The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments

概要

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock." Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs ("office stock"). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.