Sometimes simple words of encouragement or inspirations can lead to incredible things. This is the case with Asteria Health. Asteria Health is a company that believes in making a difference. Our products make a difference in the lives of patients. In addition, our products and level of service make a difference in clinics, hospitals or other healthcare facilities by creating a partnership based on quality, integrity, and excellence. It is our goal to be the best source of sterile and non-sterile products for any healthcare facility that takes pride in making a difference in the lives of their patients.

Asteria Health is a company that believes in making a difference

This drive and commitment to be a source for making a difference is what led Asteria Health to voluntarily go beyond the regulations of USP 795 and USP 797 as a pharmacy and register with the FDA as an Outsourcing Facility. Under The Drug Quality and Security Act of 2013, a compounding pharmacy could volunteer to register as an outsourcing facility with the FDA and meet all requirements of section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). Pharmacies that elect to register with the FDA as an Outsourcing Facility are commonly referred to as a 503B Pharmacy or 503B Outsourcing Facility.

As a 503B Outsourcing Facility, Asteria Health has committed to delivering quality, integrity, and excellence by incorporating current good manufacturing practices (CGMP) in accordance with part 210 and part 211 of the Code of Federal Regulations Title 21 (CFR 210 & 211). In addition, Asteria Health has embraced a pharmaceutical quality by design (QbD) approach for the development of compounded preparations. This development approach for success revolves around defined objectives with an emphasis on understanding products and processes and includes process controls based on sound science and quality risk management.

Asteria Health has committed to delivering quality, integrity, and excellence

We have taken the necessary steps to be an Outsourcing Facility you can trust for your sterile and non-sterile compounded preparations. From inception to production, Asteria Health has always been about making a difference. For example, we have developed and utilize innovative packaging for our hormone pellets that help with product recognition and reduce waste due to broken or damaged pellets. We also work with our clients to find out how we can make our products better or easier to administer in their practice. We realize the ultimate goal is to make a difference in the lives of patients but we also strive to make a difference in each setting that uses our product.

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