Compounded Drug Products
Drugs - Pharmacy Benefit
© Blue Cross and Blue Shield of Montana
Current Effective Date:
December 27, 2013
Original Effective Date:
December 27, 2013
September 27, 2013
Compound drugs are defined as those drugs that are changed from the original U. S. Food and Drug Administration (FDA) dosage form.
Pharmacy compounding is the customized preparation of a medicine in a way that is not available from major drug manufacturers. Pharmacy compounding includes the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner's prescription. Compounding does not generally include mixing or reconstituting commercial products in accordance with the manufacturer's instructions or the product's approved labeling.
The quality of a finished compounded drug product can be affected by numerous factors including the quality of the active pharmaceutical ingredient used and the compounding practices of the pharmacy in which the product is created.
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- United Press International – Health Business – Compound drugs outside FDA scope. Missouri City, Texas UPI (2006 May 26). http:// www.upi . com/HealthBusiness/>
- National Community Pharmacists Association (NCPA) – Federal court upholds pharmacists ability to compound drugs landmark decision a victory for millions of patients. Alexandria, Virginia: (2006 June 2) 2006 Press Release.
- Held, M.R., Begier, E.M., et al. Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state. Pediatrics (2006 July) 118(1):e212-5.
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- Columbia Laboratories Press Release – FDA has issued an approvable letter to Adeza Biomedical for their 17-alpha-hydroxyprogesterone caproate (trademarked Gestiva™). (Accessed 2006 October 21) http://www.cbrxir.com .
- Dodd, J.M., Flenady, V., et al. Prenatal administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth. Cochrane Database System Review (2006) (1): CD004947.
- FDA—2006 Limited FDA Survey of Compounded Drug Products. U.S Food and Drug Administration – Center for Drug Evaluation and Research (2006) www.fda.gov (accessed 2009, April 14).
- FDA—Consumer Update: The special risks of pharmacy compounding. Food and Drug Administration. (2007 May 31) www.fda.gov (accessed 2009, April 14).
- Position Statement: The 2012 Hormone Therapy Position Statement of The North American Menopause Society. Menopause: The Journal of the North American Menopause Society. (2012) 19(3):257-271.