Are your bulk drug substance suppliers on FDA’s hit list?
FDA is keeping a running list of Active Pharmaceutical Ingredient suppliers who are in violation of current good manufacturing practices (CGMP). This is because compounding finished drugs starting from active pharmaceutical ingredients (APIs) presents risks to patients if substandard materials are used. Some of the suppliers named are well-known and respected in the compounding industry.
If your practice site obtains bulk drug substances for use in compounding prescription drugs:
1. Visit FDA’s website to know your API supplier and understand if other suppliers are in question.
2. If your supplier is on the list, contact them to verify the APIs purchased have met the required GMP standards.
3. Take continuing pharmacy education courses focused on supplier qualification, drug component selection, and quality assurance to learn more about this topic and to protect your site from future issues of this nature.