Pew: Compounders Need Regulatory Transparency, Market Reforms

The Pew Charitable Trusts calls for FDA to provide more regulatory clarity and predictability for 503B compounders, among a slew of recommendations in a compounding report issued Monday (June 29). Pew says FDA needs to be more transparent about the severity and expected duration of drug shortages, and needs to create clear processes for alerting the public when a compounder has resolved facility inspection issues. Industry and health care stakeholders also should take steps to create a safer, stronger drug...