FDA Releases Draft Guidance, "Insanitary Conditions at Compounding Facilities."
Wednesday, August 3, 2016
Posted by: Dagmar Anderson
The U.S. Food & Drug Administration (FDA) today issued a draft guidance, Insanitary Conditions at Compounding Facilities, that identifies examples of insanitary conditions that can result in patient harm.
"FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. The draft guidance has a public comment period of 60 days."
Please click here to review FDA's guidance.
IACP Preparing to Submit Comments
IACP is thoroughly reviewing the guidance, and will be submitting comments by the October 3, 2016 deadline. We encourage our members to do the same. We will provide our comments to our membership prior to submitting to FDA. You are welcome and urged to submit these comments as your own.
IACP Statement to Media on FDA's Guidance
“Upon initial review of the FDA’s new draft guidance “Insanitary Conditions at Compounding Facilities”, IACP is appreciative of the FDA’s efforts to further define and clarify what the Agency feels are insanitary conditions. While we will be fully participating in the commenting process for this draft guidance, we are encouraged by the fact that the Agency utilizes definitions and standards found in USP Chapter <797>. We do have concerns around some items which could be related to cGMP and will fully identify these issues in our comments. However, overall, this draft guidance along with the FDA’s recent notice regarding inspections gives the industry a clearer picture as to the Agency’s process when it comes to investigations of pharmacies who comply with Section 503A of the Federal Food, Drug and Cosmetic Act.” - John Voliva, RPh, IACP Executive Vice President
Please email IACP at email@example.com if you have any questions.