served as basis for removal from the Reg-
istry. Such regulations shall provide a rea-
sonable time period to correct the grounds 
for removal. 
‘‘(ii) LIMITATION
REGARDING
AP-
PEALS PROCESS.—The appeals process es-
tablished 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 Sec-
retary determines, in the Secretary’s 
sole discretion, that the violation of a 
Registry requirement is materially sig-
nificant, such a violation is not likely 
to be curable, or the applicant has en-
gaged 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 phar-
macy website from applying under paragraph (1) for 
VerDate Mar 15 2010 
23:42 Feb 28, 2012
Jkt 019200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H4095.IH
H4095
smartinez on DSK6TPTVN1PROD with BILLS
re-inclusion of the website on the Registry subse-
quent 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 Asso-
ciation of Boards of Pharmacy or other private enti-
ties to— 
‘‘(A) review applications submitted under 
subsection (d)(1) and evaluate whether the on-
line pharmacy website satisfies the criteria de-
scribed under subsection (c); 
‘‘(B) on an ongoing basis, review and iden-
tify online pharmacy websites for which no ap-
plication has been submitted under subsection 
(d)(1) and evaluate whether these online phar-
macies satisfy the criteria described under sub-
section (c); 
‘‘(C) make recommendations to the Sec-
retary 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 Adminis-
tration of online pharmacy websites that do not 
satisfy such criteria; and 
VerDate Mar 15 2010 
23:42 Feb 28, 2012
Jkt 019200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H4095.IH
H4095
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(E) provide services to maintain the Reg-
istry. 
‘‘(2) CONTRACTING.—In contracting with enti-
ties under this subsection, the Secretary— 
‘‘(A) may waive such provisions of the 
Federal Acquisition Regulation, except for pro-
visions relating to confidentiality of informa-
tion, as necessary for the efficient implementa-
tion of this subsection and for selecting such 
entities; and 
‘‘(B) shall select entities that have dem-
onstrated a history of competency in reviewing, 
evaluating, and determining the legitimacy of 
online pharmacy websites, based on standards 
approved by the United States National Asso-
ciation 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 Sec-
retary. 
VerDate Mar 15 2010 
23:42 Feb 28, 2012
Jkt 019200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H4095.IH
H4095
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(B) On at least a monthly basis, the enti-
ty shall submit to the Secretary an updated list 
of legitimate online pharmacy websites rec-
ommended for inclusion on the Registry. 
‘‘(f) USE OF REGISTRY.— 
‘‘(1) PUBLIC
AVAILABILITY.—The Secretary 
shall— 
‘‘(A) make the Registry available to Inter-
net advertising services, financial transaction 
providers, domain name registries, domain 
name registrars, other domain name authori-
ties, information location tool service providers, 
and others as determined necessary and appro-
priate by the Secretary to promote public health 
and safety; 
‘‘(B) make the Registry available to con-
sumers 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— 
VerDate Mar 15 2010 
23:42 Feb 28, 2012
Jkt 019200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H4095.IH
H4095
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(A) engage in a campaign to educate con-
sumers on the availability and use of the Reg-
istry 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 pub-
lic 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 Reg-
istry. 
‘‘(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 
VerDate Mar 15 2010 
23:42 Feb 28, 2012
Jkt 019200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H4095.IH
H4095
smartinez on DSK6TPTVN1PROD with BILLS