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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.

Important Documents

Consumer Information

Selected Enforcement Actions on Unapproved Drugs
  • 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

Drug Approval Application Process

Related Links

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