New group reframes the cause of specialty compounding

The fungal meningitis tragedy touched off by the contaminated products from the New England Compounding Center last year must never happen again. The American public must have confidence in the role of the pharmacy profession in this growing area of practice.

For these reasons, a group of executives from the sterile pharmaceutical compounding industry has formed the Specialty Sterile Pharmaceutical Society (SSPS; www.sterilepharma.net). The society is proposing a solution to the problem that in no way threatens traditional compounding by pharmacists.

New standards of practice

SSPS has spent months developing standards of practice, consulting with experts in sterile pharmaceutical manufacturing and sterile compounding to ensure the very highest standards for specialty pharmaceutical compounders, and it has begun to circulate these standards for peer review and adoption. We believe that our approach to this issue will be welcomed by pharmacists who currently practice sterile compounding, by those who plan to do so in the future, and by the various regulatory agencies and Congress.

The debate concerning the rapid changes in compounding and the oversight of a budding new industry of specialty sterile compounding practices is at a crucial point. Our nation’s healthcare system is dependent on these compounding practices. This is partly a result of the rapid response by compounding pharmacies in meeting these critical needs, triggered by legitimate demand and the resourcefulness of entrepreneurial pharmacists who provide solutions to a severe problem. It is conservative to say that these pharmacists have saved thousands of lives by providing critical, life-sustaining drugs that otherwise would not have been available because of national drug shortages.

The facts are clear. We had a very unfortunate tragedy, but we still need life-sustaining sterile pharmaceuticals. More regulation for the industry is necessary and imminent. Pharmacists preparing sterile preparations must incorporate a different science into their practice, the science of quality control. If a pharmacy practice has extended its scope beyond traditional pharmacy undertakings, then a higher standard of quality control becomes essential.

SSPS is a new organization founded to support a proposed tier of nontraditional pharmaceutical manufacturing through the establishment of stringent standards of practice (according to applicable Good Manufacturing Practices), to ensure the safety and welfare of the public, and advance the availability of specialty sterile preparations for patients served by the nation’s hospitals and physician practices.

A new model

Pharmacy compounding is at a crossroads, owing to the demand for a nontraditional model of pharmaceutical production. We have an opportunity to clarify our role in this new model and provide safe, lifesaving services to our healthcare system. A new tier of regulation for specialty pharmaceutical companies is necessary, and SSPS has arisen to communicate the key messages of this new industry.

Those key points include the establishment of a new tier of manufacturing (specialty manufacturing), strict safety standards, and the importance of lifesaving sterile pharmaceutical preparations to our country’s healthcare system.

SSPS will need the support of members in order to engage the issues on the regulatory and legislative fronts. If you desire to see pharmacy extend the scope of practice within our healthcare system, please consider joining our alliance. If you believe in the highest standards for specialty compounding and the optimal safety and welfare of patients, please consider joining. If you understand that vigilance in legislative and regulatory affairs is necessary to expand the profession’s role, please join our ranks. Any individual or company actively engaged in preparing specialty sterile pharmaceuticals is eligible for membership.

For more information about SSPS standards for small-batch pharmaceuticals, the founding board members, and SSPS activities, please visit our website at www.sterilepharma.net. I look forward to forging a new tier of safety and opportunity with you!

Dell McCarley, PharmD, is president of the newly launched Specialty Sterile Pharmaceutical Society (www.sterilepharma.net).