The International Academy of Compounding Pharmacists (IACP) is seeking a federal statutory change to provide coverage for compounded medicines for all Medicare and Medicaid enrollees. The Social Security Act requires that all covered drugs be approved by the FDA for safety and effectiveness. However, the FDA does not review or approve the raw drug chemical, only finished drug products submitted by manufacturers in specific doses, specific dosage forms, for specific indications. Even though compounding pharmacists use the same raw drug chemicals in compounding as the manufacturers use for their products, the compounded product per se is not “approved by the FDA” and therefore cannot be covered under the federal programs.
IACP is looking for regulatory change that will accommodate both the need for safety and effectiveness while supporting the right of the physician to prescribe and the pharmacist to compound medicine. Regulatory change is no easy task but a start has been made.
The impetus behind seeking this change is the patient. Some patient medication needs can only be met with medicines specifically designed for them whether it be individualized dose or dosage form.
The best way to support IACP’s efforts is to let you representatives in Congress know the inportance of compounding for your health.