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 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 Fri, Feb 13, 2015 @ 10:02 AM
People buy from those they like and trust. It’s a fact! Think about it. We don’t have the luxury today of wasting time buying from people who aren’t truthful, transparent, and forthright. This is especially true in the healthcare industry. It is not just our dollars at stake if we make bad buying decisions...our patients can suffer if we choose poorly.
From now on, JCB will refer to our “customers” as PARTNERS. Partners help each other grow and flourish. Partners look out for each other and ensure that their respective businesses are successful. Partners share success in many ways. If you partner with a company that is truthful, transparent, and forthright, you can rest assured that you will be successful. Your success will be evident by repeat patient visits, the referrals your patients will give, and the reputation that you will develop. Communication is also key to a successful partnership. Over the years, JCB has developed very successful partnerships based on our ability and desire to ask questions about your practice, provide sound clinical information, and keep our partners up to date on changes and innovation. We look forward to developing new partnerships and strengthening current relationships.
We have some very exciting news to share with you in our next communication. Please check your email over the next couple of days for an announcement that will solidify JCB Laboratories as the leader in sterile compounded products.
Brian Williamson, PharmD
Posted By Greg Rockers on Wed, Feb 11, 2015 @ 08:02 AM
To our valued partners:
I am pleased to announce Steve Strickland as the new National Sales Director for JCB Laboratories. Steve has over 20 years of experience in the pharmaceutical industry in a variety of roles and is a tremendous addition to the JCB team. With his considerable sales leadership experience, I am confident you will find Steve a welcome resource. His record of success is a clear indication of his commitment to providing excellent customer service with uncompromising integrity. Steve’s values are a perfect fit with the JCB commitment to deliver the safest, highest quality products to your patients.
This commitment to quality is something you have come to know over the past decade and is the hallmark of JCB Laboratories. Unmatched customer service is a pillar to that commitment. Steve looks forward to enhancing our mutual partnership through an expanded direct account management team which will further improve our first in class service you have come to expect and deserve.
In the coming weeks, Steve and his sales team look forward to the opportunity to meet you and continue to develop the trust you have placed in JCB Laboratories.
We appreciate your business!
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 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.
Posted By Greg Rockers on Sun, Jan 19, 2014 @ 15:01 PM
JCB Laboratories is excited to announce that we have installed a new continuous monitoring system in our cleanroom and drug storage areas. This system is typically found in FDA-registered facilities or large manufacturing plants. This system is the first in the country to be introduced and commissioned in a sterile compounding pharmacy. What does this mean to you? It gives you and your patients an added layer of security and safety. This state-of-the-art system (called Lighthouse) gives us LEADING indicators of potential environmental and system failures vs. traditional TRAILING indicators that only allow the user to respond after a problem has occurred. Much like you constantly monitor a patient during surgery we are constantly monitoring the health of our clean room. If you know what’s happening to the patient/cleanroom at all times you can usually correct the issue before it escalates. See the press release below for details!
Posted By Greg Rockers on Fri, Aug 30, 2013 @ 09:08 AM
Criteria to Demand From Your Sterile Compounding Partner
The compounding pharmacy supplying sterile office use products must place quality above everything else. For a sterile products compounding pharmacy, this means, at a minimum, that the pharmacy:
Maintains a constant state of control in their cleanroom
Continuous monitoring of temperature, humidity and pressure differentials
Daily, weekly and monthly environmental monitoring
Regular certification of all cleanrooms and laminar flow hoods by an accredited third party
Meets or exceeds USP <797>
This includes meeting the requirements for sterility, fungal, endotoxin and potency testing
Is accredited by the Pharmacy Compounding Accreditation Board
Has a robust set of Standard Operating Procedures that have been reviewed by an accrediting body
This includes a recall procedure that is regularly tested and allows the pharmacy to track every ingredient and device used to compound a particular product and recall it within hours.
Labeling products with labels that meet ISMP (Institute for Safe Medication Practices) guidelines.
This includes a barcode that allows health systems to integrate compounded medications into their automated dispensing systems
All labels for compounded product will clearly state:
This Is A Compounded Product
For Office Use Only
Not for Resale
Posted By Greg Rockers on Wed, Jul 03, 2013 @ 15:07 PM
The old adage is that a picture is worth a thousand words. With that spirit in mind, I invite you to take a look at these pictures of “what not to do” when it comes to medication labeling and storage. As a pharmacist who talks to providers on a daily basis, I have seen and heard of many of the following examples. Have you? Send me an email with your thoughts (firstname.lastname@example.org).
Picture #1-Notice the storage bin is labeled atropine 1mg/mL but the vials are actually atropine 0.4mg/mL.
Picture #2- A sticker that you can write on is a much better plan than writing the drug name directly on the syringe. Regardless of the lack of aesthetics on this syringe, please also notice there is no concentration, time or date on the syringe below:
Picture #3-Multiple drugs and strengths are co-mingled in this tray
Picture #4- We have better ways to label!
Picture #5 – No identifying label.
Picture #6 – Keep Hemoccult away from Timpoptic
I want to emphasize that these pictures are not the norm at any of the facilities we have ever visited. JCB knows that a common goal that all health care providers share is the safe care of their patients. It is our hope that, by seeing these pictures, you are put in the mindset of thinking of ways to improve the safety in medication labeling and storage. Please send me examples of how you do things the right way. I will compile your submissions and then share these best practices in a future blog.
Many thanks to consultant pharmacist Sheldon Sones for these pictures-he calls these Never Ever pictures. Sheldon S. Sones, R.Ph. FASCP, is President of Sheldon S. Sones and Associates, a pharmacy and accreditation consulting firm based in Newington, Connecticut. Established in 1985, the group specializes in safe medication management and pharmacy consulting to free standing and hospital based ambulatory surgical, endoscopy, and renal dialysis centers with expertise in accreditation success. In addition, his service provides nationally recognized educational programs for medical and nursing staffs with a focus on safe medication strategies and quality measure and improvement opportunities. Visit his website at http://www.sheldonsones.com/home.html .
Posted By Brian Williamson on Thu, Feb 21, 2013 @ 14:02 PM
While the aforementioned article was referring to commercial manufacturers, I think some people have the same opinions regarding compounded products. I have two concerns with this focus on the lowest price and the belief that all products are equivalent. First, do you really want to use the compounding pharmacy that competes solely by offering the lowest price? The customers I speak with want a sterile compounder that is accredited by the Pharmacy Compounding Accreditation Board (PCAB) and one that meets or exceeds the United States Pharmacopeia (USP) 797 requirements. They want a compounding pharmacy they can trust to make sure their patients receive the best care possible. Secondly, it appears that not all products undergo the same sterility, endotoxin and potency testing. Ask your compounder for their policy and procedure on testing sterile products. Does your compounding pharmacy test per USP 797 guidelines? They should, but the recent dramatic increase in the number of test samples sent in to analytical labs appears to indicate that not every pharmacy follows USP 797. I recently spoke with one of our independent testing laboratories and they said their business tripled in the two months following the deadly meningitis outbreak caused by contaminated compounded steroids. That seems to indicate that not everyone was testing properly prior to the tragedy.
Now is the time for you to take critical look into your compounding pharmacy. Ask the tough questions of your high risk sterile compounding pharmacy. Make sure you have all the documentation you need not only to give you peace of mind but also to satisfy your regulatory auditors.