Compounding pharmacies and the entire compounding industry has been under the microscope on a national level since the 2012 calamity where 64 patients died due to receiving contaminated drugs. Since that tragedy, the FDA was designated as the primary agency responsible for overseeing and regulating the compounding pharmacies. They subsequently classified and divided compounding pharmacy operations into two sectors: 503A Compounding Pharmacies and 503B Outsourcing Facilities.
Understanding the 503A vs. the 503B Designations
503B Outsourcing Facilities
The Drug Quality and Security Act, signed into law on November 27, 2013, created a new section 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a pharmacy compounder can become an outsourcing facility by registering with the FDA and paying a fee. Once registered, an outsourcing facility must meet specific conditions to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval requirements and product labeling requirements. The law requires that drugs be compounded in compliance with 21 CFR Part 210 and 211 (cGMP) either by or under the direct supervision of a licensed pharmacist in a registered facility. The FDA will inspect all 503B facilities based on their risk level assessment. Any deviations from cGMP or other FDA requirements observed during an inspection will be documented on an FDA Form 483 and will lead to further FDA actions up to and including medication recalls, consent decree, and litigation. Currently, there are 71 registered 503B facilities and ALL but 2 that have been inspected have been issued an FDA Form 483. The biggest reason for the high level of FDA actions is that the vast majority of compounding pharmacists are not trained in or familiar with cGMP unless they have had significant experience in pharmaceutical manufacturing.
503A Compounding Pharmacies
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 lea 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 a great risk of unwittingly waiving their rights to an aggressive FDA inspector.
Who Can Help You Be Prepared For the “Inevitable” FDA Inspection?
All compounding pharmacies should have policies and procedures as well as a defined plan of what to do when the FDA shows up at their business for an inspection. At HCC we have an in-house staff of experienced pharmacy consultants (all pharmacists with compounding experience) that can assess your pharmacy and operations to identify areas of risk and assist with mitigation. HCC also works closely with knowledgeable and experienced FDA law attorneys that can help protect your rights and potentially interact with the FDA inspectors when they arrive at your pharmacy. Contact us today to discuss how to best prepare your pharmacy for the inevitable FDA inspection.
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 operations. Contact us online now or call us today at 800-642-1652 for a free consultation.