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Unapproved Compounded Inhalation Drugs

Audience: Pharmacists, other healthcare professionals, and consumers

[Posted 08/10/2006] The FDA notified consumers and healthcare professionals that RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services are manufacturing and distributing unapproved compounded inhalation drugs nationwide. These drugs, compounded by pharmacists, are used to treat life-threatening conditions such as asthma, emphysema, bronchitis, and cystic fibrosis. Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness and are often not produced according to good drug manufacturing practice, which may expose patients to unnecessary risks. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered. FDA encourages patients to use FDA-approved drugs whenever possible.

[August 10, 2006 - Press Release - FDA]

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