‘‘(c) TREATING PROVIDER VERIFICATION REQUIRE-
MENTS.—The treating provider verification requirements 
of this subsection are as follows: 
‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
person may sell a prescription drug in interstate 
commerce through an Internet site only if— 
‘‘(A) the sale is in accordance with a pre-
scription of the treating provider of the patient 
involved; 
‘‘(B) the seller verifies the prescription in 
accordance with paragraph (3); 
‘‘(C) the seller maintains a record of direct 
communications in accordance with paragraph 
(4); and 
‘‘(D) the seller complies with the prohibi-
tion of paragraph (5) against alteration of the 
prescription. 
‘‘(2) 
LIMITATION.—The 
treating 
provider 
verification requirements of this subsection apply 
with respect to a prescription drug only if— 
‘‘(A) the prescription drug is included in 
schedule II, III, or IV of section 202(c) of the 
Controlled Substances Act; or 
‘‘(B) the Secretary for purposes of this 
section identifies the prescription drug as po-
tentially subject to abuse, diversion, and mis-
use. 
‘‘(3) VERIFICATION REQUIREMENT.— 
‘‘(A) REQUIREMENT.—A seller verifies a 
prescription in accordance with this paragraph 
if— 
‘‘(i) the patient involved or the pa-
tient’s treating provider presents the pre-
scription, directly or by facsimile or elec-
tronic mail, to the seller; or 
‘‘(ii) the seller verifies the prescription 
by direct communication with the treating 
provider involved. 
‘‘(B) 
INFORMATION.—When 
seeking 
verification of a prescription under subpara-
graph (A)(ii), a seller shall provide to the treat-
ing provider the following information: 
‘‘(i) Patient’s full name and address. 
‘‘(ii) Identification of the drug by a 
national drug code number. 
‘‘(iii) Quantity to be dispensed. 
‘‘(iv) Date of patient request. 
‘‘(v) Date and time of verification re-
quest.
‘‘(vi) Name of contact person at sell-
er’s company, including facsimile and tele-
phone number. 
‘‘(C) VERIFICATION EVENTS.—A prescrip-
tion is verified under subparagraph (A)(ii) only 
if one of the following occurs: 
‘‘(i) The treating provider confirms 
the prescription is accurate by direct com-
munication with the seller. 
‘‘(ii) The treating provider informs 
the seller that the prescription is inac-
curate and provides the accurate prescrip-
tion. 
‘‘(iii) The treating provider fails to 
communicate with the seller within 48 
hours, or a similar time as defined by the 
Commissioner of Food and Drugs, after 
receiving from the seller the information 
described in subparagraph (B). 
‘‘(D) INVALID PRESCRIPTION.—If a treat-
ing provider informs a seller before the deadline 
under subparagraph (C)(iii) that the prescrip-
tion is inaccurate or expired, the seller shall not 
fill the prescription. The treating provider shall 
specify the basis for the inaccuracy or invalidity
of the prescription. If the prescription commu-
nicated by the seller to the treating provider is 
inaccurate, the treating provider shall correct it. 
‘‘(4) RECORD
REQUIREMENT.—A seller shall 
maintain for at least 2 years a record of all direct 
communications with a treating provider regarding 
the sale of a prescription drug, including verification 
of the prescription involved. 
‘‘(5) NO ALTERATION.— 
‘‘(A) IN GENERAL.—A seller may not alter 
a prescription for a prescription drug. 
‘‘(B) EXCEPTIONS.—Notwithstanding sub-
paragraph (A)— 
‘‘(i) if the same prescription drug is 
manufactured by the same company and 
sold under multiple labels to individual 
providers, the seller may fill the prescrip-
tion with a prescription drug manufactured 
by that company under another label; and 
‘‘(ii) the seller may fill the prescrip-
tion with a generic version of the prescrip-
tion drug. 
‘‘(6) DEFINITIONS.—In this subsection:
‘‘(A) The term ‘direct communication’ in-
cludes communication by telephone, facsimile, 
or electronic mail. 
‘‘(B) The term ‘generic version of the pre-
scription drug’ means, with respect to a pre-
scription drug, a drug for which an application 
is approved under section 505(j) and for which 
the relevant listed drug described in section 
505(j)(2) is such prescription drug. 
‘‘(C) The term ‘seller’ means a person that 
sells a prescription drug in interstate commerce 
through an Internet site. 
‘‘(D) The term ‘treating provider’ means a 
health care provider (including a nurse) licensed 
by law to administer the prescription drug in-
volved who— 
‘‘(i) has performed a documented pa-
tient evaluation of the individual involved 
(including a patient history and physical 
examination) to establish the diagnosis for 
which the prescription drug involved is pre-
scribed, has discussed with the individual 
his or her treatment options and the risks 
and benefits of treatment, and maintains
contemporaneous medical records on the 
individual; 
‘‘(ii) is providing care in consultation 
with a health care provider described in 
clause (i) and who has access to the med-
ical records of the patient involved; or 
‘‘(iii) is providing care as part of an 
on-call or cross-coverage arrangement with 
a health care provider described in clause 
(i). 
‘‘(d) STATE NOTICE REQUIREMENTS.—A person that 
sells a prescription drug in interstate commerce through 
an Internet site shall provide to each State authority that 
licenses or otherwise authorizes the person to dispense the 
prescription drug the following information: 
‘‘(1) A statement that the person is selling pre-
scription drugs through an Internet site. 
‘‘(2) The name, Internet address, street ad-
dress, and telephone number of the person’s busi-
ness for selling such drugs. 
‘‘(e) DEFINITION.—In this section, the term ‘pre-
scription drug’ means a drug subject to section 503(b).’’. 
(b) INCLUSION AS PROHIBITED ACT.—Section 301 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331) is amended by inserting after paragraph (k) the fol-
lowing: 
‘‘(l) The sale of a prescription drug, or the ownership 
or operation of an illegal Internet pharmacy, in violation 
of section 503B.’’. 
(c) LINKS TO ILLEGAL INTERNET PHARMACY.—Sec-
tion 302 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 332) is amended by adding at the end the fol-
lowing: 
‘‘(c) In the case of a violation of section 503B relat-
ing to an illegal Internet pharmacy, the district courts of 
the United States and the United States courts of the Ter-
ritories shall have jurisdiction to order a provider of an 
interactive computer service to remove, or disable access 
to, a site violating such section, or a link to a site violating 
such section, that resides on a computer server that such 
provider controls or operates. Such relief shall— 
‘‘(1) be available only after provision to the pro-
vider of notice and an opportunity to appear; 
‘‘(2) not impose any obligation on the provider 
to monitor its service or to affirmatively seek facts 
indicating activity violating section 503B; 
‘‘(3) specify the provider to which the relief ap-
plies; and
‘‘(4) specifically identify the location of the site 
or link to be removed, or to which access is to be 
disabled.’’. 
SEC. 3. DISTRIBUTION AND LABELING OF DRUGS. 
(a) DRUG PEDIGREES.—With respect to any State 
that imposes a requirement on the manufacturer or dis-
tributor of a drug to provide information to persons receiv-
ing the drug regarding prior sales, purchases, or trades 
of the drug, the Secretary of Health and Human Services 
shall— 
(1) encourage the State to allow the manufac-
turer or distributor to take advantage of techno-
logical advances, including by providing such infor-
mation electronically; and 
(2) at the request of the State, provide tech-
nical assistance in implementing the requirement. 
(b) CHAIN-OF-CUSTODY REQUIREMENTS.—Chapter 
V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) (as amended by section 2) is amend-
ed— 
(1) in section 502, by adding at the end the fol-
lowing: 
‘‘(x) If it is a drug with respect to which the manufac-
turer, importer, distributor, or retailer fails to comply with 
the chain-of-custody requirements of section 503C.’’; and
(2) by inserting after section 503B (as added 
by section 2) the following: 
‘‘SEC. 503C. CHAIN-OF-CUSTODY REQUIREMENTS. 
‘‘(a) IN GENERAL.—Not later than January 1, 2007, 
the Secretary shall promulgate chain-of-custody require-
ments applicable to each manufacturer, importer, dis-
tributor, and retailer of a prescription drug. 
‘‘(b) MANUFACTURERS.—The chain-of-custody re-
quirements promulgated under this section shall require 
each manufacturer of a prescription drug— 
‘‘(1) to incorporate a unique identifier into the 
packaging or labeling of the drug; 
‘‘(2) to track the drug through the point of de-
livery to the retailer of the drug; and 
‘‘(3) to maintain, either directly or through a 
contractor, a database on the movement of the drug. 
‘‘(c) IMPORTERS, DISTRIBUTORS, AND RETAILERS.— 
The chain-of-custody requirements promulgated under 
this section shall require each importer, distributor, and 
retailer of a prescription drug to assist in the tracking 
of the drug under this section by reporting the receipt of 
the drug to the manufacturer. 
‘‘(d) PRESCRIPTION DRUG.—In this section, the term 
‘prescription drug’ means a drug subject to section 503(b).
‘‘(e) EFFECTIVE DATE.—The chain-of-custody re-
quirements promulgated by the Secretary under this sec-
tion shall take effect on January 1, 2009.’’. 
(c) GRANTS FOR COMMUNITY PHARMACISTS.—The 
Secretary of Health and Human Services may make 
grants to community pharmacists to assist such phar-
macists to comply with tracking requirements imposed on 
such pharmacists by drug manufacturers, importers, or 
distributors as a result of the amendments made by sub-
section (b). 
SEC. 4. RESTRICTION ON PERSONAL USE EXEMPTION FOR 
IMPORTING CONTROLLED SUBSTANCES. 
Paragraph (2) of section 1006(a) of the Controlled 
Substances Import and Export Act (21 U.S.C. 956(a)) is 
amended by striking ‘‘may not import the controlled sub-
stance’’ and all that follows and inserting: ‘‘may not im-
port the controlled substance into the United States— 
‘‘(1) in an amount that exceeds 50 dosage units 
of the controlled substance; or 
‘‘(2) in the case of a controlled substance in 
schedule II, III, or IV, more than 1 time during any 
30-day period.’’.
SEC. 5. WORKING GROUP ON PHARMACEUTICAL COUNTER-
FEITING. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs, shall convene a working group (in this section re-
ferred to as the ‘‘working group’’) to conduct a study and 
submit a report on pharmaceutical counterfeiting. 
(b) MEMBERS.—The Secretary shall invite to serve 
as members of the working group representatives of the 
following: 
(1) Domestic regulatory agencies. 
(2) Domestic and international law enforcement 
officials. 
(3) Multinational organizations, such as the 
World Trade Organization and the World Health 
Organization. 
(4) The United States Trade Representative. 
(5) The pharmaceutical industry. 
(6) Trade associations, including associations 
representing each step of the pharmaceutical deliv-
ery system (including representatives of drug manu-
facturers and pharmacists). 
(c) STUDY.—The study conducted by the working 
group on pharmaceutical counterfeiting shall consider the 
following: