Drug compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
The FDA does not verify the safety, quality, or effectiveness of compounded drugs before they are marketed. Health risks can be associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub-potent or super-potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.
If a compounded drug does not meet appropriate quality standards it can cause serious injury or death, which may result in FDA warnings and litigation.
Attorneys, physicians, insurers, employers, and other potential parties to litigation need to understand the types of litigation issues that may arise in connection with a compounded drug injury.