FDA Website with Index to Major Warning Letters

FDA's website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

PharmacyCompounding/default.htm contains an index with links to major compliance 

actions and major warning letters issued to compounder through March 2011.  Anyone

considering doing business with a compounder should check to see if warning letter or 

action has been taken by the FDA or the state pharmacy boards.    The index for the FDA

website  appears as follows:

Pharmacy Compounding

Pharmacy Compounding News

• FDA Statement on Makena¹ (3/30/2011)
• News for Pharmacy Compounders in Regards to Possible Melamine Contamination of Pharmaceutical Components² (9/28/2009)
• Medical Center Pharmacy v. Mukasey³ (8/14/2008)

Significant Compliance Actions

• 2010
  • FDA News: FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure⁴ (4/7/2010)
    • Pure Med Spa⁵
    • All about you medispa⁶
    • Idinhealth⁷
    • Spa 35⁸
    • Monarch medispa⁹
    • Medical Cosmetic¹⁰
    • Zipmed and Mesoone¹¹
  • Warning Letters
    • VanderVeer Center, 11/18/10, Center for Drug Evaluation and Research (CDER)¹²
    • Med Prep Consulting, 7/9/10, New Jersey District Office¹³
    • J & F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory, 4/9/2010, Baltimore District Office¹⁴
      
      
• 2009
  • Warning Letters
    • Hopewell Pharmacy and Compounding Center, 9/28/2009, Center for Drug Evaluation and Research (CDER)¹⁵
• 2008
  • FDA News: FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs¹⁶ (1/9/2008)
    • Panorama Compounding Pharmacy¹⁷
    • Saint John's Medical Plaza Pharmacy¹⁸
    • Murray Avenue Apothecary¹⁹
    • Village Compounding Pharmacy²⁰
    • Pharmacy Compounding Specialties²¹
    • Reed's Compounding Pharmacy²²
    • Pacifica Pharmacy²³
  • Warning Letters
    • Civic Center Pharmacy, 12/16/2008, Los Angeles District Office ²⁴
    • Steven's Pharmacy, 11/12/2008, Los Angeles District Office²⁵
    • Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER)²⁶
    • Newman Inc., (dba Medi-Stat), 6/24/2008, New Orleans District Office²⁷
    • Farmacia La Salud Inc., 3/26/2008 San Juan District Office²⁸
    • Bellevue Pharmacy Solutions, 1/14/2008, Kansas City District Office²⁹
    • American Hormones, Inc., 1/10/2008, New York District Office ³⁰
• 2007
  • Warning Letters
    • Med-South Pharmacy Inc., 9/28/2007, New Orleans District Office³¹
    • PharMEDium Services, LLC, 4/13/2007, Dallas District Office³²
    • ComputeRx/Broncho-Dose, Ltd. 3/21/2007, New England District Office³³
    • Kalchem International, Inc., 1/8/2007, Dallas District Office ³⁴
• 2006
  • FDA News: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams³⁵ (12/5/2006)
    • Triangle Compounding Pharmacy³⁶
    • University Pharmacy³⁷
    • Custom Scripts Pharmacy³⁸
    • Hal’s Compounding Pharmacy, Inc.³⁹
    • New England Compounding Center⁴⁰
  • FDA News: FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs⁴¹ (8/10/2006)
    • Rotech Healthcare, Inc.⁴²
    • CCS Medical⁴³
  • Warning Letters
    • Spoonamore Drug Co., Inc., 12/1/2006, Cincinnati District Office ⁴⁴
    • Health Dimensions, Inc., 11/27/2006, Detroit District Office ⁴⁵
    • Pharmacy Creations, 10/31/2006, New Jersey District Office⁴⁶
    • Wedgewood Village Pharmacy, 10/31/2006, New Jersey District Office⁴⁷
    • B. Braun Medical Inc., 3/15/2006, Philadelphia District Office⁴⁸
    • Southern Meds Joint Venture, LLC, 2/15/2006, New Orleans District Office⁴⁹
• 2004
  • FDA News: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production⁵⁰
  • Warning Letters
    • Axium Healthcare Pharmacy⁵¹
    • Drugs Are Us (dba Hopewell Pharmacy)⁵²
    • Peoples Pharmacy, Inc.⁵³
    • Spectrum Chemicals and Laboratory Products⁵⁴

Pharmacy Compounding Advisory Committee Materials⁵⁵

Compounding Surveys

• Report: 2006 Limited FDA Survey of Compounded Drug Products⁵⁶
• Report: Limited FDA Survey of Compounded Drug Products⁵⁷ (2/13/2003)