Home America Pentec Health’s 503B Outsourcing Facility Now Licensed in California

Pentec Health’s 503B Outsourcing Facility Now Licensed in California

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Pentec Health, Inc., an established leader in sterile compounding with an FDA registered 503B Outsourcing Facility, has added California to their list of 43 licensed states. In early February, California’s Board of Pharmacy visited Pentec Health’s Pennsylvania location to inspect the facility and evaluate the safety of their processes. After several days of careful review, the Board determined that Pentec Health met and/or exceeded the quality standards as set forth by the state of California, and, therefore, granted Pentec Health’s license to ship their 503B formulated sterile dosage forms to that state.

Pentec Health’s state-of-the-art outsourcing facility is designed to maintain cGMP compliance to ensure quality and safety. The company’s validated process avoids the risk of human error and technical variability. This commitment to quality excellence is reflected in the company’s innovative product configurations, Snap-N-Go® vials, and Dilute-N-Go® syringes. These concentrated, sterile solutions deliver a precise dose or a desired concentration once their contents are introduced and mixed with a diluent bag of choice. Every batch produced at the facility proactively includes a quality assurance report detailing its purity, potency, sterility, and stability.

“We are thrilled to expand our reach into the state of California,” said Joseph Cosgrove, Chairman, President, and CEO of Pentec Health. “We believe that Snap-N-Go and Dilute-N-Go can truly transform pharmacy workflows and, ultimately, benefit patients. We want these innovations available nationwide in order to meet the needs of those who depend on the quality and safety of sterile preparations every day.”

Snap-N-Go and Dilute-N-Go are designed to help offer the peace of mind of a manufacturer with the efficiency of an outsourcing provider – enabling safe, accurate medication for healthcare providers. With proper use, these products have been shown to reduce the majority of error-prone steps in traditional compounding and help the hospital pharmacy eliminate most of the inherent costs that are associated with drug waste.

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