Of course, deadiversion.usdoj.gov doesn't exactly make it easy to figure out where to post the comments. It's also unusual for the 60 day comment period to begin after the implementation of a law. Suggests this law was rushed out with little forethought....

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However to zero in on where we can make our actual comments, goto http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480944156 and click the link at the top that says: "Docket DEA-2009-0004"

A. Reasons for the Legislation
The unlawful use of pharmaceutical
controlled substances has reached
alarming levels in the United States in
recent years, causing a substantial
detrimental effect on the public health
and safety. According to the most
recently published National Survey on
drug Use and Health (2007),5 6.9
million Americans reported using
psychotherapeutic drugs 6 nonmedically
during the prior month.7 With specific
regard to pain relievers, 5.2 million
respondents reported abusing these
drugs,8 which is an 18 percent increase
from 2004.9 This study further indicates
that, in the United States, the abuse of
prescription drugs is second only to that
of marijuana and is higher than the
abuse of cocaine, heroin and
hallucinogens combined.10 Among
persons aged 12 and older who reported
using illicit drugs for the first time in
2007, abuse of pain relievers was the
most common category of first-time
illicit drug use.11
The false sense of security that some
associate with the abuse of these
substances is also alarming. Many
mistakenly believe that if a drug may be
prescribed for medical use, abusing that
drug cannot be as harmful as abusing
more conventional ‘‘street’’ drugs, such
as heroin or cocaine. According to the
2005 Partnership Attitude Tracking
Study 12, 40 percent of teens surveyed
believe that prescription medicines are
‘‘much safer’’ to use than illegal drugs.
Furthermore, the same study concluded
that 31 percent believe there is ‘‘nothing
wrong’’ with using prescription
medicines without a prescription ‘‘once
in awhile.’’ 13
One of the main factors contributing
to the nationwide increase in the
diversion of pharmaceutical controlled
substances has been the rise in the
number of Internet sites that sell or
facilitate the sale of these drugs for other
than legitimate medical purposes. While
in-person ‘‘prescription mills’’
(practitioners’ offices that readily
supply drug seekers with prescriptions
for controlled substances without
establishing a legitimate medical basis
for doing so) have always been, and
remain, a significant source of
diversion, the advent of rogue Web sites
that cater to those who abuse
pharmaceutical controlled substances
has allowed the criminal operators of
these sites to exploit the anonymity of
the Internet to generate illicit sales of
controlled substances (and/or
prescriptions therefor) that far exceed
those of any in-person prescription mill.
This is particularly evident when
examining the data relating to the sales
of hydrocodone, which is the most
widely abused pharmaceutical
controlled substance in the United
States. According to data registered
distributors of controlled substances
provided to DEA 14 in 2006, 34
pharmacies in the United States that
were supplying rogue Internet sites
dispensed a total of more than 98
million dosage units of hydrocodone.
Hence, these pharmacies each
dispensed an average of approximately
2.9 million dosage units of hydrocodone
per pharmacy in a single year. By means
of comparison, the average pharmacy in
the United States dispenses
approximately 88,000 dosage units of
hydrocodone per year.
Congress passed the Ryan Haight Act
precisely because of ‘‘the increasing use
of prescription controlled substances by
adolescents and others for nonmedical
purposes, which has been exacerbated
by drug trafficking on the Internet.’’ 15
The person for whom the Act was
named, Ryan Haight, was ‘‘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.’’ 16 According to the Senate
Report accompanying the legislation,
‘‘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.’’ 17
The Senate Report then cited a list of
examples of persons in the United
States who had died from overdoses of
controlled substances obtained via the
Internet.18

B. Common Methods Employed by
Operators of Rogue Web Sites That Sell
Pharmaceutical Controlled Substances
The rogue Web sites that the Ryan
Haight Act seeks to eliminate take on a
variety of appearances and use a variety
of methods. One common factor is that
all these Web sites are marketed toward
drug seekers who are willing to pay a
premium to obtain pharmaceutical
controlled substances without having a
legitimate medical need for them. While
the ‘‘business models’’ that the
operators of these sites employ to evade
detection by law enforcement and/or to
create the facade of compliance with the
law have evolved significantly over
time, there tend to be three categories of
participants in these schemes: the
prescribing practitioner; the pharmacy
that fills the prescriptions; and the
criminal facilitator (a non-DEA
registrant) who runs the operation.19
While it has always been illegal to
dispense a controlled substance without
a legitimate medical purpose, prior to
the Act, a rogue operator could design
a site that would make it clear to drug
seekers that pharmaceutical controlled
substances could be obtained through
the site without a legitimate medical
purpose. For example, a typical rogue
site would display prominently on its
homepage a list of the pharmaceutical
controlled substances that it sold and
prompt customers to click on their
desired drugs. These Web sites could
easily be found by using any of various
Internet search engines and entering
search terms such as ‘‘hydrocodone no
prescription.’’ Unsolicited e-mails or
other forms of online advertising and
marketing often steered potential
customers to these Web sites; the
advertisements announced that
controlled substances could be readily
obtained through the Web site without
an in-person medical evaluation and
sometimes without even a
prescription—thus insuring a drug
seeking customer could obtain the
controlled substance without a
legitimate medical need.
Thus, prior to passage of the Act,
attracting customers was relatively easy
for these rogue Web sites. However, to
deliver the goods that the customers
were seeking (pharmaceutical controlled
substances and/or prescriptions for
such), the operator of the rogue Web site
usually had to enlist the services of two
types of DEA registrants: a practitioner
and pharmacy. Thus, the typical
criminal facilitator had to recruit an
unscrupulous practitioner willing to
prescribe controlled substances without
a legitimate medical evaluation obtained
through a bona fide doctor-patient
relationship. While the overwhelming
majority of practitioners would want no
part of this type of improper
arrangement, criminal facilitators were
able to find some unscrupulous
practitioners willing to participate.
Investigations have revealed that these
facilitators often target practitioners
who carry significant debt, such as those
recently graduated from medical school,
or those who have retired and are
looking for some ‘‘extra income.’’
Regardless of the motivations of the
participating practitioners, the
facilitator would persuade them to enter
into an agreement whereby they would
agree to write prescriptions for
controlled substances without adhering
to the standard professional practices
employed by practitioners when
evaluating the medical condition of
patients and determining the
appropriate treatment in return for
payment from the facilitator based on
the number of prescriptions they would
write. These arrangements operated in
several ways. In some instances, the
facilitator would arrange for a
practitioner to issue prescriptions for
controlled substances based solely on
reviewing online questionnaires the
customers submitted to the Web site.
Other schemes involved facilitators
requiring the customers of the Web site
to fax some documentation that
purported to be the customers’ ‘‘medical
records’’ and then having an
unscrupulous practitioner issue
prescriptions for controlled substances
based on a ‘‘review’’ of these faxed
documents. A third type of scheme
involved the facilitator having
customers of the Web site call a
telephone number staffed by employees
of the site, answer a series of questions
purporting to create a ‘‘medical
history,’’ and then have unscrupulous
practitioners write the prescriptions
based on these answers. Whatever the
methods employed, these rogue Web
site operations were merely a sham, as
every step in the process was designed
to sell customers controlled substances
and/or prescriptions for controlled
substances without regard to actual
medical need.
Some criminal facilitators have been
content to take in the profits associated
with selling the prescriptions for
controlled substances. (Some rogue Web
sites charge customers a separate fee for
arranging the issuance of prescriptions.)
Others have sought to increase their
profits by also having customers fill the
prescriptions through a pharmacy
affiliated with the Web site. To achieve
the latter, the criminal facilitator needed
to enter into an agreement with an
unscrupulous pharmacy that was
willing—for a fee—to fill prescriptions
for controlled substances with
essentially no questions asked and for as
many prescriptions as the Web site
could steer toward the pharmacy.20 In
addition to paying the pharmacy for the
cost of the drugs, the criminal facilitator
would also typically pay the pharmacy
an agreed upon amount that, in some
instances, amounted to millions of
dollars. Given the amount of money to
be made from these arrangements, DEA
has seen pharmacies close their doors
completely to walk-in customers and
convert their entire business to filling
orders generated from rogue Web sites.
In some instances, criminal facilitators
have used multiple brick and mortar
pharmacies to service their list of drug
seeking customers. In other cases, a
single pharmacy has supplied multiple
rogue Web sites.
These rogue Web sites generally
provide the customer with a wide
variety of quick and easy payment
methods, such as cash-on-delivery, lines
of credit, and credit ‘‘gift’’ cards. They
also typically structure the various steps
of the ordering process so as to link and
shift the buyer to different Web sites,
making it difficult for investigators to
connect payments, products, and Web
providers together. Rarely do such rogue
Web sites contain any identifying
information about where the online
pharmacy is located or who owns or
operates the Web site. On the contrary,
these Web sites frequently fluctuate in
name and number minute by minute.
Finally, the typical rogue Web site fails
to provide any information on how a
patient may contact the prescribing
practitioner or the pharmacist to consult
with them about the drug(s) ordered,
including drug interactions and adverse
reactions.
Recognizing that these rogue Web
sites fuel the abuse of prescription
controlled substances and thereby
increase the number of resulting
overdoses and other harmful
consequences, Congress passed the
Ryan Haight Act to prevent the Internet
from being exploited to facilitate such
unlawful drug activity

The Act contains specific examples of
conduct which would violate 21 U.S.C.
841(h)(1). These examples in the Act,
however, are not an exclusive list of the
types of conduct that constitute
violations of 21 U.S.C. 841(h)(1). With
this proviso made clear, 21 U.S.C.
841(h)(2) lists the following as examples
of violations:
(A) Delivering, distributing, or dispensing
a controlled substance by means of the
Internet by an online pharmacy that is not
validly registered with a modification
authorizing such activity as required by [21
U.S.C. 823(f)] (unless exempt from such
registration);
(B) Writing a prescription for a controlled
substance for the purpose of delivery,
distribution, or dispensation by means of the
Internet in violation of [21 U.S.C. 829(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 [21
U.S.C. 823(f) or 829(e)];
(D) Offering to fill a prescription for a
controlled substance based solely on a
consumer’s completion of an online medical
questionnaire; and
(E) Making a material false, fictitious, or
fraudulent statement or representation in a
notification or declaration under [21 U.S.C.
831(d) or (e)].
As these examples are largely selfilluminating,
and some have already
been addressed in this preamble, only
limited further amplification is
provided here. Paragraph (C), in
particular, reflects that the Act was
intended not only to prohibit DEA
registrants from using the Internet to
facilitate the unlawful dispensing of
controlled substances, but to also
prohibit non-DEA registrants from doing
so. Most notably, paragraph (C) is aimed
squarely at the criminal facilitator
whose ‘‘business plan’’ for operating a
rogue online pharmacy is to recruit an
unscrupulous practitioner to write
prescriptions based on insufficient or
nonexistent medical evaluations and/or
an unscrupulous pharmacist to fill such
prescriptions.
The Act contains certain categories of
conduct that do not result in the
participants falling within the Act’s
definition of an online pharmacy.
Specifically, 21 U.S.C. 841(h)(3) states:
(A) This subsection [21 U.S.C.
841(h)(1)] does not apply to:
(i) The delivery, distribution, or
dispensation of controlled substances by
nonpractitioners to the extent authorized by
their registration under [the CSA];
(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
VerDate Nov<24>2008 18:18 Apr 03, 2009 Jkt 217001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\06APR2.SGM 06APR2 pwalker on PROD1PC71 with RULES2
Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations 15605
33 Under the CSIEA, the importation of controlled
substances into the United States is prohibited
except by persons registered with DEA to do so or
persons exempted from such requirement. 21 U.S.C.
952, 957, 960. In accordance with the CSIEA, DEA
has issued a regulation authorizing a person to
import certain controlled substances for personal
medical use, provided the person has the drugs in
his possession upon entering the United States,
makes the required declaration to the U.S. Customs
and Border Protection, and otherwise complies
fully with the requirements of the regulation. 21
CFR 1301.26; 69 FR 55343 (2004). Under no
circumstances is it permissible under the CSIEA or
the regulations for a person to have controlled
substances shipped into the United States for
personal medical use.
34 United States v. Katz, 445 F.3d 1023, 1031 (8th
Cir. 2006), cert. denied, 127 S.Ct. 421 (2006).
35 United States v. Lawson, 682 F.2d 480, 482 (4th
Cir. 1982) (citations omitted), cert. denied, 459 U.S.
991 (1982).
by another person in a manner consistent
with section 230(c) of the Communications
Act of 1934 [47 U.S.C. 230(c)] shall not
constitute such selection or alteration of the
content of the communication.
(B) The exceptions under subclauses (I)
and (II) of subparagraph (A)(iii) shall not
apply to a person acting in concert with a
person who violates paragraph (1).
Thus, paragraph (A)(i) allows DEAregistered
nonpractitioners (such as
manufacturers and distributors) to
utilize the Internet in carrying out
activities authorized by their DEA
registrations (and otherwise in
conformity with the CSA) without being
subject to liability under 21 U.S.C.
841(h)(1). Paragraph (A)(ii) allows for
Web sites that advocate the use of
controlled substances or contain pricing
information ‘‘without attempting to
propose or facilitate an actual
transaction involving a controlled
substance.’’ Paragraph (A)(iii) exempts
from application of 21 U.S.C. 841(h)(1)
Internet service providers, Web hosting
services, and certain other specified
entities that do not alter content of
Internet transmissions. However, it is
crucial to bear in mind that the
exception of paragraph (A)(iii) does not
apply to ‘‘a person acting in concert
with a person who violates [21 U.S.C.
841(h)(1)].’’ Thus, any person whose
conduct would be sufficient to prove
that he conspired to violate 21 U.S.C.
841(h)(1), or aided and abetted such
violation, is not immune from
prosecution under paragraph (A)(iii).
The second new criminal offense
added by the Act is 21 U.S.C.
843(c)(2)(A). This provision expressly
prohibits using the Internet to advertise
illegal transactions in controlled
substances. Specifically, this provision
states:
It shall be unlawful for any person to
knowingly or intentionally use the Internet,
or cause the Internet to be used, to advertise
the sale of, or to offer to sell, distribute, or
dispense, a controlled substance where such
sale, distribution, or dispensing is not
authorized by [the CSA] or by the Controlled
Substances Import and Export Act.

The RHA seems to say all OCS's are considered online pharmacies even if they say they are referral services. I have not noticed any OCS displaying the info the this law requires on their Webs.
Is there any OCS rep here that can comment on this?

IN ACCORDANCE WITH THE RYAN HAIGHT LAW/AMENDMENT TO THE FEDERAL CONTROLLED SUBSTANCES ACT, WE HAVE NOW CEASED OPERATIONS.

I noticed this too A. Basically, ALL OCS will have to be licensed through the DEA to be considered legit is how I read it...

(51) The term ‘‘deliver, distribute, or
dispense by means of the Internet’’ refers,
respectively, to any delivery, distribution, or
dispensing of a controlled substance that is
caused or facilitated by means of the Internet.
This definition is plainly broad in
scope, encompassing any activity
utilizing the Internet that causes or
facilitates the delivery, distribution, or
dispensing of a controlled substance.
This definition is incorporated into the
Act’s definition of an ‘‘online
pharmacy’’:
(52) The term ‘‘online pharmacy’’ * * *
means [with certain exceptions discussed
below] 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.
The definition of ‘‘online pharmacy’’ is
also broad in scope. First, it includes
not only a ‘‘person’’ 23 but also any other
‘‘entity’’ or ‘‘Internet site’’—‘‘whether in
the United States or abroad’’—that
otherwise meets the definition of an
‘‘online pharmacy.’’ Second, it also
includes not only any such person,
entity or Internet site ‘‘that knowingly or
intentionally delivers, distributes, or
dispenses * * * a controlled substance
by means of the Internet,’’ but also any
such one who ‘‘offers or attempts’’ to do
so.

It looks like what they offer, referrals to doctors offering in-person consultations, is within the law and it does not look like they can be considered an online pharmacy.

Has anyone noticed any "online pharmacy" or OCS changing their Web to include the info and disclimers required by this law or any OCS's doing business as usual as if the RHA was not about them?

1ST Class Care Has Changed their Home Page!

Our Mission:

Our reason to exist is to arrange that you can consult with a sympathetic and respectful medical practitioner who is resident and licensed in the u.s. and who will thoughtfully consider your complaint and authorize appropriate treatment and medication – all with outstanding personalized customer service. In accordance with the "Ryan Haight Online Pharmace Consumer Protection Act of 2008" our consultation cycle can begin only with an in person face to face medical evaluation by the practitioner who issues a precription to you for a controlled substance. The practioner will decide upon the number and timing of all subsequent "follow up" telephone consultations as may be required by good practice and local law. The initial in person medical evaluation will take place in the state in which the practitioner is licensed. We encourage the practitioners who work with us, and subject to their professional decision, to follow a "no refill-one month follow up" protocol, to include necessary blood work in their exam and to secure a patient agreement when appropriate."

1st Class Care complies with the requirements of Section 311(c) of 21 U.S.G. 802 with respect to the delivery, sale or offer for sale of controlled substances. Please Click Here for information to Section 311(c). With respect to said compliance, 1st Class Care emphasizes that it is not a "pharmacy" in the usual sense and does not posess,sell or ship any medication whatsoever and has submitted all registration information required by Section 311(c) reflects that situation.

News Release [print-friendly page]
FOR IMMEDIATE RELEASE
Contact: Garrison Courtney
Number: 202-307-7977
April 13, 2008

New Rules Governing Internet Pharmacies Go Into Effect TODAY
Regulations Implement Ryan Haight Act

APR 13 -- (Washington, DC)- New Drug Enforcement Administration (DEA) regulations implementing the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 go into effect Monday, April 13. These regulations will help to prevent the illegal diversion of powerful medications that can cause harm to consumers for whom they were not intended, for the profit of those who are not licensed to handle them and who would exploit the uninformed. The Interim Final Rule was published in the Federal Register this week, and the public has 60 days from its publication to submit comments to the DEA.

The Ryan Haight Act, named for an 18-year-old who died after overdosing on a prescription painkiller he obtained on the Internet from a medical doctor he never saw, was enacted on October 15, 2008, through the joint efforts of his mother, Francine Haight, and members of Congress, with the support of the DEA.

“Now that this law has been put into force it will be harder for cyber-criminals to supply controlled substances over the Internet and easier for us to prosecute them,” said DEA Acting Administrator Michele M. Leonhart. “These regulations add important new provisions to prevent the illegal distribution of controlled substances through the Internet. Its implementation will increase Internet safety and help prevent tragedies like Ryan Haight’s death from happening again.”

The statute amends the Controlled Substances Act (CSA) by adding several new provisions to prevent the illegal distribution of controlled substances by means of the Internet, including:

New definitions, such as “online pharmacy” and “deliver, distribute, or dispense by means of the Internet”;
A requirement of at least one face-to-face patient medical evaluation prior to issuance of a controlled substance prescription;
Registration requirements for online pharmacies;
Internet pharmacy website disclosure information requirements; and
Prescription reporting requirements for online pharmacies.
Consistent with the CSA itself, the Ryan Haight Act relates solely to controlled substances. Controlled substances are those psychoactive drugs and other substances – including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids – that are placed in one of the five schedules of the CSA due to their potential for abuse and likelihood that they may cause psychological or physical dependence when abused. Controlled substances constitute only a small percentage of all pharmaceutical drugs. Approximately 10 percent of all drug prescriptions written in the United States are for controlled substances, with the remaining approximately 90 percent of prescriptions being written for non-controlled substances. The amendments to the CSA made by the Ryan Haight Act, as well as the regulations being issued here, do not apply to non-controlled substances.

Unscrupulous or “rogue” Internet pharmacies exist to profit from the sale of controlled prescription medicines to buyers who have not seen a doctor and don’t have a prescription from a registered physician. The pharmacies lack quality assurance and accountability, and their products pose a danger to buyers. They pretend to be authentic by operating websites that advertise powerful drugs with the “approval” of a “doctor” working for the drug trafficking network. Prescription medications are powerful drugs that, while lifesaving under some circumstances, can be harmful or even lethal under others, and registered physicians and pharmacists exist to advise consumers on the difference. DEA maintains a hotline for reporting suspicious Internet pharmacies. Call 1-877-792-2873 or click on the “Report Suspicious Internet Pharmacies” icon on the home page of http://www.deadiversion.usdoj.gov.

Like Haight, nearly one in five teenagers (19%) has used a prescription medication to get high, according to the 2008 Partnership Attitude Tracking Survey (PATS) conducted by the Partnership for a drug-Free America. The same survey found that two in five teens believe the fallacy that prescription medicines obtained without a prescription are “much safer” to use than illegal drugs. The 2008 Monitoring the Future survey sponsored by the National Institute on drug Abuse found that 7 of the top 10 drugs abused by high school seniors are prescription or over-the-counter medications. Prescription drugs are now as common as marijuana as the gateway to recreational drug use and abuse by teenagers.

For more information clarifying these new regulations or for information on how to submit written or electronic comments about them within the 60-day comment period, go to http://www.deadiversion.usdoj.gov. For more information on Ryan Haight, go to http://www.familieschangingamerica.org/board-story-ryan-h.html. For general information about drugs (including prescription drugs), drug abuse and prevention, go to http://www.getsmartaboutdrugs.com.

I'm a bit reluctant/nervous about bringing it to the pharmacy as I'm thinking they are focused on the new regs, and probably not willing to discuss the dates.
A difficult spot, as I know I have legit need for the meds, but don't want to debate laws with whomever I submit it too, or be told I'm breaking the law.