The FDA plans to gather information from 250 compounding outsourcing pharmacies amid safety and quality concerns.
In a May 1 notice, the agency said it will survey outsourcing facilities about challenges and opportunities related to market and business viability, compliance, quality production and interactions with the FDA.
Drug compounding is the mixing or altering of ingredients to meet a patient’s medication needs, especially during times of drug shortages. They are not FDA-approved medications but the agency monitors and conducts for-cause inspections of compounding pharmacies, which are typically regulated by state boards of pharmacy.
The agency said it “continues to find concerning quality and safety problems” during inspections of compounding outsourcing facilities.
“What are outsourcing facilities’ challenges when implementing federal current good manufacturing practices and quality expertise?” are among the survey questions asked.
