Out of the Gates 
  E-Newsletter from Gates Healthcare Associates
December 2013
In This Issue
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Welcome to the inaugural issue of Out of the Gates, a new monthly e-newsletter from Gates Healthcare Associates!

Through Out of the Gates, our team of experts will provide insights and updates on a variety of topics and issues in our rapidly evolving health care and pharmacy markets. In this issue, we touch on the shifting regulatory landscape for pharmacies, offer helpful tidbits in a "Did You Know?" feature by Senior Associate Ken Speidel, and share interesting articles on health care policy, business, and research. 

I hope you enjoy Out of the Gates and will use it as a resource for your practice. Please feel free to contact us with your feedback.

Sincerely,
Ernest P. Gates Jr., R.Ph, FASCP, FIACP, FACA
The Value of Current 'c' in cGMP

The acronym cGMP stands for "current Good Manufacturing Practice." The "c" is typically lowercase in the nomenclature to show that GMP standards are constantly changing -- a variable due to continuous improvement in industry practices.

 

Change is certainly coming to the compounding pharmacy profession. This month, the Food and Drug Administration started implementing the Drug Quality and Security Act. A key component of the new law calls for large-scale compounders to register voluntarily as "outsourcing facilities," thus submitting to greater scrutiny by the FDA and complying with cGMP requirements.

 

While some compounders already adhere to the most rigorous manufacturing standards, other pharmacies may choose to move in this direction. This requires significant investment in facilities, equipment, training, expertise and operations. The price of admission may be high -- yet worth it because FDA-registered, cGMP-compliant pharmacies could become the preferred source for major compounded drug customers such as hospitals.

 

It's worth noting that the FDA itself has started referring to "CGMP" with a capital C, indicating the agency, which was criticized for acting too slowly on NECC (another acronym that's become ubiquitous in the compounding world), is placing greater emphasis on being "Current."


Did You Know?
Microbes outnumber human cells by 10 to 1! These bacteria and viruses are so tiny that together they make up only 1-3 percent of our total body mass. Yet, in a way, we really are walking, talking petri dishes. 

That's why pharmacies engaged in sterile compounding must establish aseptic preparation areas and ensure their staff follows aseptic technique to minimize the chance of contamination.

A pioneer in compounding, Gates Healthcare Associates helps clients design and build clean rooms, monitor compliance with USP 795 and 797 standards, deliver staff training, and assist in obtaining third-party accreditation, such as PCAB.
-- Ken Speidel, R.Ph, PharmD, Senior Associate

Gates' Take on Pharmacy Tech Jobs

Gates Healthcare Associates offered its industry expertise to Health Callings, an online career site for healthcare professionals, for a recent article on the pharmacy technician job market. 

 

Ernie Gates, president of the firm, noted that the Affordable Care Act (aka "Obamacare") will expand healthcare coverage and therefore increase prescription orders. Pharmacy techs are expected to step up and take on greater roles. "I think that the doors will be open for a lot more opportunities," Gates said.

 

To view the full article, click here.

 

Gates Healthcare Associates is a pharmaceutical and healthcare consulting firm that provides extensive clinical, programmatic, and regulatory knowledge and insight to an array of organizations nationally and abroad. We help our clients confront and overcome challenges and obstacles to growth, positioning them for long term business success.

 

 

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