[Federal Register Volume 71, Number 111 (Friday, June 9, 2006)]
[Notices]
[Pages 33466-33467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9032]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0478]


Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Marketed Unapproved Drugs--
Compliance Policy Guide.'' The guidance describes how FDA intends to 
exercise its enforcement discretion with regard to drugs marketed in 
the United States that do not have required FDA approval for marketing. 
This document supersedes 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) review.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 request. Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm.

[[Page 33467]]

1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Center for Drug 
Evaluation and Research (HFD-316), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8964.

SUPPLEMENTARY INFORMATION:

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 OTC 
drug 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 drug monograph, have 
not provided FDA with evidence demonstrating that their products are 
safe and effective. Therefore, FDA has an interest in taking steps to 
encourage the manufacturers of these products either to obtain the 
required evidence and comply with the approval provisions of the 
Federal Food, Drug, and Cosmetic Act or to remove the products from the 
market. FDA wants to achieve these goals 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 come to our attention either 
during inspections or through outside sources.

II. The Guidance

    FDA is announcing the availability of a guidance entitled 
``Marketed Unapproved Drugs--Compliance Policy Guide.'' In the Federal 
Register of October 23, 2003 (62 FR 60702), FDA announced the 
availability of a draft guidance of the same title and gave interested 
persons an opportunity to submit comments by December 22, 2003. In 
response to comments received, the agency revised the guidance to 
include editorial corrections and clarification of policies, including 
clarification of when and how we intend to exercise our enforcement 
discretion. The revisions also clarify the discussion of 
``grandfather'' status and expressly state that no part of the guidance 
is a finding as to the legal status of any particular drug product.
    This document supersedes section 440.100 entitled ``Marketed New 
Drugs Without Approved NDAs or ANDAs'' (CPG 7132c.02) of the CPG. It 
applies to any new drug required to have FDA approval for marketing, 
including new drugs covered by the OTC review.
    The goals of the guidance are to address the following issues: (1) 
Clarify for FDA personnel and the regulated industry how the FDA 
intends to exercise its enforcement discretion regarding unapproved 
drugs and (2) emphasize that illegally marketed drugs must obtain FDA 
approval.
    The guidance reflects the agency's desire to address these issues 
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 guidance explains that FDA will 
continue to give priority to enforcement actions involving unapproved 
drugs with potential safety risks, that lack evidence of effectiveness, 
and 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. It confirms that the agency will continue longstanding 
policies regarding firms making unapproved drugs who are violating the 
act in other respects and clarifies how the agency plans to address 
formulation changes made to evade an enforcement action.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9032 Filed 6-8-06; 8:45 am]
BILLING CODE 4160-01-S