The vast majority of compounding pharmacies that are currently operating within the United States are actually state licensed facilities that are classified as such under section 503A of the the United States Federal Food, Drug, and Cosmetic Act (sometimes referred to as either the FFDCA, FDCA, or FD&C). The FD&C is a group of federal laws that were first enacted by the US Congress in 1938 and granted authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of all foods, drugs and medications, medical devices, plus cosmetics that are sold within the USA. Although initially replacing the previous Pure Food and Drug Act of 1906 after more than one-hundred deaths were caused by a sulfanilamide preparation where diethylene glycol was used to dissolve the drug and make a liquid form (sometimes referred to as the “Elixir Sulfanilamide Disaster”), the FD&C has been amended numerous times, most recently the requirements being added regarding bioterrorism preparations.
What Defines a 503a Compounding Pharmacy?
A 503a pharmacy is allowed to compound drugs that are not FDA-approved, are not subject to the requirement that labeling bear adequate directions for use, and are not subject to CGMP requirements, plus are dispensed to a patient only based on the individual patient’s needs (and thus require a valid Rx or prescription). These pharmacies are primarily under the jurisdiction of their domicile State’s Board of Pharmacy (BoP), or equivalent, and held to that individual 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) as their rules regarding compounding. Additionally, chapter 800 has just recently been published and is now being evaluated by every BoP for possible adoption and incorporation.
Is a Compounding Pharmacy’s Adherence Sufficient?
Most pharmacists believe that adherence to State rules, statutes and all applicable USP guidelines is the extent of their regulatory responsibility. They would be wrong!
The FDA has jurisdiction anywhere drug products are prepared, packed, or held regarding “Insanitary Conditions”, which also includes all 503a pharmacies. The FDA has recently been utilizing this narrow provision to gain entry to all 503a pharmacies, often accompanied by local State BoP inspectors, to “evaluate operating conditions currently being demonstrated” by compounding pharmacies. So far they have “observed” the operations of many dozens of 503a’s every year and the numbers, frequency and pace of these inspections are rapidly escalating and increasing. The FDA inspectors will spend several days reviewing and observing the pharmacy’s compounding operations. However, it’s critical to know that the FDA inspectors will evaluate the pharmacy NOT based on either the individual State rules or the USP guidance, but instead on the far more stringent Current Good Manufacturing Practices (cGMP).
What are the Current Good Manufacturing Practices (cGMP)?
The Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration’s formal rules and regulations that basically cover all of the the design, monitoring, control, and maintenance of manufacturing processes and facilities operating in the US. Note that the actual compliance by the facility is regulated by the FDA and are the exact same regulations that all drug manufacturers must follow. When an actual inspection is completed, any concerns by the inspectors and any observed deviations are listed on the FDA form 483 (Observations) and published on the FDA website. Depending on the nature of the observations, pharmacies are then required to submit a corrective action plan and undergo a follow up inspection, usually in about twelve to eighteen months after the initial inspection had taken place. If the observations initially observed are deemed as “Significant”, or the 503a does not adequately respond and produce a viable plan to address the initial observations that were documented, the FDA has several options available that may result in a Warning Letter, a drug recall, and / or a Consent Decree for the pharmacy found deficient and in violation. Please note that a Consent Decree is also known commonly as the “Death Penalty” for the pharmacy!
How Do I Get Prepared For an FDA Inspection?
An increased tempo of FDA inspections of compounding (503a) pharmacies over the last three years has made understanding and meeting their expectations vitally important for the continued viability and operation of any compounding pharmacy. All 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 “get ready” and be prepared for it.
Preparation by a 503a pharmacy for a potential FDA inspection actually must begin with a complete understanding of how an FDA inspector actually evaluates a compounding 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 extremely valuable reference is a free newsletter, produced by an HCC affiliated consultant, that documents and evaluates each and every FDA form 483 that’s issued to any 503a or 503b facility. This newsletter analyzes and discusses each observation that the FDA inspector identifies for a particular pharmacy, thus providing the reader with a deeper understanding of what the FDA expectations actually are. The free newsletter can be obtained thru this sign up link: https://us12.list-manage.com/subscribe?u=a2e4c7b0e4f8a701c196f1671&id=5c73c07d24. After signing up, you will receive all new newsletters generated via an email.
The next step, once the pharmacy manager is familiar with the actual FDA inspection process and the FDA’s expectations, is to conduct a thorough assessment of the situation that currently exists at the pharmacy: including the business’s physical facility, 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 now critically important to understanding that these practices are more than just “USP On Steroids”, as is frequently stated.
Who Can Help My Compounding Pharmacy Get Prepared for an FDA Inspection?
Healthcare Consultants (HCC) can provide you with experienced pharmacy consultants that have extensive knowledge of both the USP and the cGMP requirements, as well as the FDA inspection actual expectations. From assessing every single 483 that’s ever been issued to both 503a pharmacies and 503b outsourcing facilities, our material expert consultants are keenly aware of the FDA expectations and know the “routine”, plus will help you to be prepared. They will identify the specific areas of risk for compounding pharmacies such as yours, plus assist your managers in both the corrective action planning that’s required and its implementation, thereby lessening the risk of possible “observations” by FDA inspectors should they “visit” your pharmacy.
Here at HCC, we recommend this “enhanced” survey for all medium to large sterile compounding pharmacies as a means of minimizing the impact of an unexpected FDA inspection. We personally have seen far too many 503a pharmacies caught by surprise when the FDA showed up in their lobby demanding immediate access to the pharmacy.
Healthcare Consultants (HCC) provides compounding (503a) pharmacies and outsourcing (503b) facilities with scalable and client defined comprehensive assessments. Our expert consultants, experienced pharmacists and cGMP experts, can evaluate the business globally or focused on specific areas such as pharmacy operations, regulatory compliance, workflow, facility suitability, inventory management, financial performance, quality assurance, and risk evaluation.
About HealthCare Consultants
From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consultant firm of choice for over 30+ years now. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations. We can assist with expert advice in any area of your pharmacy business or practice.
We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now, plus be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.