Three years ago I worked for a Pharmacy owner who became critically ill and was forced to discontinue his collaboration in the business. Unfortunately, the pharmacy doors were going to be closed, jobs were going to be lost, and customers were going to be placed in an unexpected dilemma. After much prayer, consideration and due diligence, my husband and I made the decision to acquire this pharmacy. Simultaneously, regulations were continually changing with the new DQSA Act being put into place. We were signing up for a much higher standard of governance than what we were accustomed to. A year and a half was dedicated to working alongside licensed consultants. After this time, we elected to register as a 503B which included FDA jurisdiction. In doing this, we willingly included the FDA with the perspective we had readily met all of their requirements and standards.
Unfortunately, the FDA felt we had not met all of the expectations of a 503B pharmacy. In an effort to adhere to the highest level of patient safety and meet all state and federal regulatory, we began working closely in partnership with the FDA. To accomplish this, we temporarily shut down the pharmacy, deregistered as a 503B, and recalled all of our sterile products. We then waited for the FDA’s inspections and written approval before resuming sterile and non-sterile operations. We additionally agreed to a Federal Consent Decree that allowed us to be overseen by the FDA with regular inspections to ensure compliance. We are proud to say we have overcome obstacles and now have their written approval. We are thankful for all of those who helped us in the process to achieve this status.
It is our commitment at Downing Labs to adhere to the highest standards to ensure quality and patient safety. In working with the FDA, we have confirmed that the extra testing on finished products and equipment, added detailed procedures and increased training for personnel has made a tremendous improvement in the quality of our products. This is one more thing that makes us stand out above other pharmacies. We know there will always be room for improvement to strive for perfection. We look forward to working with the FDA and Pharmacy Boards to continue to reach for this goal for years to come.
Welcome, and thank you for visiting our website. We are delighted to have the opportunity to assist you with your pharmacy needs and for you to become another satisfied customer of Downing Labs.
Owner of Downing Labs, LLC
SOME INFO ABOUT DOWNING LABS LLC
Dallas, TX Retail Pharmacy offering customized compounding services
YEARS OF EXPERIENCE