CAPS® Experts & Quality Assurance Programs to be Featured at NHIA 2018
Central Admixture Pharmacy Services, Inc. (CAPS®) will showcase its regulatory expertise and quality assurance programs at this year’s National Home Infusion Association (NHIA) Conference & Exposition at the Phoenix Convention Center from April 23-26.
Mike Koch, Senior Vice President, CAPS Professional Services, and Eric Bauer, RPh, Senior Consultant for CAPS, will be featured speakers at The Sterile Compounding Clinic at NHIA. The Clinic will deliver comprehensive hands-on training for physicians, nurses, pharmacists, and pharmacy technicians for specialty and home infusion therapy.
Mike Koch will discuss the evolution of 503B entities and their regulatory requirements. Attendees will then be able to assess whether registering as a 503B outsourcing facility is right for their business. Eric Bauer will discuss a risk-based approach to determining an appropriate beyond-use-date (BUD) for compounded sterile products, including parenteral nutrition, in accordance with USP <797> revisions and proposed USP <800> regulations. Attendees also will learn about the various sterility testing methods used to extend BUDs and when and how to apply them in their operations.
CAPS has been a front-runner in implementing the Food and Drug Administration’s (FDA) 503B quality assurance requirements under the Drug Quality and Security Act (DQSA). CAPS representatives will be at booth #215 to highlight the company’s Test, Hold and ReleaseSM (THR®) program. THR is designed to ensure that every compounded drug batch from CAPS’ 503B outsourcing facilities meets the new standards for cGMP release testing for sterility, potency, and endotoxin prior to shipment. CAPS also offers a Certificate of Release for each batch to give customers peace of mind.
CAPS was among the first outsourcing facilities in the nation to fully adopt release testing.
“Our existing high quality standards were further strengthened with THR implementation,” Koch said. “When it comes to patient safety, we believe that 100% release testing from our 503B facilities is the only sure way to assure the level of quality demanded by our customers.”
As a market leader in customized Parenteral Nutrition (PN) and provider of quality sterile compounding services for more than 25 years, CAPS also will feature CAPS ConsultingSM, a service designed to help hospital pharmacists and pharmacies remain compliant in light of new regulations as a result of the DQSA. As part of this service, CAPS Consulting offers a ReadyCheckSM quality assurance program – an on-site USP <797> and USP <800> compliance analysis performed by auditors, who conduct a comprehensive assessment of compounding, dispensing, clean room processes, testing and monitoring, media fills, and training.
To further underscore its commitment to servicing its customers, CAPS is expanding its sterile compounding outsourcing services with a new state-of-the-art, 503B outsourcing facility in Phoenix, AZ. The facility, which is scheduled to open this summer, will complement its two existing 503B facilities located in San Diego, CA and Allentown, PA.