Microsoft word - updated_nabp internet drug outlet report_may 2012
Internet Drug Outlet
Updated Progress Report for State and Federal Regulators: April 2012 – Re-Issued May 14, 2012
TABLE OF CONTENTS
INTRODUCTION . 3
A. Findings of Site Reviews . 4
B. Recommended Internet Pharmacies . 5
C. Accreditation and Approval Applicant Screenings . 6
DRUG SHORTAGES CREATE NICHE FOR SWINDLERS . 6
Gray-Market Risks . 6
B. Counterfeit Medications and Unapproved Foreign Drugs . 7
C. Fake Pharmacy Schemes . 9
D. Registrars' Role in Illicit Drug Sites . 10
OUTREACH . . EDUCATION . . ACTION! . 11
A. Pharmacy gTLD Initiative . 11
B. NABP Task Force on Internet Pharmacy Practice . 11
AWARXE Consumer Protection Program . 12
APPENDIX: Internet Drug Outlet Identification Program Criteria . 14
INTERNET DRUG OUTLET IDENTIFICATION PROGRAM
UPDATED PROGRESS REPORT: April 2012 – Re-Issued May 14, 2012
Criminals, like legitimate enterprises, adapt to the rhythms of supply and demand. Unfortunately,
when the legitimate suppliers fall short of fulfilling consumer demand, crooks rush in to fill the
void. This age-old pattern has come to light amidst the current prescription drug shortages. The
ongoing shortage of certain medications has created a lucrative niche market for counterfeiters
and so-called gray-market distributors. The National Association of Boards of Pharmacy®
(NABP®) has assisted in the investigations of operations that turn a blind eye to pharmacy laws
and patient safety in the interest of their own financial gain. Additionally, NABP has identified
illegal online drug sellers that exploit consumers' worries about prescription drug shortages to
sell substandard, unapproved knock-offs of brand-name drugs that are available in plentiful
supply through normal legal channels. Such rogue sites are among the more than 9,000 Web sites
NABP has found to be operating out of compliance with pharmacy laws and practice standards
established in the United States to protect the public health. These rogue sites – composing the
vast majority (96%) of the total number of sites NABP staff has reviewed – are posted to the Not
Recommended list on the NABP Web site to serve as a resource for health care professionals and
patients alike. Among these rogue sites are several that offer medications listed on the Food and
Drug Administration (FDA) list of drugs in short supply.
Regulators, enforcement agencies, and patient safety advocates worldwide are honing in on this
criminal activity that freely spans the globe in a tangled web of international affiliations and
back-door deals. In response, NABP, with the support of a global coalition of pharmacy
stakeholders, is taking on an unprecedented, but necessary, initiative to hold online drug sellers
accountable to the pharmacy laws and patient safety standards established by responsible
jurisdictions worldwide to protect the public health. NABP is applying to the International
Corporation for Assigned Names and Numbers (ICANN) to obtain and operate a .pharmacy top-
level domain. The plan will create a safe and secure space on the Internet for legitimate Web site
operators. These exploits and efforts will be discussed further in sections III and IV of this report.
A. Findings of Site Reviews: As of
March 30, 2012, NABP has
conducted initial reviews and, via a
Internet Drug Outlets Reviewed
subsequent review, verified its
findings on 9,677 Internet drug
outlets selling prescription
medications. During the period from
January 1, 2012 through March 30,
2012, staff identified nearly 900
additional Internet drug outlets
operating out of compliance with
state and federal laws and/or NABP
patient safety and pharmacy practice
standards. These findings bring the total number of sites operating out of compliance with
laws and standards to 9,349, or 96.61% of the 9,677 Internet drug outlets reviewed and
verified. These illegitimate Internet drug outlets are listed as Not Recommended in the
"Buying Medicine Online" section, under Consumers, on the NABP Web site. Sites listed as
Not Recommended include those that were found to be noncompliant at the time of review
but may since have been deactivated.
The 9,349 Internet drug outlets currently listed as Not Recommended on the NABP Web site
are characterized as follows:
• 2,211 have a physical address located outside of the US (though most rogue sites do
not post any address)
• 8,122 do not require a valid prescription • 5,505 issue prescriptions per online consultation or questionnaire only • 4,648 offer foreign or non-FDA-approved drugs • 1,523 do not have secure sites • 3,363 have server locations in foreign countries • 9,062 appear to be affiliated with a network • 1,049 dispense controlled substances
Of the total 9,677 sites reviewed, 259 (2.68%) appear to be potentially legitimate, ie, meet
program criteria that could be verified solely by looking at the sites. Sixty-nine (0.71%) of the
9,677 reviewed sites have been accredited through NABP's Verified Internet Pharmacy
Practice SitesCM (VIPPS®) or Veterinary-Verified Internet Pharmacy Practice SitesCM (Vet-
VIPPS®) programs, or approved through the NABP e-Advertiser ApprovalCM Program. The
criteria against which NABP evaluates Internet drug outlets are provided in the appendix of
FINDINGS OF NABP SITE REVIEWS
Findings of NABP Site Reviews as of March 30, 2012
B. Recommended Internet Pharmacies: NABP, along with FDA and other
patient safety advocates, continues to recommend that patients use
Internet pharmacies accredited through the VIPPS and Vet-VIPPS
programs when buying medication online. These sites have undergone
and successfully completed the thorough NABP accreditation process,
which includes a review of all policies and procedures regarding the
practice of pharmacy and dispensing of medicine over the Internet, as
well as an on-site inspection of facilities used by the site to receive, review, and dispense
medicine. Currently, 48 VIPPS and Vet-VIPPS pharmacy sites, representing more than
12,000 pharmacies, are listed as Recommended Internet Pharmacies. Several more
applications are in progress.
C. Accreditation and Approval Applicant Screenings: In addition to
identifying rogue sites, the Internet Drug Outlet Identification program
staff continues to assist in screening applicant Web sites for the VIPPS,
Vet-VIPPS, and e-Advertiser Approval programs. Sites that have
received e-Advertiser Approval status do not fill new prescription drug orders via the
Internet, and thus, are ineligible for VIPPS, but accept refill requests from their existing
customers, provide drug information or pharmacy information, or offer other prescription
drug-related services. Sites that have received e-Advertiser Approval status have been found
to be safe, reliable, and lawful. These sites are listed on the NABP Web site as Approved e-
Advertisers. The standards that NABP screens e-Advertiser Approval Program applicants
against are posted in the e-Advertiser Approval Program section, under Accreditation, on the
NABP Web site. These standards are essentially the same as those used to assess Internet
drug outlets, only modified to accommodate a broader range of drug-related practices. As of
March 30, 2012, 21 entities were listed on the NABP Web site as Approved e-Advertisers,
and several more applications are in progress.
DRUG SHORTAGES CREATE NICHE FOR SWINDLERS
A. Gray-Market Risks: The number of drugs in short supply more than tripled from 61 in 2005
to more than 200 by the end of 2010, and the University of Utah Drug Information Service
reported a record high of 180 drug shortages from January 1 to July 31, 2011. Sterile
injectables accounted for the majority of the drug shortages in 2010-2011. The most critical
shortages involve cancer, antibiotic, nutrition, and electrolyte-imbalance medicines,
according to FDA. For many community pharmacies, health-system pharmacies, and patients,
the lack of availability of needed – and often life-saving – medications through official,
authorized supply channels means resorting to unconventional and more dangerous means of
obtaining the medications, sometimes turning to unknown sellers online. The unfulfilled
demand for these medications has created a lucrative niche market for counterfeiters and so-
called gray-market distributors.
The primary problem with gray-market drug sellers is that health care facilities and patients
have no assurance that the substances they receive are what they are purported to be. Many of
the replacement drugs purchased online are unregulated, meaning there are no safeguards in
place to ensure their identity, safety, or efficacy, where and under what conditions they were
made, or how they were handled.
As a February 2012 issue of Journal of Medical Internet Research correctly reports, "FDA
shortage drugs are widely marketed over the Internet. Suspect online drug sellers and
intermediaries dominate these sales offers." The report, "Online Availability and Safety of
Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics," warns that
"patients, providers, and policymakers should be extremely cautious in procuring shortage
drugs through Internet sourcing." The authors found 291 offers online for 68 of the FDA
shortage-listed drugs, mostly by rogue Internet drug outlets selling direct to consumers
without a prescription. In fact, two-thirds of the online drug sellers discovered in this study
are represented on the NABP list of Not Recommended sites. These illegal online drug sellers
pose serious risks to patient health. The risk is especially high with vaccines, which represent
half the products on the FDA Biologics Product Shortages list because, as noted in the
November 2011 issue of Vaccine, these products require specialized quality control, storage,
and transportation to maintain their safety and efficacy, posing a higher-than-average patient
risk when mishandled.
B. Counterfeit Medications and Unapproved Foreign Drugs: In
recent months, gray-market activity has proved not only costly
‘This is exactly
and suspicious, but dangerous, with multiple appearances of
why it's illegal to sell unapproved
counterfeit drugs finding their way into the legitimate
medication supply. The unfortunate reality for an unknown
overseas in the U.S.'
number of cancer and other patients in the US and abroad is
that their health care providers administered to them unknown
substances, thought to be life-saving medication, obtained through untrustworthy sources.
In a May 7, 2012 weekly update, Partnership for Safe Medicines (PSM) brings to light the
dangers of prescription drug counterfeiting in recognition of World Malaria Day. The PSM
update cites a blog post by Tom Kubic, president and CEO of the Pharmaceutical Security
Institute, titled "Malaria And Me: How Americans Are Part Of The World Of Global
Medicine Counterfeiting," which highlights the potential dangers of unbridled international
distribution. "A key benefit of globalization is that lifesaving medications can be readily
transferred from anywhere in the world to countries like Ghana, Kenya, and South Africa.
Unfortunately, globalization has also brought criminal organizations that take advantage of
the need for these medications," says Kubic, who is also on the PSM Board. "Criminals cheat
patients out of lifesaving medications. They counterfeit everything from anti-fungals and
antibiotics to chemotherapy and antivirals. A medication with no healing power is worthless.
Whether the victim is a child with malaria in Lagos, or a child with cancer in Los Angeles,
neither will be cured, and both may be killed by the counterfeiter's malice.
Earlier this year, multiple vials of counterfeit Avastin® were purchased by 19 medical clinics
in the US, FDA reported on February 14, 2012. The fake Avastin was sold to doctors in the
US by Montana Healthcare Solutions, and was shipped by a company in the United Kingdom
with the same owner, CBS News reported on March 22, 2012. CBS states that the proprietor,
Tom Haughton, also reportedly owns several pharmaceutical-related businesses in Barbados.
NABP was consulted during the CBS investigation and provided comment in a March 22
CBS News segment, available online at www.cbsnews.com/8301-505263_162-57402214/fake-
avastin-shipper-tied-to-canadadrugs.com.1 CBS linked the fake Avastin shipper, Tom
Haughton, to Canadadrugs.com, which, CBS reports, utilizes Haughton as a key supplier.2
CanadaDrugs.com denies any involvement in the counterfeit Avastin. Haughton states he did
not know the Avastin was counterfeit.
In the CBS report, NABP Executive Director/Secretary Carmen Catizone, MS, RPh, DPh,
explains that of the shipments NABP has seen, "No drugs that are being shipped via the
Internet to U.S. consumers from these websites we've identified actually come from Canada
or have actually been approved by Health Canada." For years, FDA, NABP, and other
entities interested in protecting the public health have warned that, outside the closed and
tightly regulated domestic drug supply chain, the safeguards put in place to ensure the
identity, efficacy, and safety of prescription medications no longer apply. As CBS News
reports, regulators and law enforcement officials say "this is exactly why it's illegal to sell
unapproved drugs from overseas in the U.S."
Still more recently, another injectable cancer medication, originating from a foreign source
and purchased by US medical practices, has been determined to be counterfeit. FDA alerted
health care professionals on April 3, 2012, that laboratory tests confirmed a counterfeit
version of Roche's Altuzan® 400 mg/16 ml (bevacizumab), which is not approved by FDA
1 NABP identified some 3,000 Web site domain names registered to Tom Haughton, many resolving to Canadadrugs.com. NABP has identified CanadaDrugs.com as Not Recommended because NABP believes that it offers unapproved medications from numerous foreign sources to US patients without a valid prescription. See, eg, www.canadadrugs.com/search.php?keyword=sildenafil and the "Your Guarantee" section of CanadaDrugs.com.
2 As referenced in the aforementioned March 22, 2012 CBS News article, CanadaDrugs.com offers US consumers numerous non-FDA approved medications sourced from India, Turkey, Australia, and the United Kingdom. For example, US consumers visiting the CanadaDrugs.com Web site are offered tadalafil, the generic version of the erectile dysfunction drug Cialis®, and ezetimibe, the generic version of the cholesterol lowering drug Zetia®, both sourced from Global Drug Supply Ltd in Barbados. Tom Haughton is the owner of Global Drug Supply and is a supplier of CanadaDrugs.com, as reported in a March 7, 2012 Wall Street Journal article entitled "Drug Distributor Is Tied to Imports of Fake Avastin." Neither tadalafil nor ezetimibe is FDA approved.
for use in the US, contains no active ingredient. Medical practices obtained the counterfeit
Altuzan and other unapproved products through foreign sources, in particular from Richards
Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune
Marketing Inc, FDA reports, adding that many, if not all, of the products sold and distributed
through this distributor are not FDA approved.
In the hopes of avoiding further influx of such unapproved drugs, PSM has composed, and
NABP has signed on to a letter to Congress opposing potential amendments to the
Prescription Drug User Fee Act that would allow drug importation, undermining US drug
safety protocols in the process. The letter states, "Drug importation advocates believe that
drugs purchased from countries such as Canada and the United Kingdom are safe because of
their strict health regulations. Unfortunately, this is simply not true. There is no regulation for
products trans-shipped through ‘safe' countries such as Canada and the United Kingdom and
thus, Americans would be put at great risk." In reference to the appearances of counterfeit
cancer medications in US health care facilities, the letter states, "Such incidents demonstrate
conclusively that if trained doctors cannot reliably source their medications, we will endanger
all Americans by encouraging them to break the closed, secure drug supply chain."
On its home page, www.safemedicines.org, PSM provides a tool that patients can use to see if
doctors in their state purchased counterfeit cancer medications. The PSM Web site also posts
a link to a YouTube video describing prescription drug counterfeiting and encouraging
patients to use VIPPS-accredited Internet pharmacies when purchasing medication online.
C. Fake Pharmacy Schemes: Three US Congressional committees are investigating schemes in
which individuals obtained pharmacy licenses only to use them as a means for purchasing
short-supply cancer drugs that they then sold to gray-market wholesalers for a profit. The
House Committee on Oversight and Government Reform stated in a March 21, 2012 news
release that it had obtained documents indicating that, rather than dispensing the medication
to patients, these pharmacies instead transferred them to wholesaler companies owned by the
same individuals. The wholesalers then sold the drugs back into the gray market, sometimes
in violation of state law and at exorbitant markups. "It appears that some of these individuals
essentially established ‘fake pharmacies' to obtain drugs that are in critically short supply and
are desperately needed to treat patients with cancer and others diseases," Committee
Chairman Elijah Cummings states in the news release. These findings are part of a broader
ongoing investigation launched October 5, 2011. NABP provided information that assisted in
NABP has found that rogue Internet drug
outlets also exploit consumers' concern over
‘Prescription Drug Shortage?
Get Your Viagra Prescription
prescription drug shortages to spread
misinformation and sell counterfeit and
substandard drugs, such as erectile dysfunction
(ED) medications – many of them knockoffs of legitimate brands – that are not in short
supply. One such site, SuperPforce.com, distorts the situation to deceive consumers with the
headline, "Prescription Drug Shortage? Get Your Viagra Prescription Online." The site sells a
variety of unapproved fake versions of common ED medications, all without a prescription. It
states, in mock concern, "Pharmacists everywhere are unable to fill prescriptions due to a
lack of inventory. . leaving some folks to fill their Viagra prescription online."
D. Registrars' Role in Illicit Drug Sites: In the last several years, NABP has reached out to
several domain name registrars and other Internet service providers, encouraging them to stop
enabling illegal online drug sellers. Some of these outreach efforts have been met with a
helpful willingness to protect consumers from rogue Internet drug outlets. Others, however,
approach this trend as a business opportunity. NABP sent a letter on March 13, 2012, urging
ICANN to take action against Internet.bs, a domain name registrar that has been found to be
responsible for 44% of the Web sites that NABP has designated as Not Recommended due to
their noncompliance with pharmacy practice laws. NABP took this step after learning of an
investigation by LegitScript that found that Internet.bs sponsors one-third of the world's
active rogue Internet drug outlets, even though it is the registrar for only about 0.2% of the
world's domain names overall.
The LegitScript report, available at www.legitscript.com, details an undercover investigation
of Internet.bs in which the company agreed to help researchers, who were posing as an
international cybercrime network, sell fake cancer medications and controlled substances
without a prescription. Undercover researchers told Internet.bs that they planned to create
thousands of Web sites that would sell controlled substance medications without requiring a
prescription, as well as unapproved formulations of various cancer medications to be falsely
marketed as genuine "branded" pharmaceuticals. The report includes screenshots of e-mail
messages in which Internet.bs welcomed the business, saying that it is "one of the safest
[registrars] for pharma domains," and offered to help the registrants avoid being shut down
by drug safety regulators. The undercover researchers ultimately were able to register
hundreds of Web sites with names such as oxycodonenoprescription.com and genuine-anti-
cancer-drugs.com, and post fake online pharmacy content, LegitScript reports.
Subsequently, Internet.bs agreed to prohibit any domain names that are listed on NABP's Not
Recommended list – unless they are sanctioned by any one of three other organizations
whose standards NABP does not recognize because they are out of compliance with US
federal and state pharmacy laws.
OUTREACH . . EDUCATION . . ACTION!
A. Pharmacy gTLD Initiative: NABP announced to its member boards of pharmacy in late
February 2012 that the Association will stand with the global pharmacy community in
applying to ICANN to obtain and operate the .pharmacy top-level domain. ICANN has
opened a new round of assigning generic top-level domains (gTLDs; ie, the text to the right
of the "dot" in an Internet address, such as .com, .net, .gov). This process will allow for
industries, corporations, and locations to secure a customized, secured gateway for their
organization or community, and will likely result in the creation of many new gTLDs, such as
.hotel, .London, and .bank. This action by ICANN comes at a time when NABP, the boards
of pharmacy, and other stakeholders are focused on efforts to ensure a safe and secure
location on the Internet for legitimate pharmacies to operate and for patients to acquire
medications. To that end, NABP is taking on this unprecedented, but necessary, initiative to
hold online drug sellers accountable to the pharmacy laws and patient safety standards
established by responsible jurisdictions worldwide to protect the public health.
Under this plan, use of the .pharmacy domain will be restricted to legitimate Web site
operators the world over that adhere to the pharmacy laws specific to the jurisdictions in
which the pharmacy is domiciled and to which it sells prescription drugs. As such, it will
provide a powerful tool to educate consumers, distinguish legitimate Internet pharmacies
from the throngs of illicit drug sellers, and reinforce the value of purchasing medications only
from trustworthy online sources. In recent months, NABP has been networking with
pharmacy stakeholders internationally to generate public support for this effort, and to
demonstrate to ICANN that the global community is behind this initiative. The application
window closed on April 12, 2012, and ICANN will post the list of applicants and applied-for
gTLDs on April 30. Initial results are expected to be released on November 12.
B. NABP Task Force on Internet Pharmacy Practice: To address patient risks associated with
illegal online drug sellers, NABP convened a Task Force on Internet Pharmacy Practice on
March 6-7, 2012, whose charge was to review existing Internet pharmacy practices, review
current state laws and regulations, VIPPS standards, and the Model State Pharmacy Act and
Model Rules of the National Associations of Boards of Pharmacy language, and to examine
future opportunities and challenges in an emerging global environment. Task force members
also discussed current federal legislative efforts, as well as the need for increased education
and awareness. For instance, NABP has publicly stated its support of the Online Pharmacy
Safety Act of 2011, which would require the US Department of Health and Human Services
to create a consumer-accessible registry of legitimate, law-abiding Internet pharmacy Web
sites to provide consumers with a resource to help them make informed decisions when
buying medication online. The task force recommendations will be presented at the NABP
108th Annual Meeting set for May 19-22, 2012, in Philadelphia, PA, and subsequently will
be available on the NABP Web site. The Annual Meeting also will include a special session
to address the critical issue of drug shortages and its implications for patients, pharmacists,
and boards of pharmacy.
C. AWARXE Consumer Protection Program: The AWARXE® consumer protection program,
provided by NABP, joins forces with patient safety advocates in reaching out to educate
consumers on the dangers of rogue Internet drug outlets, substandard and counterfeit drug
products, and the importance of proper medication storage
and disposal. This spring, AWARXE has worked with Drug
Enforcement Administration (DEA) to promote its fourth
National Prescription Drug Take-Back Day. This event, set
for April 28, 2012, allows consumers a convenient way to safely dispose of unneeded
medications, including prescription pain pills and other controlled substance medications,
which can only be accepted for disposal when law enforcement is present. Thousands of
DEA-coordinated collection sites will be available across the country. During the previous
three DEA National Prescription Drug Take-Back Days, consumers disposed of 995,185
pounds (498.5 tons) of unwanted medication, reducing the risk of diversion and misuse.
More information and a link to the DEA Take-Back Day collection site locator is available
on the AWARXE Web site, WWW.AWARERX.ORG.
Additionally, AWARxE public service announcements (PSAs) are being delivered via
Internet, social media, and radio. The PSAs, in addition to the "Does a Drug Dealer Lurk in
Your Medicine Cabinet?" ad, which appeared in the April 2012 issue of the AARP Bulletin
(circulation 22 million), encourage consumers to participate in the DEA National
Prescription Drug Take-Back Day, and to learn about other steps they can take to protect
their loved ones from prescription drug misuse and abuse. AWARxE video and radio PSAs
stress that most Americans who abuse prescription drugs – including 12 and 13-year-olds –
get them from friends and family for free, some taking them right out of the medicine
cabinet. AWARxE radio PSAs were distributed to radio stations targeted to complement
video PSAs that were provided to television stations in 16 geographical markets. In addition,
Internet Web sites and bloggers that focus on health care, parenting, and other issues
relevant to AWARxE were provided with Web site banners and content for use in
encouraging their readers to visit the AWARxE Web site. Each Internet blog post, Web site
banner, or Web site article brings AWARxE just a click away to readers.
The problems of prescription drug shortages, gray-market wholesalers, and illegal online drug
sellers are intertwined. Patients and health care providers must be educated about which
medications are in short supply, and how to distinguish legitimate sources from conniving frauds.
Likewise, regulators, law enforcement, and patient safety advocates must work together, across
jurisdictional borders, and derive new methods and partnerships to protect the public health.
NABP continues to encourage these efforts and to work with the state boards of pharmacy,
federal regulators, and other public and private stakeholders to educate the public about
counterfeit drugs and other potential dangers of buying medication from unknown and
unapproved sources over the Internet. The Association remains committed to upholding the
integrity of the practice of pharmacy – in any practice setting – and ensuring that patients have
access to safe and effective prescription drugs.
Through communication and cooperation, NABP strives to advance the efforts of regulators and
other entities to curtail the online trade of illicit and counterfeit medications. As always, NABP
welcomes feedback on these reports, and on its Internet program, to determine how we can better
serve your needs and better protect patients from these threats. In addition, we ask that you share
with NABP any knowledge or concerns you might have pertaining to illegally or unprofessionally
operating Internet drug outlets, so that we may support your efforts, assist in your research, or
pass the information along as appropriate. As we have seen, the combined efforts of multiple
parties are a powerful force in bringing about positive change and protecting the public health,
and we anticipate further improvement in the future.
For further information, please contact Melissa Madigan, policy and communications director, via
e-mail at firstname.lastname@example.org.
Internet Drug Outlet Identification Program Criteria
Patient Safety and Pharmacy Practice Standards
1. Pharmacy licensure. The pharmacy must be licensed or registered in good standing to operate a
pharmacy or engage in the practice of pharmacy in all required jurisdictions.
2. DEA registration. The pharmacy, if dispensing controlled substances, must be registered with
the US Drug Enforcement Administration (DEA).
3. Prior discipline. The pharmacy and its pharmacist-in-charge must not have been subject to
significant recent and/or repeated disciplinary sanctions.
4. Pharmacy location. The pharmacy must be domiciled in the United States.
5. Validity of prescription. The pharmacy shall dispense or offer to dispense prescription drugs
only upon receipt of a valid prescription, as defined below, issued by a person authorized to prescribe under state law and, as applicable, federal law. The pharmacy must not distribute or offer to distribute prescriptions or prescription drugs solely on the basis of an online questionnaire or consultation without a preexisting patient-prescriber relationship that has included a face-to-face physical examination, except as explicitly permitted under state telemedicine laws or regulations.
Definition. A valid prescription is one issued pursuant to a legitimate patient-prescriber
relationship, which requires the following to have been established: a) The patient has a
legitimate medical complaint; b) A face-to-face physical examination adequate to establish the
legitimacy of the medical complaint has been performed by the prescribing practitioner, or
through a telemedicine practice approved by the appropriate practitioner board; and c) A logical
connection exists between the medical complaint, the medical history, and the physical
examination and the drug prescribed.
6. Legal compliance. The pharmacy must comply with all provisions of federal and state law,
including but not limited to the Federal Food, Drug, and Cosmetic Act and the Federal Controlled Substances Act (including the provisions of the Ryan Haight Online Pharmacy Consumer Protection Act, upon the effective date). The pharmacy must not dispense or offer to dispense medications that have not been approved by the US Food and Drug Administration.
7. Privacy. If the pharmacy Web site transmits information that would be considered Protected
8. Patient services. The pharmacy must provide on the Web site an accurate US street address of
the dispensing pharmacy or corporate headquarters. The pharmacy must provide on the Web site an accurate, readily accessible and responsive phone number or secure mechanism via the Web site, allowing patients to contact or consult with a pharmacist regarding complaints or concerns or in the event of a possible adverse event involving their medication.
9. Web site transparency. The pharmacy must not engage in practices or extend offers on its Web
site that may deceive or defraud patients as to any material detail regarding the pharmacy, pharmacy staff, prescription drugs, or financial transactions.
10. Domain name registration. The domain name registration information of the pharmacy must be
accurate, and the domain name registrant must have a logical nexus to the dispensing pharmacy. Absent extenuating circumstances, pharmacy Web sites utilizing anonymous domain name registration services will not be eligible for approval.
11. Affiliated Web sites. The pharmacy, Web site, pharmacy staff, domain name registrants, and any
person or entity that exercises control over, or participates in, the pharmacy business must not be affiliated with or control any other Web site that violates these standards.
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