CPS Publishes Guidance for Evaluating Outsourced Compounding Facilities

Monday, December 5, 2016 9:30:00 AM

FOR IMMEDIATE RELEASE: December 5, 2016

CONTACT: Rod Recor Rod.Recor@cpspharm.com; 901-462-9082

 

Guidance for Evaluating Outsourced Compounding Facilities Based on Four-Year Study Released for December 2016 ASHP Meeting

Comprehensive Pharmacy Services Reveals Best Practices to Ensure Quality and Mitigate Risk from Outsourced Compounding Sites at ASHP December Meeting

Memphis, TN – Following a four year study of 250 sterile compounding sites by a team of 16 sterile compounding specialists, Comprehensive Pharmacy Services (CPS) has published an in depth white paper: Evaluating Outsourced Compounding Facilities, Under the Latest Federal Compounding Regulations. The white paper is designed as a thorough guide for hospitals and pharmacies to use as a resource when selecting compounding facilities that meet federal and state regulations in order to reduce risk and protect patient safety.   

In late 2012, contaminated drugs from a New England compounding pharmacy killed 64 and sickened more than 750 people nationwide. In response, federal and state agencies increased their oversight of outsourced drug manufacturers in order to reduce the potential for contamination. The short supply of common classes of drugs needed to treat patients has complicated the situation, and health system pharmacists have turned to outsourced sterile compounding as a means of supplying those necessary medications.

“It’s the classic ‘Catch-22’ where health systems need outsourced compounding facilities, but the regulatory requirements have become more stringent and complex,” said Len Gray, PharmD, Vice President of Health System Clinical Services for CPS. “Our goal is to assist hospitals and pharmacists in their assessment of compounding operations so the sterile preparations they provide their patients are safe, of the highest quality, and meet state and federal requirements.”

The white paper provides guidance and considerations for evaluating a compounding facility for:

  • Regulatory Compliance with State and Federal Agencies
  • Quality and Patient Safety Standards
  • Sterility Maintenance
  • Labeling and Packaging
  • Ordering Processes

“Shortages of common classes of drugs are not going away anytime soon, and federal regulation and state enforcement of existing statutes related to compounding facilities are expected to continue and possibly increase,” said Marvin Finnefrock, PharmD, Divisional President of Clinical and Purchasing Services at CPS. “We want to ensure that hospitals and pharmacists have the tools they need to meet regulations while providing safe compounded sterile drugs for their patient populations.”

CPS’ dedicated team also works with health systems to mitigate risk with sterile preparations and meet US Pharmacopia (USP) 797 and 800 requirements for both compounded and hazardous drugs. CPS is continually updating and revising its resources and tools that address current and emerging regulatory issues facing hospital pharmacies.

CPS chose the ASHP Midyear Clinical Meeting and Exhibition to launch the white paper because it is the largest gathering of pharmacists in the world. With its focus on improving patient care and medication safety, the meeting is attended by more than 20,000 pharmacy professionals around the globe. ASHP was founded in 1942 and represents over 40,000 pharmacists, student pharmacists, and pharmacy technicians who serve as patient care providers on healthcare teams in acute and ambulatory settings.

For more information on how CPS can provide support in compounding site assessment, email: cpsinfo@cpspharm.com.

Click link to access the white paper: Evaluating Outsourced Compounding Facilities, Under the Latest Federal Compounding Regulations

About Comprehensive Pharmacy Services

Founded 45 years ago and employing over 2,000 pharmacy professionals, Comprehensive Pharmacy Services is the nation’s oldest and largest provider of pharmacy support services to more than 600 hospitals and healthcare facilities pharmacies. CPS helps hospital pharmacists tackle complex problems such as medication reconciliation, hyper-inflated drug costs, standardization, centralized distribution, retail pharmacies, compliance, 340B programs and much more, leading to increased quality, reduced admissions and lower costs. For more information, visit http://www.cpspharm.com.