FDA Tells Congress "No Office-Use"
In addition to all the confusion surrounding Outsourcing Facilities (OFs), pharmacies have been told that office-use would continue to be governed under State laws. Specifically, there are more than six Statements on the Record from both the House and Senate stating that FDA does not have jurisdiction to prohibit pharmacies for compounding for office-use (or for the administration within a doctor’s office or hospital), and that it's an issue that should be left to the States.
FDA recently sent the House Energy & Commerce (E&C) Committee responses to Questions for the Record (QFRs) stating that despite the Congressional intent, FDA will use its “discretion” to prohibit all office-use compounding by pharmacies under 503A. FDA also has begun sending warning letters that express to pharmacies that solely based on the fact they are compounding for office-use for doctor’s office and/or hospitals, that they are a manufacturer and thus, in violation of the Food, Drug, and Cosmetic Act. This is represents a huge concern for pharmacies and Congress. To respond, it is IACP's understanding that Congressman Morgan Griffith (R-VA) intends to send a letter to FDA that expresses concern and disappointment with FDA’s most recent actions on prohibiting office use.
Click here for FDA’s most recent responses to the House E&C Committeeregarding prohibiting office-use (the answer from FDA is on page 10)
IACP is continuing to monitor this situation, and will provide updates as they occur. Please email IACP at firstname.lastname@example.org with any questions.