Introducing an Innovative Solution
ABOUT US
Blending 503b and 503a Strategies to Tackle Drug Supply Chain Challenges for Health Systems.
In November 2013, President Barack Obama signed the Compounding Quality Act (DQSA), mandating the compounding industry to adhere to specific guidelines ensuring the safety and quality of their prepared products. The emergence of 503b Outsourcing facilities was a pivotal development, playing an integral role in the hospital drug supply. However, existing registered 503b outsourcing facilities fall short of meeting the immediate demands of health systems during drug shortages. Allocations and limited facility capacity often hinder a rapid response to critical shortages, causing disruptions in patient care reported by hospitals nationwide. This not only impacts the quality of patient care but also contributes to a significant rise in the drug spend of health systems.
Currently, only 73 registered 503b outsourcing facilities cater to over 6,000 hospitals in the U.S. These facilities, with their limited production capacities, predominantly focus on repackaging non-patient specific medications for health systems, neglecting to pivot and address critical drug shortages. Recognizing the substantial risk to patients, the FDA released a new Guidance Document in October 2021, removing previous restrictions that hindered health systems from practicing at the apex of their pharmacy licenses concerning compounding amid drug shortages.
At Signature RX, we've revolutionized the approach to these challenges. By seamlessly integrating 503b and 503a strategies, we ensure a dynamic response to critical drug shortages. Our innovative model goes beyond the limitations of traditional 503b outsourcing facilities, offering a proactive solution that meets the immediate demands of health systems.
With a focus on quality, efficiency, and a commitment to patient care, Signature RX is reshaping the landscape of pharmaceutical solutions, providing a reliable source for health systems to navigate and overcome drug supply chain challenges.
Building a
Sustainable Future
OUR MISSION
We are an orchestrated alliance of companies, featuring PharmaPac, SignatureRX, and BKG Medical Supplies. Each entity plays a unique yet interconnected role, ensuring a seamless and impactful healthcare experience for professionals and patients alike.