Compounded medications are made from scratch. Individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.
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.
Representatives promote compounded product and sterile compound products which are made to order for each physician’s specifications. These customized products are mailed by the pharmacy directly to each patient.
Regulatory Information
- The FDA approval process is intended only for mass-produced drugs made by manufacturers and is not required for compounds. Because compounded medications are personalized for individual patients, it is not possible for each formulation to go through the FDA’s drug-approval process, which takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.
- 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, not the FDA.
