The vast majority of compounding pharmacies in the US are state licensed facilities classified under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A 503a pharmacy is allowed to compound drugs which are not FDA-approved, are not subject to the requirement that labeling bear adequate directions for use, and are not subject to CGMP requirements, and are provided to a patient only based on individual patient need (a valid prescription). These pharmacies are primarily under the jurisdiction of their domicile State’s Board of Pharmacy (BoP), or equivalent, and held to that State’s rules and statutes regarding compounding. Most States have adopted in part or in full the United States Pharmacopeia (USP) published guidelines (chapters 71, 85, 795, 797, and 1116 – chapter 800 is currently being litigated and is being evaluated by every state Board of Pharmacy) as their rules regarding compounding. Most pharmacists believe that adherence to State rules, statutes and applicable USP guidance is the extent of their regulatory responsibility. They would be wrong.
Can the FDA Inspect a 503a Compounding Pharmacy & Facility?
The FDA has jurisdiction anywhere drug products are prepared, packed, or held regarding “Insanitary Conditions”, which includes 503a pharmacies. They have used this narrow provision to gain entry, often accompanied by local State Board of Pharmacy inspectors, to compounding pharmacies (many dozens per year and increasing) spending several days reviewing and observing the pharmacy’s compounding operations. The FDA inspectors will evaluate the pharmacy not based on State rules or USP guidance, but rather the far more stringent current good manufacturing practices (cGMP) – the same regulations that drug manufacturers must follow. Any concerns or deviations are listed on the FDA form 483 (Observations) and published on their website. Depending on the nature of the observations, pharmacies are required to submit a corrective action plan and undergo a follow up inspection, usually in 12-18 months. More significant findings may result in a Warning Letter, a drug recall, and / or a Consent Decree (a “death penalty” for the pharmacy!).
The increased tempo of FDA inspections of compounding (503a) pharmacies may have been temporarily blunted during COVID-19 but is expected to return quickly and continue to increase. This makes understanding and meeting the FDA’s expectations vital for the continued viability of any compounding pharmacy. Pharmacy managers and owners of compounding pharmacies, especially those compounding “High Risk” medications and / or shipping into other states, must be aware of the likelihood of an unannounced FDA inspection and what they can do to best prepare for it.
How To Prepare For A Potential FDA Inspection
Preparation by a 503a pharmacy for a potential FDA inspection begins with an understanding of how an FDA inspector evaluates a pharmacy. A guidance document published by the FDA regarding insanitary conditions in compounding facilities can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/insanitary-conditions-compounding-facilities-guidance-industry. Another valuable reference is a free newsletter, produced by a 503 Quality Matters (503QM) partner, that evaluates every FDA form 483 issued to any 503a or b facility. This newsletter analyzes and discusses each observation that the FDA inspector identifies for a particular pharmacy, which provides the reader with a deeper understanding of FDA expectations. The free newsletter can be obtained thru this sign up link: https://us12.list-manage.com/subscribe?u=a2e4c7b0e4f8a701c196f1671&id=5c73c07d24. The next step, once the pharmacy manager is familiar with FDA expectations, is to conduct a thorough assessment of the pharmacy facilities, operations, policy & procedures, training, and quality management. Remember, the FDA does not use USP guidance as a reference! The FDA uses cGMP as the gold standard. Becoming conversant in cGMP is vital to understanding that these practices are more than just “USP on steroids”.
503QM can provide consultants with extensive knowledge of both USP and cGMP requirements as well as FDA expectations. By assessing every 483 issued to 503a pharmacies and 503b outsourcing facilities, our team of experts are keenly aware of FDA expectations. They can identify areas of risk for compounding pharmacies and assist managers in corrective action planning and implementation, thereby lessening the risk of “observations” by FDA inspectors, should they visit your pharmacy.
503QM recommends this “enhanced” survey for all medium to large sterile compounding pharmacies as a way of minimizing the impact of an unexpected FDA inspection. We have seen too many 503a pharmacies caught by surprise when the FDA shows up in their lobby demanding access to the pharmacy. We strongly suggest 503a pharmacies that are engaged in high risk compounding and / or ship compounded medications to other states establish a relationship with a knowledgeable attorney so as to develop a plan of action should the FDA target your pharmacy for an inspection. 503QM works closely with attorneys that specialize in healthcare law, pharmacy law, and FDA actions and can offer referrals.
About 503 Quality Matters (503QM)
503 Quality Matters (503QM) is a nationally renowned consulting firm focused on the compounded medication space, providing compounding (503a) pharmacies, outsourcing (503b) facilities, and pharmaceutical manufacturers with scalable and client defined comprehensive assessments. Our expert inhouse consultants, experienced pharmacists, cGMP experts, and other subject matter experts (SMEs) can evaluate your business globally, or focus on specific areas of your operation (such as pharmacy operations, regulatory compliance, workflow, facility suitability, inventory management, financial performance, quality control / quality assurance, and risk evaluation).
If you or your organization is interested, please contact us online now, or call us at (877) 503-7687 to discuss how we can help guide you in this highly complex and regulated industry. Our inhouse experts here at 503QM have decades of direct hands-on experience in the fields of drug compounding and manufacturing.
