More than 80 percent of the raw active pharmaceutical ingredients (APIs) come into the United States from overseas.
Compounding team cannot inspect every pharmacy, identify every Web site selling unsafe or ineffective compounded products or test every coming into the United States. To aid its mission, the Pharmacy Compounding team tries to increase public awareness and understanding regarding compounded drugs and the potential risks. Many patients do not know that a compounded drug is not an -approved drug and therefore the safety and efficacy are unknown. Unlike drug manufacturers, pharmacies are not required to report adverse events related to compounded drugs, so adverse events are often undocumented and unreported.
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has found that some of these APIs are not produced in -registered and inspected facilities. These APIs are not produced under cGMP requirements. Compounding team has seen problems such as contamination, adulteration or lack of purity with these APIs. An example found was the contaminated heparin . Produced and distributed from , it resulted in numerous deaths and hundreds of adverse reactions. Compounding team cannot inspect every pharmacy, identify every Web site selling unsafe or ineffective compounded products or test every coming into the United States. To aid its mission, the Pharmacy Compounding team tries to increase public awareness and understanding regarding compounded drugs and the potential risks. Many patients do not know that a compounded drug is not an -approved drug and therefore the safety and efficacy are unknown. Unlike drug manufacturers, pharmacies are not required to report adverse events related to compounded drugs, so adverse events are often undocumented and unreported.
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