‘‘(A) The street address and telephone 
number of—
‘‘(i) the Internet pharmacy’s place of 
business; and 
‘‘(ii) the Internet pharmacy’s super-
vising pharmacist. 
‘‘(B) All States in which the Internet phar-
macy is licensed or otherwise authorized to dis-
pense prescription drugs. 
‘‘(C) If the Internet pharmacy makes re-
ferrals to, or solicits on behalf of, a practitioner 
or a group of practitioners for prescription serv-
ices—
‘‘(i) the name, street address, and 
telephone number of such practitioner or 
group; and 
‘‘(ii) each State in which each practi-
tioner involved is licensed or otherwise au-
thorized to prescribe drugs. 
‘‘(D) A statement that the Internet phar-
macy will dispense prescription drugs only upon 
a showing of a prescription. 
‘‘(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.
establish the diagnosis for which the pre-
scription drug involved is prescribed, has 
discussed with the individual his or her 
treatment options and the risks and bene-
fits of treatment, and maintains contem-
poraneous medical records on the indi-
vidual; 
‘‘(ii) a health care provider who is 
providing care in consultation with a 
health care provider described in clause (i) 
and who has access to the medical records 
of the patient involved; or 
‘‘(iii) a health care provider who 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. 4. DISTRIBUTION AND LABELING OF DRUGS. 
(a) DRUG PEDIGREE AMENDMENTS.—Paragraph (1) 
of section 503(e) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353(e)) is amended—
(1) in subparagraph (A), by striking ‘‘Each per-
son who is engaged in the wholesale distribution of 
a drug subject to subsection (b) and who is not the 
manufacturer or an authorized distributor of record 
of such drug shall’’ and inserting ‘‘Subject to sub-
paragraph (C), each person who is engaged in the 
wholesale distribution of a drug subject to subsection 
(b) shall’’; and 
(2) by adding after subparagraph (B) the fol-
lowing:
‘‘(C) Subparagraph (A) applies to the manufacturer 
of a drug or the authorized distributor of record of a drug 
only if—
‘‘(i) the drug is included in schedule II of sec-
tion 202(c) of the Controlled Substances Act; or 
‘‘(ii) the Secretary designates the drug for pur-
poses of this subparagraph, taking into consideration 
the impact to public health that would result from 
counterfeiting or diversion of the drug, the price of 
the drug, the volume of the drug, the dosage form 
of the drug, the clinical uses of the drug, the history 
of counterfeiting or diversion of the drug, and 
whether products similar to the drug have a history 
of counterfeiting or diversion.’’. 
(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 3) is amend-
ed—
(1) in section 502, by adding at the end the fol-
lowing: 
‘‘(w) If it is a drug with respect to which the manu-
facturer, importer, distributor, or retailer fails to comply 
with the chain-of-custody requirements of section 503C.’’; 
and
(2) by inserting after section 503B the fol-
lowing: 
‘‘SEC. 503C. CHAIN-OF-CUSTODY REQUIREMENTS. 
‘‘(a) IN GENERAL.—Not later than January 1, 2006, 
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, 2008.’’. 
(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. 5. 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 import 
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. 6. 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. 
(c) STUDY.—The study conducted by the working 
group on pharmaceutical counterfeiting shall consider the 
following: 
(1) How to enhance supply-chain security. 
(2) Consumer education on counterfeiting 
issues.
(3) Employing technology designed to frustrate 
organized and sophisticated criminals intent on com-
promising the world’s drug supply. 
(4) How industry could assist law enforcement 
by analyzing suspected counterfeit drugs to deter-
mine authenticity. 
(5) How industry can collaborate on issues re-
lated to pharmaceutical counterfeiting without re-
vealing trade secrets or other confidential informa-
tion. 
(d) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the working group shall sub-
mit a report to the Congress on the results of the study 
conducted under this section, including recommendations 
on measures to reduce or eliminate problems associated 
with pharmaceutical counterfeiting. 
SEC. 7. BASELINE RESEARCH ON PRESCRIPTION DRUG 
ABUSE. 
(a) RESEARCH.—The Secretary of Health and 
Human Services shall conduct research on issues related 
to prescription drug abuse, including the following: 
(1) Enhancing existing public use surveys and 
other sources so as to provide appropriate baseline 
data and data on the natural history and context of 
prescription drug use in order to evaluate the extent
and nature of potential problems and guide correc-
tive actions which reduce the problems without unin-
tentionally hindering patient access. 
(2) The phenomenon of iatrogenic addiction, in-
cluding the actual incidence and prevalence of iatro-
genic addiction, the factors that modulate the risk of 
such addiction, and the extent to which concern 
about iatrogenic addiction impacts health care deliv-
ery. 
(3) Development of postapproval surveillance 
approaches that can detect and address potential 
risks of abuse and misuse, including risks in diverse 
patient populations that did not previously appear at 
risk for diversion or abuse, and in geographic re-
gions that have been relatively absent from risk. 
(4) Methods to better translate new ideas about 
terminology, diagnosis, and management of addic-
tion diseases into clinical practice at the primary 
care and specialist levels. 
(5) Reliable, useful assessment tools for addic-
tion in the clinical setting of initial and ongoing 
treatment of conditions requiring the use of con-
trolled substances. 
(6) Development of better methods of ensuring 
patient adherence to prescribed drug regimens.
(7) Relative contributions of genetic, psycho-
social, environmental, and behavioral factors to ad-
diction to prescription opioids. 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit to the Congress a report on 
the results of the research conducted under this section. 
SEC. 8. DATABASE FOR DRUG ABUSE MORTALITY REPORT-
ING. 
Section 505 of the Public Health Service Act (42 
U.S.C. 290aa–4) is amended—
(1) in subparagraph (B) of subsection (c)(1), by 
striking ‘‘, as indicated in reports by coroners’’; and 
(2) by adding at the end the following: 
‘‘(e) With respect to the activities of the Adminis-
trator under subsections (a) and (c)(1)(B) relating to the 
collection of data on the number of deaths occurring as 
a result of substance abuse, the Administrator—
‘‘(1) shall expand and intensify collection activi-
ties to maintain a comprehensive, national database 
on such deaths; and 
‘‘(2) shall require medical examiners, coroners, 
and other appropriate persons to report to the Ad-
ministrator for purposes of collecting data on such 
deaths.’’
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