FDA Regulation of Compounded Drugs

Welcome to CDER's web page on pharmacy compounding. CDER has created web this page so readers can follow the Agency's activities on pharmacy compounding.

Pharmacy Compounding News

• Warning Letter
  • Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER)
    [PDF] [HTML]
• Medical Center Pharmacy v. Mukasey (8/14/2008)

Guidance for Industry

• Guidance for FDA Staff and Industry, Compliance Policy Guides Manual, Sec 460.200, Pharmacy Compounding. [HTML] or [PDF ] (6/7/2002)
  • Federal Register Notice Announcing the Availability of the Pharmacy Compounding Compliance Policy Guide [HTML] or [PDF ] (6/7/2002)

Regulations

• List of Drug Products That Have Been Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness: Proposed Rule (10/8/1998)
• List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness: Final Rule [HTML] or [PDF ] (3/9/1999)

Significant Compliance Actions

• 2008
  • "Bio-identical" Hormone Therapy
  • FDA News: FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (1/9/2008)
    
  • Warning Letters
    • Panorama Compounding Pharmacy [PDF ] [HTML]
    • Saint John's Medical Plaza Pharmacy [PDF ] [HTML]
    • Murray Avenue Apothecary [PDF ] [HTML]
    • Village Compounding Pharmacy [PDF ] [HTML]
    • Pharmacy Compounding Specialties [PDF ] [HTML]
    • Reed's Compounding Pharmacy [PDF ] [HTML]
    • Pacifica Pharmacy [PDF ] [HTML]
  • Questions and Answers: Compounded Menopausal Hormone Therapy
  • Bio-Identicals: Sorting Myths from Facts
  • Obtaining an IND for Estriol
    
    
  • Warning Letters
    • Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER) [PDF] [HTML]
    • Newman Inc., (dba Medi-Stat), 6/24/2008, New Orleans District Office [PDF] [HTML]
    • Farmacia La Salud Inc., 3/26/2008 San Juan District Office [PDF] [HTML]
    • Bellevue Pharmacy Solutions, 1/14/2008, Kansas City District Office [PDF ] [HTML]
    • American Hormones, Inc., 1/10/2008, New York District Office [PDF] [HTML]
      
      
• 2007
  • Warning Letters
    • Med-South Pharmacy Inc., 9/28/2007, New Orleans District Office [PDF] [HTML]
    • PharMEDium Services, LLC, 4/13/2007, Dallas District Office [PDF] [HTML]
    • ComputeRx/Broncho-Dose, Ltd. 3/21/2007, New England District Office [PDF] [HTML]
    • Kalchem International, Inc., 1/8/2007, Dallas District Office [PDF] [HTML]
      
      
• 2006
  • FDA Warns Five Firms To Stop Compounding Topical Anesthetic Cream (12/5/2006)
  • FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs (8/10/2006)
  • Warning Letters
    • Spoonamore Drug Co., Inc., 12/1/2006, Cincinnati District Office [PDF] [HTML]
    • Health Dimensions, Inc., 11/27/2006, Detroit District Office [PDF] [HTML]
    • Pharmacy Creations, 10/31/2006, New Jersey District Office [PDF] [HTML]
    • Wedgewood Village Pharmacy, 10/31/2006, New Jersey District Office [PDF] [HTML]
    • B. Braun Medical Inc., 3/15/2006, Philadelphia District Office [PDF] [HTML]
    • Southern Meds Joint Venture, LLC, 2/15/2006, New Orleans District Office [PDF ] [HTML]

Public Presentations

• Report: 2006 Limited FDA Survey of Compounded Drug Products
• Report: Limited FDA Survey of Compounded Drug Products  (2/13/2003)

• Section 127, Application of Federal Law to Practice of Pharmacy Compounding
• Court Decision - Western States Medical Center v. Shalala, 99-17424, February 6, 2001
• Supreme Court Decision - Thompson et al. v. Western States Medical Center et al., U.S. Supreme Court Case No. 01-344, Decided April 29, 2002  

• CDER FDA Modernization Act Page
• FDA Modernization Act Page
• Consumer Update: The Special Risks of Pharmacy Compounding

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Date created: December 15, 2005, updated November 19, 2008

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