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 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 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 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 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 Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM
There have been a lot of questions surrounding the Drug Quality and Security Act (DQSA) that created the 503B Outsourcing Facility category. Now it looks like CMS may not authorize payment for compounded drugs covered by Medicare unless those drugs were supplied by an Outsourcing Facility that is compliant with FDCA Section 503B.
JCB Labs was one of the first sterile compounding pharmacies to register with the FDA as a 503B Outsourcing Facility. That means that there should be no question whether or not drugs you buy from us will be covered. For more information on this very important topic, please go to this link for an interesting article and food for thought.
Posted By Brian Williamson on Thu, May 16, 2013 @ 17:05 PM
For those facilities that order mitomycin, 5-FU and other cytotoxic drugs from JCB Laboratories, you have likely noticed that JCB ships these products in yellow bags clearly marked as “Cytotoxic”. It is important to realize that cytotoxics and hazardous drugs should be handled and disposed of according to current national guidelines. If your facility does not currently have a cytotoxic/hazardous drug handling and disposal program then one should be developed. All personnel who handle and/or dispose of cytotoxic and/or hazardous drugs should be trained on proper identification of their properties, handling requirements, location of Material Safety Data Sheets (MSDS) binders, and accidental spill or contact procedures.
Cytotoxics and/or hazardous drugs can be disposed in two types of containers: 1) clearly marked yellow sharps containers, or 2) black universal drug waste containers. An absorbent material should be placed in the bottom of the containers. Some facilities use paper towels and I have heard of others that use a special absorbent material similar to kitty litter. The absorbent material is to prevent aerosolization of any residual liquids into the facility air or accidental spillage if the containers are knocked over. Each facility should be contracted with a certified disposal service that can pick up and dispose of the containers according to current EPA guidelines. There are several companies that provide this service and it is likely that you are already using a company to pick up your biohazard waste.
More detailed information can be located at the National Institute for Occupational Safety and Health (NIOSH) web site: http://www.cdc.gov/NIOSH/
If you do not currently have policy and procedures for handling cytotoxics and hazardous drugs, your consultant pharmacist may be a good resource to help you develop them.
Posted By Brian Williamson on Wed, Apr 24, 2013 @ 15:04 PM
The sterile compounding industry has been under a microscope for the last six months. Since the New England Compounding Center tragedy, a few other compounding pharmacies have issued voluntary and mandatory product recalls. The recalls have been primarily related to “lack of assurance of sterility” and have been brought about by either patient infections, floating material in products, or both. Additionally, the FDA has completed the inspection of 30 compounding pharmacies and the information gathered is being summarized and processed to determine how to regulate compounders going forward.
It is important to note that all the FDA inspections were done using current Good Manufacturing Practices (cGMP) standards instead of USP 797. Sterile compounding pharmacies are regulated by state boards of pharmacy and most boards require sterile compounding pharmacies to be compliant with USP 797. So, it is not surprising that all of the pharmacies received inspectional observations form FDA 483 when inspected against cGMP standards. USP 797 has been the “gold standard” for sterile compounding pharmacies for years. Products prepared and the testing of those products using USP 797 procedures results in sterile products that are safe. It is when sterile compounding pharmacies cut corners or do not follow USP 797 to the letter that problems can occur.
The cGMP standards are more stringent than USP 797 in some areas, most notably in air sampling requirements and validation of compounding and testing methods. Going forward, we expect there to be requirements put in place that incorporate parts of USP 797 and cGMP. The greatest predictor of things to come can be summarized by a statement made on March 23, 2013 by FDA Commissioner, Margaret A. Hamburg, M.D. Her statements indicate that the FDA, in cooperation with state boards of pharmacy, will continue inspections of compounding pharmacies. Commissioner Hamburg asked Congress to draft legislation establishing minimum federal standards for firms that compound sterile drug products, and wants Congress to enhance the FDA’s authority to inspect pharmacies, asking for the “FDA [to] have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.” Two areas that the FDA seems to be set on changing or adding oversight is compounding of sterile products in anticipation of an order or prescription and large-scale interstate shipping of products. We have already seen many states either starting to enforce their regulations regarding “office-use vs. prescription” compounding, or implement emergency regulations to prohibit office-use compounding, or both.
So, what does this mean for you, for JCB, and for the patients you serve? As many of you know, the changes made by many states requiring prescriptions for compounds is a logistical nightmare. It is time consuming, costly, and likely not the best approach to ultimately protecting patient safety. There are better ways to track lot numbers of products to individual patients and many of you are already doing this. Nevertheless, JCB Labs will comply with the rules and regs put in place by each state board of pharmacy and will help you remain compliant as well. If you are in a state that requires prescriptions for office use compounds, we will continue to ask you for prescriptions unless or until the regulations are changed.
It appears that the FDA will likely have more oversight in the compounding industry. Whether or not this happens, JCB will continue to provide sterile products of the highest quality and help ensure the safety of your patients. JCB’s facility is always open for you to visit or audit. If you do come to visit JCB, we are confident that you will leave completely satisfied that you are working with a sterile compounding partner you can trust.
Posted By Brian Williamson on Tue, Mar 12, 2013 @ 08:03 AM