S 980
4-1-08, Senate Passed Bill by Unanimous Consent
110th CONGRESS
2d Session
S. 980
AN ACT
To amend the Controlled Substances Act to address online pharmacies.
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 `Ryan Haight Online Pharmacy Consumer Protection
Act of 2008'.
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED SUBSTANCES
DISPENSED BY MEANS OF THE INTERNET.
Section 309 of the Controlled Substances Act (21 U.S.C. 829) is amended
by adding at the end the following:
`(e) Controlled Substances Dispensed by Means of the Internet-
`(1) No controlled substance may be delivered, distributed, or dispensed
by means of the Internet without a valid prescription.
`(2) As used in this subsection:
`(A) The term `valid prescription' means a prescription that is
issued for a legitimate medical purpose in the usual course of professional
practice by--
`(i) a practitioner who has conducted at least 1 in-person medical
evaluation of the patient; or
`(ii) a covering practitioner.
`(B)(i) The term `in-person medical evaluation' means a medical
evaluation that is conducted with the patient in the physical presence
of the practitioner, without regard to whether portions of the evaluation
are conducted by other health professionals.
`(ii) Nothing in clause (i) shall be construed to imply that 1 in-person
medical evaluation demonstrates that a prescription has been issued
for a legitimate medical purpose within the usual course of professional
practice.
`(C) The term `covering practitioner' means, with respect to a patient,
a practitioner who conducts a medical evaluation (other than an
in-person medical evaluation) at the request of a practitioner who--
`(i) has conducted at least 1 in-person medical evaluation of
the patient or an evaluation of the patient through the practice
of telemedicine, within the previous 24 months; and
`(ii) is temporarily unavailable to conduct the evaluation of
the patient.
`(3) Nothing in this subsection shall apply to--
`(A) the delivery, distribution, or dispensing of a controlled substance
by a practitioner engaged in the practice of telemedicine; or
`(B) the dispensing or selling of a controlled substance pursuant
to practices as determined by the Attorney General by regulation,
which shall be consistent with effective controls against diversion.'.
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO THE
DELIVERY OF CONTROLLED SUBSTANCES BY MEANS OF THE INTERNET.
(a) In General- Section 102 of the Controlled Substances Act (21 U.S.C.
802) is amended by adding at the end the following:
`(50) The term `Internet' means collectively the myriad of computer
and telecommunications facilities, including equipment and operating
software, which comprise the interconnected worldwide network of networks
that employ the Transmission Control Protocol/Internet Protocol, or
any predecessor or successor protocol to such protocol, to communicate
information of all kinds by wire or radio.
`(51) The term `deliver, distribute, or dispense by means of the Internet'
refers, respectively, to any delivery, distribution, or dispensing
of a controlled substance that is caused or facilitated by means of
the Internet.
`(52) The term `online pharmacy'--
`(A) means a person, entity, or Internet site, whether in the United
States or abroad, that knowingly or intentionally delivers, distributes,
or dispenses, or offers or attempts to deliver, distribute, or dispense,
a controlled substance by means of the Internet; and
`(i) manufacturers or distributors registered under subsection
(a), (b), (c), or (d) of section 303 who do not dispense controlled
substances to an unregistered individual or entity;
`(ii) nonpharmacy practitioners who are registered under section
303(f) and whose activities are authorized by that registration;
`(iii) any hospital or other medical facility that is operated
by an agency of the United States (including the Armed Forces),
provided such hospital or other facility is registered under section
303(f);
`(iv) a health care facility owned or operated by an Indian tribe
or tribal organization, only to the extent such facility is carrying
out a contract or compact under the Indian Self-Determination
and Education Assistance Act (25 U.S.C. 450 et seq.);
`(v) any agent or employee of any hospital or facility referred
to in clause (iii) or (iv), provided such agent or employee is
lawfully acting in the usual course of business or employment,
and within the scope of the official duties of such agent or employee,
with such hospital or facility, and, with respect to agents or
employees of health care facilities specified in clause (iv),
only to the extent such individuals are furnishing services pursuant
to the contracts or compacts described in such clause;
`(vi) mere advertisements that do not attempt to facilitate an
actual transaction involving a controlled substance;
`(vii) a person, entity, or Internet site that is not in the United
States and does not facilitate the delivery, distribution, or
dispensing of a controlled substance by means of the Internet
to any person in the United States;
`(viii) a pharmacy registered under section 303(f) whose dispensing
of controlled substances via the Internet consists solely of--
`(I) `refilling prescriptions for controlled substances in schedule
III, IV, or V', as defined in paragraph (55); or
`(II) `filling new prescriptions for controlled substances in
schedule III, IV, or V', as defined in paragraph (56); or
`(ix) any other persons for whom the Attorney General and the
Secretary have jointly, by regulation, found it to be consistent
with effective controls against diversion and otherwise consistent
with the public health and safety to exempt from the definition
of an `online pharmacy'.
`(53) The term `homepage' means the opening or main page or screen
of the website of an online pharmacy that is viewable on the Internet.
`(54) The term `practice of telemedicine' means, for purposes of this
title, the practice of medicine in accordance with applicable Federal
and State laws by a practitioner (other than a pharmacist) who is
at a location remote from the patient and is communicating with the
patient, or health care professional who is treating the patient,
using a telecommunications system referred to in section 1834(m) of
the Social Security Act (42 U.S.C. 1395m(m)), and that--
`(A) is being conducted--
`(i) while the patient is being treated by, and physically located
in, a hospital or clinic registered under section 303(f); and
`(ii) by a practitioner--
`(I) acting in the usual course of professional practice;
`(II) acting in accordance with applicable State law; and
`(III) registered under section 303(f) in the State in which
the patient is located, unless the practitioner--
`(aa) is exempted from such registration in all States under
section 302(d); or
`(bb) is--
`(AA) an employee or contractor of the Department of Veterans Affairs
who is acting in the scope of such employment or contract; and
`(BB) registered under section 303(f) in any State or is utilizing
the registration of a hospital or clinic operated by the Department
of Veterans Affairs registered under section 303(f);
`(B) is being conducted while the patient is being treated by, and
in the physical presence of, a practitioner--
`(i) acting in the usual course of professional practice;
`(ii) acting in accordance with applicable State law; and
`(iii) registered under section 303(f) in the State in which the
patient is located, unless the practitioner--
`(I) is exempted from such registration in all States under
section 302(d); or
`(aa) an employee or contractor of the Department of Veterans
Affairs who is acting in the scope of such employment or contract; and
`(bb) registered under section 303(f) in any State or is using
the registration of a hospital or clinic operated by the Department
of Veterans Affairs registered under section 303(f);
`(C) is being conducted by a practitioner--
`(i) who is an employee or contractor of the Indian Health Service,
or is working for an Indian tribe or tribal organization under
its contract or compact with the Indian Health Service under the
Indian Self-Determination and Education Assistance Act (25 U.S.C.
450 et seq.);
`(ii) acting within the scope of the employment, contract, or
compact described in clause (i); and
`(iii) who is designated as an Internet Eligible Controlled Substances
Provider by the Secretary under section 311(g)(2);
`(D)(i) is being conducted during a public health emergency declared
by the Secretary under section 319 of the Public Health Service
Act (42 U.S.C. 247d); and
`(ii) involves patients located in such areas, and such controlled
substances, as the Secretary, with the concurrence of the Attorney
General, designates, provided that such designation shall not be
subject to the procedures prescribed by subchapter II of chapter
5 of title 5, United States Code;
`(E) is being conducted by a practitioner who has obtained from
the Attorney General a special registration under section 311(h);
`(F) is being conducted--
`(i) in a medical emergency situation--
`(I) that prevents the patient from being in the physical presence
of a practitioner registered under section 303(f) who is an
employee or contractor of the Veterans Health Administration
acting in the usual course of business and employment and within
the scope of the official duties or contract of that employee
or contractor;
`(II) that prevents the patient from being physically present
at a hospital or clinic operated by the Department of Veterans
Affairs registered under section 303(f);
`(III) during which the primary care practitioner of the patient
or a practitioner otherwise practicing telemedicine within the
meaning of this paragraph is unable to provide care or consultation;
and
`(IV) that requires immediate intervention by a health care
practitioner using controlled substances to prevent what the
practitioner reasonably believes in good faith will be imminent
and serious clinical consequences, such as further injury or
death; and
`(ii) by a practitioner that--
`(I) is an employee or contractor of the Veterans Health Administration
acting within the scope of that employment or contract;
`(II) is registered under section 303(f) in any State or is
utilizing the registration of a hospital or clinic operated
by the Department of Veterans Affairs registered under section
303(f); and
`(III) issues a controlled substance prescription in this emergency
context that is limited to a maximum of a 5-day supply which
may not be extended or refilled; or
`(G) is being conducted under any other circumstances that the Attorney
General and the Secretary have jointly, by regulation, determined
to be consistent with effective controls against diversion and otherwise
consistent with the public health and safety.
`(55) The term `refilling prescriptions for controlled substances
in schedule III, IV, or V'--
`(A) means the dispensing of a controlled substance in schedule
III, IV, or V in accordance with refill instructions issued by a
practitioner as part of a valid prescription that meets the requirements
of subsection (b) or (c) of section 309, as appropriate; and
`(B) does not include the issuance of a new prescription to an individual
for a controlled substance that individual was previously prescribed.
`(56) The term `filling new prescriptions for controlled substances
in schedule III, IV, or V' means a prescription for an individual
for a controlled substance in schedule III, IV, or V, if--
`(A) the pharmacy dispensing that prescription has previously dispensed
to the patient that same controlled substance other than by means
of the Internet and pursuant to the valid prescription of a practitioner
that meets the applicable requirements of sections 309(b) or (c)
(in this paragraph referred to as the `original prescription');
`(B) the pharmacy contacts the practitioner who issued the original
prescription at the request of that individual to determine whether
the practitioner will authorize the issuance of a new prescription
for that individual for the controlled substance described in subparagraph
(A); and
`(C) the practitioner, acting in the usual course of professional
practice, determines there is a legitimate medical purpose for the
issuance of the new prescription.'.
(b) Registration Requirements- Section 303(f) of the Controlled Substances
Act (21 U.S.C. 823(f)) is amended in the matter preceding paragraph
(1)--
(1) in the first sentence, by adding after `schedule II, III, IV,
or V' the following: `and shall modify the registrations of pharmacies
so registered to authorize them to dispense controlled substances
by means of the Internet'; and
(2) in the second sentence, by striking `if he determines that the
issuance of such registration' and inserting `or such modification
of registration if the Attorney General determines that the issuance
of such registration or modification'.
(c) Reporting Requirements- Section 307(d) of the Controlled Substances
Act (21 U.S.C. 827(d)) is amended by--
(1) designating the text as paragraph (1); and
(2) inserting after paragraph (1), as so designated by this Act, the
following:
`(2) Each pharmacy with a modified registration under section 303(f)
that authorizes the dispensing of controlled substances by means of
the Internet shall report to the Attorney General the controlled substances
it dispenses, in the amount specified, and in such time and manner
as the Attorney General by regulation shall require, except that the
Attorney General, under this paragraph, may not require any pharmacy
to report any information other than the total quantity of each controlled
substance that the pharmacy has dispensed each month. For purposes
of this subsection, no reporting shall be required unless the pharmacy
has met 1 of the following thresholds in the month for which the reporting
is required:
`(A) 100 or more prescriptions dispensed.
`(B) 5,000 or more dosage units of all controlled substances combined.'.
(d) Online Prescription Requirements-
(1) IN GENERAL- The Controlled Substances Act is amended by inserting
after section 310 (21 U.S.C. 830) the following:
`ADDITIONAL REQUIREMENTS RELATING TO ONLINE PHARMACIES AND TELEMEDICINE
`Sec. 311. (a) In General- An online pharmacy shall display in a visible
and clear manner on its homepage a statement that it complies with the
requirements of this section with respect to the delivery or sale or
offer for sale of controlled substances and shall at all times display
on the homepage of its Internet site a declaration of compliance in
accordance with this section.
`(b) Licensure- Each online pharmacy shall comply with the requirements
of State law concerning the licensure of pharmacies in each State from
which it, and in each State to which it, delivers, distributes, or dispenses
or offers to deliver, distribute, or dispense controlled substances
by means of the Internet, pursuant to applicable licensure requirements,
as determined by each such State.
`(c) Internet Pharmacy Site Disclosure Information- Each online pharmacy
shall post in a visible and clear manner on the homepage of each Internet
site it operates, or on a page directly linked thereto in which the
hyperlink is also visible and clear on the homepage, the following information
for each pharmacy that delivers, distributes, or dispenses controlled
substances pursuant to orders made on, through, or on behalf of, that
website:
`(1) The name and address of the pharmacy as it appears on the pharmacy's
Drug Enforcement Administration certificate of registration.
`(2) The pharmacy's telephone number and email address.
`(3) The name, professional degree, and States of licensure of the
pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge
can be contacted.
`(4) A list of the States in which the pharmacy is licensed to dispense
controlled substances.
`(5) A certification that the pharmacy is registered under this part
to deliver, distribute, or dispense by means of the Internet controlled
substances.
`(6) The name, address, telephone number, professional degree, and
States of licensure of any practitioner who has a contractual relationship
to provide medical evaluations or issue prescriptions for controlled
substances, through referrals from the website or at the request of
the owner or operator of the website, or any employee or agent thereof.
`(7) The following statement, unless revised by the Attorney General
by regulation: `This online pharmacy will only dispense a controlled
substance to a person who has a valid prescription issued for a legitimate
medical purpose based upon a medical relationship with a prescribing
practitioner. This includes at least one prior in-person medical evaluation
or medical evaluation via telemedicine in accordance with applicable
requirements of section 309 of the Controlled Substances Act (21 U.S.C.
829).'.
`(d) Notification- (1) Thirty days prior to offering a controlled substance
for sale, delivery, distribution, or dispensing, the online pharmacy
shall notify the Attorney General, in the form and manner as the Attorney
General shall determine, and the State boards of pharmacy in any States
in which the online pharmacy offers to sell, deliver, distribute, or
dispense controlled substances.
`(2) The notification required under paragraph (1) shall include--
`(A) the information required to be posted on the online pharmacy's
Internet site under subsection (c) and shall notify the Attorney General
and the applicable State boards of pharmacy, under penalty of perjury,
that the information disclosed on its Internet site under subsection
(c) is true and accurate;
`(B) the online pharmacy's Internet site address and a certification
that the online pharmacy shall notify the Attorney General of any
change in the address at least 30 days in advance; and
`(C) the Drug Enforcement Administration registration numbers of any
pharmacies and practitioners referred to in subsection (c), as applicable.
`(3) An online pharmacy that is already operational as of the effective
date of this section, shall notify the Attorney General and applicable
State boards of pharmacy in accordance with this subsection not later
than 30 days after the effective date of this section.
`(e) Declaration of Compliance- On and after the date on which it makes
the notification under subsection (d), each online pharmacy shall display
on the homepage of its Internet site, in such form as the Attorney General
shall by regulation require, a declaration that it has made such notification
to the Attorney General.
`(f) Reports- Any statement, declaration, notification, or disclosure
required under this section shall be considered a report required to
be kept under this part.
`(g) Notice and Designations Concerning Indian Tribes-
`(1) IN GENERAL- For purposes of sections 102(52) and 512(c)(6)(B),
the Secretary shall notify the Attorney General, at such times and
in such manner as the Secretary and the Attorney General determine
appropriate, of the Indian tribes or tribal organizations with which
the Secretary has contracted or compacted under the Indian Self-Determination
and Education Assistance Act (25 U.S.C. 450 et seq.) for the tribes
or tribal organizations to provide pharmacy services.
`(A) IN GENERAL- The Secretary may designate a practitioner described
in subparagraph (B) as an Internet Eligible Controlled Substances
Provider. Such designations shall be made only in cases where the
Secretary has found that there is a legitimate need for the practitioner
to be so designated because the population served by the practitioner
is in a sufficiently remote location that access to medical services
is limited.
`(B) PRACTITIONERS- A practitioner described in this subparagraph
is a practitioner who is an employee or contractor of the Indian
Health Service, or is working for an Indian tribe or tribal organization
under its contract or compact under the Indian Self-Determination
and Education Assistance Act (25 U.S.C. 450 et seq.) with the Indian
Health Service.
`(h) Special Registration for Telemedicine-
`(1) IN GENERAL- The Attorney General may issue to a practitioner
a special registration to engage in the practice of telemedicine for
purposes of section 102(54)(E) if the practitioner, upon application
for such special registration--
`(A) demonstrates a legitimate need for the special registration;
and
`(B) is registered under section 303(f) in the State in which the
patient will be located when receiving the telemedicine treatment,
unless the practitioner--
`(i) is exempted from such registration in all States under section
302(d); or
`(ii) is an employee or contractor of the Department of Veterans
Affairs who is acting in the scope of such employment or contract
and is registered under section 303(f) in any State or is utilizing
the registration of a hospital or clinic operated by the Department
of Veterans Affairs registered under section 303(f).
`(2) REGULATIONS- The Attorney General shall, with the concurrence
of the Secretary, promulgate regulations specifying the limited circumstances
in which a special registration under this subsection may be issued
and the procedures for obtaining such a special registration.
`(3) DENIALS- Proceedings to deny an application for registration
under this subsection shall be conducted in accordance with section
304(c).
`(i) Reporting of Telemedicine by VHA During Medical Emergency Situations-
`(1) IN GENERAL- Any practitioner issuing a prescription for a controlled
substance under the authorization to conduct telemedicine during a
medical emergency situation described in section 102(54)(F) shall
report to the Secretary of Veterans Affairs the authorization of that
emergency prescription, in accordance with such requirements as the
Secretary of Veterans Affairs shall, by regulation, establish.
`(2) TO ATTORNEY GENERAL- Not later than 30 days after the date that
a prescription described in subparagraph (A) is issued, the Secretary
of Veterans Affairs shall report to the Attorney General the authorization
of that emergency prescription.
`(j) Clarification Concerning Prescription Transfers- Any transfer between
pharmacies of information relating to a prescription for a controlled
substance shall meet the applicable requirements under regulations promulgated
by the Attorney General under this Act.'.
(2) TECHNICAL AND CONFORMING AMENDMENTS- The table of contents for
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public
Law 91-513; 84 Stat. 1236) is amended by inserting after the item
relating to section 310 the following:
`Sec. 311. Additional requirements relating to online pharmacies and
telemedicine.'.
(e) Offenses Involving Controlled Substances in Schedules III, IV, and
V- Section 401(b) of the Controlled Substances Act (21 U.S.C. 841(b))
is amended--
(A) in subparagraph (C), by striking `1 gram of' before `flunitrazepam';
(B) in subparagraph (D), by striking `or in the case of any controlled
substance in schedule III (other than gamma hydroxybutyric acid),
or 30 milligrams of flunitrazepam'; and
(C) by adding at the end the following:
`(E)(i) In the case of any controlled substance in schedule III,
such person shall be sentenced to a term of imprisonment of not
more than 10 years and if death or serious bodily injury results
from the use of such substance shall be sentenced to a term of imprisonment
of not more than 20 years, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18, United
States Code, or $500,000 if the defendant is an individual or $2,500,000
if the defendant is other than an individual, or both.
`(ii) If any person commits such a violation after a prior conviction
for a felony drug offense has become final, such person shall be
sentenced to a term of imprisonment of not more than 20 years and
if death or serious bodily injury results from the use of such substance
shall be sentenced to a term of imprisonment of not more than 30
years, a fine not to exceed the greater of twice that authorized
in accordance with the provisions of title 18, United States Code,
or $1,000,000 if the defendant is an individual or $5,000,000 if
the defendant is other than an individual, or both.
`(iii) Any sentence imposing a term of imprisonment under this subparagraph
shall, in the absence of such a prior conviction, impose a term
of supervised release of at least 2 years in addition to such term
of imprisonment and shall, if there was such a prior conviction,
impose a term of supervised release of at least 4 years in addition
to such term of imprisonment.';
(A) by striking `3 years' and inserting `5 years';
(B) by striking `6 years' and inserting `10 years';
(C) by striking `after one or more prior convictions' and all that
follows through `have become final,' and inserting `after a prior
conviction for a felony drug offense has become final,'; and
(A) by striking `2 years' and inserting `6 years';
(B) by striking `after one or more convictions' and all that follows
through `have become final,' and inserting `after a prior conviction
for a felony drug offense has become final,'; and
(C) by adding at the end the following `Any sentence imposing a
term of imprisonment under this paragraph may, if there was a prior
conviction, impose a term of supervised release of not more than
1 year, in addition to such term of imprisonment.'.
(f) Offenses Involving Dispensing of Controlled Substances by Means
of the Internet- Section 401 of the Controlled Substances Act (21 U.S.C.
841) is amended by adding at the end the following:
`(g) Offenses Involving Dispensing of Controlled Substances by Means
of the Internet- (1) It shall be unlawful for any person to knowingly
or intentionally--
`(A) deliver, distribute, or dispense a controlled substance by means
of the Internet, except as authorized by this title; or
`(B) aid or abet (as such terms are used in section 2 of title 18,
United States Code) any activity described in subparagraph (A) that
is not authorized by this title.
`(2) Examples of activities that violate paragraph (1) include, but
are not limited to, knowingly or intentionally--
`(A) delivering, distributing, or dispensing a controlled substance
by means of the Internet by an online pharmacy that is not validly
registered with a modification authorizing such activity as required
by section 303(f) (unless exempt from such registration);
`(B) writing a prescription for a controlled substance for the purpose
of delivery, distribution, or dispensation by means of the Internet
in violation of section 309(e);
`(C) serving as an agent, intermediary, or other entity that causes
the Internet to be used to bring together a buyer and seller to engage
in the dispensing of a controlled substance in a manner not authorized
by sections 303(f) or 309(e);
`(D) offering to fill a prescription for a controlled substance based
solely on a consumer's completion of an online medical questionnaire;
and
`(E) making a material false, fictitious, or fraudulent statement
or representation in the submission to the Attorney General under
section 311.
`(3)(A) This subsection does not apply to--
`(i) the delivery, distribution, or dispensation of controlled substances
by nonpractitioners to the extent authorized by their registration
under this title;
`(ii) the placement on the Internet of material that merely advocates
the use of a controlled substance or includes pricing information
without attempting to propose or facilitate an actual transaction
involving a controlled substance; or
`(iii) except as provided in subparagraph (B), any activity that is
limited to--
`(I) the provision of a telecommunications service, or of an Internet
access service or Internet information location tool (as those terms
are defined in section 231 of the Communications Act of 1934 (47
U.S.C. 231)); or
`(II) the transmission, storage, retrieval, hosting, formatting,
or translation (or any combination thereof) of a communication,
without selection or alteration of the content of the communication,
except that deletion of a particular communication or material made
by another person in a manner consistent with section 230(c) of
the Communications Act of 1934 (47 U.S.C. 230(c)) shall not constitute
such selection or alteration of the content of the communication.
`(B) The exceptions under subclauses (I) and (II) of subparagraph (A)(iii)
shall not apply to a person acting in concert with a person who violates
paragraph (1).
`(4) Any person who knowingly or intentionally violates this subsection
shall be sentenced in accordance with subsection (b) of this section.'.
(g) Publication- Section 403(c) of the Controlled Substances Act (21
U.S.C. 843(c)) is amended by--
(1) designating the text as paragraph (1); and
(2) adding at the end the following:
`(2)(A) Except as authorized by this title, it shall be unlawful for
any person by means of the Internet to knowingly advertise the sale
or distribution of, or to offer to sell, distribute, or dispense, a
controlled substance.
`(B) Examples of activities that violate subparagraph (A) include, but
are not limited to, knowingly or intentionally causing the placement
on the Internet of an advertisement that refers to or directs prospective
buyers to Internet sellers of controlled substances who are not registered
with a modification under section 303(f).
`(C) Subparagraph (A) does not apply to material that either--
`(i) merely advertises the distribution of controlled substances by
nonpractitioners to the extent authorized by their registration under
this title; or
`(ii) merely advocates the use of a controlled substance or includes
pricing information without attempting to facilitate an actual transaction
involving a controlled substance.'.
(h) Injunctive Relief- Section 512 of the Controlled Substances Act
(21 U.S.C. 882) is amended by adding at the end the following:
`(c) State Cause of Action Pertaining to Online Pharmacies- (1) In any
case in which the State has reason to believe that an interest of the
residents of that State has been or is being threatened or adversely
affected by the action of a person, entity, or Internet site that violates
the provisions of section 303(f), 309(e), or 311, the State may bring
a civil action on behalf of such residents in a district court of the
United States with appropriate jurisdiction--
`(A) to enjoin the conduct which violates this section;
`(B) to enforce compliance with this section;
`(C) to obtain damages, restitution, or other compensation, including
civil penalties under section 402(b); and
`(D) to obtain such other legal or equitable relief as the court may
find appropriate.
`(2)(A) Prior to filing a complaint under paragraph (1), the State shall
serve a copy of the complaint upon the Attorney General and upon the
United States Attorney for the judicial district in which the complaint
is to be filed. In any case where such prior service is not feasible,
the State shall serve the complaint on the Attorney General and the
appropriate United States Attorney on the same day that the State's
complaint is filed in Federal district court of the United States. Such
proceedings shall be independent of, and not in lieu of, criminal prosecutions
or any other proceedings under this title or any other laws of the United
States.
`(B) Upon receiving notice respecting a civil action pursuant to this
section, the United States shall have the right to intervene in such
action, upon so intervening, to be heard on all matters arising therein,
and to file petitions for appeal.
`(C) Service of a State's complaint on the United States as required
in this paragraph shall be made in accord with the requirements of rule
4(i)(1) of the Federal Rule of Civil Procedure.
`(3) For purposes of bringing any civil action under paragraph (1),
nothing in this Act shall prevent an attorney general of a State from
exercising the powers conferred on the attorney general of a State by
the laws of such State to conduct investigations or to administer oaths
or affirmations or to compel the attendance of witnesses of or the production
of documentary or other evidence.
`(4) Any civil action brought under paragraph (1) in a district court
of the United States may be brought in the district in which the defendant
is found, is an inhabitant, or transacts business or wherever venue
is proper under section 1391 of title 28, United States Code. Process
in such action may be served in any district in which the defendant
is an inhabitant or in which the defendant may be found.
`(5) No private right of action is created under this subsection.
`(6) No civil action may be brought under paragraph (1) against--
`(B) an Indian Tribe or tribal organization, to the extent such tribe
or tribal organization is lawfully carrying out a contract or compact
under the Indian Self-Determination and Education Assistance Act;
or
`(C) any employee of the United States or such Indian tribe or tribal
organization, provided such agent or employee is acting in the usual
course of business or employment, and within the scope of the official
duties of such agent or employee therewith.'.
(i) Forfeiture of Facilitating Property in Drug Cases- Section 511(a)(4)
of the Controlled Substances Act (21 U.S.C. 881(a)(4)) is amended to
read as follows:
`(4) Any property, real or personal, tangible or intangible, used
or intended to be used to commit, or to facilitate the commission,
of a violation of this title or title III, and any property traceable
thereto.'.
(j) Import and Export Act- Section 1010(b) of the Controlled Substances
Import and Export Act (21 U.S.C. 960(b)) is amended--
(A) by striking `or any quantity of a controlled substance in schedule
III, IV, or V, (except a violation involving flunitrazepam and except
a violation involving gamma hydroxybutyric acid)';
(B) by inserting `, or' before `less than one kilogram of hashish
oil'; and
(C) striking `imprisoned' and all that follows through the end of
the paragraph and inserting `sentenced in accordance with section
401(b)(1)(D) of this title (21 U.S.C. 841(b)(1)(E)).';
(2) by adding at the end the following:
`(5) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule III, such person shall
be sentenced in accordance with section 401(b)(1)(E).
`(6) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule IV (except a violation
involving flunitrazepam), such person shall be sentenced in accordance
with section 401(b)(2).
`(7) In the case of a violation of subsection (a) of this section
involving a controlled substance in schedule V, such person shall
be sentenced in accordance with section 401(b)(3).'; and
(3) in paragraph (3), by striking `, nor shall a person so sentenced
be eligible for parole during the term of such a sentence' in the
final sentence.
(1) IN GENERAL- Except as provided in paragraph (2), the amendments
made by this Act shall take effect 180 days after the date of enactment
of this Act.
(2) DEFINITION OF PRACTICE OF TELEMEDICINE-
(A) IN GENERAL- Until the earlier of 3 months after the date on
which regulations are promulgated to carry out section 311(h) of
the Controlled Substances Act, as amended by this Act, or 15 months
after the date of enactment of this Act--
(i) the definition of the term `practice of telemedicine' in subparagraph
(B) of this paragraph shall apply for purposes of the Controlled
Substances Act; and
(ii) the definition of the term `practice of telemedicine' in
section 102(54) of the Controlled Substances Act, as amended by
this Act, shall not apply.
(B) TEMPORARY PHASE-IN OF TELEMEDICINE REGULATION- During the period
specified in subparagraph (A), the term `practice of telemedicine'
means the practice of medicine in accordance with applicable Federal
and State laws by a practitioner (as that term is defined in section
102 of the Controlled Substances Act (21 U.S.C. 802)) (other than
a pharmacist) who is at a location remote from the patient and is
communicating with the patient, or health care professional who
is treating the patient, using a telecommunications system referred
to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)),
if the practitioner is using an interactive telecommunications system
that satisfies the requirements of section 410.78(a)(3) of title
42, Code of Federal Regulations.
(C) RULE OF CONSTRUCTION- Nothing in this subsection may be construed
to create a precedent that any specific course of conduct constitutes
the `practice of telemedicine' (as that term is defined in section
102(54) of the Controlled Substances Act, as amended by this Act)
after the end of the period specified in subparagraph (A).
(l) Guidelines and Regulations-
(1) IN GENERAL- The Attorney General may promulgate and enforce any
rules, regulations, and procedures which may be necessary and appropriate
for the efficient execution of functions under this Act or the amendments
made by this Act, and, with the concurrence of the Secretary of Health
and Human Services where this Act or the amendments made by this Act
so provides, promulgate any interim rules necessary for the implementation
of this Act or the amendments made by this Act, prior to its effective
date.
(2) SENTENCING GUIDELINES- The United States Sentencing Commission,
in determining whether to amend, or establish new, guidelines or policy
statements, to conform the Federal sentencing guidelines and policy
statements to this Act and the amendments made by this Act--
(A) shall consult with the Department of Justice, experts and other
affected parties concerning which penalties for scheduled substances
amended by this Act should be reflected in the Federal sentencing
guidelines; and
(B) should not construe any change in the maximum penalty for a
violation involving a controlled substance in a particular schedule
as being the sole reason to amend a, or establish a new, guideline
or policy statement.
(m) Annual Report- Not later than 180 days after the date of enactment
of this Act, and annually for 2 years after the initial report, the
Drug Enforcement Administration, in consultation with the Department
of State, shall submit to Congress a report describing--
(1) the foreign supply chains and sources of controlled substances
offered for sale without a valid prescription on the Internet;
(2) the efforts and strategy of the Drug Enforcement Administration
to decrease the foreign supply chain and sources of controlled substances
offered for sale without a valid prescription on the Internet; and
(3) the efforts of the Drug Enforcement Administration to work with
domestic and multinational pharmaceutical companies and others to
build international cooperation and a commitment to fight on a global
scale the problem of distribution of controlled substances over the
Internet without a valid prescription.
SEC. 4. RULE OF CONSTRUCTION.
Nothing in this Act or the amendments made by this Act shall be construed
as authorizing, prohibiting, or limiting the use of electronic prescriptions
for controlled substances.
Passed the Senate April 1 (legislative day, March 13), 2008.
Attest:
Secretary.
110th CONGRESS
2d Session
S. 980
AN ACT
To amend the Controlled Substances Act to address online pharmacies.
