Compounding after NECC: Higher standards, superior outcomes


Sterile compounders have voluntarily undertaken several upgrades to their processes and products. The results benefit patients, pharmacists, and the profession overall.

Ernest Gates Jr.The pharmacy profession in the United States has come a long way since the 1821founding of the Philadelphia College of Pharmacy. But in an era of vastly more complex technologies and regulations, our history still offers relevant lessons.

See also: Quality assurance in a post-NECC world

The challenge of change is clear. Following the New England Compounding Center tragedy of 2012, regulators and pharmacies are paying increased attention to quality control and implementation of rules. The Drug Quality and Security Act of 2013 has conferred enhanced responsibilities and powers on FDA, states, and pharmacies. I have seen more change in the nearly three years since NECC than during some 40 previous years as a pharmacist.

An evolving process

Some of that change is the result of an ever more sophisticated industry that is making discoveries and sharing best practices. The balance consists of regulations, which may not always be greeted with universal acclaim.

See also: Specialization is pharmacy's future

We should not be surprised. Rules are written by human beings and subject to politics. Those who draft them may not appreciate the intricacies of the pharmaceutical industry, or they may not be reaching for exactly the right remedy.

In such cases, pharmacists are right to push back. The International Academy of Compounding Pharmacists (IACP), for example, is urging revisions to draft FDA regulations governing oversight of compounding pharmacies.

But political and regulatory dynamics should not be viewed as a distraction or expensive annoyance, much less a barrier to growth and success. They are better understood as part of a 200-year-old national dialogue seeking an ever safer and more effective role for the pharmacist in improving the nation’s health and well-being.

Need to meet and exceed

Those apothecaries who met in Philadelphia in 1821 were not ordered to do so by any government agency. Yet, meeting in Carpenters’ Hall, where the Founding Fathers had signed the Declaration of Independence, they established a college of pharmacy and a pharmacists’ association. They drafted a constitution and a code of ethics. Soon, previously secret formulas for patent medicines were published. The science of pharmacy began to make its way into colleges. Professional journals were founded.

True, it was far from the practice of pharmacy we know today. But our profession traces its legal and regulatory roots to 1820s Philadelphia. And those founders sensed something that we must acknowledge and embrace: We may not know what the future holds, but because there is a dire need out there for what we do, we must meet and exceed every standard that society determines necessary.

We recall our profession’s history not simply out of curiosity, but for the lesson it imparts: To succeed in the 21st century, compounding pharmacies must commit themselves to the highest standards of quality and excellence.

That includes complying fully with all federal and state rules. And it means putting greater emphasis on training, which is happening. But the goal must be clear: No one should walk into the compounding lab without knowing everything about that lab, its equipment and layout, the formulations, and what role he or she is to fulfill there.

In short, if you’re going to be a compounder, you have to commit to being the best, to identifying your best practices and then going still further. In our dauntingly complicated profession, there is too much room for error to do anything less.

Errors are costly in any profession, but seldom do they result in injury or death. In ours, they could.


Commit to the highest

Those pharmacy pioneers voluntarily crafted rules for themselves in order to advance their infant profession. We who inherit their legacy can only build upon it if we commit ourselves to the highest standards. That is why sterile compounders have raised the bar on their own by taking several steps: hiring microbiologists to examine their clean rooms, seeking the most talented graduates and training them still further, knowing their suppliers, and building more capacity than they need now - because lack of space increases potential for errors.

These steps are neither easy nor inexpensive. We take them because the lives of those we serve are in our hands each day. If we meet the standards demanded of us - and which we demand of ourselves - there is no more rewarding profession.

Ernest P. Gates Jr. is the president of Gates Healthcare Associates (, a Massachusetts-based pharmaceutical and healthcare consulting firm.

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