[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4095 Introduced in House (IH)]
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Online Pharmacy Safety 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 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 National 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 enacted 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 increase 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 Americans, has bought or currently buys prescription
medication online without a valid prescription;
(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 illegal online drug
sellers contributes to a growing prescription 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 illegal online
drug sellers are manufactured by criminals who deliberately and
fraudulently misrepresent the product in order to trick
consumers into thinking they are purchasing a legitimate and
safe medicine;
(11) these counterfeit drugs are frequently manufactured in
unsanitary conditions and may contain the wrong ingredients,
lack active ingredients, have insufficient or contaminated
active ingredients, or contain too many active ingredients;
(12) counterfeit drugs obtained from illegal online 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 Cosmetic Act (21
U.S.C. 353(b)) is amended--
(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 writing 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 prescription 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 pursuant 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 prescription is a valid
prescription.''; and
(2) by adding at the end the following:
``(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 conducted 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 evaluation'
means a medical evaluation that is conducted with the
patient in the physical presence of the practitioner,
without regard to whether portions of the evaluation
are conducted by other health professionals.
``(ii) Nothing in clause (i) shall be construed to
imply that 1 in-person medical evaluation 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 practitioner who
conducts a medical evaluation (other than an in-person
medical evaluation) at the request of a licensed
practitioner who--
``(i) has conducted at least 1 in-person
medical evaluation of the patient or an
evaluation of the patient through the practice
of telemedicine, within the previous 24 months;
and
``(ii) is temporarily unavailable to
conduct the evaluation of the patient.
``(C) The term `practice of telemedicine' has the
meaning given that term in section 102 of the
Controlled Substances Act.
``(8) For purposes of paragraphs (6) and (7), an in-person
medical evaluation of the patient is not required if--
``(A) the prescribing practitioner is issuing a
prescription or dispensing a legend drug in accordance
with the Expedited Partner Therapy in the Management of
Sexually Transmitted Diseases guidance document issued
by the Centers for Disease Control and Prevention; or
``(B) the prescription, administration, or
dispensing is through a public health clinic or other
distribution mechanism approved by the State health
authority in order to prevent, mitigate, or treat a
pandemic illness, infectious disease outbreak, or
intentional or accidental release of a biological,
chemical, or radiological agent.
``(9) The Secretary may by regulation establish exceptions
to the requirements described in paragraphs (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 `dispensing pharmacy'
means a pharmacy that dispenses, 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).
``(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, including 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 facilitates 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 payment;
``(B) refer consumers to a separate website to
conduct or facilitate online payment for the purpose of
receiving a prescription drug without a valid
prescription; or
``(C) otherwise engage in a financial transaction
for prescription drugs by means of the Internet.
``(7) Prescription drug.--The term `prescription drug'
means a drug that is subject to section 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:
``(A) Prescription drugs ordered, sold, dispensed,
distributed, supplied, or provided through or by the
online pharmacy website are sold, dispensed,
distributed, supplied, or provided solely by dispensing
pharmacies that are domiciled in the United States and
that maintain pharmacy licensure, a permit, or
registration in good standing in all United States
jurisdictions where such dispensing pharmacies provide
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 registration, unless such registration
is not required by Drug Enforcement Administration
regulations.
``(C) Each dispensing pharmacy affiliated with, or
that dispenses, distributes, supplies, or provides
prescription drugs on behalf of the online pharmacy
website, dispenses, distributes, supplies, provides, or
offers or attempts to dispense, distribute, supply, or
provide, prescription 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 online pharmacy
website, complies with applicable Federal and State
laws and regulations applicable to pharmacy practice.
``(E) The online pharmacy website prominently
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 consumer to
contact or consult with the pharmacist 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.
``(G) The domain name registration information
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, including any
operator, content owner, or domain name registrant of
the online pharmacy website, is not affiliated with,
and does not own or control any other online pharmacy
website that violates the requirements under this
paragraph.
``(I) The online pharmacy website, including any
operator, content owner, or domain name registrant of
the online pharmacy website, is not affiliated with,
and does not own or control, 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 regulations
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 online pharmacy website and each
dispensing pharmacy affiliated with, or that dispenses,
distributes, 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 requirements of the
HIPAA Privacy Rule.
``(K) The online pharmacy website complies with
other requirements as determined appropriate 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 develop an
application process through which an interested operator,
content owner, or domain name registrant 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 by the Secretary and shall include, at a minimum,
information to determine whether the online pharmacy 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 application.--
``(A) In general.--The Secretary shall take
reasonable steps to identify online pharmacy websites
for which no application has been submitted under
paragraph (1) and evaluate whether these online
pharmacy websites satisfy 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
pharmacy website shall be notified of such placement.
``(C) Additional information required.--In cases
where satisfaction of the criteria 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 section, the
Secretary shall promulgate regulations--
``(i) to establish the timeframes
applicable to informing online pharmacy website
operators, content owners, or domain name
registrants that submit an application 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 owners, or domain
name registrants that submit such an
application regarding corrective actions that
would need to be taken to establish compliance
with the Registry requirements;
``(iii) to establish an appeal process
giving online pharmacy website operators,
content owners, or domain name registrants 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
licensed pharmacy domiciled in the United
States the ability to request a determination
as to whether such pharmacy is an `online
pharmacy website' for purposes of the Registry;
and
``(v) to address other procedural matters
regarding the receipt and evaluation of
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 require the Secretary--
``(i) to disclose information that may
impede an ongoing or potential criminal or
regulatory investigation; or
``(ii) to provide an opportunity for appeal
in cases where the Secretary determines, in the
Secretary's sole discretion, that the violation
of a Registry requirement is materially
significant, such a violation is not likely to
be curable, or the applicant has engaged in a
pattern of violations 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 pharmacy website from the
Registry--
``(i) upon determination that the online
pharmacy website is not in compliance with the
criteria as established by this section;
``(ii) upon determination that the online
pharmacy website was mistakenly included in the
Registry; or
``(iii) for good cause as determined by the
Secretary based on credible evidence.
``(B) Process.--If the Secretary determines 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 registrant 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 process.--
``(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 provide information to
correct matters that served as basis for
removal from the Registry. Such regulations
shall provide a reasonable time period to
correct the grounds for removal.
``(ii) Limitation regarding appeals
process.--The appeals process established under
clause (i) shall in no case require the
Secretary--
``(I) to disclose information that
may impede an ongoing or potential
criminal or regulatory investigation;
or
``(II) to provide an opportunity
for appeal in cases where the Secretary
determines, in the Secretary's sole
discretion, that the violation of a
Registry requirement is materially
significant, such a violation is not
likely to be curable, or the applicant
has engaged in a pattern of violations
of Federal or State law.
``(5) Re-inclusion on registry.--Nothing in this section
prohibits an interested operator, content owner, or domain name
registrant of an online pharmacy website from applying under
paragraph (1) for re-inclusion of the website on the Registry
subsequent to the website's removal from the Registry.
``(e) Contracts With Private Entities.--
``(1) In general.--The Secretary may enter into contracts
with the United States National Association of Boards of
Pharmacy or other private entities to--
``(A) review applications submitted under
subsection (d)(1) and evaluate whether the online
pharmacy website satisfies the criteria described under
subsection (c);
``(B) on an ongoing basis, review and identify
online pharmacy websites for which no application has
been submitted under subsection (d)(1) and evaluate
whether these online pharmacies satisfy the criteria
described under subsection (c);
``(C) make recommendations to the Secretary as to
whether an online pharmacy website, either through
application or through identification under
subparagraph (B), satisfies the criteria under
subsection (c);
``(D) notify the Food and Drug Administration of
online pharmacy websites that do not satisfy such
criteria; and
``(E) provide services to maintain the Registry.
``(2) Contracting.--In contracting with entities under this
subsection, the Secretary--
``(A) may waive such provisions of the Federal
Acquisition Regulation, except for provisions relating
to confidentiality of information, as necessary for the
efficient implementation of this subsection and for
selecting such entities; and
``(B) shall select entities that have demonstrated
a history of competency in reviewing, evaluating, and
determining the legitimacy of online pharmacy websites,
based on standards approved by the United States
National Association of Boards of Pharmacy.
``(3) Terms of contract.--A contract with an entity under
this subsection shall include such terms and conditions as
specified by the Secretary, including the following:
``(A) The entity shall monitor the Internet on an
ongoing basis in order to sufficiently maintain a
current list of legitimate online pharmacy websites for
consideration by the Secretary.
``(B) On at least a monthly basis, the entity shall
submit to the Secretary an updated list of legitimate
online pharmacy websites recommended for inclusion on
the Registry.
``(f) Use of Registry.--
``(1) Public availability.--The Secretary shall--
``(A) make the Registry available to Internet
advertising services, financial transaction providers,
domain name registries, domain name registrars, other
domain name authorities, information location tool
service providers, and others as determined necessary
and appropriate by the Secretary to promote public
health and safety;
``(B) make the Registry available to consumers and
other interested persons through publication on the
Internet website of the Food and Drug Administration;
and
``(C) specify the Registry criteria used to
designate legitimate online pharmacy websites on the
Internet website of the Food and Drug Administration.
``(2) Consumer education.--The Secretary shall--
``(A) engage in a campaign to educate consumers on
the availability and use of the Registry to promote
public health and safety through means as determined
appropriate and necessary by the Secretary, which may
include radio, television, print media, and Internet
public service announcements; and
``(B) make consumer education materials available,
on the Internet website of the Food and Drug
Administration and in a consumer-friendly form and
manner, regarding how to safely purchase drugs over the
Internet.
``(g) Refusal of Service; Immunity.--
``(1) Refusal of service.--A domain name registry, domain
name registrar, other domain name authority, financial
transaction provider, information location tool service
provider, or Internet advertising service, acting in good faith
based on the Registry, may cease or refuse to provide services
to an online pharmacy website that is not included on the
Registry.
``(2) Immunity from liability.--If an entity described in
paragraph (1), including the directors, officers, employees, or
agents of the entity, acting in good faith, ceases or refuses
to provide services to an online pharmacy website that is not
included on the Registry--
``(A) no cause of action may be brought under any
Federal or State law against the entity for such
cessation or refusal; and
``(B) no administrative proceeding may be
instituted against the entity for such cessation or
refusal.''.
SEC. 5. EFFECTIVE DATE.
This Act (and the amendments made by this Act) shall take effect on
the date that is 180 days after the date of enactment of this Act.
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