

4 (1) MAIL-ORDER PHARMACY REQUIREMENTS.— 

5 A mail-order pharmacy may only dispense a generic 

6 drug in substitution for brand name drug (or a 

7 brand name drug in substitution for a generic drug) 

8 if the mail-order pharmacy— 

9 (A) notifies the customer that the phar10 macy will request that the prescriber provide an 

11 authorization to make such a substitution; and 

12 (B) after providing such notification, ob13 tains the express written authorization of the 

14 prescriber of the drug to make such a substi15 tution. 

16 (2) PRESCRIBER REQUIREMENTS.—If a pre17 scriber provides an authorization under paragraph 

18 (1)(B) to a mail-order pharmacy, the prescriber 

19 shall provide notice to the customer of such action. 

20 (c) CIVIL MONETARY PENALTIES.— 

21 (1) IN GENERAL.—The Secretary of Health and 

22 Human Services may assess a civil monetary penalty 

23 against a mail-order pharmacy in an amount not to 

24 exceed $500 for each violation, by such pharmacy, of 

25 the requirements of— 


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1 (A) subsection (a) (relating to notice to 

2 customers); or 

3 (B) subsection (b)(1) (relating to obtaining 

4 authorization from prescribers before making 

5 drug substitutions). 

6 (2) PROCEDURE AND JUDICIAL REVIEW.—Sub7 sections (b), (c), and (d) of section 307 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

9 335b) apply to a civil monetary penalty under para10 graph (1) in the same manner that such subsections 

11 apply to civil penalties under subsection (a) of such 

12 section 307. 

13 (d) DEFINITIONS.—For purposes of this section: 

14 (1) BRAND NAME DRUG.—The term ‘‘brand 

15 name drug’’ means a prescription drug for which an 

16 application is approved under section 505(c) of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 355(c)), including an application referred to in sec19 tion 505(b)(2) of such Act. 

20 (2) GENERIC DRUG.—The term ‘‘generic drug’’ 

21 means a prescription drug that— 

22 (A) has lost the patent protection that is 

23 provided to a single manufacturer or multiple 

24 manufacturers; and 


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1 (B) is widely available from multiple man2 ufacturers. 

3 (3) MAIL-ORDER PHARMACY.—The term ‘‘mail4 order pharmacy’’ means a pharmacy that— 

5 (A) is State-licensed; and 

6 (B) conducts its pharmaceutical business 

7 primarily through mail services. 

8 (e) PREEMPTION.—This section preempts the laws of 

9 any State to the extent that such State laws are incon10 sistent with this section. 

11 (f) EFFECTIVE DATE.—This section shall take effect 

12 on January 1, 2011. 

Æ 


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