Compounding Oversight: Could Third-Party Inspection Solve The Problem?
Executive Summary
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.
You may also be interested in...
Compounding: Hamburg Asks Purchasers, States To Push Outsourcer Registration
Letters seek help encouraging large-scale compounders to register with the agency as outsourcing facilities; FDA also seeks nominations for its compounding advisory committee.
Compounding Guidance Creates Subtle Pressure On Traditional Compounders
FDA will enforce USP standards, a regulatory first.
Compounding Deal In Congress Allows Voluntary FDA Oversight Of Large-Scale Facilities
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.