FDA is cracking down on physicians; What you need to know!
How does FDA define drug compounding?
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a sterile or non-sterile medication tailored to the needs of a patient.
Compounded drugs are not FDA-approved, however. The administration continues to be concerned both about facilities compounding drugs in unsanitary conditions and offices producing compounded drugs on a large scale that are not patient specific. The FDA has documented medical waste and dust built up in hood filters, mold and exposed insulation in ceilings and even toaster ovens and non-sterile disinfectant used to sterilize instruments and compounding areas. With these infractions, it is important that our compounding pharmacies meet the expectations laid out by our administration, even if it does at times prove to be a burden on some practices .
What are the FDA's thoughts on Physician Compounding?
The FDA draft guidance titled “Insanitary Conditions in Compounding Pharmacies” suggested that state boards of pharmacy should enforce extreme standards on physician offices. The FDA has investigated numerous outbreaks of infections and deaths resulting from contaminated drug products produced under unsanitary conditions . While you may not mean harm by preparing medicine inside your practice, from the agency's point of view, more stringent requirements and enforcement in the form of severe penalties for doctors who are not in compliance with the law are necessary to save lives. And let's be honest, a hood is not the same as a proper clean room. As well, when your practice grows and you begin to treat more and more patients, more medication is going to end up moving through your practice, easily becoming a “large scale” operation as defined by the FDA. Meeting USP 797 guidelines, however, would require a monumental investment of resources that small and medium sized practices just can't afford and would not be practical anyways. And remember, the rules for in-office compounding only allow for a maximum of 3 ingredients and 2 injections.
In-office Hoods vs. USP 797 Guidelines
Hoods do not cover a doctor for compounding in their office. This is because FDA asks state boards to treat doctors as “commercial compounding manufacturing facilities” when they exceed the maximum number of ingredients for in-office compounding. If a doctor does not follow USP797 guidelines, which call for a full positive pressure clean room, he or she becomes liable for their compounded medications and can be subject to FDA, State Board of Pharmacy, and licensing board repercussions.
Why is this concerning?
In the past 3 years FDA has :
- Conducted more than 350 inspections, including 85 inspections of outsourcing facilities.
- Issued more than 130 warning letters advising compounders of significant violations of federal law.
- Issued more than 30 letters referring inspectional findings to state regulatory agencies.
- Overseen about 100 recalls involving compounded drugs.
- Worked with the Department of Justice on a number of civil and criminal enforcement actions.
- Issued more than 18 draft guidances, seven final guidances, two proposed rules, a final rule, and a draft memorandum of understanding.
This level of enforcement proves that the agency is serious about enforcing standards on perceived risks and dangers to vulnerable patients. Whether the actual risk of contamination is real or not, the risk to your practice is most certainly real! A crackdown on doctors might not seem fair, however, there are simple and easily implemented solutions that will allow you to operate in compliance with the law and without the risk of facing a disciplinary board and putting your medical license on the line.
Vertisis Makes Compliance Simple!
Vertisis is a 503A compounding pharmacy and we have already made the investment to be USP 797 compliant. When you allow us to prepare medication for you, you allow us to take on the burden of liability should an adverse event occur. This can shield your practice from potentially devastating lawsuits and allows you to remain in compliance with FDA regulations. Remember, if you mixing more than 3 ingredients at a time, you are at risk!
Using Vertisis makes financial sense. Shift the costs of maintaining a sterile facility and laboratory technicians to us while you take advantage of our competitive pricing. Why expose yourself to needless risk, either from a malpractice suit or a stiff fine from the FDA or other regulatory boards? Get right with the law and health standards you know your patients deserve. Call Vertisis now and let us tell you more about how we can help!
-  United States, Food & Drug Administration. (2017). FDA'S HUMAN DRUG COMPOUNDING PROGRESS REPORT Three Years After Enactment of the Drug Quality and Security Act. Silver Springs, MD: U.S. Food and Drug Administration.
-  United States, Food & Drug Administration, Office of Compliance. (2016). Insanitary Conditions at Compounding Facilities. Silver Spring, MD: FDA.
-  FDA. (2017, January 1). Compounding - FDA Implementation of the Compounding Quality Act. Retrieved March 01, 2017, from https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm375804.htm