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…
In the fast-paced healthcare environment, access to critical medications is essential for providing timely, effective patient care. Ensuring the right medications are on hand when needed can be a logistical challenge for hospital pharmacies. This is where a reliable 503B outsourcing facility offering a “Buy & Ship Now” option becomes invaluable. By allowing hospital pharmacies…
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…
This post is our third in a series of blogs looking at how hospitals make the difficult decision to compound their own drugs versus selecting an outsourcing partner. The decision involves a great deal more than a clean room and a vial of medication. A wide range of indirect costs are specifically related to risk…
Compounding in pharmacies is an important alternative for patients who require medication that is not commercially available. Compounding has become a vital need in healthcare with the state of drug shortages affecting hospitals and patients. The need for compounded medications is essential for patient care in the US healthcare system. Most hospital pharmacies depend on…
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…
Due to the important role of healthcare in maintaining the health of the general public in society, it is highly regulated with plenty of governmental oversight. The Pharmaceutical Research and Manufacturers of America have estimated that close to 3.6 billion prescriptions are dispensed each year in the United States. It is estimated that 30 to…
Please Note: The following article pertains to industry wide Inspections and is not representative of SCA Pharma. The healthcare industry is undeniably one of the most important sectors of the economy. Tasked with the responsibility of ensuring good health among the general public, the healthcare system has a vital role in ensuring the well-being of…
Utilizing an outsourcing organization helps meet the demands placed on hospitals and outpatient facilities to ensure patients receive their medications on time and as prescribed. By Brenden Roche, Senior Marketing Coordinator; SCA Pharmaceuticals Recent trends have shown the vast migration from inpatient facilities such as hospitals to outpatient facilities. In fact, there are now nearly…
503A vs. 503B: PHARMACY DESIGNATIONS & THEIR SIGNIFICANCE For a very long time, humans have battled with the ravages of the natural world in a multitude of ways. During the earliest eons of our existence, the only real way that people had to fight off illnesses was through their own immune systems. But this came…