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110th Congress                                                   Report
                                 SENATE
 2d Session                                                     110-521

======================================================================



 
      RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2007

                                _______
                                

   November 17 (legislative day, September 17, 2008).--Ordered to be 
                                printed

                                _______
                                

Mr. Leahy, from the Committee on the Judiciary, submitted the following

                              R E P O R T

                         [To accompany S. 980]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on the Judiciary, to which was referred the 
bill (S. 980) to amend the Controlled Substances Act to address 
online pharmacies, reports favorably thereon, with an 
amendment, and recommends that the bill, as amended, do pass.

                                CONTENTS

                                                                   Page
  I. Background and Purpose of the Ryan Haight Online Pharmacy Consumer 
     Protection Act of 2007...........................................1
 II. History of the Bill and Committee Consideration..................8
III. Section-by-Section Summary of the Bill..........................12
 IV. Congressional Budget Office Cost Estimate.......................17
  V. Regulatory Impact Evaluation....................................19
 VI. Conclusion......................................................19
VII. Changes to Existing Law Made by the Bill, as Reported...........19

 I. Background and Purpose of the Ryan Haight Online Pharmacy Consumer 
                         Protection Act of 2007

    Senators Feinstein and Sessions introduced the Online 
Pharmacy Consumer Protection Act of 2007 on March 23, 2007. 
Senators Biden, Coleman, Leahy, and Cornyn cosponsored the 
legislation (renamed the Ryan Haight Online Pharmacy Consumer 
Protection Act of 2007).
    This legislation responds to the increasing use of 
prescription controlled substances by adolescents and others 
for non-medical purposes, which has been exacerbated by drug 
trafficking on the Internet. The Department of Justice (DOJ) 
has acknowledged that this ``is a very significant problem and 
is a major concern of DOJ and the DEA.''\1\
---------------------------------------------------------------------------
    \1\Oversight of the U.S. Department of Justice: Hearing Before the 
S. Comm. on the Judiciary, 110th Cong. (Jan. 18, 2007) [hereinafter 
Jan. 2007 DOJ Hearing], Responses to Questions for the Record Posed to 
Alberto Gonzales, Att'y Gen. of the United States at 11.
---------------------------------------------------------------------------

                             A. BACKGROUND

    The Ryan Haight Online Pharmacy Consumer Protection Act of 
2007 is the latest in a series of bills introduced to address 
the problem of rogue Internet pharmacies. The current 
legislation has origins in, but has also been modified 
substantially from, previous bills: S. 3834, the Online 
Pharmacy Consumer Protection Act of 2006, introduced by 
Senators Sessions and Feinstein in the 109th Congress; S. 399, 
the Internet Pharmacy Consumer Protection Act, introduced by 
Senators Coleman and Feinstein in the 109th Congress; and S. 
2464, the Internet Pharmacy Consumer Protection Act, introduced 
by Senators Coleman and Feinstein in the 108th Congress.

                        B. NEED FOR LEGISLATION

1. The alarming rise in abuse of prescription controlled substances

    Over the past decade, the United States has experienced a 
growing epidemic of prescription controlled substance abuse 
involving opiates like OxyContin and Vicodin, depressants like 
Valium and Xanax, and stimulants like Ritalin and Adderall. As 
Joseph A. Califano, Jr., former U.S. Secretary of Health, 
Education and Welfare and now President and Chief Executive 
Officer of the National Center on Addiction and Substance Abuse 
(CASA) at Columbia University, testified before this Committee, 
``Over the past 12 years, the fastest growing drug abuse among 
our Nation's children involves prescription drugs.''\2\
---------------------------------------------------------------------------
    \2\Rogue Online Pharmacies: the Growing Problem of Internet Drug 
Trafficking: Hearing Before the S. Comm. on the Judiciary, 110th Cong. 
(2007) [hereinafter Rogue Online Pharmacies Hearing] (testimony of 
Joseph A. Califano, President and Chief Executive Officer, Nat'l Ctr. 
on Addiction and Substance Abuse).
---------------------------------------------------------------------------
    In its 2005 report, Under the Counter: The Diversion and 
Abuse of Controlled Prescription Drugs in the U.S., the 
National Center on Addiction & Substance Abuse (CASA) reported 
that, from 1992 to 2002, prescriptions written for such 
controlled drugs increased more than 150 percent, 12 times the 
rate of increase in population and almost three times the rate 
of increase in prescriptions written for all other drugs.\3\ 
The number of 12- to 17-year-olds who abused controlled 
prescription drugs jumped 212 percent and the number of adults 
18 and older abusing such drugs climbed 81 percent. Abuse of 
prescription controlled substances has grown at a rate twice 
that of marijuana abuse; five times that of cocaine abuse; and 
60 times that of heroin abuse.\4\
---------------------------------------------------------------------------
    \3\Under the Counter: The Diversion and Abuse of Controlled 
Prescription Drugs in the U.S., Nat'l Ctr on Addiction & Substance 
Abuse (CASA) at Columbia Univ., July 2005, at 3, available at http://
www.casacolumbia.org/absolutenm/articlefiles/380-
Under%20the%20Counter%20-%20Diversion.pdf.
    \4\Id. at 16.
---------------------------------------------------------------------------
    Mr. Califano told the Committee about the troubling 
implications that prescription drug abuse posed to children. 
From 1992 to 2002, new abuse of prescription opiates among 12- 
to 17-year-olds was up an astounding 542 percent, more than 
four times the rate of increase among adults. In 2003, 2.3 
million 12- to 17-year-olds (nearly one in 10) abused at least 
one prescription controlled substance; for 83 percent of them, 
the drug was an opiate. According to Califano, ``Teens who 
abuse controlled prescription drugs are twice as likely to use 
alcohol, five times likelier to use marijuana, 12 times 
likelier to use heroin, 15 times likelier to use ecstasy and 21 
times likelier to use cocaine, compared to teens who do not 
abuse such drugs.''\5\
---------------------------------------------------------------------------
    \5\Rogue Online Pharmacies Hearing, supra note 2.
---------------------------------------------------------------------------
    Joseph T. Rannazzisi, Deputy Assistant Administrator of the 
Office of Diversion Control at the U.S. Drug Enforcement 
Administration (DEA), confirmed in testimony before the 
Committee that there has been an ``alarming'' increase in non-
medical use of addictive prescription drugs. Nationally, misuse 
of prescription drugs was second only to marijuana in 2005, in 
part due to a false sense of security associated with the abuse 
of prescription substances. Mr. Rannazzisi testified that 
``many feel as though if a doctor can prescribe it, the drug 
can't be as harmful to your health [as illegal drugs sold on 
the street].''\6\ In reality, however, prescription controlled 
substances are not just highly dangerous, but also potentially 
lethal. The consequences for people who seek prescription 
controlled drugs illegally over the Internet can be severe. 
According to the DEA, abuse of prescription drugs can be just 
as dangerous and deadly as the consequences of abusing cocaine 
and heroin.
---------------------------------------------------------------------------
    \6\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi, Deputy Assistant Adm'r, Office of Diversion 
Control, U.S. Drug Enforcement Admin.).
---------------------------------------------------------------------------
    In testimony before the Committee at a Department of 
Justice Oversight hearing in January 2007, Attorney General 
Alberto Gonzales confirmed that the Department was concerned 
about the non-medical use of prescription controlled 
substances, and he verified that such drugs were ``the fastest 
rising category of drug abuse in recent years.''\7\
---------------------------------------------------------------------------
    \7\Jan. 2007 DOJ Hearing, supra note 1, (statement of Alberto 
Gonzales, former Att'y Gen. of the United States); see also, Department 
of Justice Oversight: Hearing Before the S. Comm. on the Judiciary, 
110th Cong. (April 19, 2007) [hereinafter Apr. 2007 DOJ Hearing] 
(statement of Alberto Gonzales, former Att'y Gen. of the United 
States).
---------------------------------------------------------------------------
    President George W. Bush has also acknowledged the growing 
problem of prescription drug abuse. On March 1, 2008, in his 
national radio address, President Bush noted that abuse of 
prescription drugs among the Nation's youth was a growing 
problem, and that the total number of Americans who have died 
from prescription drug overdoses was also increasing.\8\
---------------------------------------------------------------------------
    \8\President George W. Bush, Radio Address: 2008 National Drug 
Control Policy (Mar. 1, 2008) [hereinafter Bush Radio Address], 
available at http://www.whitehouse.gov/news/releases/2008/03/
20080301.html.
---------------------------------------------------------------------------

2. Lack of effective controls over prescribed controlled substances 
        distributed by rogue Internet pharmacies

    Although many online pharmacies are legitimate businesses 
that offer safe and convenient services similar to those 
provided by traditional neighborhood pharmacies and large chain 
drugstores, other online pharmacies, often referred to as 
``rogue sites,'' engage in the illegal practices of 
distributing controlled substances without prescriptions or 
using a truncated prescription process so flawed that medical 
authorities reject it.\9\
---------------------------------------------------------------------------
    \9\``You've Got Drugs!'' IV: Prescription Drug Pushers on the 
Internet, Nat'l Ctr on Addiction & Substance Abuse (CASA) at Columbia 
Univ., May 2007, at 7 [hereinafter You've Got Drugs IV] (``The 
Federation of State Medical Boards of the United States, Inc., the 
American Medical Association, the National Association of Boards of 
Pharmacy, and the Drug Enforcement Administration (DEA) all agree that 
online consultations cannot take the place of a face-to-face physical 
examination with a legitimate physician.''), available at http://
www.casacolumbia.org/absolutenm/articlefiles/380-
2007%20You've%20Got%20Drugs%20IV.pdf.
---------------------------------------------------------------------------
    Mr. Rannazzisi testified that the Internet has created a 
new marketplace and delivery system for drug traffickers. Mr. 
Rannazzisi called the Internet a ``perfect medium'' for the 
sale of illicit drugs, connecting people from anywhere around 
the world at any time and cloaking them in anonymity, and said 
that the Internet allows for a more rapid means of diverting 
large quantities of controlled substances.\10\
---------------------------------------------------------------------------
    \10\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
    Indeed, many rogue Internet pharmacies appear to have been 
set up for the very purpose of promoting large sales of 
controlled substances. According to Mr. Rannazzisi, in 2006, 34 
known or suspected rogue Internet pharmacies dispensed 
98,566,711 dosages of hydrocodone combination products.\11\ 
These 34 pharmacies alone dispensed enough hydrocodone 
combination products to supply 410,000 actual patients with a 
one-month supply at the maximum amount recommended per 
prescription. Mr. Rannazzisi said that a typical, traditional, 
independent brick and mortar pharmacy sells about 180 
prescriptions per day. Of these sales, only 11 percent involved 
controlled substances. However, the typical online pharmacy 
sells around 450 prescriptions each day--425 of these sales, or 
95 percent, involve controlled substances.\12\
---------------------------------------------------------------------------
    \11\Id.
    \12\Id.
---------------------------------------------------------------------------
    Unfortunately, the number of rogue Internet sites only has 
grown. In CASA's fourth annual report on this topic, entitled 
You've Got Drugs! IV: Prescription Drug Pushers on the 
Internet, it found that from 2006 to 2007 there had been:
           A 70 percent increase in the number of 
        websites advertising or selling controlled prescription 
        drugs, from 342 to 581;\13\
---------------------------------------------------------------------------
    \13\You've Got Drugs IV, supra note 9, at 4.
---------------------------------------------------------------------------
           A 135 percent increase in the number of 
        websites advertising prescription controlled 
        substances, from 168 to 394;\14\
---------------------------------------------------------------------------
    \14\Id. at 5.
---------------------------------------------------------------------------
           A seven percent increase in the number of 
        websites selling prescription controlled substances, 
        from 174 to 187 (between 2004 and 2007, the number 
        websites selling prescription controlled substances 
        rose steadily from 154 in 2004 to 187 in 2007);\15\
---------------------------------------------------------------------------
    \15\Id.
---------------------------------------------------------------------------
           Eighty-four percent of the websites selling 
        prescription controlled substances do not require a 
        prescription from the patient's physician;\16\ and
---------------------------------------------------------------------------
    \16\Id.
---------------------------------------------------------------------------
           No controls to stop the sale of these drugs 
        to children.\17\
---------------------------------------------------------------------------
    \17\Id. at 7.
---------------------------------------------------------------------------
    The current mechanism for certifying Internet pharmacy 
practice is purely voluntary.\18\ Of the 187 selling sites 
identified by CASA in 2007, only two were certified by Verified 
Internet Pharmacy Practice SitesTM (VIPPS ).\19\ 
Most often, according to Mr. Califano, ``Online purchase of 
controlled prescription drugs happens beneath the radar screens 
of Internet providers, financial institutions, shippers and 
parents.''\20\
---------------------------------------------------------------------------
    \18\Verified Internet Pharmacy Practice SitesTM 
(VIPPS ), Nat'l Ass'n. of Bds. of Pharmacy, available at http://
www.nabp.net/index.html?target=/vipps/intro.asp&.
    \19\Verified Internet Pharmacy Practice SitesTM 
(VIPPS ), http://www.nabp.net/ (last visited Oct. 16, 2007) (the 
National Association of Boards of Pharmacy reported that 13 pharmacies 
had received VIPPS certification as of Oct. 16, 2007).
    \20\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph A. Califano).
---------------------------------------------------------------------------
    A recent study by the British Broadcasting Corporation 
(BBC) revealed the wide scope of rogue Internet pharmacies 
operating worldwide.\21\ The BBC sought to identify all of the 
websites selling six popular prescription drugs online. In 
total, the BBC identified 3,160 online pharmacies. The number 
of the websites offering prescription controlled substances was 
not identified, but controls were clearly lacking--many 
websites advertised the fact that no prescription was required 
to buy medicines, and only four had VIPPS  accreditation. 
According to the BBC, many of the websites falsely claimed 
VIPPS  accreditation, and half of the websites did not 
safeguard customer details. The websites were also heavily 
trafficked--the websites averaged 32,000 visitors daily, which 
could equate to 2 billion in annual sales for the 
six drugs examined by the BBC study.\22\
---------------------------------------------------------------------------
    \21\Drug Website Safety Fears Raised, BBC News, Aug. 19, 2007, 
http://news.bbc.co.uk/2/hi/health/6951254.stm.
    \22\Id.
---------------------------------------------------------------------------
    In short, at a minimum, ``[t]ens of thousands of 
`prescriptions' are written each year for controlled and non-
controlled prescription drugs through such Internet pharmacies, 
which do not require medical records, examinations, lab tests 
or follow-ups.''\23\
---------------------------------------------------------------------------
    \23\You've Got Drugs IV, supra note 9, at 7.
---------------------------------------------------------------------------
    Mr. Rannazzisi testified that the problem extends beyond 
Internet sales.\24\ The sheer volume of prescription controlled 
substances being dispensed anonymously over the Internet also 
contributes significantly to other downstream methods of 
diversion, like children and young adults who obtain 
prescription controlled substances from the family medicine 
cabinet or other family and friends. Mr. Rannazzisi said that 
when these downstream individuals obtain these substances, they 
generally acquire only a few pills at a time. In contrast, 
individuals ordering over the Internet frequently receive 100-
120 pills at a time, making the Internet purchaser a 
potentially much higher-volume source for friends and family 
than the family medicine cabinet.\25\
---------------------------------------------------------------------------
    \24\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi).
    \25\Id.
---------------------------------------------------------------------------

3. Disastrous consequences

    Ease of access to the Internet, combined with lack of 
medical supervision, has led to tragic consequences in the 
online purchase of prescription controlled substances. News 
reports continue to document the growing list of examples:
     In 1999, an autopsy of 43-year-old Juris Abolins 
identified traces of OxyContin and diazepam (generic Valium). 
Relatives also found a bottle of Tussionex, a cough suppressant 
containing hydrocodone, which Abolins had purchased from a 
website based in Texas. Abolins had told friends he was 
suffering from kidney stones, but an autopsy found no evidence 
of this condition.\26\
---------------------------------------------------------------------------
    \26\The Victims, Washington Post, Oct. 21, 2003, at A15, available 
at http://www.washingtonpost.com/wp-dyn/content/article/2007/06/28/
AR2007062801388.html.
---------------------------------------------------------------------------
     In September 2001, Douglas Townsend of South 
Carolina died after driving his car into a fence. His family 
said he took a generic form of the tranquilizer Xanax, which he 
purchased from myprivatedoc.com, a now-defunct website based in 
Mesa, Arizona.\27\
---------------------------------------------------------------------------
    \27\Id.
---------------------------------------------------------------------------
     In April 2003, Elizabeth Carr found her 47-year-
old husband and former triathlete, James Lewis, dead on their 
living room couch. An autopsy found excessive amounts of the 
painkiller Darvon, purchased through Internet pharmacies based 
in South Africa, Thailand, and Vietnam.\28\
---------------------------------------------------------------------------
    \28\Id.
---------------------------------------------------------------------------
     In July 2003, 33-year-old mother Sandra M. Waltz 
died of an overdose of Soma and generic Darvon. Her family 
discovered that she had ordered drugs from a computer at her 
workplace.\29\
---------------------------------------------------------------------------
    \29\Id.
---------------------------------------------------------------------------
     In December 2003, 19-year-old Jason Surks died of 
an accidental overdose of Xanax, which he had been buying along 
with OxyContin over the Internet.\30\
---------------------------------------------------------------------------
    \30\Vincent Todaro, Center to memorialize local overdose victim 
Jason Surks, 19, died last year due to his abuse of prescription drugs, 
The Sentinel, Aug. 19, 2004; see also Linda Surks, A Lethal 
Prescription, Partnership for a Drug-Free America (May 18, 2006), 
http://www.drugfree.org/Portal/Memorials/A_Lethal_Prescription.
---------------------------------------------------------------------------
     In December 2003, Robin Bartlett of Florida died 
from complications of drug overuse after receiving 4,000 doses 
of prescription drugs, including Schedule II narcotics like 
hydrocodone, that were purchased over the Internet over a 
period of just 3\1/2\ months. After she died, her husband 
continued to get messages from Internet-based distributors, 
asking why his wife had not reordered more controlled 
substances.\31\
---------------------------------------------------------------------------
    \31\Thomas Tryon, Wife's death leads husband to sue Internet 
prescription purveyors, Sarasota Herald-Tribune, Oct. 16, 2005, at F1.
---------------------------------------------------------------------------
     In April 2004, 30-year-old plastics salesman Craig 
Schmidt suffered brain damage and nearly died after taking the 
anxiety drug Xanax and the painkiller Ultram, both of which he 
had purchased over the Internet. Schmidt reasoned that 
``spending $400 for brand-name drugs like Xanax and Ultram 
simply seemed easier and more discreet than visiting a 
doctor.'' But three weeks after taking tablets containing 2mg 
of Xanax (quadruple the typical initial dosage a physician 
would normally prescribe) he awoke in a Chicago hospital room 
with hypoxic encephalopathy--widespread brain damage.\32\
---------------------------------------------------------------------------
    \32\Keith Epstein, The Deadly Side Effects of Net Pharmacies, 
Business Week, Dec. 18, 2006, available at http://www.businessweek.com/
magazine/content/06_51/b4014070.htm; see also Abdon M. Pallasch, Man 
Sues Over Online Prescription, Chicago Sun-Times, Jan. 10, 2006, at 8.
---------------------------------------------------------------------------
     In 2006, Justin Pearson of St. Cloud, Minnesota 
died on Christmas Day of an overdose after receiving at least 
12 shipments of drugs purchased over the Internet. The man who 
sold Pearson and others controlled substances made $24 million 
before he was stopped, even though at least two other people 
had also died within 18 months of buying such drugs.\33\
---------------------------------------------------------------------------
    \33\David Unze, Internet Operation Puts Man in Prison, St. Cloud 
Times, Aug. 3, 2007, at 1B.
---------------------------------------------------------------------------

4. Demonstrated need for a federal legislative solution

    The DOJ recognizes the need for legislation to address the 
Internet-based pharmacy problem. During a July 2006 Department 
of Justice oversight hearing before this Committee, Attorney 
General Gonzales testified that the sale of pharmaceuticals 
over the Internet was a great concern and that rogue Internet 
pharmacies gave drug abusers the ability to obtain controlled 
substances and circumvent the law, as well as sound medical 
practice. The Attorney General testimony noted that because the 
websites associated with these online pharmacies either posted 
no identifying information or simply gave false information, it 
was difficult for law enforcement to track any of the 
individuals behind the websites. The Attorney General also 
noted that the DOJ was using all available tools to investigate 
and shut down rogue Internet pharmacies, but left no doubt of 
the difficulties law enforcement was facing in these 
investigations.\34\
---------------------------------------------------------------------------
    \34\Department of Justice Oversight: Hearing Before the S. Comm. on 
the Judiciary, 110th Cong. (July 18, 2006) (statement of Alberto 
Gonzales, former Att'y Gen. of the United States).
---------------------------------------------------------------------------
    In January 2007, Attorney General Gonzales testified that 
problems with the illegal sale of prescription drugs over the 
Internet remained and that increased enforcement efforts were 
simply not enough. Mr. Gonzales indicated that the DOJ looked 
forward to working with Congress to enact additional 
enforcement tools to address the problem.\35\
---------------------------------------------------------------------------
    \35\Jan. 2007 DOJ Hearing, supra note 1; see also, Apr. 2007 DOJ 
Oversight, supra note 7.
---------------------------------------------------------------------------
    In responses to written follow-up questions, Mr. Gonzales 
explained that Internet technology had outpaced the enforcement 
scheme set forth in the 1970 Controlled Substances Act, which 
was enacted many years before the development and widespread 
use of the Internet.\36\ Mr. Gonzales stated that the evolution 
of Internet technology had created a haven for individuals to 
operate rogue Internet pharmacies anonymously. Noting that 
currently no statutory definition of a valid doctor/patient 
relationship existed, Mr. Gonzales's testimony indicated that 
additional statutory clarification relating to the sale of 
controlled substances over the Internet would allow law 
enforcement to more readily distinguish between legitimate and 
rogue online pharmacies, and would also help in gathering 
information pointing to drug abuse patterns.\37\
---------------------------------------------------------------------------
    \36\Jan. 2007 DOJ Hearing, supra note 1, at 12.
    \37\Id.
---------------------------------------------------------------------------
    Mr. Gonzales also testified that the statutory penalties 
associated with the sale of Schedule III-V controlled 
substances, the most common controlled substances sold over the 
Internet, were too lenient.\38\ In later testimony before the 
Committee, Mr. Rannazzisi also singled out Schedule III and IV 
controlled substances, including hydrocodone combination 
products and anabolic steroids, as ``increasingly accessible 
and often illegally purchased through the Internet.''\39\
---------------------------------------------------------------------------
    \38\Id.
    \39\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
    On March 1, 2008, in his national radio address, President 
George W. Bush called on Congress to enact legislation to 
address rogue Internet pharmacies.\40\ While noting that 
legitimate Internet pharmacies provide substantial benefits, 
the President said that the Internet has created the 
opportunity for unscrupulous doctors and pharmacists to profit 
from addiction. The President specifically mentioned Ryan 
Haight, for whom the bill is named, who died of an overdose of 
pain killers that were illegally prescribed over the Internet, 
and called on Congress to pass legislation to end the illegal 
sale of prescription drugs over the Internet.\41\
---------------------------------------------------------------------------
    \40\Bush Radio Address, supra note 8.
    \41\Id.
---------------------------------------------------------------------------
    Other groups have also called on Congress to enact 
legislation to address this problem. For example, CASA has 
noted that the lack of clarity in Federal and State law over 
what constitutes a legitimate prescription and has stated that 
enforcement efforts on the part of law enforcement to address 
rogue Internet websites have been hampered by the lack of clear 
legislation on the issue.\42\ CASA further concluded that 
because the Internet transcends State lines, Federal action is 
essential to address rogue Internet pharmacies.\43\
---------------------------------------------------------------------------
    \42\You've Got Drugs IV, supra note 9, at 3.
    \43\Id. at 8.
---------------------------------------------------------------------------
    The bill has received endorsements from law enforcement 
organizations such as the Fraternal Order of Police and the 
National Narcotics Officers' Associations Coalition, from 
industry representatives such as the Healthcare Distribution 
Management Association, AmerisourceBergen Corporation, eBay 
Inc., and GoDaddy.com, and from the Federation of State Medical 
Boards.

          II. History of the Bill and Committee Consideration


                      A. INTRODUCTION OF THE BILL

    Senators Feinstein and Sessions introduced S. 980, the 
Online Pharmacy Consumer Protection Act of 2007, on March 23, 
2007. The bill was referred to the Senate Committee on the 
Judiciary. Following the introduction of S. 980, Senators 
Biden, Coleman, Leahy and Cornyn joined as cosponsors of this 
legislation.

                       B. COMMITTEE CONSIDERATION

    On May 16, 2007, the Judiciary Committee held a hearing 
entitled, ``Rogue Online Pharmacies: The Growing Problem of 
Internet Drug Trafficking.''\44\ Witnesses at the hearing 
included: (1) Francine Haight of Laguna Niguel, California, 
Founder of Ryan's Cause; (2) Joseph T. Rannazzisi, Deputy 
Assistant Administrator of the Office of Diversion Control at 
the U.S. Drug Enforcement Administration; (3) Joseph A. 
Califano, Jr., Chairman and President of the National Center on 
Addiction and Substance Abuse at Columbia University (and 
former U.S. Secretary of Health, Education and Welfare); (4) A. 
Thomas McLellan, Ph.D., Executive Director of the Treatment 
Research Institute at the University of Pennsylvania; and (5) 
Philip Heymann, the James Barr Ames Professor of Law at Harvard 
Law School (and former U.S. Deputy Attorney General).
---------------------------------------------------------------------------
    \44\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph A. Califano).
---------------------------------------------------------------------------
    During the hearing, Ms. Haight testified about her son 
Ryan, who died from an overdose of controlled substances that 
he ordered over the Internet at age 17.\45\ Ryan, described as 
``the boy next door,'' was an honor student who maintained an 
academic average of at least 4.0 throughout high school, and a 
varsity athlete. Ryan also was computer savvy and was 
considering a possible career in computers after college. On 
February 12, 2001, Ryan's mother found him in bed, lifeless. 
Later analysis established an overdose of Vicodin, with traces 
of Valium and Morphine. His family did not know how Ryan had 
obtained such drugs until a friend of Ryan said he had bought 
them over the Internet. After examining Ryan's computer, the 
Haights learned that a doctor Ryan had never seen prescribed 
the medications, and an online pharmacy had delivered them to 
him at home. Ms. Haight testified, ``We did not know that drug 
dealers were in our own family room.'' Six years after the 
tragedy, Ms. Haight said that little has changed: ``I am still 
shocked at the ease and availability of buying controlled 
substances on the Internet. I still receive emails to purchase 
drugs daily.'' She concluded: ``Tighter controls on the sale of 
controlled substances on the Internet will not totally solve 
the drug problem, but I guarantee it will help and it's a good 
place to start.''\46\
---------------------------------------------------------------------------
    \45\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Francine Haight, Founder, Ryan's Cause).
    \46\Id.
---------------------------------------------------------------------------
    Mr. Rannazzisi testified about the methods historically 
used by many rogue Internet pharmacies, and named three primary 
facilitators of illegal pharmaceutical sales--the doctor, the 
pharmacy, and the Internet facilitator.\47\ His testimony noted 
that these sales are promoted by Internet facilitators who lack 
medical training and are not DEA registrants and that these 
facilitators target doctors with significant debt and convince 
them to approve prescriptions because prospective Internet 
clients submit minimum ``medical history'' forms through the 
website.\48\ Mr. Rannazzisi testified that such doctors approve 
prescriptions for Schedule III or IV controlled substances with 
the mistaken belief or justification that these substances are 
not as dangerous as those listed in Schedule II.\49\ According 
to Mr. Rannazzisi, for every online prescription that doctors 
authorize, the Internet facilitator pays the doctor $10 to $25, 
and law enforcement has discovered website-affiliated 
physicians who authorized hundreds of online prescriptions a 
day.\50\
---------------------------------------------------------------------------
    \47\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi).
    \48\Id.
    \49\Id.
    \50\Id. See also You've Got Drugs IV, supra note 9, at 7 (The 
National Center on Addiction and Substance Abuse calls such physicians 
``script doctors,'' who ``are willing to write prescriptions for a 
fee.'' It has identified some fees for certain prescriptions as high as 
$180); and Epstein, supra note 32 (noting that an ``accomplished'' 
doctor of this type, as the hired hand of an online pharmacy, 
``typically approves Internet prescriptions at a rate of more than 
1,000 a day--without communicating with the purchaser, or in many 
cases, reading the questionnaire.'' It estimates that ``[a]n ambitious 
doctor [of this type] can earn over $1 million a year.''). See also 
http://sid.senate.gov/dana/home/
launch.cgi?url=http%3A%2F%2Fwww.congress.gov%2F (Unfortunately, as the 
Congressional Research Service notes, ``laws governing medical practice 
vary widely in strength and effectiveness from State to State. While 
some states have strong laws that explicitly prohibit activities such 
as prescribing drugs without conducting an in-person examination, other 
states have weak laws, lax enforcement, or both.'')
---------------------------------------------------------------------------
    Mr. Rannazzisi testified that Internet facilitators also 
recruit brick and mortar pharmacies into their online schemes, 
often targeting small, independent pharmacies struggling to 
make ends meet.\51\ According to the DEA, the Internet 
facilitator tells these pharmacies that all they have to do is 
fill and ship these prescriptions to customers. In addition to 
paying the pharmacy for the cost of the prescription, the 
Internet facilitator also pays the pharmacy a negotiated fee, 
sometimes amounting to millions of dollars.
---------------------------------------------------------------------------
    \51\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph T. Rannazzisi).
---------------------------------------------------------------------------
    Mr. Rannazzisi also testified that Internet facilitators 
host the websites that draw online customers into the rogue 
Internet pharmacy scheme. According to Mr. Rannazzisi, these 
websites often mislead customers by advertising the website as 
an actual pharmacy. In reality, the rogue Internet websites 
offer only a few pharmaceutical products for sale, typically 
limited to prescription controlled substances and lifestyle 
drugs. Mr. Rannazzisi testified that website advertising 
typically emphasizes the ability of online customers to acquire 
controlled substances without prescription or an appropriate 
medical examination, and none of the rogue Internet pharmacies 
require an in-person medical examination from a licensed 
physician. He also testified that rogue Internet pharmacy 
websites rarely contain any identifying information on the 
website about where the pharmacy is physically located or who 
owns and operates it.\52\
---------------------------------------------------------------------------
    \52\Id.
---------------------------------------------------------------------------
    In addition, Mr. Rannazzisi's testimony highlighted how 
customers of rogue Internet pharmacies obtain prescription 
controlled substances online. Typically, customers simply 
filled out a medical questionnaire, without any meaningful 
interaction between a doctor and the customer. In many cases, 
the questionnaire simply is a ruse created to identify exactly 
what type of prescription controlled substance the customer 
wants to purchase. In some cases, such website questionnaires 
will not permit the customer to continue until specific 
information justifying the purchase of a particular 
prescription controlled substance is entered.\53\
---------------------------------------------------------------------------
    \53\Id.
---------------------------------------------------------------------------
    Mr. Rannazzisi also noted that prescription controlled 
substances in the United States are legitimately prescribed and 
dispensed within a closed system of distribution. With rogue 
Internet pharmacies, however, complicity exist among all of the 
participants, effectively eliminating all of the normal checks 
and balances. While acknowledging that rogue sites outside of 
the United States may prove more difficult to regulate, Mr. 
Rannazzisi testified that the ``DEA believes a majority of the 
rogue sites operating today are based in the United States and 
work in concert with unscrupulous doctors and pharmacies.'' 
Other evidence indicated that offshore and foreign rogue sites 
are also a very significant problem.\54\
---------------------------------------------------------------------------
    \54\Id.
---------------------------------------------------------------------------
    Mr. Califano testified that Federal enforcement efforts 
aimed at illegal Internet drug trafficking was complicated by 
outdated Federal law enacted before the advent of the 
Internet.\55\ Given the widespread public health threat that 
rogue Internet pharmacies posed, Mr. Califano called on 
Congress to take action legislatively to clarify Federal law to 
prohibit the sale or purchase of prescription controlled 
substances on the Internet without a valid prescription, and to 
require certification of online pharmacies to assure that they 
meet rigorous standards of professional practice. Mr. Califano 
specifically described S. 980 as an important ``step in the 
right direction.''\56\
---------------------------------------------------------------------------
    \55\Rogue Online Pharmacies Hearing, supra note 2 (testimony of 
Joseph A. Califano).
    \56\Id.
---------------------------------------------------------------------------
    Dr. McLellan, whose Treatment Research Institute first 
completed a study of this issue in 2004, testified that 
``anyone--regardless of age or medical need can purchase 
pharmaceutical grade opiates, barbiturates, benzodiazepines and 
stimulants over the Internet without a prescription.''\57\ 
Despite intensive publicity in the past,\58\ Dr. McLellan 
testified that nothing has changed and that it remains as easy 
to buy prescription controlled substances online as it is to 
buy a book or compact disc. He noted that while illicit drug 
use by teens had dropped 23% over the past five years, new 
users of prescription drugs have caught up with new users of 
marijuana. Dr. McLellan blamed the increase in prescription 
drug abusers on the rise of rogue Internet pharmacies. He 
testified that ``Internet savvy teenagers with their own credit 
cards or access to their parents' cards are increasingly 
disposed to prescription drugs to get high.'' In particular, 
Dr. McLellan singled out OxyContin and Vicodin--both in the 
same family of drugs as heroin--as two drugs teenagers are 
increasingly abusing. However, unlike heroin, OxyContin and 
Vicodin are appropriate for pain management when prescribed and 
taken under a physician's care, but are frequently available in 
large quantities through unscrupulous doctors and rogue 
Internet pharmacies.\59\
---------------------------------------------------------------------------
    \57\Rogue Online Pharmacies Hearing, supra note 2 (statement of A. 
Thomas McLellan, Ph.D., Executive Dir., Treatment Research Inst., Univ. 
of Penn.).
    \58\See, e.g., Gilbert M. Gaul and Mary Pat Flaherty, Doctors 
Medicate Strangers on Web, Washington Post, Oct. 23, 2003, at A1.
    \59\Rogue Online Pharmacies Hearing, supra note 2 (statement of A. 
Thomas McLellan).
---------------------------------------------------------------------------
    Dr. McClellan also discussed some of the more troubling 
marketing principles of Internet pharmacies' websites--
including free or discounted first orders, shipments with no 
identifying information, and even credit card billings for drug 
orders made to look like charged ``ring tones'' for a student's 
cellular phone. While deferring to others on the proper policy 
response, Dr. McLellan testified:

          [We] should do all in our power to put it out of the 
        reach of children. . . . for the majority of people in 
        this country suffering from addiction, the roots of the 
        disease can be traced to adolescence. More than 95% of 
        people who are dependent on alcohol or other drugs 
        started before they were 20 years old.\60\
---------------------------------------------------------------------------
    \60\Id.

    Mr. Heymann testified that despite the public outcry 
against rogue Internet pharmacies, nothing was being done 
legislatively to stop the problem.\61\ In Mr. Heymann's view, 
however, many rogue websites selling such narcotic painkillers 
as OxyContin and Vicodin are located abroad and will not be 
deterred by U.S. threats of increased penalties. Accordingly, 
Mr. Heymann suggested broader legislative approaches, such as 
Government funding of a private monitoring group, with immunity 
granted to companies taking actions recommended by that group. 
Other suggestions included legislation forcing Internet search 
engines to place warning banners on all online pharmacy 
websites, and efforts by Congress to enlist credit card 
companies and banks in enforcement efforts.\62\ Mr. Heymann 
noted that his suggestions arose after six plenary meetings at 
Harvard Law School, which were attended by a collaboration of 
affected parties, including leaders of companies that play key 
roles in Internet commerce, banks, credit card companies and 
private carriers.\63\ However, Mr. Heymann acknowledged that 
``not all agreed with each of our recommendations'' that were 
being suggested by the plenary group's 5-6 leaders. While 
leading credit card companies and Internet service providers 
did express general support for many of the plenary group's 
ideas, their preference was for encouraging voluntary 
compliance rather than legislative or regulatory mandates. 
Several plenary participants, as well as several panelists at a 
Judiciary Committee roundtable briefing held by the Internet 
Drug Caucus Advisory Committee on June 22, expressed opposition 
to adding these proposals to S. 980.
---------------------------------------------------------------------------
    \61\Rogue Online Pharmacies Hearing, supra note 2 (statement of 
Philip Heymann, James Barr Ames Professor of Law, Harvard Law School, 
former U.S. Deputy Att'y Gen. of the United States).
    \62\Id. (``[O]n receipt of information about illicit transactions 
from independent monitoring groups or from their own internal monitors, 
the financial institutions would and should be expected to identify the 
accounts that are being abused, presumably by putting through a `test' 
order of their own. The drug merchant's bank would be contractually 
obligated to know its customer and to take steps to penetrate any 
pseudonyms used by the drug dealer. The dealer's merchant bank would 
also cut off credit to the offending account and to those behind the 
account if it is really a front--furnishing the information it learns 
about the illegal transaction to other credit card companies and to law 
enforcement.'').
    \63\``KeepInternetNeighborhoodsSafe'':AProposalforPreventingthe
1AIllegal Internet Sales of Controlled Substances to Minors, Harvard 
Law School Internat'l Ctr. for Criminal Justice, July 13th, 2006, 
available at http://www.law.harvard.edu/programs/criminal-justice/kins-
draft.pdf.
---------------------------------------------------------------------------
    In addition to the hearing before the Senate Judiciary 
Committee in the 110th Congress, other congressional hearings 
have also examined problems of rogue Internet pharmacies, 
providing background for this legislation. For example, the 
Permanent Subcommittee on Investigations of the Senate's 
Committee on Homeland Security and Governmental Affairs held a 
hearing on June 17, 2004, following the issuance of a 
Government Accountability Office report that documented the 
ease with which prescription drugs, including addictive 
narcotic pain killers, could be purchased over the Internet 
without a prescription.\64\ On March 27, 2003 and March 18, 
2004, the House of Representatives' Committee on Government 
Reform also held hearings at which the FDA's Associate 
Commissioner for Policy and Planning discussed illegal Internet 
sales of controlled substances.\65\
---------------------------------------------------------------------------
    \64\Buyer Beware: The Danger of Purchasing Pharmaceuticals over the 
Internet--Day 2 Federal and Private Sector Responses: Hearing Before 
the Permanent Subcommittee on Investigations, S. Comm. on Homeland 
Security and Governmental Affairs 108th Cong., (2004); U.S. Gen. 
Accounting Office, Internet Pharmacies: Some Pose Safety Risks for 
Consumers and Are Unreliable in Their Business Practices (2004), 
available at http://www.gao.gov/new.items/d04888t.pdf.
    \65\Hearings Before the H. Comm. on Gov't Reform on Internet Drug 
Sales, 108th Cong. (2003, 2004) (testimony of William K. Hubbard, 
Assoc. Comm'r for Policy and Planning, Food and Drug Admin., Dep't of 
Health and Human Servs.).
---------------------------------------------------------------------------
    Chairman Leahy placed S. 980 on the Committee's executive 
business meeting agenda for consideration on September 20, 
2007, and the bill was considered by the Committee on that same 
day. Senator Feinstein introduced an amendment in the nature of 
a substitute to the original bill which was adopted by the 
Committee. In addition to making various substantive changes, 
the substitute named the bill in honor of Ryan Haight. The 
Committee, by voice vote, reported the Ryan Haight Online 
Pharmacy Consumer Protection Act of 2007, with an amendment in 
the nature of a substitute, favorably to the full Senate.

              III. Section-by-Section Summary of the Bill


Section 1. Short title

    This section provides that the legislation may be cited as 
the ``Ryan Haight Online Pharmacy Consumer Protection Act of 
2007,'' in honor of Ryan Haight, a California high school 
honors student and athlete who died in 2001 from an overdose of 
controlled substances that he had purchased from a rogue online 
pharmacy.

Section 2. Requirement of a valid prescription for controlled 
        substances dispensed by means of the Internet

    This section adds a new subsection to section 309 of the 
Controlled Substances Act that requires a ``valid 
prescription'' for dispensing a controlled substance over the 
Internet. A ``valid prescription'' is defined as one issued for 
a legitimate medical purpose in the usual course of 
professional practice, by a practitioner who has conducted at 
least one in-person medical evaluation of the patient, or a 
covering practitioner (as requested by a practitioner who had 
conducted an in-person medical evaluation of the patient within 
the past 24 months). Certain telemedicine practices are 
exempted from the in-person medical evaluation requirement.
    The Committee recognizes that telemedicine is a practice 
tool that can improve health outcomes and reduce costs. It is 
not the intent of the Committee to restrict the legitimate 
practice of telemedicine or the emerging practices of 
telemedicine which are consistent with medical practice 
guidelines of the State in which the practitioner is licensed, 
provided such practices do not contravene the goal of 
effectively controlling the diversion of controlled substances.
    The Committee recognizes that telemedicine offers options 
for specialty and primary care not available in many remote 
areas, and that practitioners with prescriptive authority are 
often not available on-site at the time of tele-consultations. 
It is not the intent of the Committee to place unnecessary 
restrictions on the operations or growth of telemedicine 
organizations that both conduct telemedicine consultations and 
provide Internet prescription services to its patients.
    Accordingly, the statute provides that the Attorney General 
and the Secretary of Health and Human Services may promulgate 
regulations that allow for the full practice of telemedicine 
consistent with medical practice guidelines, so long as those 
regulations continue to effectively control diversion. The 
Committee anticipates that the Attorney General and the 
Secretary may update these regulations on an ongoing basis to 
reflect changes in telemedicine.
    The legislation is intended to regulate practices related 
to the delivery, distribution, or dispensing of schedule II, 
III, IV, and V controlled substances by means of the Internet. 
The bill does not address the delivery, distribution, or 
dispensing of any non-controlled substance by means of the 
Internet or any other means. The bill is not intended to 
infringe upon the powers of the Department of Health and Human 
Services and its Secretary with respect to non-controlled 
substances. Nor is it intended to infringe upon the traditional 
power of the States to regulate the practices of medicine and 
pharmacy with respect to the prescription of non-controlled 
substances. It is not the intent of the Committee to affect the 
delivery, distribution, or dispensing of non-controlled 
substances, approved by the Secretary of Health and Human 
Services or the regulatory bodies of the States, by means of 
the legislation.

Section 3. Amendments to the Controlled Substances Act

    This section makes a number of changes to the Controlled 
Substances Act:
            Section 3(a)--Definitions
    This subsection defines ``Internet'', ``deliver, 
distribute, or dispense by means of the Internet'', ``online 
pharmacy,'' and ``practice of telemedicine.'' It also exempts 
from the definition of an ``online pharmacy'' non-pharmacy 
practitioners and mere advertisements that do not attempt to 
facilitate an actual transaction.
    It is not the intent of the Committee, in paragraph 
(55)(B), to prohibit a licensed pharmacist, acting pursuant to 
a patient's request via the Internet, and in the usual course 
of professional practice, from contacting the patient's 
prescriber and receiving an order for a new prescription for a 
previously prescribed controlled substance that has expired or 
has no remaining valid refills. Similarly, as a general rule, 
it is not the intent of the Committee, in paragraphs (56)(A), 
(B), and (C) to prohibit a pharmacist from contacting a 
practitioner under all the circumstances described in either 
paragraph (55) or (56). The lone exception is that a 
practitioner, acting in the usual course of professional 
practice and for a legitimate medical purpose, can direct the 
pharmacist that the patient should be prescribed a different 
controlled substance and specify the new prescription, provided 
that the pharmacist subsequently contacts the patient by 
telephone or in person to notify the patient of the 
practitioner's change in prescription and provides appropriate 
information and instructions to the patient regarding the 
change in medication.
    Therefore, it is the intent of the Committee that the 
modified registration, reporting, and website posting 
requirements applicable to online pharmacies would not apply to 
DEA-registered pharmacies whose Internet business consists 
solely of permitting consumers to use the pharmacy's Internet 
site to order refills in the scenarios described above.
            Section 3(b)--Registration requirements
    This subsection establishes that a pharmacy that seeks to 
dispense controlled substances via the Internet must register 
in accordance with regulations to be promulgated by the 
Attorney General.
            Section 3(c)--Reporting requirements
    This subsection requires that online pharmacies must report 
on substances dispensed in accordance with regulations to be 
promulgated by the Attorney General.
            Section 3(d)--Online pharmacy licensing and disclosure 
                    requirement
    This subsection requires that online pharmacies must 
clearly display notification that they comply with certain 
requirements set forth in the bill: Pharmacies must post 
information regarding: name of the owner, owner's contact 
information, list of states in which the pharmacy is licensed 
to distribute prescription drugs or controlled substances, name 
of the pharmacy, street address of the pharmacy, name and 
degree of pharmacist in charge, contact information for 
pharmacist in charge, and the name and contact information of 
affiliated practitioners. Their websites must also post a 
statement of compliance. Online pharmacies must also notify the 
Attorney General and State boards of pharmacy 30 days before 
they begin delivering, distributing, or dispensing a controlled 
substance.
            Section 3(e)--Increased penalties for illegal distribution 
                    of schedules III-V controlled substances
    This subsection increases the penalties for all illegal 
distributions of Schedule III, IV and V controlled substances 
(not just Internet sales). For Schedule III controlled 
substances, the maximum penalties are increased to 10 years for 
first offenders and 20 years for repeat offenders, and to 20 
and 30 years, respectively, if death or serious bodily injury 
results. For Schedule IV substances, the new penalties are 5 
years for first offenders and 10 years for repeat offenders. 
For Schedule V repeat offenders, the maximum penalty increases 
to 6 years. Supervised release terms after imprisonment for a 
Schedule V offense are also authorized for the first time.
            Section 3(f)--Internet sales of controlled substances
    This subsection clarifies that knowingly causing or 
facilitating the delivery or dispensing of controlled 
substances over the Internet in violation of this Act can be 
prosecuted and penalized in the same manner as illegal hand-to-
hand drug sales. The subsection clarifies, however, that this 
provision does not apply to persons who register and follow the 
requirements of this Act, to those who merely advocate usage or 
list pricing information but do not promote or facilitate an 
actual transaction involving a controlled substance, or to 
anyone providing telecommunications, Internet services, or 
links to other websites unless they are acting in concert with 
persons violating this Act.
            Section 3(g)--Advertising controlled substances
    This subsection clarifies that Internet sales of controlled 
substances must follow the terms of this Act.
            Section 3(h)--Injunctive relief
    This subsection authorizes State attorneys general to file 
civil lawsuits in Federal court against online pharmacies and 
obtain nationwide relief if the residents of a State are 
threatened or adversely affected by noncompliance, and the U.S. 
Attorney General is notified in advance and also given a chance 
to intervene in the case within 120 days.
            Section 3(i)--Forfeiture
    This subsection expands the scope of property subject to 
civil forfeiture under Federal drug laws, to encompass ``any 
property used, in any manner or part, to commit or to 
facilitate the commission of a violation'' under titles II or 
III of the Comprehensive Drug Abuse Prevention and Control Act.
    Concerns have been expressed about the potential impact of 
this provision upon responsible companies engaged in providing 
Internet marketplaces, electronic payment services, or similar 
e-commerce services whose property may be used without the 
companies' knowledge and consent to commit the new criminal 
offenses created by the bill to address illicit online 
pharmacies. Since such offenses will necessarily involve use of 
the Internet and likely will involve electronic payments, the 
Committee thinks it prudent to spell out its intent as to how 
this new authority should be used in this context.
    The intent of section 3(i), as applied to online 
pharmacies, is to authorize Federal civil forfeiture of non-
innocent owners' property that facilitates violations of the 
new statutes created by the bill. In this manner, this 
provision of the bill is intended to provide Federal law 
enforcement with an additional tool to combat the proliferation 
of Internet-based criminal operations that employ ever-changing 
methods and technologies to deliberately distribute 
pharmaceutical controlled substances without a sound medical 
basis. This expanded civil forfeiture authority is necessary to 
provide law enforcement with a more effective and rapid means 
to bring to a halt the operation of such rogue Web sites, which 
the bill is designed to prohibit.
    However, section 3(i) is not intended to authorize 
forfeiture of the property, including the computer equipment, 
facilities or networks of legitimate Internet marketplace 
companies or payment card systems that take reasonable 
precautions against the illegal use of their property, do not 
consent to such use, and, upon learning of any such use, do all 
that reasonably can be expected under the circumstances to 
terminate it. The Committee notes that responsible companies in 
this sector have adopted strong policies against use of their 
networks, websites, or services for illegal purposes, and have 
cooperated with law enforcement when they learned that their 
services were being abused for criminal purposes. The Committee 
commends those companies and encourages them to maintain and 
strengthen their anti-crime policies and their efforts to 
prevent criminal use of their property.
    The Committee is aware that many existing civil forfeiture 
statutes authorize forfeiture of property that is involved in 
or facilitates other violations of Federal law that may be 
facilitated through the abuse of the Internet. This existing 
authority has not had disruptive impact on legitimate Internet 
marketplaces, payment card systems, or their legitimate 
customers because it has been exercised carefully and prudently 
to date, in accordance with internal controls intended to 
prevent misuse. The Committee urges that such careful 
enforcement continue in service of the dual goals of detecting 
and preventing criminal use of the Internet and fostering the 
healthy growth of legitimate e-commerce.
            Section 3(j)--Import and Export Act
    This subsection makes the same penalty changes to the 
Import and Export Act that are being made to the Controlled 
Substances Act, so that illegal imports and exports of 
controlled substances will continue to receive the same 
penalties as illegal domestic sales.
            Section 3(k)--Effective date
    This subsection clarifies that the Act will become 
effective 60 days after enactment.
            Section 3(l)--Regulations and guidelines
    This subsection specifies that the Attorney General shall 
promulgate regulations as necessary to effect the Act, and the 
U.S. Sentencing Commission shall add or modify the Sentencing 
Guidelines as warranted.
            Section 3(m)--Report to Congress
    This subsection establishes that the DEA, after consulting 
with the State Department, must provide a report to Congress 
within 180 days of the Act's enactment, and annually thereafter 
for 2 years, describing the foreign supply chains and sources 
of controlled substances illegally offered over the Internet, 
and the efforts and strategies being used to confront these 
challenges globally.\66\
---------------------------------------------------------------------------
    \66\As CASA recommends, ``[T]he State Department should encourage 
and assist foreign Governments to crack down on Internet sites 
illegally selling controlled prescription drugs to U.S. citizens.''
---------------------------------------------------------------------------

             IV. Congressional Budget Office Cost Estimate

    The Committee sets forth, with respect to the bill, S. 980, 
the following estimate and comparison prepared by the Director 
of the Congressional Budget Office under section 402 of the 
Congressional Budget Act of 1974:
                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, October 25, 2007.
Hon. Patrick J. Leahy,
Chairman, Committee on the Judiciary,
U.S. Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 980, the Ryan Haight 
Online Pharmacy Consumer Protection Act of 2007.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mark 
Grabowicz.
            Sincerely,
                                                   Peter R. Orszag.
    Enclosure.

S. 980--The Ryan Haight Online Pharmacy Consumer Protection Act

    Summary: S. 980 would require businesses that distribute 
controlled substances using the Internet to register with the 
Drug Enforcement Administration (DEA). CBO estimates that 
implementing S. 980 would have no significant net cost to the 
Federal Government. Enacting the bill could affect direct 
spending and revenues, but CBO estimates that any net effects 
would not be significant.
    S. 980 contains an intergovernmental mandate as defined in 
the Unfunded Mandates Reform Act (UMRA) because it would 
preempt certain State regulations governing controlled 
substances that are manufactured, distributed, or dispensed via 
the Internet. CBO estimates, however, that states would incur 
few, if any, costs as a result of that preemption, and 
therefore the costs to comply with the mandate would be well 
below the threshold established in UMRA ($66 million in 2007, 
adjusted annually for inflation).
    The registration and reporting requirements and the 
requirement of a valid prescription for Internet distribution 
of controlled substances constitute private-sector mandates as 
defined in UMRA. CBO estimates that the direct costs of those 
mandates would not exceed the threshold established in UMRA 
($131 million in 2007, adjusted annually for inflation).
    Estimated cost to the Federal Government:

Spending subject to appropriation

    S. 980 would establish new crimes and increase penalties 
for activities relating to illegal use of controlled 
substances. Because the bill would establish new offenses, the 
government would be able to pursue cases that it otherwise 
would not be able to prosecute. We expect that S. 980 would 
apply to a relatively small number of offenders, however, so 
any increase in costs for law enforcement, court proceedings, 
or prison operations would not be significant. Any such costs 
would be subject to the availability of appropriated funds.

Direct spending and revenues

    S. 980 would require businesses that distribute controlled 
substances using the Internet to register with the DEA. The DEA 
would charge a registration fee of $551 for a three-year 
period. Based on information from the DEA about the likely 
number of new registrants, CBO estimates that the agency would 
collect no more than a few million dollars each year. The DEA 
would spend those fees without further appropriation, mostly in 
the same year, to conduct inspections and carry out 
administrative activities related to the new registrants. Thus, 
CBO estimates that S. 980 would have no significant net effect 
on DEA spending.
    Because those prosecuted and convicted under S. 980 could 
be subject to criminal fines, the Federal government might 
collect additional fines if the legislation is enacted. 
Criminal fines are recorded as revenues, then deposited in the 
Crime Victims Fund, and later spent. CBO expects that any 
additional revenues and direct spending would not be 
significant because of the small number of cases likely to be 
affected.
    Estimated impact on State, local, and Tribal Governments: 
S. 980 contains an intergovernmental mandate as defined in UMRA 
because it would preempt certain State regulations of 
controlled substances that are manufactured, distributed, or 
dispensed via the Internet. Under current law, states license 
pharmacies and doctors to dispense controlled substances within 
each state. This bill would prohibit the sale of controlled 
substances that are sold over the Internet without a 
prescription and would require doctors to have at least one in-
person consultation with patients for whom they prescribe 
controlled medications. Currently, all states allow medications 
to be purchased via the Internet, but some states do not 
specifically require in-person consultations for prescriptions. 
Enacting this provision would preempt State authority. CBO 
estimates, however, that states would incur few, if any, costs 
as a result of that preemption, and therefore the costs to 
comply with the mandate would be well below the threshold 
established in UMRA ($66 million in 2007, adjusted annually for 
inflation).
    Estimated impact on the private sector: The registration 
and reporting requirements and the requirement to have a valid 
prescription for distributing controlled substances via the 
Internet constitute private-sector mandates as defined in UMRA. 
CBO estimates that the direct costs of those mandates would not 
exceed the threshold established in UMRA ($131 million in 2007, 
adjusted annually for inflation).
    Estimate prepared by: Federal costs: Mark Grabowicz; Impact 
on State, local, and Tribal Governments: Melissa Merrell; 
Impact on the private sector: Colin Baker.
    Estimate approved by: Theresa Gullo, Deputy Assistant 
Director for Budget Analysis.

                    V. Regulatory Impact Evaluation

    In compliance with paragraph 11(b)(1), rule XXVI of the 
Standing Rules of the Senate, the Committee finds that the 
passage of S. 980 will require the Department of Justice to 
promulgate regulations governing the registration of, and 
reporting requirements imposed on, online pharmacies that 
dispense controlled substances by means of the Internet, and 
may require the Department of Health and Human Services and the 
Department of Justice to promulgate regulations governing 
certain practices relating to the practice of telemedicine.

                             VI. Conclusion

    The Congressional Research Service has stated:

          The current legal framework for regulating online 
        pharmacies and doctors is a patchwork of Federal and 
        State laws regarding controlled substances, 
        prescription drugs, pharmacies, and the practice of 
        medicine. Although many doctors and pharmacies who use 
        the Internet prescribe and dispense drugs in a safe and 
        legal fashion, others have exploited gaps in the 
        current system to prescribe and dispense potentially 
        dangerous quantities of highly addictive prescription 
        drugs.\67\
---------------------------------------------------------------------------
    \67\See Legal Issues Related to Prescription Drug Sales on the 
Internet (RS21711, updated September 19, 2007) https://sid.senate.gov/
dana/home/launch.cgi?url=http%3A%2Fst%2F www.congress.gov%2F.

    Passage and enactment of the bipartisan Ryan Haight Online 
Pharmacy Consumer Protection Act of 2007, S. 980, will address 
the intolerable ``wide-open channel of distribution'' that 
currently exists for prescription controlled substances sold 
over the Internet, which represents an ``easy availability 
[that] has enormous implications for public health, 
particularly the health of our children.''\68\ The Committee 
believes that the time has come for Congress to act, and that 
S. 980 is an appropriate response that should be adopted by 
Congress.
---------------------------------------------------------------------------
    \68\You've Got Drugs IV: Prescription Drug Pushers on the Internet, 
at 8 (White Paper issued by the National Center on Addiction and 
Substance Abuse at Columbia University, May 2007).
---------------------------------------------------------------------------

       VII. Changes to Existing Law Made by the Bill, as Reported

    In compliance with paragraph 12 of rule XXVI of the 
Standing Rules of the Senate, changes in existing law made by 
S. 980, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

TITLE 21, UNITED STATES CODE

           *       *       *       *       *       *       *


CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL

           *       *       *       *       *       *       *



Subchapter I--Control and Enforcement

           *       *       *       *       *       *       *



Part A--Introductory Provisions

           *       *       *       *       *       *       *



Sec. 802. Definitions

    As used in this subchapter:
          (1) * * *

           *       *       *       *       *       *       *

          (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 
        to all kinds by wire or radio.
          (51) The term ``deliver, distribute, or dispense by 
        means of the Internet'' refers, respectively, to any 
        deliver, 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
                  (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 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) mere advertisements that do not 
                        attempt to facilitate an actual 
                        transaction involving a controlled 
                        substance; or
                          (iv) a person, entity, or Internet 
                        site which 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.
          (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 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)).

           *       *       *       *       *       *       *


Part C--Registration of Manufacturers, Distributors, and Dispensers of 
                         Controlled Substances


Sec. 823. Registration requirements

    (a) * * *

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    (i) Dispenser of Controlled Substances by Means of the 
Internet.--
          (1) An online pharmacy shall obtain a 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 by means of the Internet.

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Sec. 827. Records and reports of registrants

    (a) Inventory.--

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    (d) Periodic Reports to Attorney General.--
          (1) Every manufacturer registered under section 823 
        of this title shall, at such time or times and in such 
        form as the Attorney General may require, make periodic 
        reports to the Attorney General of every sale, delivery 
        or other disposal by him of any controlled substance, 
        and each distributor shall make such reports with 
        respect to narcotic controlled substances, identifying 
        by the registration number assigned under this 
        subchapter the person or establishment (unless exempt 
        from registration under section 822(d) of this title) 
        to whom such sale, delivery, or other disposal was 
        made.
          (2) A pharmacy registered under section 303(i) shall 
        report to the Attorney General the controlled 
        substances dispensed under such registration, in such 
        manner and accompanied by such information as the 
        Attorney General by regulation shall require.

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Sec. 829. Prescriptions

    (a) * * *

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    (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 one 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 the clause (i) shall be 
                construed to imply that one 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 one in-
                        person medical evaluation of the 
                        patient during the 24-month period 
                        ending on the date of that medical 
                        evaluation; 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 if--
                          (i) the telemedicine is being 
                        conducted while the patient is being 
                        treated by, and physically located in, 
                        a hospital or clinic registered under 
                        section 303(f), and the practitioner 
                        conducting the practice of telemedicine 
                        is registered under section 303(f) in 
                        the State in which the patient is 
                        located and is acting in the usual 
                        course of professional practice and in 
                        accordance with applicable State law;
                          (ii) the telemedicine is being 
                        conducted while the patient is being 
                        treated by, and in the physical 
                        presence of, a practitioner registered 
                        under section 303(f) who is acting in 
                        the usual course of professional 
                        practice, and the practitioner 
                        conducting the practice of telemedicine 
                        is registered under section 303(f) in 
                        the State in which the patient is 
                        located and is acting in the usual 
                        course of professional practice and in 
                        accordance with applicable State law; 
                        or
                          (iii) the telemedicine 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; or
                  (B) The dispensing or selling of a controlled 
                substance pursuant to the practices as 
                determined by the Attorney General by 
                regulation, which shall be consistent with 
                effective controls against diversion.

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Sec. 830. Regulation of listed chemicals and certain machine

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Sec. 831. 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 
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.
    (c) Compliance.--No online pharmacy or practitioner shall 
deliver, distribute, or dispense by means of the Internet a 
controlled substance 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 Pharmacy 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 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 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 on 
                behalf of the online pharmacy is registered 
                under this part to deliver, distribute, or 
                dispense by means of the Internet controlled 
                substances.
          (4) The name, address, professional degree, and 
        licensure of practitioners who provide medical 
        consultations through the website for the purpose of 
        providing prescriptions.
          (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 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 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 (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.

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                     Part D--Offenses and Penalties


Sec. 841. Prohibited acts A

    (a) Unlawful Acts.--

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    (b) Penalties.--Except as otherwise provided in section 
849, 859, 860, or 861 of this title, any person who violates 
subsection (a) of this section shall be sentenced as follows:
          (1)(A) * * *

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          (C) In the case of a controlled substance in schedule 
        I or II, gamma hydroxybutyric acid (including when 
        scheduled as an approved drug product for purposes of 
        section 3(a)(1)(B) of the Hillory J. Farias and 
        Samantha Reid Date-Rape Drug Prohibition Act of 2000), 
        or [1 gram of] flunitrazepam, except as provided in 
        subparagraphs (A), (B), and (D), 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 less than twenty years or 
        more than life, a fine not to exceed the greater of 
        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. 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 30 
        years and if death or serious bodily injury results 
        from the use of such substance shall be sentenced to 
        life imprisonment, a fine not to exceed the greater of 
        twice that authorized in accordance with the provisions 
        of title 18 or $2,000,000 if the defendant is an 
        individual or $10,000,000 if the defendant is other 
        than an individual, or both. Notwithstanding section 
        3583 of title 18, any sentence imposing a term of 
        imprisonment under this paragraph shall, in the absence 
        of such a prior conviction, impose a term of supervised 
        release of at least 3 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 6 years in addition to such term of imprisonment. 
        Notwithstanding any other provision of law, the court 
        shall not place on probation or suspend the sentence of 
        any person sentenced under the provisions of this 
        subparagraph which provide for a mandatory term of 
        imprisonment if death or serious bodily injury results, 
        nor shall a person so sentenced be eligible for parole 
        during the term of such a sentence.
          (D) In the case of less than 50 kilograms of 
        marihuana, except in the case of 50 or more marihuana 
        plants regardless of weight, 10 kilograms of hashish, 
        or one kilogram of hashish oil [or in the case of any 
        controlled substance in schedule III (other than gamma 
        hydroxybutyric acid), or 30 milligrams of 
        flunitrazepam], such person shall, except as provided 
        in paragraphs (4) and (5) of this subsection, be 
        sentenced to a term of imprisonment of not more than 5 
        years, a fine not to exceed the greater of that 
        authorized in accordance with the provisions of title 
        18 or $250,000 if the defendant is an individual or 
        $1,000,000 if the defendant is other than an 
        individual, or both. 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 10 
        years, a fine not to exceed the greater of twice that 
        authorized in accordance with the provisions of title 
        18 or $500,000 if the defendant is an individual or 
        $2,000,000 if the defendant is other than an 
        individual, or both. Notwithstanding section 3583 of 
        title 18, any sentence imposing a term of imprisonment 
        under this paragraph 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.
          (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 the case of a controlled substance in schedule 
        IV, such person shall be sentenced to a term of 
        imprisonment of not more than [3 years] 5 years, a fine 
        not to exceed the greater of that authorized in 
        accordance with the provisions of title 18 or $250,000 
        if the defendant is an individual or $1,000,000 if the 
        defendant is other than an individual, or both. If any 
        person commits such a violation [after one or more 
        prior convictions of him for an offense punishable 
        under this paragraph, or for a felony under any other 
        provision of this subchapter or subchapter II of this 
        chapter or other law of a State, the United States, or 
        a foreign country relating to narcotic drugs, 
        marihuana, or depressant or stimulant substances, have 
        become final] 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 [6 
        years] 10 years, a fine not to exceed the greater of 
        twice that authorized in accordance with the provisions 
        of title 18 or $500,000 if the defendant is an 
        individual or $2,000,000 if the defendant is other than 
        an individual, or both. Any sentence imposing a term of 
        imprisonment under this paragraph shall, in the absence 
        of such a prior conviction, impose a term of supervised 
        release of at least one year 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 2 years in addition to such term of imprisonment.
          (3) In the case of a controlled substance in schedule 
        V, such person shall be sentenced to a term of 
        imprisonment of not more than one year, a fine not to 
        exceed the greater of that authorized in accordance 
        with the provisions of title 18 or $100,000 if the 
        defendant is an individual or $250,000 if the defendant 
        is other than an individual, or both. If any person 
        commits such a violation [after one or more convictions 
        of him for an offense punishable under this paragraph, 
        or for a crime under any other provision of this 
        subchapter or subchapter II of this chapter or other 
        law of a State, the United States, or a foreign country 
        relating to narcotic drugs, marihuana, or depressant or 
        stimulant substances, have become final] 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 [2 years] 6 years, a fine 
        not to exceed the greater of twice that authorized in 
        accordance with the provisions of title 18 or $200,000 
        if the defendant is an individual or $500,000 if the 
        defendant is other than an individual, or both. 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.

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    (h) 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) 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 a pharmacy not registered under section 
                303(i);
                  (B) writing a prescription for a controlled 
                substance for the purpose of delivery, 
                distribution, or dispensation by means of the 
                Internet in violation of subsection 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(i) or 309(e); and
                  (D) 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 subsection 
        (g)(1).
          (4) Any person who knowingly or intentionally 
        violates this subsection shall be sentenced in 
        accordance with subsection (b) of this section.

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Sec. 843. Prohibited acts C

    (a) * * *

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    (c) Advertisement.--
          (1) It shall be unlawful for any person to place in 
        any newspaper, magazine, handbill, or other 
        publications, any written advertisement knowing that it 
        has the purpose of seeking or offering illegally to 
        receive, buy, or distribute a Schedule\1\ I controlled 
        substance. As used in this section the term 
        ``advertisement'' includes, in addition to its ordinary 
        meaning, such advertisements as those for a catalog of 
        Schedule\1\ I controlled substances and any similar 
        written advertisement that has the purpose of seeking 
        or offering illegally to receive, buy, or distribute a 
        Schedule\1\ I controlled substance. The term 
        ``advertisement'' does not include material which 
        merely advocates the use of a similar material, which 
        advocates a position or practice, and does not attempt 
        to propose or facilitate an actual transaction in a 
        Schedule\1\ I controlled substance.
          (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 under section 303(i).
          (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.

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Part E--Administrative and Enforcement Provisions

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Sec. 881. Forfeitures

    (a) Subject Property.--The following shall be subject to 
forfeiture to the United States and no property right shall 
exist in them:
          (1) * * *

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          (4) [All conveyances, including aircraft, vehicles, 
        or vessels, which are used, or are intended for use, to 
        transport, or in any manner to facilitate the 
        transportation, sale, receipt, possession, or 
        concealment of property described in paragraph (1), 
        (2), or (9).] 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.

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Sec. 882. Injunctions

    (a) Jurisdiction.--The district courts of the United States 
and all courts exercising general jurisdiction in the 
territories and possessions of the United States shall have 
jurisdiction in proceedings in accordance with the Federal 
Rules of Civil Procedure to enjoin violations of this 
subchapter.
    (b) Jury Trial.--In case of an alleged violation of an 
injunction or restraining order issued under this section, 
trial shall, upon demand of the accused, be by a jury in 
accordance with the Federal Rules of Civil Procedure.
    (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.

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Subchapter II--Import and Export

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Sec. 960. Prohibited acts A

    (a) Unlawful Acts.--

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    (b) Penalties.--
          (1) * * *

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          (3) In the case of a violation under subsection (a) 
        of this section involving a controlled substance in 
        schedule I or II, gamma hydroxybutyric acid (including 
        when scheduled as an approved drug product for purposes 
        of section 3(a)(1)(B) of the Hillory J. Farias and 
        Samantha Reid Date-Rape Drug Prohibition Act of 2000), 
        or flunitrazepam, the person committing such violation 
        shall, except as provided in paragraphs (1), (2), and 
        (4), 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 less than 
        twenty years and not more than life, a fine not to 
        exceed the greater of 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. 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 30 years and if death or 
        serious bodily injury results from the use of such 
        substance shall be sentenced to life imprisonment, a 
        fine not to exceed the greater of twice that authorized 
        in accordance with the provisions of title 18 or 
        $2,000,000 if the defendant is an individual or 
        $10,000,000 if the defendant is other than an 
        individual, or both. Notwithstanding section 3583 of 
        title 18, any sentence imposing a term of imprisonment 
        under this paragraph shall, in the absence of such a 
        prior conviction, impose a term of supervised release 
        of at least 3 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 6 years in addition to such term of imprisonment. 
        Notwithstanding the prior sentence, and notwithstanding 
        any other provision of law, the court shall not place 
        on probation or suspend the sentence of any person 
        sentenced under the provisions of this paragraph which 
        provide for a mandatory term of imprisonment if death 
        or serious bodily injury results[, nor shall a person 
        so sentenced be eligible for parole during the term of 
        such a sentence].
          (4) In the case of a violation under subsection (a) 
        of this section with respect to less than 50 kilograms 
        of marihuana, except in the case of 100 or more 
        marihuana plants regardless of weight, less than 10 
        kilograms of hashish, or less than one kilogram of 
        hashish oil, [or any quantity of a controlled substance 
        in schedule III, IV, or V,\3\ (except a violation 
        involving flunitrazepam and except a violation 
        involving gamma hydroxybutyric acid)] the person 
        committing such violation shall be [imprisoned not more 
        than five years, or be fined not to exceed the greater 
        of that authorized in accordance with the provisions of 
        title 18 or $250,000 if the defendant is an individual 
        or $1,000,000 if the defendant is other than an 
        individual, or both. If a sentence under this paragraph 
        provides for imprisonment, the sentence shall, 
        notwithstanding section 3583 of title 18, in addition 
        to such term of imprisonment, include (A) a term of 
        supervised release of not less than two years if such 
        controlled substance is in schedule I, II, III, or (B) 
        a term of supervised release of not less than one year 
        if such controlled substance is in schedule IV] 
        sentenced in accordance with section 401(b)(1)(D) of 
        this title (21 U.S.C. 841(b)(1)(E)).
          (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).