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Understanding Product Development in 503B Outsourcing Facilities

Product development in 503B outsourcing facilities involves a detailed, highly regulated process. Every compounded medication produced by facilities like SCA Pharma must be safe, compliant, and aligned with the needs of healthcare institutions. This blog dives deeper into the product development process, covering each phase from discovery to post-launch monitoring. The Product Development Process The development…

Racheal Adams to participate in FDA’s Compounding Quality Center of Excellence Virtual Conference

SCA Pharma Director of Corporate Quality Racheal Adams, will join leading industry experts for the FDA’s 2021 Compounding Quality Center of Excellence Virtual Conference titled “Culture of Quality” being held September 13-15. The virtual conference will bring together outsourcing facilities, regulators and industry leadership to engage on emerging industry topics and best practices to improve…

How to Properly Decipher an FDA Form 483

In your role, you’re likely responsible for vetting potential supplier partners on behalf of your hospital or GPO. You’ve undoubtedly been asked to request each Form 483 and decipher the unnecessarily complex jargon of the FDA. Mosaic by design, it is extremely important that you know how to properly interpret an FDA Form 483. According…