About our Facility

Located in the same corporate park as our 503A facility in Boothwyn, PA, our dedicated 503B facility now enables us to provide non-patient-specific compounded sterile preparations to hospitals and other institutional pharmacies. It’s registered with the U.S. Food and Drug Administration (FDA) as a Human Drug Outsourcing Facility under Section 503B of the Federal Food, Drug and Cosmetic Act and has been inspected for compliance with that agency’s stringent current Good Manufacturing Practice (cGMP) in both its design and operation.

Pentec Health’s state-of-the-art outsourcing facility is designed to maintain cGMP compliance to ensure quality and safety. Our validated compounding process removes the risk of human error and technical variability. While a building is supported by mortar, its functioning relies on people. That’s why we bolstered our outsourcing facility’s leadership team with key staff across all departments that possess expertise in FDA/regulatory interactions and cGMP best practices.

Every dose produced at our facility includes a quality assurance/quality control certificate detailing its purity, potency, sterility and stability. With this unprecedented transparency and innovation, your hospital can confidently place its trust in Pentec Health for 503B outsourcing.

Discover how our 503B facility can help you.

Request a tour of our facility, learn about our 503B product line or place an online order with us. Pentec Health 503B Facility
9 Creek Parkway
Boothwyn, PA 19061 CustomerService@pentechealth.com Phone: 866-956-4376 Fax: 844-742-6150

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