Skip to Content


Draft Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Marketed Unapproved Drugs; Compliance Policy Guide.” This draft guidance describes how FDA intends to exercise its enforcement discretion with Start Printed Page 60703regard to drugs marketed in the United States that do not have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) review.


Submit written or electronic comments on the draft guidance by December 22, 2003.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


Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Start Further Info


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

End Further Info End Preamble Start Supplemental 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 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 approval.

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​cder/​guidance/​index.htm.

Start Signature

Dated: October 15, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 03-26753 Filed 10-20-03; 3:00 pm]