Amendments to the Controlled Substances Act relating to the delivery of controlled substances or prescription drugs 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:

(47)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. (48)The term deliver, distribute, or dispense by means of the Internet refers, respectively, to any delivery, distribution, or dispensing of a controlled substance or prescription drug that is caused or facilitated by means of the Internet. (49)The term online pharmacy— (A)means a person, entity, or Internet site, whether in the United States or abroad, that delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense, a controlled substance or prescription drug by means of the Internet; and (B)does not include— (i)manufacturers or distributors registered under subsection (a), (b), (c), or (d) of section 303 who do not dispense controlled substances or prescription drugs; (ii)nonpharmacy practitioners who are registered under section 303(f); or (iii)mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance or prescription drug. (50)The term prescription drug means a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act. (51)The term homepage means the first page of a website that is viewable on the Internet.

(b)

Registration requirements

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following new subsection:

(i)

Dispenser of controlled substances or prescription drugs by means of the internet

(1)A pharmacy that seeks to deliver, distribute, or dispense by means of the Internet a controlled substance or prescription drug shall obtain a separate registration specifically authorizing such activity, in accordance with regulations promulgated by the Attorney General. In determining whether to grant an application for such registration, the Attorney General shall apply the factors set forth in subsection (f). (2)Registration under this subsection shall be in addition to, and not in lieu of, registration under subsection (f). (3)This subsection does not apply to pharmacies that merely advertise by means of the Internet but do not attempt to facilitate an actual transaction involving a controlled substance or prescription drug by means of the Internet.

(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 new paragraph:

(2)A pharmacy registered under section 303(i) shall report to the Attorney General the controlled substances or prescription drugs dispensed under such registration, in such manner and accompanied by such information as the Attorney General by regulation shall require.

(d)

Online prescription requirement

Section 309 of the Controlled Substances Act (21 U.S.C. 829) is amended by adding at the end the following new subsection:

(e)

Controlled substances and prescription drugs dispensed by means of the Internet

(1)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 that is based upon a qualifying medical relationship by a practitioner registered by the Attorney General under this part; (B)the term qualifying medical relationship— (i)means a medical relationship that exists when the practitioner— (I)has conducted at least one medical evaluation with the user in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals; or (II)conducts a medical evaluation of the patient as a covering practitioner and is not prescribing a controlled substance in schedule I, II, III, or IV; and (ii)shall not be construed to imply that one medical evaluation described in clause (i) demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice; and (C)the term covering practitioner means, with respect to a patient, a practitioner who conducts a medical evaluation, without regard to whether the medical evaluation of the patient involved is an in-person evaluation, at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. (2)In addition to the requirements of subsections (a) through (c), no controlled substance or prescription drug may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.

(e)

Online prescription requirements

The Controlled Substances Act is amended by adding after section 310 (21 U.S.C. 830) the following:

311.

Online pharmacy licensing and disclosure requirements

(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 or prescription drugs 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 or prescription drugs by means of the Internet. (c)

Compliance

No online pharmacy or practitioner shall deliver, distribute, or dispense by means of the Internet a controlled substance or prescription drug without a valid prescription (as defined in section 309(e)) and each online pharmacy shall comply with all applicable requirements of Federal and State law. (d)

Internet Site Disclosure Information

Each online pharmacy site shall post in a visible and clear manner on the homepage of its Internet site or on a page directly linked from its homepage the following: (1)The name of the owner, street address of the online pharmacy's principal place of business, telephone number, and email address. (2)A list of the States in which the online pharmacy, and any pharmacy which dispenses, delivers, or distributes a controlled substance or prescription drug on behalf of the online pharmacy, is licensed to dispense controlled substances or prescription drugs and any applicable license number. (3)For each pharmacy identified on its license in each State in which it is licensed to engage in the practice of pharmacy and for each pharmacy which dispenses or ships controlled substances or prescription drugs on behalf of the online pharmacy: (A)The name of the pharmacy. (B)The street address of the pharmacy. (C)The name, professional degree, and licensure of the pharmacist-in-charge. (D)The telephone number at which the pharmacist-in-charge can be contacted. (E)A certification that each pharmacy which dispenses or ships controlled substances or prescription drugs on behalf of the online pharmacy is registered under this part to deliver, distribute, or dispense by means of the Internet controlled substances or prescription drugs. (4)The name, address, professional degree, and licensure of practitioners who prescribe controlled substances or prescription drugs on the basis of information obtained through the Internet site. (5)A telephone number or numbers at which the practitioners described in paragraph (4) may be contacted. (6)The following statement, unless revised by the Attorney General by regulation: This online pharmacy will only dispense a controlled substance or prescription drug to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner, which includes at least one prior in-person medical evaluation. This online pharmacy complies with section 309(e) of the Controlled Substances Act (21 U.S.C. 829(e)).. (e)

Notification

(1)Thirty days prior to offering a controlled substance or prescription drug 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 or prescription drugs. (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 (d) 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 to subsection (d) 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 (d), 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. (f)

Declaration of compliance

On and after the date on which it makes the notification under subsection (e), 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. (g)

Reports

Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.

(f)

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— (1)in paragraph (1)— (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 inserting 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, 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, 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

;

(2)in paragraph (2) by— (A)striking 3 years and inserting 5 years; (B)striking 6 years and inserting 10 years; (C)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 (3)in paragraph (3) by— (A)striking 2 years and inserting 6 years; (B)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)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. (g)

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)Except as authorized by this title, it shall be unlawful for any person to knowingly or intentionally cause or facilitate the delivery, distribution, or dispensing by means of the Internet of a controlled substance. (2)Violations of this subsection include— (A)delivering, distributing, or dispensing a controlled substance by means of the Internet by a pharmacy not registered under section 303(i); (B)writing a prescription for a controlled substance for the purpose of dispensing by means of the Internet in violation of subsection 309(e); and (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(i) or 309(e). (3)This subsection does not apply to— (A)the distribution of controlled substances by nonpractitioners to the extent authorized by their registration under this title; (B)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 (C)(i)the dispensing or selling of a prescription drug pursuant to telemedicine practices sponsored by— (I)a hospital that has in effect a provider agreement under title XVIII of the Social Security Act (relating to the Medicare program); or (II)a group practice that has not fewer than 100 physicians who have in effect provider agreements under such title; or (ii)the dispensing or selling of a prescription drug pursuant to practices that promote the public health, as determined by the Secretary of Health and Human Services by regulation. (4)Any person who knowingly or intentionally violates this subsection shall be sentenced in accordance with subsection (b) of this section.

(h)

Offenses involving the dispensing of prescription drugs by means of the internet

(1)

In general

Part D of the Controlled Substances Act (21 U.S.C. 841 et seq.) is amended by inserting after section 403 the following:

403A.

Penalty for unlawful sale of prescription drugs by means of the internet

(a)

Prohibited act

(1)

In general

Except as authorized by this title, it shall be unlawful for any person to knowingly or intentionally cause or facilitate the delivery, distribution, or dispensing by means of the Internet of a prescription drug. (2)

Violations

Violations of this subsection include— (A)delivering, distributing, or dispensing a prescription drug by means of the Internet by a pharmacy not registered under section 303(i); (B)writing a prescription for a prescription drug for the purpose of dispensing by means of the Internet in violation of subsection 309(e); and (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 prescription drug in a manner not authorized by sections 303(i) or 309(e). (b)

Penalties

Any person who violates subsection (a)— (1)shall be fined under title 18, United States Code, imprisoned not more than 1 year, or both; or (2)if the violation was committed after 1 or more prior convictions of the offender for an offense punishable under subsection (a), or for a crime under any other provision of this title or title III or any other law of the United States relating to narcotic drugs, marijuana, or depressant or stimulant substances have become final, shall be fined under title 18, United States Code, imprisoned not more than 2 years, or both. (c)

Forfeiture

(1)A person convicted of a violation of subsection (a) shall forfeit to the United States any interest of such person in any property involved in or derived from such violation. (2)Any property subject to forfeiture under paragraph (1) may be forfeited to the United States in accordance with the procedures under chapter 46 of title 18, United States Code. (d)

Exceptions

Subsections (a) through (c) do not apply to— (1)the dispensing or selling of a prescription drug pursuant to telemedicine practices sponsored by— (A)a hospital that has in effect a provider agreement under title XVIII of the Social Security Act (relating to the Medicare program); or (B)a group practice that has not fewer than 100 physicians who have in effect provider agreements under such title; or (2)the dispensing or selling of a prescription drug pursuant to practices that promote the public health, as determined by the Secretary of Health and Human Services by regulation.

(2)

Conforming amendment

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 403 the following:

403A. Penalty for Unlawful Sale of Prescription Drugs By Means of the Internet..

(i)

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)It shall be unlawful for any person to use the Internet, or cause the Internet to be used, to advertise the sale of, or to offer to sell, distribute, or dispense, a controlled substance or prescription drug except as authorized by this title. (B)Violations of this paragraph include causing the placement on the Internet of an advertisement that refers to or directs prospective buyers to sellers of controlled substances or prescription drugs who are not registered under section 303(i). (C)This paragraph does not apply to material that either— (i)advertises the distribution of controlled substances or prescription drugs by nonpractitioners to the extent authorized by their registration under this title; or (ii)merely advocates the use of a controlled substance or prescription drug or includes pricing information without attempting to facilitate an actual transaction involving a controlled substance or prescription drug.

(j)

Injunctive relief

Section 512 of the Controlled Substances Act (21 U.S.C. 882) is amended by adding to the end of the section the following new subsection:

(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(i), 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)(i)Not later than 120 days after the later of the date on which a State's complaint is served on the Attorney General and the appropriate United States Attorney, or the date on which the complaint is filed, the United States shall have the right to intervene as a party in any action filed by a State under paragraph (1). (ii)After the 120-day period described in clause (i) has elapsed, the United States may, for good cause shown, intervene as a party in an action filed by a State under paragraph (1). (iii)Notice and an opportunity to be heard with respect to intervention shall be afforded the State that filed the original complaint in any action in which the United States files a complaint in intervention under clause (i) or a motion to intervene under clause (ii). (iv)The United States may file a petition for appeal of a judicial determination in any action filed by a State under this section. (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 Federal Rule of Civil Procedure 4(i)(1). (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.

(k)

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.

(l)

Import and export act

Section 1010(b) of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is amended— (1)in paragraph (4) by— (A)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)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. (m)

Effective date

The amendments made by this Act shall become effective 60 days after the date of enactment of this Act. (n)

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 subtitle, including any interim rules necessary for the immediate implementation of this Act, on 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 guidelines and policy statements to this Act and the amendments made by this Act, may not construe any change in the maximum penalty for a violation involving a controlled substance in a particular schedule as requiring an amendment to, or establishing a new, guideline or policy statement.