Sterile compounding can present unique challenges for health care providers. Regulations are stringent and can change quickly, requiring sterile compounding companies to be adaptable. Due to recent industry events, the FDA is conducting more random inspections to ensure compliance, resulting in increased costs and the exit of some providers. Patients are left vulnerable, potentially experiencing disruptions in receiving their medication and accessing therapy.
Section 503B of The Food Drug and Cosmetic Act requires that facilities registered with the FDA as sterile compounding outsourcing must comply with CGMP requirements.
The Heritage Solution
We have created a reliable sterile compounding network composed of 503B certified providers. This allows us to keep pace with changing regulations without a lapse in service. We also manage the contract with the provider and conduct all administrative and credentialing work to make it effortless for you. We thoroughly vet the sterile compounding companies to ensure compliance and accreditation standards. Having a broad network of these providers in place helps ensure superior pricing and the timely, reliable access to services that you expect.