Posted By Greg Rockers on Tue, Feb 24, 2015 @ 09:02 AM
In the world of sterile compounding, much has changed over the last two years. Prior to the passage of the Drug Quality and Security Act (DQSA) in November 2013, USP 797 was the quality standard for compounded sterile products (CSPs). Now that the DQSA has passed, providers have the option of getting their CSPs from 503B Outsourcing Facilities (OF) that must follow current Good Manufacturing Processes (cGMP). This significantly higher cGMP standard is preferred among physicians, pharmacists and nurses who want to make sure they give their patients CSPs of the highest possible quality. In fact, both the FDA and CMS have stated their preference that providers purchase CSPs only from FDA registered 503B Outsourcing Facilities.
One significant change that is a result of becoming a 503B Outsourcing Facility is the CSP testing requirements. The requirements are so much more than simply sterility, endotoxin and potency testing. The level of rigor, suitability and specificity is significantly higher. The sterility test must comply with United States Pharmacopeia (USP) 71, the endotoxin test must comply with USP 85 and the potency tests must be based on the compendial method described in the products’ USP monograph. Make sure your CSP provider is performing these tests at the required level and make sure you ask your Outsourcing Facility for these test results!
As a consequence of the cost and lengthy time requirements of this level of testing, the days of compounding sterile products one, two or even fifty at a time are over. To maximize efficiency, control costs and ensure consistent, high-quality products, Outsourcing Facilities must produce their products in larger batches. JCB Laboratories’ has decreased its’ formulary of products and invested considerable time and resources into manufacturing processes to make sure all products meet the highest standard. That is the JCB commitment to your patients and that is what I call value!
While, in rare cases, this may mean the product you used to get from JCB is no longer available, it certainly does not mean we are not innovating, researching and compounding new products. We have been and always will be a dependable, reliable source for innovative new compounds and for drug shortage products. As you go to conferences and learn about new CSP options or when a drug shortage has an adverse effect on your ability to take care of patients, let us know. We welcome the opportunity to compound CSPs that you need the most.
Greg Rockers. R.Ph.
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 Fri, May 16, 2014 @ 11:05 AM
The passing of the Drug Quality and Security Act (DQSA) in November of 2013 was one of the most significant events in the compounding industry in decades. The DQSA came to fruition after many months of debate and controversy over who had authority and jurisdiction over sterile compounding pharmacies. The result was that a sterile compounding pharmacy could voluntarily register with the FDA as a 503B Outsourcing Facility. According to the DQSA, this type of registration allows a sterile compounding pharmacy to ship products via interstate commerce without the need for specific patient prescriptions. However, it does place the pharmacy squarely under the jurisdiction of the FDA and subjects the facility to current Good Manufacturing Practices (cGMP). cGMP are the regulations that large pharmaceutical manufacturing firms must adhere to in their daily practices. Complying with cGMP can be a daunting task and not every sterile compounder will elect to register as an Outsourcing Facility.
In reality, after 6 months under the DQSA, very little has changed. There are still many things evolving regarding federal and state enforcement of the Act. It will likely take several more months to determine how the FDA and State Boards of Pharmacy will work together to enforce compliance. It is clear that many State Boards of Pharmacy will require registered Outsourcing Facilities to register in their state as either drug distributors, wholesalers, manufacturers or, in some cases, all three! In addition, some states are requiring that Outsourcing Facilities have a pharmacy license in their state, while the DQSA stated that an Outsourcing Facility didn’t even have to be a pharmacy?!
What is not clear is whether the FDA registration will override State Boards of Pharmacy requirements. JCB is actively pursuing all appropriate registration in each state to ensure that we stay in compliance and are able to continue shipping product to health care providers. This process will take some time but we have made significant progress. We started with states that require prescriptions for products being administered to patients within a healthcare facility in an effort to help them become more efficient as soon as possible. JCB is contacting current clients in those states where the appropriate registration has been obtained and approved. Clients have been very excited and relieved. We will continue to keep you updated on any changes that occur related to individual state boards or with the FDA.