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

Compounded Sterile Products-Higher Standards and Increased Patient Safety

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.

Your Partner,

 

Greg Rockers. R.Ph.

VP-Business Development

Tag: Sterile Compounding, USP 797, Quality, Partnership, 503B, compounding, outsourcing facility, FDA, cGMP, CMS, DQSA, innovating,

Partners

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. 

 

Your Partner,

Brian Williamson, PharmD

President

Tag: Quality, Integrity, Partnership, Success, Trust, Transparent, Truthful, Forthright,

New National Sales Director

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.

VP-Business Development

Tag: Customer Service, Quality, Integrity, Partnership, Experience, Leadership,