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 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.