[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3399 Introduced in Senate (IS)]

<DOC>






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Domain Reform for Unlawful Drug 
Sellers Act'' or the ``DRUGS Act''.

SEC. 2. DOMAIN NAMES USED TO FACILITATE THE ONLINE SALE OF DRUGS 
              ILLEGALLY.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

``SEC. 524B. DOMAIN NAMES USED TO FACILITATE THE ONLINE SALE OF DRUGS 
              ILLEGALLY.

    ``(a) In General.--A registry operator or registrar shall--
            ``(1) not later than 24 hours after receipt of a 
        notification from a trusted notifier respecting a domain name 
        that is used to facilitate the online sale of drugs illegally 
        and that is under the control of the registry operator or 
        registrar, lock the domain name; and
            ``(2) not later than 7 days after receipt of such 
        notification, suspend the domain name.
    ``(b) Notice.--Subsection (a) shall apply in the case of a 
notification by a trusted notifier that includes, at a minimum--
            ``(1) the domain name being reported to the appropriate 
        registry operator or registrar;
            ``(2) the date of observation that the domain name was used 
        to facilitate the online sale of drugs illegally;
            ``(3) a summary of the alleged activities that constitute a 
        domain name being used to facilitate the online sale of drugs 
        illegally; and
            ``(4) a statement that evidence of offering drugs 
        illegally, such as a screenshot, has been retained, and is 
        available to be shared with the registry operator or registrar.
    ``(c) Registrant Appeal.--
            ``(1) In general.--Any registrant whose domain name is 
        locked and suspended pursuant to subsection (a) may appeal such 
        action to the trusted notifier pursuant to paragraph (2). The 
        domain name shall remain locked and suspended until a final 
        determination of the merits of the appeal has been made.
            ``(2) Appeals.--
                    ``(A) In general.--In bringing such an appeal, the 
                registrant for the locked and suspended domain name may 
                do any of the following:
                            ``(i) Contact the applicable registry 
                        operator or registrar to request information 
                        regarding the business name, or personal name 
                        if the trusted notifier is not a business, and 
                        the email address, of the trusted notifier who 
                        submitted the notification regarding the domain 
                        name.
                            ``(ii) Dispute the notification by 
                        submitting the following to the applicable 
                        trusted notifier:
                                    ``(I) A copy of the registrant's 
                                pharmacy licenses for all jurisdictions 
                                where it offered to ship prescription 
                                medicines at the time of the 
                                notification where such licensure is 
                                legally required in such jurisdiction, 
                                or a copy of registrant's affiliated 
                                pharmacy's licenses for all 
                                jurisdictions where the registrant 
                                offered to facilitate the shipment of 
                                prescription medicines at the time of 
                                the notification where such licensure 
                                is legally required in such 
                                jurisdiction.
                                    ``(II) The license information of 
                                the medical practitioner involved in 
                                issuing the prescription facilitated in 
                                part by the registrant's domain name 
                                where practitioner licensure is legally 
                                required in such jurisdiction.
                    ``(B) Provision of information.--Within 15 days 
                after receiving a request under subparagraph (A)(i), a 
                registry operator or registrar shall provide the 
                requested information.
                    ``(C) Investigation.--The applicable trusted 
                notifier shall--
                            ``(i) conduct a reasonable investigation 
                        regarding the registrant and its domain name to 
                        determine whether notification under subsection 
                        (a) was improper; and
                            ``(ii) in conducting such investigation, 
                        consider the information provided by the 
                        registrant under subparagraph (A).
                    ``(D) Successful appeal.--If the appeal is 
                successful, the registry operator or registrar shall 
                lift the suspension and unlock the domain name within 
                15 days.
    ``(d) Rule of Construction.--Nothing in this section prohibits a 
registry operator or registrar from locking and suspending a domain 
name used to facilitate the online sale of drugs illegally before 
receipt of a notification under this section from a trusted notifier.
    ``(e) Definitions.--In this section:
            ``(1) Domain name.--The term `domain name' means a name 
        that--
                    ``(A) identifies a specific location on the 
                internet that belongs to a particular person; and
                    ``(B) consists of 2 or more textual segments 
                separated by dots.
            ``(2) Domain name used to facilitate the online sale of 
        drugs illegally.--The term `domain name used to facilitate the 
        online sale of drugs illegally' means a domain name that 
        identifies a location on the internet, a primary or significant 
        purpose of which is to introduce or deliver for introduction 
        into interstate commerce a drug or controlled substance in 
        violation of this Act or the Controlled Substances Act.
            ``(3) Lock.--The term `lock' means, with respect to a 
        domain name, for the registry operator or registrar to 
        systematically prevent the domain name from being updated, 
        transferred, or deleted during the balance of the registration 
        of the domain name, which may be achieved using domain name 
        registration protocols.
            ``(4) Prescription drug.--The term `prescription drug' 
        means a drug subject to section 503(b)(1).
            ``(5) Registrar.--The term `registrar' means an 
        organization that--
                    ``(A) manages the registration of domain names; and
                    ``(B) during the registration process--
                            ``(i) verifies that the requested domain 
                        name meets registry requirements; and
                            ``(ii) submits the name to the appropriate 
                        registry operator.
            ``(6) Registry.--The term `registry' means an authoritative 
        master database of the domain names registered in a top-level 
        domain.
            ``(7) Registry operator.--The term `registry operator' 
        means an organization that maintains a registry, including by--
                    ``(A) receiving requests from registrars to add, 
                delete, or modify domain names; and
                    ``(B) making the requested changes in the registry.
            ``(8) Suspend.--The term `suspend' means, with respect to a 
        domain name, for the registry operator or registrar to 
        systematically disable the functionality of the domain name 
        through a hold or suspension during the balance of the 
        registration of the domain name, which may be achieved using 
        domain name registration protocols.
            ``(9) Trusted notifier.--The term `trusted notifier' 
        includes the following (and the designees and agents thereof):
                    ``(A) The Food and Drug Administration.
                    ``(B) The Department of Justice, including the Drug 
                Enforcement Administration.
                    ``(C) The Department of Homeland Security.
                    ``(D) A State attorney general.
                    ``(E) A State board of pharmacy.
                    ``(F) A nonprofit organization with a membership or 
                governance comprised exclusively of representatives 
                of--
                            ``(i) agencies or officials specified in 
                        any of subparagraphs (A) through (E); or
                            ``(ii) similarly positioned (as determined 
                        by the Commissioner of Food and Drugs) agencies 
                        or officials.
                    ``(G) Any entity currently under contract or in a 
                public-private partnership with the Food and Drug 
                Administration or the Drug Enforcement Agency to share 
                information related to online drug sales.
                    ``(H) Any other entity identified by the Food and 
                Drug Administration as a trusted notifier for purposes 
                of this section, taking into consideration, at minimum, 
                whether the entity--
                            ``(i) is registered to do business in the 
                        United States;
                            ``(ii) agrees to share notification data, 
                        upon request, with the Food and Drug 
                        Administration and the Drug Enforcement Agency;
                            ``(iii) does not knowingly or with willful 
                        ignorance approve or do business with entities 
                        that fail to adhere to the regulations of the 
                        Food and Drug Administration or the Drug 
                        Enforcement Agency; and
                            ``(iv) has published on the website of such 
                        entity policies and procedures for how the 
                        entity will issue notifications under 
                        subsection (a).''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff) The failure by a registry operator or registrar to lock and 
suspend any domain name in its control in violation of section 524B.''.
    (c) Applicability.--Sections 301(fff) and 524B of the Federal Food, 
Drug, and Cosmetic Act, as added by this section, shall apply beginning 
on the date that is 60 days after the date of enactment of this Act.
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