The Food and Drug Administration (FDA) has warned three firms, RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nation-wide.
Responsible officials at firms that do not properly address violations identified in FDA warning letters risk further enforcement, including injunctions that prevent further violations and seizure of their products that violate the law.
The three firms warned by FDA say that they produce inhalation drugs as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug. This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy compounding and the agency's action is not targeting this practice.
Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. These are potentially life-threatening conditions for which numerous FDA-approved drugs are available. Compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not know that they are receiving compounded products. 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.