[Federal Register: October 23, 2003 (Volume 68, Number 205)]
[Page 60702-60703]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0478]

Draft Guidance on Marketed Unapproved Drugs; Compliance Policy 
Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Marketed Unapproved Drugs; 
Compliance Policy Guide.'' This draft guidance describes how FDA 
intends to exercise its enforcement discretion with

[[Page 60703]]

regard to drugs marketed in the United States that do not have required 
FDA approval for marketing. This document will, when finalized, 
supersede section 440.100 entitled ``Marketed New Drugs Without 
Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide 
(CPG). It applies to any new drug required to have FDA approval for 
marketing, including new drugs covered by the over-the-counter (OTC) 

DATES: Submit written or electronic comments on the draft guidance by 
December 22, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self addressed adhesive 
label to assist the office in processing your requests. Submit written 
comments on the draft guidance to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Center for Drug 
Evaluation and Research (HFD-316), Food and Drug Administration, 1451 
Rockville Pike, Rockville, MD 20852, 301-827-8964.


I. Background

    In the United States, as many as several thousand drug products are 
marketed illegally without required FDA approval. The manufacturers of 
these drugs have neither received FDA approval to legally market their 
drugs, nor have the drugs been marketed in accordance with a final 
over-the-counter (OTC) monograph. The drug approval and OTC monograph 
processes play an essential role in ensuring that all drugs are both 
safe and effective. Manufacturers of new drugs that lack required 
approval, including those that are not marketed in accordance with an 
OTC monograph, have not provided FDA with evidence demonstrating that 
their products are safe and effective. Therefore, FDA has an interest 
in taking steps to either encourage the manufacturers of these products 
to obtain the required evidence and comply with the approval provisions 
of the Federal Food, Drug, and Cosmetic Act (the act), or to remove the 
products from the market. FDA recognizes that these goals need to be 
achieved without adversely affecting public health, imposing undue 
burdens on consumers, or unnecessarily disrupting the market.
    In general, in recent years, FDA has employed a risk-based 
enforcement approach to marketed unapproved drugs that includes efforts 
to identify illegally marketed drugs, prioritization of those drugs 
according to potential public health concerns or other impacts on the 
public health, and subsequent regulatory followup. Some of the specific 
actions the agency has taken have been precipitated by evidence of 
safety or effectiveness problems that has either come to our attention 
during inspections or was brought to our attention by outside sources.
    The goals of this draft guidance are to address the following 
issues: (1) Clarify for FDA personnel and the regulated industry how 
FDA intends to exercise its enforcement discretion regarding unapproved 
drugs and (2) emphasize that illegally marketed drugs must obtain FDA 
    The draft guidance reflects the agency's desire to address this 
issue with policies that are predictable, reasonable, and supportive of 
the public health. The agency's approach encourages companies to comply 
with the drug approval process, but it also seeks to minimize 
disruption to the marketplace and to safeguard consumer health when 
there are potential safety risks. The draft guidance explains that FDA 
will continue to give priority to enforcement actions involving 
unapproved drugs: (1) with potential safety risks, (2) that lack 
evidence of effectiveness, and (3) that constitute health fraud. It 
also explains how the agency intends to address those situations in 
which a firm obtains FDA approval to sell a drug that other firms have 
long been selling without FDA approval.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet can obtain the guidance at 

    Dated: October 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26753 Filed 10-20-03; 3:00 pm]