On January 27, 2022, the FDA announced its decision to not include Glycopyrrolate on the 503B bulks list. Following this announcement, outsourcing facilities will not be permitted to compound the drug-using bulk API, unless the product appears in the future on the FDA’s drug shortage list. Glycopyrrolate is not currently on the drug shortage list.…
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…
SCA Pharma, an FDA-registered outsourcing facility, plans to expand its sterile pharmaceutical manufacturing facility in Windsor, CT, by 40 percent. SCA Pharma has experienced continued growth during the past five years and has emerged as a leading manufacturer of compounded pharmaceuticals. The company continually seeks new opportunities to meet customer and patient needs, and creating…
Matt White is the general manager of our Little Rock site and vice president of operations. He’s also a pharmacist. In the video below, Matt discusses the effects of the pandemic on our operations and workforce, and what SCA Pharma is doing to meet challenges head-on. Click here to watch the video. You can download…
Racheal Adams is director of corporate quality at SCA Pharma as well as a pharmacist herself. In the video below, she discusses how SCA Pharma has worked with regulatory agencies not only to minimize disruptions but to maintain a focus on quality and patient care. Click here to watch the video. You can download our…
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…
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…