CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities

CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.

The 48-page draft guidance covers a wide range of CGMP topics from facility design to release testing, packaging and complaint handling. The agency said the guidance will apply while it develops specific CGMP regulations for outsourcing facilities.

“This guidance reflects FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard compounded drug products,” the agency said.