EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
Posted By Brian Williamson on Tue, Feb 10, 2015 @ 16:02 PM
You may have noticed that we made some changes to our sales team in December. We had a very successful and talented group of sales people. Due to conditions out of our control, we had to reorganize our team. This meant, unfortunately, that we released our entire team from service. We wish the former sales team much success in their future careers. We have seen communication from some of our clients that in fact some of the former sales team members have found opportunities at other sterile compounders. Once again, we wish them and their employers much success in today’s highly regulated environment of sterile compounding.
JCB has never been the “bargain basement” provider in the industry and we don’t intend to be the low-cost provider. We will remain competitive on pricing as much as safety for your patients will allow. JCB will not sell a product at a price that would indicate corner cutting practices, lack of respect for your business and reputation, or simply to compete with other providers who may not have identified their true value proposition. Think about it...do you really want the cheapest product on the market? Next time one of your vendors (any vendor, not just sterile compounders) comes to you with price as their only value proposition think about all that is missing in that deal.
As you know, the Drug Quality and Security Act (DQSA) signed into law by President Obama on November 27th, 2013 was a significant regulatory achievement. It allowed for sterile compounders to voluntarily register with the FDA as an Outsourcing Facility. JCB is one of only 41 registered Outsourcing Facilities. Registration as an Outsourcing Facility (503B Outsourcing Facility) comes with the expectation that the registrant will comply with Good Manufacturing Practices (GMP). These are the same set of regulatory compliance practices that large sterile pharma companies must comply with. As you might imagine, complying with GMP regulations is an extremely expensive and expertise-intensive endeavor. JCB has charged ahead with excitement and enthusiasm and is “all in” on this new era of sterile compounding.
The regulations in place today are there for a reason...to protect patient safety. You face the same reality in patient care. Why do patients continue to come back to your facility and refer friends and family to you? Because you have shown them that even though you may not be the cheapest provider, you do have a strong value proposition...patient safety and world-class care.
Please look for an email introducing JCB’s new National Sales Director, Steve Strickland.
Brian Williamson, PharmD
Posted By Brian Williamson on Thu, May 22, 2014 @ 17:05 PM
In January, JCB registered with the FDA as an 503B Outsourcing Facility. This registration indicates our commitment to patient safety and acknowledges that a higher level of compliance and oversight is welcomed. We also understand that in order to continue providing sterile compounded products to facilities across the country, it was necessary to align our processes more closely with current Good Manufacturing Practices (cGMP). While JCB has always incorporated cGMP thinking within our facility, it was time to raise the bar again.
In December, 2013, JCB contracted with one of the top cGMP compliance companies in the country, ProPharma Group, to improve overall compliance and robustness of our practices. ProPharma (PPG) performed a gap analysis to determine where we stood in regards to cGMP compliance. After the assessment, JCB contracted with PPG to be onsite at JCB writing new protocols, validating and revalidating equipment, and performing quality studies on JCB’s overall processes. The performance and execution of the project was flawless and PPG performed at a level much higher than expected. While this was only the initial phase of ongoing Continuous Quality Improvement and cGMP compliance, JCB and PPG worked together to achieve the goal that is and has always been priority number one...product reliability and patient safety.