Home Pharmacy practice As COVID-19 continues to rise, turn to 503Bs for help

As COVID-19 continues to rise, turn to 503Bs for help


The 503B outsourcing facilities are proving to be critical partners with the healthcare system and hospital pharmacies to help alleviate drug shortages and the impact on patients during the COVID-19 Delta variant outbreak this summer. The Medicines Quality and Safety Law, passed in 2013, authorized 503B’s outsourcing facilities to prepare certain non-sterile and sterile pharmaceutical products in anticipation of supplier needs.1 and based on meeting certain standards required by the FDA. With massive spikes in demand for critical care drugs due to the Delta variant, 503B facilities can supplement hospitals when commercial manufacturers cannot supply.

“Preparing sterile products is a complex business,” said Brian Swift, PharmD, MBA, director of pharmacy, corporate vice president and associate dean of professional affairs at Jefferson College of Pharmacy, Thomas Jefferson Teaching Hospitals in Philadelphia, Pennsylvania. “The 503B prep facilities play a critical role in how we think and execute our pharmacy strategy, especially during the pandemic. “

Here are the 5 reasons to consider a 503B composition partner:

  1. Capacity and expertise
  2. Critical staffing levels
  3. High-risk or specialized composition
  4. Elasticity
  5. Supply and demand of materials

Many 503B facilities have made significant investments in their operations, creating both expertise and operational capacity to support hundreds of hospitals and physician practice sites across the country. These 503B organizations are highly automated and have redundant systems to generate the high quality, repeatable products that we rely on as suppliers. Their product offerings have standardized over time, resulting in more profitable large-scale production, which brings substantial benefits to a hospital pharmacy.

As demand for COVID-19 continues, these same 503B facilities can leverage their scale and relationships with suppliers of active pharmaceutical ingredients and finished products to generate much-needed doses of essential drugs, such as fentanyl, midazolam and certain neuromuscular blockers. urgently needed by providers in the intensive care unit.

This “just-in-time” inventory approach can help increase drug volumes to weather times of supply shortages when traditional drug manufacturers and distributors are unable to keep pace.

Preparing drugs such as concentrated intrathecal narcotic bags or handling unsterile raw materials into a sterilized end product takes time and money. The 503Bs can take the heavy burden off of compounding high-risk drugs at a lower cost than many hospitals can achieve. Working with a 503B facility on high risk drugs also minimizes downstream risk for patients who need them.

With the pressure on virtually every hospital staff member during the Delta wave, including pharmacy workers helping with COVID-19 vaccinations and recall requests, 503B partners can quickly help by offloading the volume of product. waste rock compounds routinely at their off-site location. We are seeing a particular shortage of well-trained pharmacy technicians, so moving some of the work off the hospital campus may make sense for pharmacy executives. Most 503B facilities work closely with hospital management to coordinate delivery to various facilities as needed. This removes some of the predictable workload from the hospital pharmacy cleanroom, allowing staff members to focus on the most urgent tasks.

As the Prime Minister noted in early 2020, having a multifactorial approach to tackling drug shortages, during and outside of a pandemic, is essential to providing high-quality patient care.2 The entire US drug supply chain, and hospitals in particular, must become more resilient to cope with this peak phase of the pandemic and drive healthcare transformation for the future.

503Bs can play an important role in improving the resilience of the pharmacy supply chain, but hospitals need to choose their 503B facilities wisely. Leveraging multiple 503B partners, for example, not only avoids putting all your eggs in one basket, but also helps competing vendors improve quality while lowering costs. The diversity and strong relationships with 503B partners ultimately benefit patients.

An important aspect when choosing to work with a 503B outsourcing facility is to have a robust screening process to ensure that the highest standards are met. For 503Bs that do not pass a rigorous inspection or review, these facilities must either invest properly to meet industry standards or exit the market; There is no third option. Health system pharmacy executives expect 503B partners to put in place the appropriate controls and procedures to produce the highest quality end products.

Integrating a 503B facility into pharmacy supply chain strategy has become a key component for hospitals during the global pandemic, and this trend will continue. The ability of a 503B to quickly deliver life-saving medicines can help address market imbalances at any point in time, including one-time, regional, and emergency-related shortages, and build additional resilience for the future.

Mike Wascovitch, PharmD, MBA, RPh, is Vice President of Field Pharmacy Services at Premier, Inc, in Charlotte, NC.


1. Information for outsourcing facilities. FDA. Updated September 10, 2020. Accessed August 31, 2021. https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities

2. Premier Inc. data shows essential drugs for the care of patients with COVID-19 are rapidly sliding into a shortage. Press release. Premier Inc. March 31, 2021. Accessed August 31, 2021. https://www.premierinc.com/newsroom/press-releases/premier-inc-data-shows-drugs-essentialto-providing-care-for-covid- 19 -patients-slide-quickly-in-shortage


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