September 21, 2016 | Company News

Pentec Health Enters New Market as a 503B Outsourcing Facility

503 B Logo3@2X Copy

Pentec Health, Inc. announced today that it is registered as an Outsourcing Facility with the U.S. Food and Drug Administration (FDA) under section 503B of the Drug Quality and Security Act (DQSA). Pentec is uniquely positioned and poised to enter the rapidly expanding six billion dollar US market for compounded sterile products. The company will capitalize on expertise derived from its 33 year history as a provider of outsourced sterile compounding pharmacy services.

Pentec’s 503B launch represents the next evolutionary step in the company’s growth and diversification spanning more than three decades. Via a steady and consistent progression, the healthcare arena has witnessed the company’s transformation from a small, local sterile compounding pharmacy to a national leader providing outsourced pharmacy services to the infusion, dialysis, and pain management sectors. Pentec’s current services offer physician prescribed, patient specific, nutritional support products and services to hemodialysis providers. Its’ infusion service offerings provide pain and spasticity management to patients with implanted intrathecal pumps. Consistent with its’ culture and patient-first approach, Pentec employs Registered Nurses that have completed an accredited intrathecal training program to administer these compounded therapeutic options within a home care model.

Pentec Chairman, President and CEO Joe Cosgrove enthusiastically noted the common denominator, “Pentec has been a traditional sterile pharmacy outsource provider for over 33 years. The passage of the DQSA paved the regulatory path for us to bring our expertise to a new market. We welcome and embrace the high hurdle that the FDA has created to ensure quality and patient safety in section 503B. Pentec’s mission and core values have long held a commitment to deliver high-quality products and services with a patient driven focus. That commitment will continue to be an integral and vital aspect of our entry into the compounded sterile product market. Our customers will utilize our products with a high degree of confidence in safety, quality and consistency.”

Pentec has made substantial investments in new facilities and state of the art infrastructures to supply the 503B marketplace, all of which comply with the current Good Manufacturing Practices (cGMP) as required by the FDA. The construction of a new, large-scale outsourcing facility is the first step in a multi-tiered long-range operating plan. Pentec’s new facility incorporates state of the art, automated manufacturing equipment with in-house microbiology and chemistry labs to ensure end product quality, consistency, and regulatory compliance to support the bulk production of compounded sterile preparations. Additional enhancements supporting the business include the integration of an Enterprise Resource Planning (ERP) system fully compliant with 21 CFR Part 11 and a refined customer service interface. The e -Commerce component will make the ordering experience simple, transparent and convenient for customers. Human Resource and management expertise has also been buoyed by additional staff with specific expertise in cGMP operations and FDA/Regulatory interactions.

The new manufacturing facility compliments Pentec’s existing, and recently renovated prescription based 503A sterile compounding operation. A recent FDA inspection of the 503A facility resulted in no observations being sited and no issuance of a Form 483, a further demonstration of Pentec’s commitment to excellence. The company will continue to operate the 503A pharmacy in support of its existing businesses. The patient specific 503A pharmacy and the 503B bulk compounding facility support separate businesses and are housed at separate sites.

About Pentec Health, Inc.

For over 30 years, Pentec Health has been an industry leader in providing patient-specific compounded sterile medications for administration in dialysis centers, as well as providing in-home Specialty Infusion services and complex pharmaceutical products to patients who require access outside of a hospital setting. Pentec’s registration as an outsourcing facility, providing sterile compounds to meet the needs of the nation’s institutional healthcare segments, reinforces its’ innovation, market leadership and commitment to patients and providers.

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Pentec Health, Inc.
Tyler Cummings

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