Internet Drug Outlet
Identification Program

Progress Report for State and Federal
Regulators: August 2017

Prepared By
The National Association of Boards of Pharmacy

Table of Contents

Introduction ..................................................................................................................................... 3
Results ............................................................................................................................................ 4
A. Findings of Site Reviews to Date .................................................................................. 4
B. Recommended Internet Pharmacies ............................................................................ 7
C. .Pharmacy Program ....................................................................................................... 7
So-Called Canadian Internet Pharmacies Selling Not-So-Canadian Drugs .................................... 8
A. NABP Study Findings .................................................................................................... 9
B. Proposed Legislation Raises Concerns ....................................................................... 11
Discussion ...................................................................................................................................... 11
Appendix: Internet Drug Outlet Identification Program Standards ............................................ 13

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Internet Drug Outlet Identification Program Progress Report: August 2017

Internet Drug Outlet Identification Program
Progress Report: August 2017
Introduction
Many online drug sellers display the Canadian maple leaf as a symbol of thesafety and reliability of medications approved for sale in Canada. The drugs
they sell to customers outside of Canada, however, are often something
altogether different. Since the subject of importing prescription medicine from
Canada has made a reappearance in the halls of Congress in recent months, many health careregulators and patient safety advocates have voiced their opposition to importation, statingthat such policy would open the floodgates for unapproved and counterfeit medications of
unknown origins to enter the United States medication supply chain.
The National Association of Boards of Pharmacy® (NABP®) expressed this concern in a letter toCongress earlier this year. “In NABP’s nearly 20 years of experience in verifying internet
pharmacies, US consumers buying medications from Canadian online pharmacies rarely, if ever,receive the Health Canada-approved products afforded to Canadian customers,” NABP wrote.
“Instead, these Canadian pharmacy websites sell US patients medicines manufactured in places
where buyers would not even drink the water, eg, India, Turkey, or Southeast Asia.” According
to the US Food and Drug Administration (FDA) article, “Imported Drugs Raise Safety Concerns,”“Drugs coming to the United States from Canada may be coming from some other country andsimply passing through Canada. The drugs could also be counterfeit, contaminated, or
subpotent, among other things.”
To substantiate these concerns, NABP recently reviewed more than 100 websites with
“Canada” or “Canadian” in their name or URL, or posting a Canadian address on their websites
to see how many of them dispensed prescription medicine from outside of Canada. These sites
are among the nearly 11,700 websites selling prescription medications that NABP has reviewed
since 2008. In all, NABP has found nearly 96% of these sites to be operating illegally, out ofcompliance with state and federal laws and/or NABP patient safety and pharmacy practice
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Internet Drug Outlet Identification Program Progress Report: August 2017

standards. These findings are described in the Results section below. In many instances, thesesites are foreign drug sellers masquerading as Canadian online pharmacies but actuallydispensing medications that are approved by neither FDA nor Health Canada. In fact, nearly
three-quarters (74%) of the so-called Canadian sites NABP reviewed from July 1, 2016, throughJune 30, 2017, state on their websites that they source their drugs from countries outside of
Canada. These findings are described on pages 9 and 10 of this report. Such products are notapproved by Health Canada and would be illegal to sell in that country. Yet, online drug sellers
routinely dispense these products to patients in the US, in contravention of US federal law andendangering patient health.
Results
A. Findings of Site Reviews to Date:
As of June 30, 2017, NABP has
reviewed 11,688 internet drug outlets
selling prescription medications to US
patients. Of these, 11,142 (95.8%)
were found to be operating out ofcompliance with state and federal laws
and/or NABP patient safety andpharmacy practice standards. Thesesites are listed as
Not Recommended in the Initiatives
section of the NABP website, www.nabp.pharmacy. Of the websites identified by NABP as
Not Recommended, the majority were found to be dispensing prescription drugs without avalid prescription. These findings include sites dispensing drugs based solely on an online
questionnaire, as well as those requiring no prescription at all. Many also offer foreign andunapproved drugs that may be substandard or counterfeit. The 11,142 internet drug outlets

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Internet Drug Outlet Identification Program Progress Report: August 2017

currently listed as Not Recommended on the NABP website are characterized in the tablebelow. 1
Not Recommended Sites
Physical Location:•

2,576 (23.1%) outside US•

1,562 (14%) inside US•

6,957 (62.4%) no location posted on website•

9,908 (88.9%) do not require valid prescription•

6,257 (56.2%) issue prescriptions per online
consultations or questionnaires only•

5,744 (51.6%) offer foreign or non-FDA-approved
medications•

1,440 (12.9%) dispense controlled substances

Encryption:•

1,892 (17%) do not have secure sites, exposing
customers to financial fraud and identity theftServer Location:•

4,762 (42.7%) outside US•

5,903 (53%) inside US•

464 (4.2%) have unknown server locations•

9,681 (86.9%) appear to have affiliations with rogue
networks of internet drug outlets

Prescription Requirements:

Medications:

Affiliations:

The table above, as well as the bar graph on page 6 of this report, shows thecharacteristics of drug sites listed as Not Recommended on the NABP website as ofJune 30, 2017. More than half sell foreign or non-FDA-approved medications to US
patients, and 85.5% are either based outside of the US or, as in most cases, do notpost any physical address on the website.

1 It should be noted that the research findings NABP reports herein and on the Not Recommended list include the total number

of websites selling prescription drugs to US patients that NABP staff has reviewed and found to be out of compliance with
program standards, including those sites that were found to be noncompliant at the time of review but may since have been
deactivated. It should also be noted that the numbers reported here do not represent the entire universe of websites sellingprescription drugs illegally, but rather, a representative sampling of the online environment over the last nine years.

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Internet Drug Outlet Identification Program Progress Report: August 2017

Findings of NABP Website Reviews
12,000 11,688

11,142

11,0009,908

Number of Sites

10,000
9,000
8,000

6,957

7,000

6,257

6,000

5,744

5,000
4,000
2,576

3,000

1,562

2,000
1,000

1,892
1,440

262 2260Site Description/Characteristic

The standards against which NABP evaluates internet drug outlets are provided in the
Appendix of this report.
Two hundred sixty-two (2.3%) of the 11,688 sites selling prescription medications to US
patients were designated as reviewed. These sites lack any egregious violations that would
cause them to be ranked as Not Recommended but have not satisfied the requirements of
NABP’s Verified Internet Pharmacy Practice Sites® (VIPPS®), Veterinary-Verified Internet
Pharmacy Practice Sites® (Vet-VIPPS®), e-Advertiser ApprovalCM Program, or .Pharmacy
Verified Websites Program. Two hundred twenty-six (1.9%) of the 11,688 sites sellingprescription medications or offering resources to US patients were accredited through the
VIPPS or Vet-VIPPS programs or were approved through the e-Advertiser Approval or.Pharmacy programs.

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B. Recommended Internet Pharmacies: NABP, along with many patient
safety advocates, continues to recommend that patients use internet
pharmacies that have been reviewed and approved by NABP. These sites
include entities granted VIPPS or Vet-VIPPS accreditation, Approved
e-Advertiser status, or a .pharmacy domain name. These sites have been evaluated andfound to be in compliance with pharmacy laws and meet high standards for pharmacy
practice and patient safety. As of June 30, 2017, 80 pharmacies were listed on the NABP
website as VIPPS or Vet-VIPPS accredited, and 111 entities were listed as Approved
e-Advertisers. While the VIPPS program will continue to operate, NABP is no longer
accepting applications for the Vet-VIPPS and e-Advertiser Approval programs, as these
programs are being streamlined into the .Pharmacy Program. Several applications for VIPPS
accreditation are in progress. Including all types of .pharmacy-registered entities –pharmacy, board of pharmacy and regulatory agency, resource and referral, association andconsumer advocacy, professional, pharmaceutical manufacturer, and school and college ofpharmacy – 132 .pharmacy registered entities are listed on the Buying Safely page of the.Pharmacy Program website, www.safe.pharmacy. Over 100 .pharmacy applications are in
progress.
C. .Pharmacy Program: NABP believes strongly
that its .Pharmacy Program is the future of safe
pharmacy and pharmacy-related services provided online, offering a superior means ofdisplaying approval to consumers and other entities. It is no longer enough to have a seal of
approval that can be copied and pasted and displayed fraudulently to dupe patients into
thinking they are visiting a safe website. The .pharmacy domain name identifies legitimately
operating pharmacies and pharmacy-related entities for consumers, advertisers, and searchengine companies by incorporating the “seal of approval” into the domain name. With.pharmacy, patients know they are visiting a safe website.
NABP has, as of July 19, 2017, granted approval for 576 domain names, and 353 .pharmacy
domain names have been registered (up from 310 at the close of first quarter 2017). Of
these, 261 were registered to pharmacies, 12 were registered to professional sites, 41 were

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registered to boards of pharmacy or regulatory agencies, 18 were registered to associations
and consumer advocacy sites, 16 were registered to resource and referral sites, 3 wereregistered to manufacturers, and 2 were registered to schools or colleges of pharmacy.
Of the 353 .pharmacy domain names registered, 192 are in use, while the remaining
registered domain names are parked. Of those that are in use, 124 are registered topharmacies, 31 are registered to boards of pharmacy or regulatory agencies, 16 areregistered to associations and consumer advocacy sites, 14 are registered to resource andreferral sites, 5 are registered to professional sites, and 2 are registered to schools orcolleges of pharmacy. Of the domain names in use, 25 are being used as the registrant’s
primary web address, 156 are redirecting to another domain name, and 11 are masking
another domain name with the .pharmacy name.
.Pharmacy is a verified Top-Level Domain, meaning that applicants are evaluated forcompliance with registry standards prior to being allowed to use a .pharmacy domain name.
NABP grants use of the .pharmacy domain only to legitimate website operators that adhere
to pharmacy laws in the jurisdictions in which they are based and in which their patients andcustomers reside. As such, pharmacies licensed in Canada and dispensing medicine only topatients residing in Canada are eligible for a .pharmacy domain name, provided they meet allother program standards.
So-Called Canadian Internet Pharmacies Selling Not-So-Canadian Drugs
The regulations in Canada that ensure medication safety andefficacy – such as those prohibiting the importation of
unapproved foreign medications into the country – do not protect
US patients buying medicine from so-called Canadian online
pharmacies. These drug sellers generally source the medications
they sell to the US from all over the world – often from thirdworld countries where regulations and oversight are not as
stringent or effective as they are in the US and Canada. Sourcing
medications from outside of a tightly regulated supply chain also

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Nearly three-quarters(80, or 74%) of the
108 so-called
Canadian online
pharmacies that
NABP reviewed stateon their websites thatthey source themedications they sellfrom outside of
Canada.

Internet Drug Outlet Identification Program Progress Report: August 2017

greatly increases the chances of counterfeit medicines finding their way to consumers.
The pie chart on page 10 of this report shows the results of a year-long study NABP performed
and is based on information provided on over 100 websites. All sites reviewed in this study use“Canada” or “Canadian” in their web business name or URL, or post an address in Canada, andoffer to sell medications to customers in the US.
A. NABP Study Findings: From July 1, 2016, to June 30, 2017, NABP identified 108 websites
using “Canada” or “Canadian” in their web business name or URL, or posting an address in
Canada, all of which were offering to sell medications to customers in the US. Nearly threequarters of them (80, or 74%) stated on the website that they sourced their medications
from outside of Canada. These medications are not approved by Health Canada, nor are
they legal to sell in Canada. The remaining 28 sites did not indicate the locations from which
they source the medications they sell.
Half (54) of the 108 so-called Canadian pharmacies that NABP reviewed source themedications they sell from India, or from a combination of various countries including India,
Hong Kong, and Singapore. The likelihood of receiving substandard or counterfeit medicine
from these countries is considerable. According to the 2017 Special 301 Report issued by
the Office of the US Trade Representative (USTR), “studies have suggested that up to 20% of
drugs sold in the Indian market are counterfeit and could represent a serious threat topatient health and safety.” USTR also reports, “Ninety percent of all counterfeit
pharmaceuticals seized at the US border in Fiscal Year 2016 were shipped from ortransshipped through four economies: China, Hong Kong, India, and Singapore.”
While India was the most common source for medications sold online from so-called
Canadian pharmacies, 20% (22) of the 108 source the medications from unspecified foreign
locations, and 26% (28) do not say where they get the medications they sell. Only 14% (15)post a physical address for the pharmacy. None of the 108 sites require a valid prescription,and 27% (29) dispense controlled substances.

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Internet Drug Outlet Identification Program Progress Report: August 2017

From Where Do So-Called Canadian Internet
Pharmacies Source Their Drugs?

• 74% (80) of the
108 so-called
Canadian
pharmacy sites
NABP reviewed
source themedications theysell from outsideof Canada.
• Half (54) of themsource the drugs
they sell from
India, or India andsomecombination ofother countries.
• 20% (22) sourcethem fromunspecified
foreign locations.

Mauritius, New Zealand, Singapore, Turkey, UK, and India
Unspecified international locations
US and India
India• Only 14% (15)post a physicaladdress for thepharmacy.

US, UK, Hong Kong, India, etc
TurkeyNew Zealand
India, Singapore, Hong Kong, Germany, and Great Britain
Canada, India, Mauritius, New Zealand, Singapore, Turkey, UK, and USSingapore, UK, New Zealand, Turkey, Mauritius, India, Australia, and US
Hong Kong, India, and Pakistan
Canada, UK, Australia, and New Zealand
Does not say

Page 10 of 14• 26% (28) do not
say where they
get the drugs theysell.

• None of themrequire a validprescription.
• 27% (29) dispense
controlled
substances.

Internet Drug Outlet Identification Program Progress Report: August 2017

B. Proposed Importation Legislation Raises Concerns
These findings underscore the concerns that NABP and others have raised about proposed
legislation that would allow US consumers to import prescription medications from Canada.
“NABP and many other patient safety advocates have found that the dangers of drugs
dispensed outside of FDA’s or Health Canada’s drug approval process are significant,” NABP
wrote to Congress. “Outside these closed and tightly regulated drug supply chains, thesafeguards put in place to ensure the identity, efficacy, and safety of prescription
medications no longer apply.” FDA cites quality assurance concerns among the potential
health risks with imported drugs: “Medications that have not been approved for sale in the
United States may not have been manufactured under quality assurance procedures
designed to produce a safe and effective product.”
Among those raising such concerns is Leona Aglukkaq, who served as Canada’s minister ofhealth from 2008 until 2013. Under proposed plans to allow importation, “Canada would
simply serve as an intermediate transshipment point for unapproved drugs heading to theUnited States,” Aglukkaq said in an opinion column appearing in the May 12, 2017
Washington Post. “Canadian authorities do not inspect every shipment of products headed
for the U.S. marketplace to ensure that packages don’t contain adulterated, counterfeit or
illegal drugs. Canada does not have the resources to undertake such comprehensive
searches, and the Canadian and U.S. governments are not currently set up to facilitate sucha program.”
The Alliance for Safe Online Pharmacies (ASOP Global) dedicates a section of its website toeducating the public about Canadian internet pharmacies selling to US residents. “In short,”
ASOP Global states in its FAQs, “the drugs U.S. residents get from a site that claims to be a
Canadian online pharmacy are not Health Canada-approved and are not the same quality
drugs that a Canadian resident would receive either from the same Canadian online or brickand mortar pharmacy.”
Discussion
Buying prescription medications from a Canadian online pharmacy seems like a great deal, until
consumers realize that what they are getting is not what they bargained for. Given that online
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drug sellers presenting themselves as Canadian pharmacies rarely, if ever, sell Health Canadaapproved medicine to US consumers, and until such time as a safe and tightly regulated
international supply chain can be established, importing medication from Canada presents a
considerable public health threat. Any US policy that would allow US patients to buy
medications from so-called Canadian online pharmacies is considered by many to be
irresponsible. Such action would put patients in this country at risk of harm from counterfeit oradulterated medicines.
In keeping with its mission to assist its member boards and jurisdictions in protecting the publichealth, NABP remains committed to upholding the integrity of the practice of pharmacy – inany practice setting or location – and ensuring that patients worldwide have access to safe andeffective prescription medications. For further information, please contact Melissa Madigan,
policy and communications director, via email at mmadigan@nabp.pharmacy.

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Appendix
Internet Drug Outlet Identification Program Standards
1. Pharmacy licensure. The pharmacy must be licensed or registered in good standing tooperate a pharmacy or engage in the practice of pharmacy in all required jurisdictions.
2. DEA registration. The pharmacy, if dispensing controlled substances, must be registeredwith 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 patientprescriber 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 alegitimate medical complaint; b) A face-to-face physical examination adequate toestablish 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 statelaw, including but not limited to the Federal Food, Drug, and Cosmetic Act and theFederal Controlled Substances Act (including the provisions of the Ryan Haight Online
Pharmacy Consumer Protection Act, upon the effective date). The pharmacy must not

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dispense or offer to dispense medications that have not been approved by the US Foodand Drug Administration.
7. Privacy. If the pharmacy website transmits information that would be considered
Protected Health Information (PHI) under the Health Insurance Portability andAccountability Act (HIPAA) Privacy Rule (45 CRF 164), the information must betransmitted in accordance with HIPAA requirements, including the use of Secure-Socket
Layer or equivalent technology for the transmission of PHI, and the pharmacy must
display its privacy policy that accords with the requirements of the HIPAA Privacy Rule.
8. Patient services. The pharmacy must provide on the website an accurate US street
address of the dispensing pharmacy or corporate headquarters. The pharmacy must
provide on the website an accurate, readily accessible and responsive phone number or
secure mechanism via the website, allowing patients to contact or consult with apharmacist regarding complaints or concerns or in the event of a possible adverse event
involving their medication.
9. Website transparency. The pharmacy must not engage in practices or extend offers on
its website that may deceive or defraud patients as to any material detail regarding thepharmacy, 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 thedispensing pharmacy. Absent extenuating circumstances, pharmacy websites utilizing
anonymous domain name registration services will not be eligible for approval.
11. Affiliated websites. The pharmacy, website, 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 website that violates thesestandards.

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Internet Drug Outlet Identification Program Progress Report: August 2017