01-02-2018 09:56 AM
This is FYI. I did receive a follow up document from the microbiologist at Contec. His article is about the rotation of products and not about the sterility issue. We simply switched over to all sterile products in our cleanroom.
Am I correct that the insanitary condition document from the FDA applies to any site that performs sterile compounding, whether it is a hospital or a compounding pharmacy?? Is this correct? I would really like to have some input on this.
01-05-2018 11:04 AM
Yes, the insanitary conditions guidance would apply to any site (including hospital pharmacies) engaged in sterile compounding, although I don't believe FDA is making hospital pharmacy inspection a priority at this time. When I asked why FDA is not inspecting hosptial pharmacies, I was told by an inspector that hospital pharmacies usually assign very short BUDs and typically do not engage in high risk compounding. Additionally, I suspect that hospitals are not a priority right now because they are also inspected by boards of health, accredited by various agencies (JHACO), etc.
01-05-2018 12:15 PM
To clarify my previous post, the guidance document on insanitary conditions is as of right now a DRAFT and not a FINAL guidance document.
01-05-2018 03:57 PM
Sara and everyone else,
It doesn't matter that the guidance is in draft form, the FDA has been actively inspecting hospital pharmacies. NIH, Univ of Michigan, Univ of Washington, Dignity Health, AI DuPont Children's Hospital, OptionCare Home Infusion, and others have been inspected, cited, issued 483s and Warning Letters. If you visit this link https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm you can read all about the inspections. Everyone needs to take compliance with USP 797 seriously because if the FDA happens to visit and finds an insanitary conditions, you will be inspected as a manufacturer. This is in the DQSA law. Be aware and be prepared.
01-06-2018 12:40 PM - edited 01-06-2018 12:54 PM
I completely agree with you Eric, and the majority of the draft guidance is reasonable. Every sterile compounding pharmacy should be adhering to 797. My issue is when FDA is applying cGMP standards to compounding pharmacy. FDA says in Section D under Cleaning and Disinfecting that using non-sterile disinfecting agents and non-sterile wipes is an insanitary condition. So what to do? FDA wants sterile disinfecting agents but the current version of 797 does not require them. Does FDAs interpretation supercede 797?
01-08-2018 07:39 AM
I completely agree with Eric as well -wholeheartedly. My issue is that the FDA cites for an insanitary condition for using PreEmpt germicidal detergent because the cleaning agent is not sterile. This is not a requirement of USP 797. However, it does say this in the FDA guidance document:
"Non-sterile disinfecting agents and cleaning pads or wipes are used in the aseptic processing areas, especially the ISO 5 area. Non-sterile cleaning and disinfecting items could spread microbial spores." It seems it doesnt matter if your facility is compliant with USP 797 nor is the the state of control of your rooms considered (results of the air and surface sampling) but it only matters that you could be "potentially" introducing spores as a result of your cleaning agent.
I have not read any article or been told by anyone that items such as germicidal detergent or a sporicial can spread microbial spores if they are not sterile. It is known, through USP 797 education, that 70% IPA can contain spores and that this is the reason why 70% IPA must be sterile when used in the cleanroom facility. Does anyone have information/documentation that germcidal detergents and sporidical agents can contain spores if not sterile? This is the reason I contacted the manufacturer/distributor of PreEmpt (formerly Acell TB) regarding this issue and for their input.
Ultimately, my concern is the use of sterile cleaning agents is not in USP 797 but is in the FDA "Insanitary condition" guidance draft document. So, if FDA supercedes USP 797, then every compounding site that follows USP 797 (hospitals, compounding pharmacies, etc), will be cited for this as an insanitary condition. Will the revision of USP 797 address this issue so that the FDA Insanitary Conditions guidance document and USP 797 are consistent or will the eventual final guidance from the FDA be consistent with USP 797? I guess we will see and hope that this inconsistency gets clarified. Will the FDA consistently apply this standard to all areas that follow USP 797?
For our facility, we changed to all sterile cleaning agents in our cleaning and disinfecting process for use in our cleanroom, at great expense I may add. We will continue with this regimen and policy until final clarifiication is made and the FDA and USP 797 are consistent.
Thanks for everyones input.
01-08-2018 07:59 AM
This is a good article that stands as a reminder that there are still issues within the industry which affect patient safety.
Toward Better-Quality Compounded Drugs — An Update from the FDA
Janet Woodcock, M.D., and Julie Dohm, J.D., Ph.D.
N Engl J Med 2017; 377:2509-2512December 28, 2017DOI: 10.1056/NEJMp1712905