FDA’s Advisory Committee Schedule Hints At Re-formulated Compounding Panel
This article was originally published in The Pink Sheet Daily
The agency has not set a meeting date for the Pharmacy Compounding Drugs Advisory Committee, defunct since 2002, in its tentative schedule, but has included 13 vacancies on the panel in its list of committees in need of new members.
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Six nominees for the compounding bulk drug substances list will be discussed during the first Pharmacy Compounding Advisory Committee Meeting since its restart, but trade group proposed more than 1,500 for review.
Fourteen committee members could give advice on Good Manufacturing Practices for registered outsourcing facilities as well as help determine list of drugs that cannot be compounded.
Letters seek help encouraging large-scale compounders to register with the agency as outsourcing facilities; FDA also seeks nominations for its compounding advisory committee.