Drugs Marketed in the United
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,
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
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
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
- Guidance Document: Marketed Unapproved Drugs - Compliance Policy Guide (June 8, 2006)
- Federal Register Notice of Availability [HTML]
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
- 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)
Selected Enforcement Actions on
- 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
Back to Regulatory Information
PDF requires the free Adobe
Date created: June 8, 2006, updated: February 6, 2008