Compounding Public-Private Partnership Will Cost $25 Million

FDA is requesting $25 million from congressional appropriators to create a compounding center of excellence, which would be a public-private partnership that performs market research and Good Manufacturing Practice training, the agency explains in a newly released budget justification document. The agency also wants to conduct a pilot in which states would inspect outsourcing facilities' compliance with federal standards, and seeks an additional $2.3 million to hire 10 Office of Regulatory Affairs investigators dedicated solely to compounding. Congressional appropriators previously...