II 

117TH CONGRESS 

1ST SESSION S. 3399 

To amend the Federal Food, Drug, and Cosmetic Act to provide a process 

to lock and suspend domain names used to facilitate the online sale 

of drugs illegally, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 15, 2021 

Mr. RUBIO (for himself and Ms. KLOBUCHAR) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide a process to lock and suspend domain names 

used to facilitate the online sale of drugs illegally, and 

for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Domain Reform for 

5 Unlawful Drug Sellers Act’’ or the ‘‘DRUGS Act’’. 


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1 SEC. 2. DOMAIN NAMES USED TO FACILITATE THE ONLINE 

2 SALE OF DRUGS ILLEGALLY. 

3 (a) IN GENERAL.—Subchapter A of chapter V of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

5 et seq.) is amended by adding at the end the following: 

6 ‘‘SEC. 524B. DOMAIN NAMES USED TO FACILITATE THE ON7 LINE SALE OF DRUGS ILLEGALLY. 

8 ‘‘(a) IN GENERAL.—A registry operator or registrar 

9 shall— 

10 ‘‘(1) not later than 24 hours after receipt of a 

11 notification from a trusted notifier respecting a do12 main name that is used to facilitate the online sale 

13 of drugs illegally and that is under the control of the 

14 registry operator or registrar, lock the domain name; 

15 and 

16 ‘‘(2) not later than 7 days after receipt of such 

17 notification, suspend the domain name. 

18 ‘‘(b) NOTICE.—Subsection (a) shall apply in the case 

19 of a notification by a trusted notifier that includes, at a 

20 minimum— 

21 ‘‘(1) the domain name being reported to the ap22 propriate registry operator or registrar; 

23 ‘‘(2) the date of observation that the domain 

24 name was used to facilitate the online sale of drugs 

25 illegally; 


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1 ‘‘(3) a summary of the alleged activities that 

2 constitute a domain name being used to facilitate 

3 the online sale of drugs illegally; and 

4 ‘‘(4) a statement that evidence of offering drugs 

5 illegally, such as a screenshot, has been retained, 

6 and is available to be shared with the registry oper7 ator or registrar. 

8 ‘‘(c) REGISTRANT APPEAL.— 

9 ‘‘(1) IN GENERAL.—Any registrant whose do10 main name is locked and suspended pursuant to 

11 subsection (a) may appeal such action to the trusted 

12 notifier pursuant to paragraph (2). The domain 

13 name shall remain locked and suspended until a 

14 final determination of the merits of the appeal has 

15 been made. 

16 ‘‘(2) APPEALS.— 

17 ‘‘(A) IN GENERAL.—In bringing such an 

18 appeal, the registrant for the locked and sus19 pended domain name may do any of the fol20 lowing: 

21 ‘‘(i) Contact the applicable registry 

22 operator or registrar to request informa23 tion regarding the business name, or per24 sonal name if the trusted notifier is not a 

25 business, and the email address, of the 


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1 trusted notifier who submitted the notifica2 tion regarding the domain name. 

3 ‘‘(ii) Dispute the notification by sub4 mitting the following to the applicable 

5 trusted notifier: 

6 ‘‘(I) A copy of the registrant’s 

7 pharmacy licenses for all jurisdictions 

8 where it offered to ship prescription 

9 medicines at the time of the notifica10 tion where such licensure is legally re11 quired in such jurisdiction, or a copy 

12 of registrant’s affiliated pharmacy’s li13 censes for all jurisdictions where the 

14 registrant offered to facilitate the 

15 shipment of prescription medicines at 

16 the time of the notification where 

17 such licensure is legally required in 

18 such jurisdiction. 

19 ‘‘(II) The license information of 

20 the medical practitioner involved in 

21 issuing the prescription facilitated in 

22 part by the registrant’s domain name 

23 where practitioner licensure is legally 

24 required in such jurisdiction. 


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1 ‘‘(B) PROVISION OF INFORMATION.—With2 in 15 days after receiving a request under sub3 paragraph (A)(i), a registry operator or reg4 istrar shall provide the requested information. 

5 ‘‘(C) INVESTIGATION.—The applicable 

6 trusted notifier shall— 

7 ‘‘(i) conduct a reasonable investigation 

8 regarding the registrant and its domain 

9 name to determine whether notification 

10 under subsection (a) was improper; and 

11 ‘‘(ii) in conducting such investigation, 

12 consider the information provided by the 

13 registrant under subparagraph (A). 

14 ‘‘(D) SUCCESSFUL APPEAL.—If the appeal 

15 is successful, the registry operator or registrar 

16 shall lift the suspension and unlock the domain 

17 name within 15 days. 

18 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec19 tion prohibits a registry operator or registrar from locking 

20 and suspending a domain name used to facilitate the on21 line sale of drugs illegally before receipt of a notification 

22 under this section from a trusted notifier. 

23 ‘‘(e) DEFINITIONS.—In this section: 

24 ‘‘(1) DOMAIN NAME.—The term ‘domain name’ 

25 means a name that— 


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1 ‘‘(A) identifies a specific location on the 

2 internet that belongs to a particular person; 

3 and 

4 ‘‘(B) consists of 2 or more textual seg5 ments separated by dots. 

6 ‘‘(2) DOMAIN NAME USED TO FACILITATE THE

7 ONLINE SALE OF DRUGS ILLEGALLY.—The term ‘do8 main name used to facilitate the online sale of drugs 

9 illegally’ means a domain name that identifies a lo10 cation on the internet, a primary or significant pur11 pose of which is to introduce or deliver for introduc12 tion into interstate commerce a drug or controlled 

13 substance in violation of this Act or the Controlled 

14 Substances Act. 

15 ‘‘(3) LOCK.—The term ‘lock’ means, with re16 spect to a domain name, for the registry operator or 

17 registrar to systematically prevent the domain name 

18 from being updated, transferred, or deleted during 

19 the balance of the registration of the domain name, 

20 which may be achieved using domain name registra21 tion protocols. 

22 ‘‘(4) PRESCRIPTION DRUG.—The term ‘pre23 scription drug’ means a drug subject to section 

24 503(b)(1). 


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1 ‘‘(5) REGISTRAR.—The term ‘registrar’ means 

2 an organization that— 

3 ‘‘(A) manages the registration of domain 

4 names; and 

5 ‘‘(B) during the registration process— 

6 ‘‘(i) verifies that the requested domain 

7 name meets registry requirements; and 

8 ‘‘(ii) submits the name to the appro9 priate registry operator. 

10 ‘‘(6) REGISTRY.—The term ‘registry’ means an 

11 authoritative master database of the domain names 

12 registered in a top-level domain. 

13 ‘‘(7) REGISTRY OPERATOR.—The term ‘registry 

14 operator’ means an organization that maintains a 

15 registry, including by— 

16 ‘‘(A) receiving requests from registrars to 

17 add, delete, or modify domain names; and 

18 ‘‘(B) making the requested changes in the 

19 registry. 

20 ‘‘(8) SUSPEND.—The term ‘suspend’ means, 

21 with respect to a domain name, for the registry op22 erator or registrar to systematically disable the 

23 functionality of the domain name through a hold or 

24 suspension during the balance of the registration of 


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1 the domain name, which may be achieved using do2 main name registration protocols. 

3 ‘‘(9) TRUSTED NOTIFIER.—The term ‘trusted 

4 notifier’ includes the following (and the designees 

5 and agents thereof): 

6 ‘‘(A) The Food and Drug Administration. 

7 ‘‘(B) The Department of Justice, including 

8 the Drug Enforcement Administration. 

9 ‘‘(C) The Department of Homeland Secu10 rity. 

11 ‘‘(D) A State attorney general. 

12 ‘‘(E) A State board of pharmacy. 

13 ‘‘(F) A nonprofit organization with a mem14 bership or governance comprised exclusively of 

15 representatives of— 

16 ‘‘(i) agencies or officials specified in 

17 any of subparagraphs (A) through (E); or 

18 ‘‘(ii) similarly positioned (as deter19 mined by the Commissioner of Food and 

20 Drugs) agencies or officials. 

21 ‘‘(G) Any entity currently under contract 

22 or in a public-private partnership with the Food 

23 and Drug Administration or the Drug Enforce24 ment Agency to share information related to 

25 online drug sales. 


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1 ‘‘(H) Any other entity identified by the 

2 Food and Drug Administration as a trusted no3 tifier for purposes of this section, taking into 

4 consideration, at minimum, whether the enti5 ty— 

6 ‘‘(i) is registered to do business in the 

7 United States; 

8 ‘‘(ii) agrees to share notification data, 

9 upon request, with the Food and Drug Ad10 ministration and the Drug Enforcement 

11 Agency; 

12 ‘‘(iii) does not knowingly or with will13 ful ignorance approve or do business with 

14 entities that fail to adhere to the regula15 tions of the Food and Drug Administration 

16 or the Drug Enforcement Agency; and 

17 ‘‘(iv) has published on the website of 

18 such entity policies and procedures for how 

19 the entity will issue notifications under 

20 subsection (a).’’. 

21 (b) PROHIBITED ACT.—Section 301 of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend23 ed by adding at the end the following: 


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1 ‘‘(fff) The failure by a registry operator or registrar 

2 to lock and suspend any domain name in its control in 

3 violation of section 524B.’’. 

4 (c) APPLICABILITY.—Sections 301(fff) and 524B of 

5 the Federal Food, Drug, and Cosmetic Act, as added by 

6 this section, shall apply beginning on the date that is 60 

7 days after the date of enactment of this Act. 

Æ 


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