Drugs Marketed in the United States
That Do Not Have Required FDA Approval

The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. Drugs that are marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.

However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).

While some unapproved drugs may have benefits, there may also be risks. Patients and health professionals should carefully consider the medical condition being treated, the patient’s previous response to the drug, and the availability of approved alternatives as part of discussing the benefits and risks of any unapproved treatment.

FDA has issued a guidance entitled “Marketed Unapproved Drugs--Compliance Policy Guide” designed to make sure that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective. This guidance is the next step in an FDA initiative to ensure that all marketed U.S. drugs have required approval. The guidance clearly articulates FDA’s expectation that manufacturers of products requiring FDA approval submit applications to FDA to show that their products are safe and effective. The guidance also outlines the agency’s enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process.

• FDA Press Release: FDA Acts to Improve Drug Safety and Quality; Manufacturing of Unapproved Drug Products Containing Carbinoxamine Must Cease (Issued June 8, 2006)
• Remarks by Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs, Regarding Unapproved Drugs (Issued June 8, 2006, posted July 13, 2006)
• Statement of Steven K. Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research, Regarding Unapproved Prescription Drugs (issued June 8, 2006, posted June 9, 2006)
• Questions and Answers About Unapproved Drugs and FDA’s Enforcement Action Against Carbinoxamine Products
• Guidance Document: Marketed Unapproved Drugs - Compliance Policy Guide (June 8, 2006)
• Federal Register Notice of Availability [HTML] [PDF] (June 9, 2006). FDA announced the availability of a guidance entitled “Marketed Unapproved Drugs-Compliance Policy Guide.” The guidance describes how the 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.
• Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator
• Congressional Report - Feasibility and Cost of a New Monograph System for Marketed Unapproved Drugs  (July 2004)

Consumer Information

• Questions and Answers for Consumers About Unapproved Drugs
• Drugs@FDA -- Brand and Generic Drugs: Labels, Approval Histories, and More
• Information About the Products We Regulate
• Division of Drug Information Homepage
• Drug Information Pathfinder -- Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics

• Injectable Colchicine Products
• Hydrocodone Drug Products
• Timed-Release Drug Products Containing Guaifenesin
• PharmaFab Inc.
• Trimethobenzamide Hydrochloride Suppositories
• Ergotamine-Containing Drug Products
• Quinine Sulfate Drug Products
• Vita-Erb, Ltd.
• C. R. Canfield Co., Inc.
• Actavis Totowa, LLC
• Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
• Sheffield Laboratories, Division of Faria Limited LLC
• Concord Laboratories, Inc.
• Carbinoxamine Drug Products
• Neil Laboratories, Inc.
• Scientific Laboratories, Inc.
• Pharmakon Laboratory, Inc.
• Propharma, Inc.
• Lane Labs-USA, Inc.
• Exocrine Pancreatic Insufficiency Drug Products
• Carolina Pharmaceuticals, Inc.
• Forest Laboratories, Inc.
• Single Ingredient Guaifenesin Drug Products
• Digoxin Products for Oral Use
• Sage Pharmaceuticals, Inc.
• Levothyroxine Sodium Drug Products

January 9, 2007 Marketed Unapproved Drugs Workshop

• Meeting Agenda
• Meeting Presentations
• Transcript

Drug Approval Application Process

• Drug Approval Application Process
• Over-the-counter (OTC) Drug Products
• Regulatory Mechanisms for Marketing OTC Drug Products
  • Over-the-counter (OTC) Drug Products
  • OTC Cough/Cold Drug Products
• Chemistry, Manufacturing, and Controls
• Abbreviated New Drug Application (ANDA)
• New Drug Application (NDA)
• Investigational New Drug (IND) Application
• Demonstrating Clinical Drug Safety
• Pediatric Considerations
• User Fees and Waivers
• Small Business

Related Links

• The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective -- FDA Consumer magazine article, July, 2002.
• How to Report Problems With Products Regulated by FDA
• About FDA's New Drug Safety Initiative
• The Critical Path to New Medical Products -- The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product.

Back to Top     Back to Regulatory Information

PDF requires the free Adobe Acrobat Reader

Date created: June 8, 2006, updated: February 6, 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research