CAPS Taking Leadership Role in Changing Regulatory Environment for Pharmacies
IRVINE, CA – December 7, 2015 – As a market leader in customized Parenteral Nutrition (PN) delivery and provider of quality sterile compounding services for the past 25 years, Central Admixture Pharmacy Services, Inc. (CAPS®) unveiled its 503B quality assurance program and consulting service offering at this year’s American Society of Health-System Pharmacists (ASHP) 50th Midyear Clinical Meeting in New Orleans, LA.
With two 503B-registered outsourcing facilities – which are designated for anticipatory compounding needs including controlled substances, anesthesia syringes, and drug delivery – CAPS is a front-runner in implementing the Food and Drug Administration’s 503B requirements under the Drug Quality and Security Act. The company’s new Test, Hold and Release (THR) program ensures that every compounded drug batch from CAPS’ 503B outsourcing facilities meets the new specifications for sterility, potency, and endotoxin testing prior to release and shipment. CAPS also offers a Certificate of Release for each batch to give its customers peace of mind.
In addition, the company revealed its new consulting service in which a team of CAPS compounding experts is available to help pharmacies reach their compliance standards. As part of this service CAPS Consulting offers a ReadyCheckSM quality assurance program – an on-site USP <797> compliance analysis performed by two auditors who examine eight sections (200 criteria) including compounding, dispensing, clean room processes, testing and monitoring, media fills, and training.
“CAPS is at the forefront of helping hospitals and surgery centers navigate through the new compounding regulatory environment,” said Mike Koch, Senior Vice President, CAPS Professional Services. “We’re committed to providing our customers with programs such as THR and consultative services to help them focus on improving patient care.”
CAPS is the nation's largest network of outsourcing admixture pharmacies. A pioneer in the outsourcing of CSPs, CAPS was founded in 1991, and delivers high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities across the nation. CAPS has two 503B Outsourcing Facilities that are registered with the FDA to provide anticipatory compounding services. CAPS also has 23 state licensed 503A regional pharmacies that dispense labeled, patient-specific prescriptions including PN and chemotherapy. To learn more, visit www.capspharmacy.com.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 54,000 employees in more than 60 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.