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

Enforcement Actions

• FDA's Concerns About Unapproved Drugs
• Background Information
• Unapproved Drugs Initiative
  • Compliance Policy Guide
• Enforcement Actions
  • Drug-Based Actions
  • Firms
• Industry Information
  • Unapproved Drug Decision Tree
  • Unapproved Drugs Coordinator
    • Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator
  • Marketed Unapproved Drugs Workshop
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• Health Care Professional Information
  • Determining if a drug is FDA approved
  • Orange Book
  • NDC Directory
  • Drugs@FDA
  • Legal mechanisms to access unapproved drugs
  • Reporting of adverse events
• Consumer Information
• Important Documents
• Publications

Enforcement Actions

Since the CPG, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.

Drug-Based Actions: Since publication of the CPG, the Agency has taken enforcement action against a number of unapproved drugs:

• Balanced Salt Solution (ophthalmic) Products
• Carbinoxamine Drug Products
• Ergotamine-Containing Drug Products
• Timed-Release Drug Products Containing Guaifenesin
• Hydrocodone Drug Products
• Injectable Colchicine Products
• Topical Drug Products Containing Papain
• Quinine Sulfate Drug Products
• Trimethobenzamide Hydrochloride Suppositories

Balanced Salt Solution (ophthalmic) Products Drug Products

• Federal Register Notice [HTML][PDF ] (September 22, 2008). FDA announced its intention to take enforcement action against unapproved drug products containing Balanced Salt Solution ophthalmic products and persons who cause the manufacture of such products.
• Questions and Answers About FDA's Enforcement Action Against Unapproved Ophthalmic Balanced Salt Solution Products

Carbinoxamine Drug Products

• Federal Register Notice [HTML] [PDF ] (June 9, 2006). FDA announced its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products.
• FDA News: FDA Acts to Improve Drug Safety and Quality; Manufacturing of Unapproved Drug Products Containing Carbinoxamine Must Cease (Issued June 8, 2006)
• Questions and Answers About Unapproved Drugs and FDA's Enforcement Action Against Carbinoxamine Products

Ergotamine-Containing Drug Products

• FDA News: FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches (Issued March 1, 2007)
• Warning Letters (Issued February 26, 2007)

Timed-Release Drug Products Containing Guaifenesin

• FDA News: Federal Agents Seize more than $24 Million in Unapproved New Drugs (Issued July 30, 2008)
• Federal Register Notice [HTML] [PDF ] (May 29, 2007). FDA announced its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products.
• FDA News: FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products (Issued May 25, 2007)
• Questions and Answers About FDA's Enforcement Action Against Timed-Release Drug Products Containing Guaifenesin

Hydrocodone Drug Products

• Patient Safety News segment: Warning on Unapproved Antitussives Containing Hydrocodone (December 2007)
• FDA News: FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (Issued September 28, 2007)
• Questions and Answers About FDA's Enforcement Action Regarding Unapproved Hydrocodone Drug Products
• FDA MedWatch Safety Alert. Hydrocodone in Unapproved Prescription Products. September 28, 2007.
• Federal Register Notice [HTML] [PDF ] (September 28, 2007)

Injectable Colchicine Products

• FDA News: FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine (Issued February 6, 2008)
• Questions and Answers About FDA's Enforcement Action Against Unapproved Injectable Colchicine Products
• Federal Register Notice [HTML] [PDF ] (February 6, 2008)

Topical Drug Products Containing Papain

• Federal Register Notice [HTML][PDF ] (September 22, 2008). FDA announced its intention to take enforcement action against unapproved topical drug products containing Papain and persons who cause the manufacture of such products.
• Questions and Answers about FDA's Enforcement Action Regarding Unapproved Topical Drug Products Containing Papain

Quinine Sulfate Drug Products

• Patient Safety News segment: Danger in Products Containing Quinine (March 2007)
• Questions and Answers About FDA's Enforcement Action Against Quinine Sulfate Drug Products (updated December 15, 2006)
• Federal Register Notice [HTML] [PDF ] (December 15, 2006).
• FDA MedWatch Safety Alert. Quinine products. (December 12, 2006).
• FDA News: FDA Advances Effort Against Marketed Unapproved Drugs; Orders Unapproved Quinine Drugs from the Market (Issued December 11, 2006)

Trimethobenzamide Hydrochloride Suppositories

• Federal Register Notice [HTML] [PDF ] (April 9, 2007)
• FDA News: FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (Issued April 6, 2007)

Firms

In addition, since publication of the CPG, the Agency has taken enforcement actions against a number of firms with significant violations of current good manufacturing practice (CGMPs) or adverse event reporting requirements that also make unapproved drugs.

• Abraxis Bioscience, Inc.
• Actavis Totowa, LLC
• Amerifit Brands, Inc.
• Concord Laboratories, Inc.
• C. R. Canfield Co., Inc.
• Elge, Inc.
• G & W Laboratories, Inc.
• KV Pharmaceutical Company
• Midland Pharmaceutical LLC
• PharmaFab Inc.
• Scientific Laboratories, Inc.
• Sheffield Laboratories, Division of Faria Limited LLC
• Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
• TME Enterprises
• Vintage Pharmaceuticals, LLC
• Vita-Erb, Ltd.

Abraxis Bioscience, Inc.

• Warning Letter (Issued December 18, 2006)

Actavis Totowa, LLC

• Warning Letter (Issued August 15, 2006)

Amerifit Brands, Inc.

• Warning Letter (Issued November 7, 2007)

Concord Laboratories, Inc.

• Warning Letter (Issued July 11, 2006)

C. R. Canfield Co., Inc.

• FDA News: Permanent Injunction of Dental Products Manufacturer Furthers FDA Efforts Against Marketed Unapproved Drugs (Issued October 6, 2006)
• Consent Decree of Permanent Injunction (September 18, 2006)
• FDA Complaint for Permanent Injunction (September 15, 2006)
• Warning Letter (Issued September 24, 2004)

Elge, Inc.

• Warning Letter (Issued May 8, 2008)

G & W Laboratories, Inc.

• Warning Letter (Issued July 24, 2008)

KV Pharmaceutical Company

• FDA News: Federal Agents Seize more than $24 Million in Unapproved New Drugs (Issued July 30, 2008)

Midland Pharmaceutical LLC

• Warning Letter (Issued March 3, 2008)

PharmaFab Inc.

• FDA News: Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices (Issued April 25, 2007)
• Consent Decree of Permanent Injunction (April 24, 2007)
• FDA Complaint for Permanent Injunction (April 20, 2007)
• Warning Letter (Issued June 15, 2004)
• Warning Letter (Issued October 11, 2002)

Scientific Laboratories, Inc.

• FDA News: FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (Issued May 16, 2008)

Sheffield Laboratories, Division of Faria Limited LLC

• Warning Letter (Issued July 24, 2006)

Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.

• FDA News: FDA Continues To Tackle Unapproved Drugs (Issued October 5, 2006)
• Consent Decree of Permanent Injunction (August 10, 2006)
• FDA Complaint for Permanent Injunction (August 10, 2006)
• Warning Letter (Issued May 13, 2003)
• Warning Letter (Issued March 14, 2003)

TME Enterprises

• Warning Letter (Issued December 18, 2007)

Vintage Pharmaceuticals, LLC

• Warning Letter (Issued February 1, 2008)

Vita-Erb, Ltd.

• Order of Permanent Injunction (Filed November 14, 2006)
• FDA Supplemental Complaint for Permanent Injunction (Filed June 9, 2006)
• Warning Letter (Issued April 29, 2004)

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Date created: June 8, 2006; updated September 23, 2008

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