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 17, 2015 @ 12:02 PM
In our last blog, we shared with you that we would have some exciting news. We would like to introduce you to the BIGGER, FASTER, STRONGER JCB Laboratories that you have come to know and respect.
BIGGER! FASTER! STRONGER! These three words describe JCB Laboratories in 2015. We have begun the development and construction of a new sterile manufacturing facility in Wichita, KS. This new facility will truly be a one-of-a-kind 503B Human Drug Outsourcing Facility committed to the safety of your patients. There are too many unique features to mention in this article so you will have to come to Wichita and see it for yourself! Some of the highlights include:
The new facility will be six times BIGGER than the current facility and will comprise a whopping 49,000 square feet. It will include many new features never seen before in the sterile compounding industry, including redundant operating systems and larger areas for order fulfillment.
Automation is a key component incorporated into the design of the operations. Not only is automated equipment FASTER than traditional manual processes, it is also safer than human intervention. JCB Labs will rely heavily on custom robotic equipment, closed-system sterile filling machines, and continuous monitoring of all areas of production.
JCB has invested heavily in top talent individuals who perform on a high level at all times. This tradition of attracting, training, and maintaining high-quality performers has made us stronger over the years. We will continue to attract people who have a desire to work smarter, harder, and with a high level of determination. JCB is STRONGER because of its people, its culture and desire to service our partner clients.
We are very excited about 2015! We understand that our partner clients are the reason we have been successful. You should expect nothing less than the BIGGEST, FASTEST, and STRONGEST provider of safe compounded sterile products...off to the races!
Brian Williamson, PharmD
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.
Posted By Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM
The definition of high-risk sterile compounding is “Starting with a non-sterile Active Pharmaceutical Ingredient (API) and creating a sterile product.” We have written many articles about how important quality is in high-risk sterile compounding. JCB Labs has gone to great lengths and considerable expense to develop a facility and processes that satisfy cGMP practices and are capable of producing a sterile product every time. This is what the FDA expects from pharmacies that, like JCB Labs, are registered as 503B Outsourcing Facilities.
Please go to this link to see a very well written article concerning the importance of vetting your high-risk compounding pharmacy. The information might be invaluable to you and your facility as you decide where to get your compounded products.
Posted By Greg Rockers on Thu, Mar 06, 2014 @ 13:03 PM
In the high-risk sterile compounding world, quality is absolutely critical. Providers should demand quality compounded products and patients deserve quality compounded products. But, while quality is a word that is used often, it can be extremely difficult to truly grasp what it takes to produce the highest quality sterile products. I believe, if you ask physicians and nurses, they will say quality is extremely important in choosing a sterile compounder. Yet, when it comes to choosing what compounder to use, all too often the question of price comes first. Price has to be a factor but, if the product is not safe, choosing the wrong sterile compounder can be extremely expensive.
So, how do you make sure you are getting the absolute highest quality product at a fair price? The answer is due diligence. You must thoroughly qualify your compounding provider. Now that the Drug Quality and Security Act (DQSA) has passed, there is a higher standard in place for sterile compounders that choose to register as an Outsourcing Facility with the FDA. But verifying that your compounder is registered with the FDA is just the first step. Do not stop there when doing your research. Ask your compounder these questions:
● Do they have an automated system in place to continuously monitor the pressure, temperature and humidity in the clean room?
● How often do they conduct environmental monitoring for viable and non-viable particulate counts in the clean room)? (Monthly is good. Weekly is better.)
● Are the aseptic processing personnel tested daily for fingertip contamination?
● How do they train their employees? (Ask for specific examples)
● Do the aseptic processing personnel wear all-sterile garb?
● Do the aseptic processing personnel have any exposed skin while working in the clean room? (A hair net, mask and gown is good but complete sterile garb with no exposed skin is much better.)
● Does your compounder have a Validation Master Plan?
● Does all equipment have supporting documentation that is in working order and is all equipment checked and certified on a regular basis?
■ Has Installation Qualification been performed and documented?
■ Has Operational Qualification been performed and documented?
■ Has Performance Qualification been performed and documented?
● Does your compounder have stability and sterility studies for their compounds that they will openly share with customers
● Will they share the sterility and potency tests for products they send you?
● Will they supply quarterly Quality Assurance reports?
● How do they address audit requests?
● Do they allow unannounced audits?
● How many audits did they have last year?
● Were there any unfavorable reports?
● Have they been inspected by the FDA?
By asking these questions and carefully evaluating a high risk sterile compounder, you can make an informed decision. You deserve to rest easy knowing that your compounder spares no expense in producing sterile products of the highest quality.
JCB Labs - helping you protect your patientss.
Posted By Greg Rockers on Fri, Jan 17, 2014 @ 15:01 PM
JCB Laboratories has long been an advocate for more stringent guidelines for high risk sterile compounding so we applaud Congress for the passage of the Drug Quality and Security Act (DQSA). The passage of this bill is the result of a bipartisan effort between the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee. Now that the President has signed this piece of legislation, we will be following it closely and look forward to seeing the final regulations.
DQSA creates a new category of compounders, called Outsourcing Facilities, that will be regulated by the FDA. JCB Labs has the expectation that the DQSA will benefit our industry by leading to a higher level of integrity in compounded sterile products and therefore increasing patient safety. Since the tragedy in New England a little over a year ago, it was clear that Congress saw a need to address this issue. Choosing to register with the FDA to become an Outsourcing Facility is voluntary. It it is our expectation that providers will overwhelmingly choose sterile compounders that commit to the more stringent regulations and register with the FDA.
We hear from providers every day that sterile compounders fill a vital role in making sure critical medications are available when they need them. With a higher standard in place, and regulations that allow non-patient specific ordering, quality compounded medications can be readily available to providers. To show our support for the new legislation, JCB has started the registration process and we expect to be listed as an Outsourcing Facility very soon