Sterile Compounders Would Get Tailored Manufacturing Regs If FDA Gets New Authority
This article was originally published in The Pink Sheet Daily
FDA’s Woodcock says large-scale compounders would not be subject to all current Good Manufacturing Practices, but would be given separate regulations tailored specifically for them, similar to how it handled PET drug requirements.
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FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
Pharmacy groups and pharmaceutical manufacturers are at odds over the applicability of GMPs to outsourced pharmacy compounding operations. In the meantime, FDA is going full steam ahead and taking an aggressive enforcement approach to compounding pharmacies that violate GMPs, issuing 19 warning letters so far this year.
Iowa has contracted with a national pharmacy group to inspect facilities outside its borders. Although the program could serve as a potential model for a nationwide plan, it also could bring several problems.