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    Compounding Regulations

    Do Compounded Medications Require FDA Approval?

    The FDA approval process is intended for mass-produced drugs made by manufacturers. Because compounded medications are personalized for individual patients, the federal government has approved the use of compounded medications for those individuals who have received a prescription for that specific compounded medication.

    Is compounding legal?  Is it safe?

    Compounding has been part of healthcare since the origins of pharmacy, and is widely used today in all areas of the industry, from hospitals to nuclear medicine. Over the last few decades, compounding’s resurgence has benefited largely from advances in technology, quality control and research methodology. The Food and Drug Administration has stated that compounded prescriptions are both ethical and legal as long as they are prescribed by a licensed practitioner for a specific patient and compounded by a licensed pharmacy. In addition, compounding is regulated by state boards of pharmacy.