GMP Flexibility For Compounders Signaled In FDA Draft Guidance

Agency seeks comments on how to minimize burden of some testing requirements for registered outsourcing facilities.

FDA appears willing to allow some flexibility for compounders who must adhere to Good Manufacturing Practices, allowing for potential alternatives to minimize the burden of some testing requirements.

New draft guidance on GMPs for outsourcing facilities sets interim standards for compounders registered with the agency under the Drug...

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