I 
112TH CONGRESS 
2D SESSION 
H. R. 4095 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of Internet pharmacies. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 28, 2012 
Mr. CASSIDY (for himself and Mr. ROSS of Arkansas) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of Internet pharmacies. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Online Pharmacy Safe-
ty Act’’. 
SEC. 2. FINDINGS. 
Congress finds that— 
(1) consumers in the United States are targeted 
by organized international crime networks that use 
Internet websites to sell illegal and often dangerous 
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drugs under the guise of being legitimate online 
pharmacies; 
(2) illegal online drug sellers offer products that 
do not meet the safety standards established by 
United States laws, and recent reports from the Na-
tional Association of Boards of Pharmacy show that 
92 to 95 percent of Internet websites offering to sell 
prescription medications online are illegitimate and 
operate in clear violation of United States laws en-
acted to protect patients; 
(3) criminals are attracted to the high profit 
margin of business through illegitimate online drug 
sales, as counterfeit drug sales alone are estimated 
to have generated $75,000,000,000 in 2010, an in-
crease of 92 percent from 2005; 
(4) the World Health Organization estimates 
that 50 percent of the prescription medicines sold 
online by Internet websites that hide their physical 
address are counterfeit; 
(5) 
research 
by 
The 
Partnership 
at 
Drugfree.org found that 1 in 6 consumers in the 
United States, a total of about 36,000,000 Ameri-
cans, has bought or currently buys prescription 
medication online without a valid prescription; 
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(6) the prevalence of illegal online drug sellers, 
and their sale of counterfeit or otherwise illegitimate 
medicines, is a growing public health threat; 
(7) people have been seriously injured or killed 
by products sold by illegal online drug sellers; 
(8) the accessibility of controlled substances 
and other drugs without a valid prescription by ille-
gal online drug sellers contributes to a growing pre-
scription drug abuse problem in the United States 
that is endangering teenagers and public health; 
(9) the anonymous and unregulated nature of 
the Internet contributes to the counterfeit drug 
trade and enables counterfeit medicines to reach 
United States consumers through illegitimate online 
drug sellers posing as legitimate pharmacies; 
(10) counterfeit drugs that are sold through il-
legal online drug sellers are manufactured by crimi-
nals who deliberately and fraudulently misrepresent 
the product in order to trick consumers into think-
ing they are purchasing a legitimate and safe medi-
cine; 
(11) these counterfeit drugs are frequently 
manufactured in unsanitary conditions and may con-
tain the wrong ingredients, lack active ingredients, 
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have insufficient or contaminated active ingredients, 
or contain too many active ingredients; 
(12) counterfeit drugs obtained from illegal on-
line drug sellers have been found to contain harmful 
ingredients including arsenic, boric acid, brick dust, 
cement powder, chalk dust, floor polish, leaded road 
paint, nickel, shoe polish, and talcum powder; 
(13) United States citizens deserve access to 
safe and legitimate online pharmacies and protection 
from illegal Internet websites that sell counterfeit or 
otherwise illegitimate medication; 
(14) while the Ryan Haight Online Pharmacy 
Consumer Protection Act of 2008 (Public Law 110– 
425) has helped to prevent illegitimate online sales 
of prescribed controlled substances, illegal online 
sellers continue to sell other types of prescription 
drugs and stronger laws are needed to stop them; 
and 
(15) greater education and awareness regarding 
illegal online drug sellers will help to protect the 
United States drug supply chain from infiltration by 
unregulated and counterfeit products. 
SEC. 3. VALID PRESCRIPTIONS. 
Section 503(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(b)) is amended— 
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(1) in paragraph (1), in the matter following 
subparagraph (B), by striking ‘‘shall be dispensed’’ 
and all that follows through the end of paragraph 
(1) and inserting the following: ‘‘shall be dispensed 
only pursuant to a valid prescription that is (i) a 
written prescription of a practitioner licensed by law 
to administer such drug, (ii) an oral prescription of 
such practitioner which is reduced promptly to writ-
ing by the pharmacist, (iii) an electronic or facsimile 
prescription issued by a practitioner licensed by law 
to administer such drug, or (iv) the refill of any 
such written, oral, facsimile, or electronic prescrip-
tion if such refilling is authorized by the prescriber 
either in the original prescription, in the electronic 
or facsimile prescription, or by oral order which is 
reduced promptly to writing by the pharmacist. The 
act of dispensing a drug contrary to the provisions 
of this paragraph shall be deemed to be an act which 
results in the drug being misbranded while held for 
sale. In applying this paragraph, dispensing pursu-
ant to a prescription is deemed to be pursuant to a 
valid prescription if the dispensing occurs in good 
faith based on a reasonable belief that the prescrip-
tion is a valid prescription.’’; and 
(2) by adding at the end the following: 
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‘‘(6) For purposes of paragraph (1), the term 
‘valid prescription’ means a prescription that is 
issued for a legitimate medical purpose in the usual 
course of professional practice by— 
‘‘(A) a licensed practitioner who has con-
ducted at least 1 in-person medical evaluation 
of the patient, subject to paragraph (7); 
‘‘(B) a covering practitioner; or 
‘‘(C) a practitioner engaged in the practice 
of telemedicine. 
‘‘(7) For purposes of paragraph (6) and this 
paragraph: 
‘‘(A)(i) The term ‘in-person medical eval-
uation’ means a medical evaluation that is con-
ducted 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 clause (i) shall be con-
strued to imply that 1 in-person medical evalua-
tion demonstrates that a prescription has been 
issued for a legitimate medical purpose within 
the usual course of professional practice. 
‘‘(B) The term ‘covering practitioner’ 
means, with respect to a patient, a licensed 
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State health authority in order to prevent, miti-
gate, or treat a pandemic illness, infectious dis-
ease outbreak, or intentional or accidental re-
lease of a biological, chemical, or radiological 
agent. 
‘‘(9) The Secretary may by regulation establish 
exceptions to the requirements described in para-
graphs (6) through (8) with respect to a drug, based 
on criteria established by the Secretary.’’. 
SEC. 4. REGISTRY OF LEGITIMATE ONLINE PHARMACY 
WEBSITES. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following: 
‘‘SEC. 510A. REGISTRY OF LEGITIMATE ONLINE PHARMACY 
WEBSITES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DISPENSING PHARMACY.—The term ‘dis-
pensing pharmacy’ means a pharmacy that dis-
penses, distributes, or supplies prescription drugs 
pursuant to orders made on, through, or on behalf 
of, an online pharmacy website. 
‘‘(2) DOMAIN NAME.—The term ‘domain name’ 
has the meaning given that term in section 45 of the 
Lanham Act (15 U.S.C. 1127). 
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‘‘(3) FINANCIAL
TRANSACTION
PROVIDER.— 
The term ‘financial transaction provider’ has the 
meaning given that term in section 5362(4) of title 
31, United States Code. 
‘‘(4) INTERNET WEBSITE.—The term ‘Internet 
website’ means the collection of digital assets, in-
cluding links, indexes, or pointers to digital assets, 
accessible through the Internet that are addressed 
relative to a common domain name. 
‘‘(5) 
LEGITIMATE
ONLINE
PHARMACY 
WEBSITE.—The term ‘legitimate online pharmacy 
website’ means an online pharmacy website that is 
included in the Registry pursuant to a designation 
by the Secretary under this section. 
‘‘(6) ONLINE PHARMACY WEBSITE.—The term 
‘online pharmacy website’ means an Internet website 
that offers, sells, dispenses, or distributes, or facili-
tates the offering, sale, dispensing, or distribution 
of, prescription drugs to consumers, except that an 
Internet website shall not be considered an online 
pharmacy website if the website does not— 
‘‘(A) have the capability to accept pay-
ment; 
‘‘(B) refer consumers to a separate website 
to conduct or facilitate online payment for the 
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purpose of receiving a prescription drug without 
a valid prescription; or 
‘‘(C) otherwise engage in a financial trans-
action for prescription drugs by means of the 
Internet. 
‘‘(7) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug that is subject to sec-
tion 503(b)(1). 
‘‘(b) ESTABLISHMENT OF REGISTRY.—The Secretary 
shall establish a Registry of Legitimate Online Pharmacy 
Websites (referred to in this section as the ‘Registry’) for 
the purpose of educating consumers and promoting public 
health and safety. 
‘‘(c) CRITERIA.—The Secretary shall designate an 
online pharmacy website as a legitimate online pharmacy 
website, and include such legitimate online pharmacy 
website on the Registry, if the Secretary determines 
that— 
‘‘(1) the online pharmacy website is accredited 
by the United States National Association of Boards 
of Pharmacy Verified Internet Pharmacy Practice 
Sites program; or 
‘‘(2) the online pharmacy website meets each of 
the following requirements: 
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‘‘(A) Prescription drugs ordered, sold, dis-
pensed, 
distributed, 
supplied, 
or 
provided 
through or by the online pharmacy website are 
sold, dispensed, distributed, supplied, or pro-
vided solely by dispensing pharmacies that are 
domiciled in the United States and that main-
tain pharmacy licensure, a permit, or registra-
tion in good standing in all United States juris-
dictions where such dispensing pharmacies pro-
vide services or are required to maintain such 
licensure, permit, or registration. 
‘‘(B) Each dispensing pharmacy affiliated 
with, or that dispenses, distributes, supplies, or 
provides prescription or other drugs on behalf 
of the online pharmacy website, maintains a 
valid Drug Enforcement Administration reg-
istration, unless such registration is not re-
quired by Drug Enforcement Administration 
regulations. 
‘‘(C) Each dispensing pharmacy affiliated 
with, or that dispenses, distributes, supplies, or 
provides prescription drugs on behalf of the on-
line pharmacy website, dispenses, distributes, 
supplies, provides, or offers or attempts to dis-
pense, distribute, supply, or provide, prescrip-
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tion drugs only pursuant to a valid prescription 
(as defined in section 503(b)). 
‘‘(D) Each dispensing pharmacy affiliated 
with, or that dispenses, distributes, supplies, or 
provides prescription drugs on behalf of the on-
line pharmacy website, complies with applicable 
Federal and State laws and regulations applica-
ble to pharmacy practice. 
‘‘(E) The online pharmacy website promi-
nently displays the following information: 
‘‘(i) An accurate United States street 
address of each dispensing pharmacy or 
the corporate or other legal business entity 
headquarters of each dispensing pharmacy. 
‘‘(ii) An accurate, readily accessible, 
and responsive telephone number or other 
secure accurate means that allows the con-
sumer to contact or consult with the phar-
macist about his or her prescription drug. 
‘‘(F) The online pharmacy website does 
not make any statements, regarding the nature 
of any dispensing pharmacy or product offered 
via the website, that are materially misleading 
or fraudulent. 
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‘‘(G) The domain name registration infor-
mation applicable to the online pharmacy 
website is accurate, not anonymous, and has a 
logical nexus to a dispensing pharmacy located 
in the United States or the corporate or other 
legal business headquarters thereof. 
‘‘(H) The online pharmacy website, includ-
ing any operator, content owner, or domain 
name registrant of the online pharmacy website, 
is not affiliated with, and does not own or con-
trol any other online pharmacy website that vio-
lates the requirements under this paragraph. 
‘‘(I) The online pharmacy website, includ-
ing any operator, content owner, or domain 
name registrant of the online pharmacy website, 
is not affiliated with, and does not own or con-
trol, any other online pharmacy website that 
violates Federal or State laws and regulations 
applicable to pharmacy practice. 
‘‘(J) Information that would be considered 
protected health information under the regula-
tions promulgated under section 264(c) of the 
Health Insurance Portability and Accountability 
Act of 1996 (commonly referred to as the 
‘HIPAA Privacy Rule’) is transmitted by the 
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online pharmacy website and each dispensing 
pharmacy affiliated with, or that dispenses, dis-
tributes, supplies, or provides prescription 
drugs on behalf of the online pharmacy website, 
in accordance with the requirements of such 
Act, including the use of Secure-Socket Layer 
or equivalent technology for the transmission of 
protected health information, and the online 
pharmacy website displays its privacy policy 
and that such policy complies with the require-
ments of the HIPAA Privacy Rule. 
‘‘(K) The online pharmacy website com-
plies with other requirements as determined ap-
propriate by the Secretary, in consultation with 
other Federal and State agencies responsible 
for regulating the practice of pharmacy, for 
purposes of implementing subparagraphs (A) 
through (J). 
‘‘(d) PROCESS.— 
‘‘(1) APPLICATION.—The Secretary shall de-
velop an application process through which an inter-
ested operator, content owner, or domain name reg-
istrant of an online pharmacy website may apply for 
inclusion on the Registry. Such an application shall 
be submitted in such form and manner as required 
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by the Secretary and shall include, at a minimum, 
information to determine whether the online phar-
macy website satisfies the criteria described under 
subsection (c). Neither the Secretary nor any private 
entity with whom a contract is entered into under 
subsection (e) shall charge a fee for submission of 
an application for listing on the Registry. 
‘‘(2) 
IDENTIFICATION
WITHOUT
APPLICA-
TION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
take reasonable steps to identify online phar-
macy websites for which no application has 
been submitted under paragraph (1) and evalu-
ate whether these online pharmacy websites sat-
isfy the criteria described under subsection (c). 
‘‘(B) COMPLIANCE CONFIRMED.—In cases 
where satisfaction of the criteria described 
under subsection (c) can be verified without the 
receipt of an application, an online pharmacy 
website that the Secretary determines to satisfy 
such criteria may be designated as a legitimate 
online pharmacy website and included on the 
Registry and the operator, content owner, or 
domain name registrant of such online phar-
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macy website shall be notified of such place-
ment. 
‘‘(C) 
ADDITIONAL
INFORMATION
RE-
QUIRED.—In cases where satisfaction of the cri-
teria described under subsection (c) cannot be 
verified without additional information or some 
corrective action by the online pharmacy 
website operator, content owner, or domain 
name registrant, the online pharmacy website 
shall not be designated as a legitimate online 
pharmacy website or placed on the Registry 
until the additional information is received by 
the Secretary and the Secretary determines that 
all applicable and necessary corrective actions 
have been taken. 
‘‘(3) REGULATIONS
REGARDING
APPLICATION 
PROCESS.— 
‘‘(A) IN
GENERAL.—Not later than 180 
days after the date of the enactment of this sec-
tion, the Secretary shall promulgate regula-
tions— 
‘‘(i) to establish the timeframes appli-
cable to informing online pharmacy website 
operators, content owners, or domain name 
registrants that submit an application 
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under paragraph (1) of the acceptance or 
denial of such application; 
‘‘(ii) to address what information may 
be shared with or withheld from online 
pharmacy website operators, content own-
ers, or domain name registrants that sub-
mit such an application regarding correc-
tive actions that would need to be taken to 
establish compliance with the Registry re-
quirements; 
‘‘(iii) to establish an appeal process 
giving online pharmacy website operators, 
content owners, or domain name reg-
istrants that submit such an application 
the ability to request a second review of 
the application to determine compliance 
with the Registry requirements; 
‘‘(iv) to establish a process giving a li-
censed pharmacy domiciled in the United 
States the ability to request a determina-
tion as to whether such pharmacy is an 
‘online pharmacy website’ for purposes of 
the Registry; and 
‘‘(v) to address other procedural mat-
ters regarding the receipt and evaluation of 
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applications submitted under paragraph 
(1) as the Secretary determines necessary. 
‘‘(B) LIMITATION
REGARDING
APPEALS 
PROCESS.—The appeals process established 
under subparagraph (A)(iii) shall in no case re-
quire the Secretary— 
‘‘(i) to disclose information that may 
impede an ongoing or potential criminal or 
regulatory investigation; or 
‘‘(ii) to provide an opportunity for ap-
peal in cases where the Secretary deter-
mines, in the Secretary’s sole discretion, 
that the violation of a Registry require-
ment is materially significant, such a viola-
tion is not likely to be curable, or the ap-
plicant has engaged in a pattern of viola-
tions of Federal or State law. 
‘‘(4) AUTHORITY AND PROCESS FOR REMOVAL 
FROM REGISTRY.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
have the authority to remove an online phar-
macy website from the Registry— 
‘‘(i) upon determination that the on-
line pharmacy website is not in compliance 
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with the criteria as established by this sec-
tion; 
‘‘(ii) upon determination that the on-
line pharmacy website was mistakenly in-
cluded in the Registry; or 
‘‘(iii) for good cause as determined by 
the Secretary based on credible evidence. 
‘‘(B) PROCESS.—If the Secretary deter-
mines that an online pharmacy website shall be 
removed from the Registry under subparagraph 
(A), the Secretary shall provide notice to the 
operator, content owner, or domain name reg-
istrant of the online pharmacy website of the 
determination, the date of the removal of the 
website from the Registry, and the reasons for 
removal. 
‘‘(C) REGULATIONS
FOR
APPEAL
PROC-
ESS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall promulgate regulations that provide 
the operator, content owner, or domain 
name registrant of an online pharmacy 
website removed from the Registry the 
ability to appeal the removal and to pro-
vide information to correct matters that 
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