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.

JCB Labs Blog

Sales Team Changes

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

President

 

Tag: 503B, outsourcing facility, cGMP, DQSA, price, Continuous quality Improvement,

Risky Business - Is Price Dictating Your Decision?

Posted By Brian Williamson on Thu, Feb 21, 2013 @ 14:02 PM

Quality in your compounded sterile products (CSPs) is something you should never take for granted.  While this has always been true, the tragic events of last fall have made everyone look at sterile compounding quality with renewed focus.  As healthcare providers, no one sets out to buy an inferior product but many do not know what is involved in maintaining a quality pharmacy environment and compounding a safe compounded product.  As I talk with customers about how to vet their compounder, I typically share the fact that a pharmacist could have graduated from pharmacy school yesterday and opened a sterile products compounding pharmacy today.  However, I doubt you would want that person compounding your high risk sterile medications.   Experience in sterile products compounding is of paramount importance and you should demand a pharmacy that has an impeccable safety record.  I recently read an article that was lamenting the lack of emphasis the pharmaceutical industry places on quality.  The authors of this article (FDA staffers) are of the opinion that a lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing investments in quality. They claim that, although today’s buyers may now be more aware of quality problems with sterile injectables, buyers appear to generally discount quality concerns and to focus principally on obtaining the lowest prices possible.  This behavior is likely based on a belief that all marketed products are of equivalent quality. 

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.

Tag: Quality, compounding, sterile, price, discount,