Congressman Buddy Carter Asks Dept of Health & Human Services about Office-Use Compounding
Tuesday, March 15, 2016
Posted by: Dagmar Anderson
DQSA Coalition Milestone Report!
This morning in a House Education & Workforce Committee, Full Committee Hearing, “Examining the Policies and Priorities of the U.S. Department of Health and Human Services,” Congressman Buddy Carter (R-GA) questioned the Secretary of the U.S. Department of Health and Services Sylvia Mathews Burwell regarding office-use compounding.
Congressman Carter expressed concern that office-use provisions in the Drug Quality & Security Act (DQSA) are not being interpreted per congressional intent by the U.S. Food & Drug Administration (FDA). Secretary Burwell replied that office-use should be allowed per her understanding, and that she was prepared to work with Congress on this issue.
See the webcast archive link and the transcript below. Thank you Congressman Carter for placing this vital issue on the record!
Please click here to view the Archived Webcast from this morning's session. Congressman Carter appears at the 2.00 portion of the webcast.
Rep. Carter (R-GA-1): As a pharmacist I wanted to ask you about compounding for office-use. I am concerned about the FDA interpreting for legislative intent. The FDA continues to prevent medications to be compounded for office use. Many states have already allowed for this to take place. He pointed out that office use prevents patients from having to go to the doctor, get a prescription, then go to the pharmacists, and allows for doctors to dispense necessary medications to patients without the additional steps.
Sec. Burwell: We don’t have any guidance out preventing that, maybe my team can follow up with your staff. Right now compounding should be occurring and there should not be a problem with any rules.
Rep. Carter: The problem is that you are requiring each patient to have a prescription.
Sec. Burwell: It is my understanding that [office use] should be able to be allowed, so I look forward to working with you on that.
Rep. Carter pointed out that they are looking for a guidance on this topic, and the Secretary said they welcomed Congress’s input on any guidance.
IACP and the DQSA Coalition will continue to keep our Members apprised of updates as they are available.
Please click here for the complete hearing transcript.