Pharmacy Compounding
Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.
It's also a practice that is under scrutiny by the Food and Drug Administration (FDA) because of instances in which medications, primarily injectable medications that are intended to be sterile, have endangered public health.
Pharmacy compounding can serve an important public health need if a patient cannot be treated with an FDA-approved medication. For example, pharmacy compounding may occur if a patient needs a medication to be made without a certain dye because of an allergy. Or an elderly patient or a child may need a medicine in a liquid or suppository form that is not otherwise available.
Pharmacy Compounding News
- Public Meeting: Framework for Pharmacy Compounding: State and Federal Roles (12/19/2012)
- Consumer Update: The Special Risk of Pharmacy Compounding (12/3/2012)
- Commissioner Testimony: Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak (11/15/2012)
- Commissioner Testimony: The Fungal Meningitis Outbreak: Could It Have Been Prevented? (11/14/2012)
- Press Release: FDA reports voluntary recall of all Ameridose drug products(10/31/2012)
- Press Release: FDA repPorts conditions observed at New England Compounding Center facility (10/26/2012)
- News for Pharmacy Compounders in Regards to Possible Melamine Contamination of Pharmaceutical Components (9/28/2009)
- Medical Center Pharmacy v. Mukasey (8/14/2008)
Significant Compliance Actions
- 2013
- PharMEDium Letter (2/5/2013)
- 2012
- Warning Letters
- Warning Letters
- 2010
- FDA News: FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure (4/7/2010)
- Warning Letters
- 2009
- 2008
- FDA News: FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (1/9/2008)
- Warning Letters
- Civic Center Pharmacy, 12/16/2008, Los Angeles District Office
- Steven's Pharmacy, 11/12/2008, Los Angeles District Office
- Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER)
- Newman Inc., (dba Medi-Stat), 6/24/2008, New Orleans District Office
- Farmacia La Salud Inc., 3/26/2008 San Juan District Office
- Bellevue Pharmacy Solutions, 1/14/2008, Kansas City District Office
- American Hormones, Inc., 1/10/2008, New York District Office
- 2007
- 2006
- FDA News: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams (12/5/2006)
- FDA News: 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
- Health Dimensions, Inc., 11/27/2006, Detroit District Office
- Pharmacy Creations, 10/31/2006, New Jersey District Office
- Wedgewood Village Pharmacy, 10/31/2006, New Jersey District Office
- B. Braun Medical Inc., 3/15/2006, Philadelphia District Office
- Southern Meds Joint Venture, LLC, 2/15/2006, New Orleans District Office
- 2005
- Warning Letters
- Warning Letters
- 2004
- 2003
- Warning Letters
- 2002
- Warning Letters
Compounding Surveys- Report: 2006 Limited FDA Survey of Compounded Drug Products
- Report: Limited FDA Survey of Compounded Drug Products(2/13/2003)
Source found hereVeterinary Enterprises of Tomorrow Warning letter located here - Warning Letters
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