I 
109TH CONGRESS 
1ST SESSION H. R. 1808 
To amend the Federal Food, Drug, and Cosmetic Act to create a uniform 
certification standard for Internet pharmacies and to prohibit Internet 
pharmacies from engaging in certain advertising activities, to prohibit 
the use of certain bank instruments for purchases associated with illegal 
Internet pharmacies, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 21, 2005 
Mr. WALDEN of Oregon (for himself and Mr. DAVIS of Florida) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce, and in addition to the Committee on Financial Services, for 
a period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
create a uniform certification standard for Internet phar-
macies and to prohibit Internet pharmacies from engag-
ing in certain advertising activities, to prohibit the use 
of certain bank instruments for purchases associated 
with illegal Internet pharmacies, and for other purposes. 
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 ‘‘Safe Online Drug Act 
of 2005’’. 
SEC. 2. INTERNET SALES OF PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter 5 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following: 
‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS. 
‘‘(a) UNIFORM
CERTIFICATION
STANDARD
FOR 
INTERNET PHARMACIES.— 
‘‘(1) IN GENERAL.— 
‘‘(A) PROHIBITIONS.—Subject to subpara-
graph (B), it is a violation of this section— 
‘‘(i) for any person to sell or offer for 
sale a prescription drug or a restricted de-
vice through an Internet site— 
‘‘(I) if the Internet site fails to 
meet the standards established under 
paragraph (2); or 
‘‘(II) if the Internet site fails to 
comply with all State and Federal 
regulations for operating as an Inter-
net pharmacy; and 
‘‘(ii) for any person to own or operate 
an illegal Internet pharmacy.
‘‘(B) EXCEPTION.—Any person who sells 
or offers to sell a prescription drug or restricted 
device through an Internet site, or who owns or 
operates an Internet pharmacy, is deemed to 
meet the requirements of this section for pur-
poses of such sale, ownership, or operation if 
the Internet site or Internet pharmacy meets 
the certification standards adopted by the Sec-
retary under paragraph (2). 
‘‘(2) ESTABLISHMENT OF UNIFORM STANDARD 
FOR INTERNET PHARMACY CERTIFICATION.— 
‘‘(A) IN GENERAL.—The Secretary, acting 
through the Commissioner of the Food and 
Drug Administration, shall establish a program 
under which all Internet pharmacies operating 
in the United States are certified by the Sec-
retary as meeting the requirements of this sec-
tion for certification. 
‘‘(B) CONDITIONS FOR CERTIFICATION.— 
As a condition of certifying an Internet phar-
macy under subparagraph (A), the Secretary 
shall require the following with respect to such 
pharmacy: 
‘‘(i) Verification that, in each State in 
which the pharmacy engages in pharma-
ceutical activities, the pharmacy, and all 
the employees and agents of the pharmacy, 
are in compliance with applicable laws re-
garding— 
‘‘(I) the practice of pharmacy, in-
cluding licensing laws and inspection 
requirements; and 
‘‘(II) the manufacturing and dis-
tribution of controlled substances, in-
cluding with respect to mailing or 
shipping such substances to con-
sumers. 
‘‘(ii) Verification of controls to ensure 
that a prescription drug or restricted de-
vice is dispensed by the pharmacy only 
pursuant to a valid prescription, including 
circumstance in which the drug is shipped 
or mailed from a country under whose laws 
the drug is not a prescription drug. 
‘‘(iii) An agreement by the pharmacy 
that, upon certification under subpara-
graph (A), the facilities and business prac-
tices of the pharmacy will be subject to in-
spection by the Secretary to the extent ap-
propriate to determine whether the phar-