FOR IMMEDIATE RELEASE                                                                                              

April 15, 2016


Board of Pharmacy Specialties® Issues Call for Petition in Sterile Compounding Pharmacy Practice


Washington, D.C. – The Board of Pharmacy Specialties® (BPS), the premier post-licensure certification organization serving the pharmacy profession, has issued a call for petition in Sterile Compounding Pharmacy Practice, it was announced today. If approved, Sterile Compounding Pharmacy will be the ninth specialty offered by BPS.

According to BPS Chairman, William E. Evans, PharmD, faculty member and former chief executive officer at St. Jude Children’s Research Hospital, the BPS Board of Directors reviewed the role delineation study conducted in Sterile Compounding Pharmacy and found the results supportive of further consideration.

“Sterile compounding has a significant impact on patient safety and outcomes, which is consistent with our mission to improve patient care by promoting the recognition and value of specialized training, knowledge, and skills in pharmacy and specialty board certification of pharmacists,” Evans said.

Following a major compounding tragedy in 2012 and other similar smaller compounding events, public and healthcare organizations sought to improve safety of compounded drugs, primarily by seeking regulatory reform. In response, many state Boards of Pharmacy strengthened their compounding rules, typically by including requirements for compliance with the USP general chapters on compounding, <795> and <797>.

Congress also passed the Drug Quality and Security Act (DQSA) of 2013 which delineated compounding activities allowed under state law versus compounding by “outsourcing facilities” that should comply with U.S. FDA registration, inspection, and Current Good Manufacturing Practice (CGMP) standards.

“While these regulatory reforms have focused on facilities and processes, little has changed regarding personnel,” explained BPS board member, James A. Ponto, MS, RPh, BCNP, chief nuclear pharmacist at the University of Iowa Hospitals and Clinics and clinical professor at the University of Iowa College of Pharmacy. “It seems to me, and others, that public health and safety initiatives should include additional focus on pharmacist competency in compounding activities.”


“I want to thank the members of the Role Delineation Study Taskforce for their tremendous commitment to this process as well as the Role Delineation Study Review Panel and those pharmacists who took place in the validation survey,” said BPS Executive Director William M. Ellis, MS. “Without their efforts, we would not be able to issue a call for petition.”

In order for a new specialty to be recognized by BPS, the petition must address in detail each of the criteria deemed necessary: need; demand; number/time; specialized knowledge; specialized functions; education and training; and transmission of knowledge.

“Once we receive the petition to recognize Sterile Compounding as a BPS specialty, the Board will complete its review and render a decision within six months,” Ellis explained.  “If approved, a Sterile Compounding Pharmacy Specialty Council will be established to work with BPS and its highly qualified psychometric consultants to develop a bank of test items for certification examinations.”




The Board of Pharmacy Specialties® (BPS) was established in 1976 as an autonomous division of the American Pharmacists Association (APhA) to improve patient care and increase awareness of the need for BPS Board Certified Pharmacists as integral members of multidisciplinary healthcare teams through recognition and promotion of specialized training, knowledge, and skills in pharmacy and specialty board certification and recertification of pharmacists throughout the world.

Board certification through BPS is recognized as the gold standard for determining which pharmacists are qualified to contribute at advanced practice levels. Today close to 25,000 pharmacists are BPS board certified in eight specialties: ambulatory care pharmacy, critical care pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pharmacotherapy and psychiatric pharmacy.



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