Manufacturing Crucial Medications

Supporting Healthcare, Managing COVID-19

As vaccines begin distribution, 503B outsourcing facilities are still a ‘must-have’ resource for hospitals and ambulatory surgery centers in the midst of America’s current healthcare pandemic and beyond. As hospitals and front-line workers continue to navigate case influx, socially distancing and mask adherence, the patient experience continues to evolve. Ambulatory surgery centers are wading through state go no-go restrictions on elective surgeries, new regulations, and potential testing bottlenecks, all while balancing continued need for their services.

Labor shortages and increased demand on medications to fight COVID-19 have necessitated hospital pharmacies and surgery centers to seek outside assistance for drugs necessary to support viable patient treatment options for the critically ill.

According to The Bureau of Investigative Journalism, when drugs are in short supply, doctors must rely on alternatives that may be unfamiliar or have greater side-effects. They may also be forced to adopt measures that potentially increase the risk to certain patients in order to conserve medication for others [1]. Instead of relying on internal pharmacy compounding, 503B outsourcing may be a more efficient and safer alternative to support demand.

Supply Chain Strain

As the corona virus has permeated the country, the FDA diligently monitors medical supply chains for disruptions and shortages that could have a catastrophic effect on patient care. However, major distributors of active pharmaceutical ingredients such as China and India, have experienced slowdowns in manufacturing because of a reduced workforce.

As restrictions are lifted with new safety precautions being standardized and more elective-surgeries are scheduled, ambulatory surgery centers and physician offices continue to experience demand. A 503B outsourcing facility is a practical means to supply high-quality critical medications when a hospital is unable to do so and may have other benefits.

503B Outsourcing You Can Rely On

Fagron Sterile Services US (FSS), an FDA and DEA registered 503B, continues to expand their Operating Room (O.R.) Anesthesia portfolio to support healthcare customers across the country. This includes the addition of a new IV Bag platform in 2021.

FSS was able to move quickly and respond at the onset of COVID-19 with multiple medications used in the battle against this highly contagious virus. Many of these products have since been listed on drug shortage lists by the American Society of Health-System Pharmacists (ASHP) and the Food and Drug Administration.

• fentaNYL
• Midazolam
• HYDROmorphone
• Rocuronium
• Ketamine
• Morphine
• Lidocaine
• Ropivacaine

FSS continues to deliver industry leading turnaround times of high-quality sterile medications to hospitals, ambulatory surgery centers, clinics, and physician offices. To ensure top-tier service, FSS took supply chain precautions regarding COVID-19 and performed risk assessments of its products and the raw materials.

To date, there have not been any significant disruptions to the availability of FSS products and services. View a full product catalog and learn more about FSS independent aseptic processing environments, industry leading automation, advanced environmental monitoring and in-house laboratory testing.

FSS integrates state-of-the-art quality to provide a reliable supply of 503B outsourcing to clinicians and the patients they serve across the United States. All FSS manufacturing facilities are registered and inspected by the FDA and DEA.

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Source:

[1] Davies, Madlen, et al. “Drug Shortages Put Worst-Hit Covid-19 Patients at Risk.” The Bureau of Investigative Journalism, The Bureau of Investigative Journalism, 17 Apr. 2020, Source Link.