Compounding Oversight: Could Third-Party Inspection Solve The Problem?
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.
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Letters seek help encouraging large-scale compounders to register with the agency as outsourcing facilities; FDA also seeks nominations for its compounding advisory committee.
FDA will enforce USP standards, a regulatory first.
Compounders could submit to inspections, user fees and adverse event reporting, providing potential market advantage; Legislation, which includes track and trace draft bill, avoids compounding controversies and could be poised for swift passage.