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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
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
Significant Compliance Actions
- 2008
- 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 ]
- 2006
- FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs (12/5/2006)
- FDA Warns Five Firms To Stop Compounding Topical Anesthetic Cream (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
FDA Modernization Act
Additional Information
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Date created: December 15, 2005, updated August 15, 2008 |
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