An Open Letter from Boothwyn Pharmacy Quality Management Team
If you are a patient of Boothwyn Pharmacy, we are grateful for the opportunity to fulfill your compounding pharmacy needs. If you are not yet a patient, we hope that you will become one.
Recently you may have seen media reports mentioning Boothwyn Pharmacy. While the Commonwealth of Pennsylvania just made an announcement, this is not a new issue. There has been no new action by either the state Board of Pharmacy or the FDA since the summer. We take our past compliance issue with the utmost level of seriousness, and have learned from it.
It is important to note that we are not aware of a single patient having experienced a serious adverse event associated with the compounding of a medication by Boothwyn Pharmacy.
In an effort to be transparent with you, we wish to inform you of the progress we have made in response to this issue. The core of the compliance issue was administrative in nature and not clinical; our compounded medications are ALWAYS prepared in rooms certified to USP standards. We have, however, instituted major changes across our enterprise to go above and beyond addressing the observations raised by the federal and state governments. Briefly, we have:
Replaced our management team, including the addition of new Quality Manager, Compliance Pharmacist and Director of Pharmacy Operations positions;
Overhauled our entire Quality Assurance function, including new reporting procedures and enhanced facilities;
Conducted comprehensive staff retraining on USP and Current Good Manufacturing Practices and updated and reissued Standard Operating Procedures; and
Reinforced our longstanding program of independent third-party clean room certification and validation, ensuring continued compliance and strengthening of our quality systems..
Through these steps, we were able to complete a successful Pennsylvania state inspection that confirmed our compliance with all current standards. We have also achieved readiness for an impending unannounced inspection by the National Association of Boards of Pharmacy (NABP).
EVERY compounded sterile GLP-1 medication produced by our pharmacy undergoes comprehensive testing for sterility, endotoxins, and potency, and must successfully pass all required tests before it is dispensed – period. And through our portal we make the testing results available 24/7 for our patients. This rigorous process exceeds the industry standards outlined in the United States Pharmacopeia and puts patient safety first.
We are proud to be able to meet demand for products that are commercially unavailable or require customization. We know that we have improved many lives as a result of this work. We remain committed to running the highest quality compounding pharmacy and meeting your needs for many years to come.
If you have any concerns at all, please contact us directly at 1 (800) 476-7496. Thank you.
