An escalated rate of FDA investigations of 503a compounding pharmacies over three years has created an urgency for understanding and satisfying the expectations as the utmost paramount factor for the continued operation and viability of any compounding company. All compounding pharmacy owners and managers of all pharmacies, particularly those synthesizing “High Risk” medications and/or shipping into other states, must be mindful of the possibility of an undisclosed FDA investigation and the best course of action to take to be as prepared for it as possible.
Preparatory measures by a 503a pharmacy for a possible FDA inspection must initiate with a thorough comprehension of how an FDA investigator assesses a compounding pharmacy. A guideline document publicized by the FDA concerning unsanitary conditions in compounding facilities is an invaluable reference when seeking to understand an FDA inspection’s standards. Click here to view this document. An additional invaluable reference source is a free newsletter published by an HCC associated consultant which records and assesses each FDA form 483, which has been issued to any 503a or 503b facility. A great deal of information, and thus deeper understanding about FDA expectations, is compiled in the newsletter as it both examines and discusses in detail each examination that the FDA inspector discovers for a certain pharmacy. Click here to acquire the free newsletter. You can sign-up and receive new newsletters via e-mail.
Once the pharmacy manager is accustomed to the FDA inspection procedure and their expectations, the next step is to perform an in-depth evaluation of the present circumstances at the pharmacy, including the business’s physical location, training, operations, quality management, and policy and procedures. Bear in mind that the FDA does not reference the USP guidance but instead references the cGMP as their gold standard. Becoming familiar and knowledgeable in Current Good Manufacturing Practice regulations is vital to understanding that these implementations are more than the frequently stated “USP on Steroids.”
Luckily, you won’t need to go through this process alone. An Atlanta pharmacy FDA inspection attorney can help you even before you are faced with an FDA inspection. They can offer you help throughout the process of making sure you comply with the rules and regulations. We work with you to ensure that you handle matters within the pharmacy, appropriately avoiding any issues that might arise, and ensuring that if a problem does come up, you can manage the inspection that might come along. This is preventative maintenance and could well be worth the effort to protect you and safeguard your license.
Call an Atlanta Pharmacy FDA Inspection Attorney Today
We bring our prestigious large law firm and government service backgrounds to a small firm setting to offer you our extensive expertise in a personal, individualized approach where each case gets our full attention and our clients know they’re our priority. It’s with this personalized and customized attention that we can help protect your business against any risk by being proactive. By waiting to call an attorney, you could be jeopardizing your business if you leave it vulnerable. Consult with an Atlanta pharmacy FDA inspection attorney to get ahead of the circumstances and avoid complications. We welcome you to call Hasson Law Group LLP at (678) 701-2869 to speak with an expert attorney who has the experience required to keep you in good standing and safeguard your license. We are proud to serve the Atlanta, Georgia area since 2013.