Compounding pharmacies and 503A specialty pharmacies have been the center of FDA (U.S. Food & Drug Administration) focus ever since the tragic 64 deaths associated with the NECC (New England Compounding Center) occurred back in 2012. The 64 patients that died and the 750+ others that were injured due to the contaminated drugs compounded by the NECC were eventually directly linked to what was called “a lack of proper oversight” that the State Board of Pharmacy failed to provide to protect patients in the United States.
The FDA subsequently divided what were traditionally termed compounding pharmacies into two separate entities: 503A Compounding Pharmacies and 503B Outsourcing Facilities.
What Exactly is the Definition of a 503A Compounding Pharmacy?
The FDA defined a 503A pharmacy as what had always traditionally simply been labeled as a “compounding pharmacy”. In other words, those operations that compounded and prepared medications for individual patient use and dispensed for a specific prescription to be used ONLY by the patient that the medication was prescribed for. The 503A pharmacy is prohibited from dispensing medications for office use and is therefore limited to only drugs that a patient can use in their own home.
As always, they are required by each State Board of Pharmacy to comply with all the existing USP requirements and state rules, statutes and guidelines.
Are These 503A Pharmacies Subject to FDA Oversight?
Traditional compounding pharmacies, those state licensed pharmacies meeting the requirements of FDCA section 503A, may believe that, since they are compliant with state pharmacy rules and statutes and USP requirements (including chapters 795, 797, 71, 85, 1116), they are not subject to FDA oversight. They would be wrong. Recent aggressive FDA inspections of 503A pharmacies, often conducted in concert with the home State Board of Pharmacy inspectors, have lead to many compounding pharmacies being issued FDA Form 483s based on “Insanitary Conditions”. Under FDCA section 501(a)(2)(A) the FDA has the right to inspect anywhere medications are prepared, packed, or stored and that drugs are deemed adulterated if they are prepared, packed, or held under insanitary conditions whereby they may be contaminated with filth or rendered injurious to health. However, there are statutory restrictions on what the FDA inspectors can review within a 503A pharmacy. But if the compounding pharmacist or business owner doesn’t understand these limitations, they are at great risk of unwittingly waiving their rights to an aggressive FDA inspector.
How Do I Make Sure That My Pharmacy is 503A Compliant?
All compounding pharmacies should have a customized 503A policies and procedures manual, as well as a defined plan of what to do when the FDA shows up at their pharmacy’s door. HCC has expert in-house consultants (all are pharmacists with extensive compounding experience) that can assess your pharmacy and operations to identify areas of risk and assist with risk mitigation. HCC also works closely with knowledgeable and experienced FDA legal attorneys who are experts in the 503A pharmacy area of law and who can protect your rights, plus potentially interact with the FDA inspectors when they arrive at your pharmacy operation. In other words – be proactive and prepare your pharmacy for the inevitable FDA inspection.
Who Can Help With 503A Compliance?
As a national leader in Pharmacy Consulting for over 29 years now, HealthCare Consultants Pharmacy Staffing and Consulting can help you ensure that you are in compliance. This is a team approach and HCC is that team! HCC has experts available with many years of experience in pharmacy compounding, pharmaceutical manufacturing, cGMP design and compliance, and FDA law. Contact HCC to discuss facility and operational assessment, risk mitigation, and corrective action planning.
We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of expert in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online now or call us today at 800-642-1652 for a free consultation.