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During the pandemic, demand for certain medications skyrocketed, including analgesics which increased by 104%. Hospitals needed compounded medications to meet this spike in demand, and 503B outsourcing facilities were able to help.
Healthcare organizations should expect the contractor to allow unannounced inspections of the pharmacy and compounding facility, provided that they do not interfere with daily operations or compromise the state of microbial control.
A 503B compounding pharmacy is a manufacturing facility that produces large batches of compounded medications without patient-specific prescriptions. These facilities sell and directly distribute ready-to-use sterile medication to healthcare facilities like hospitals and ambulatory surgery centers. They are held to higher standards of regulatory compliance by the FDA and state boards of pharmacy than in-hospital pharmacies.
According to Coherent Market Insights, the U.S 503B compounding pharmacies market is estimated to be valued at US$ 985.6 million in 2022 and is expected to exhibit a CAGR of 7.6 % over the forecast period (2022-2030) They produce sterile drugs in compliance with United States Pharmacopeia (USP) chapters and National Formulary monographs, as well as cGMP. The USP and cGMP regulations guarantee that these compounded drugs are of high quality and have the proper drug strength.
In times of drug shortages, 503B facilities such as QuVa Pharma can help boost productivity and create resiliency in the hospital supply chain by creating injectable medications such as anesthetics/pain medication, sedatives, and other IV preparations.
Compounding is a practice that can benefit patients in many ways, including addressing their unique needs that may not be met by FDA-approved medications. Compounding can transform an ineffective pill into a liquid that is easier for elderly patients to swallow or mask the taste of medication to make it more appealing to pediatric patients.
However, this specialized form of drug manufacturing must adhere to strict standards set by the FDA and state boards of pharmacy. This includes compliance with United States Pharmacopeia chapters and the National Formulary monograph to ensure drug safety and purity.
Depending on the healthcare organization, outsourcing their sterile preparations to a 503B compounding pharmacy or U.S 503B compounding pharmacies facility can reduce costs and allow them to reallocate staff resources to other priorities. It can eliminate the need to hire staff for hard-to-fill pharmacy positions, thus lowering costs and increasing productivity. Also, it can reduce the time that a health system would need to spend on training new pharmacy staff.
Compounding pharmacies are vital to the drug supply chain. They provide a way to customize medications by mixing or otherwise altering ingredients, providing an alternative to commercially available drugs that aren’t right for all patients.
While shopping for compounding pharmacies, it is important to know that most compounded medications are safe, since a licensed pharmacist or physician supervises the combining and ingredient-altering processes.
Hospitals facing medication shortages and staffing shortages need a trusted compounding partner with scale, capacity, redundancy, and compliance expertise. A national 503B outsourcing facility with pharmaceutical manufacturing and cGMP experience can be the solution to these problems.
Unlike traditional pharmacy compounding, which is patient-specific, 503B outsourcing facilities can produce large batches of sterile medications with or without a prescription. These products are then procured by healthcare facilities and ambulatory surgery centers for office use. The FDA requires that these facilities follow stringent rules and regulations, known as current good manufacturing practices, to guarantee the safety and quality of their compounding processes. FDA personnel regularly inspect these facilities to ensure compliance.
financials, but also their quality metrics.” He discussed how a mature Quality Culture can support a high level of operational efficiency and cost savings at Fagron Sterile Services US and other sites. He also noted that a strong correlation exists between quality maturity attributes and Quality Behavior Attributes, which are the key to driving success at an outsourcing facility.
