Published by Coherent Market Insights
Posted on September 22, 2021
4 min readLast updated: February 3, 2026
The U.S. 503B compounding pharmacies market is projected to reach $1,508.1 million by 2028, driven by FDA guidelines and COVID-19 impacts.
In the U.S. 503B compounding pharmacies market, conventional compounding pharmacies operate without the supervision of the U.S. Food and Drug Administration (FDA). The State Boards of Pharmacy regulate the conventional compounding, also known as ‘within border’ compounding. The U.S. Pharmacopeia (USP) has set the standard pharmacy compounding practices in most U.S. states. Compounding pharmacies operate in five formats: independent stores, compounding departments in hospital, part of a big retail drug manufacturer chain, store with an online order-delivery system, and multiple-location shops. In the U.S., compounding pharmacies are majorly found in independent store format.
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Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19, as pandemic on March 11, 2020.
According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 169,604,858 cases and 3,530,837 deaths due to coronavirus disease (COVID-19) were reported till May 30, 2021, across the globe.
Impact of COVID-19 on Demand and Supply of U.S 503B Compounding Drugs
The coronavirus (COVID 19) pandemic and lockdown in various countries across the globe have impacted the financial status of businesses in all sectors. Private healthcare sector is one of the main sector that has been majorly impacted by the COVID 19 pandemic. For instance, on April 16, 2020, the U.S. Food and Drug Administration (FDA) issued the guidance document ‘Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities during the COVID-19 Public Health Emergency’. During the pandemic, the U.S. FDA received reports from hospitals regarding difficulties in obtaining FDA-approved drugs due to increased demand and supply chain interruptions. Some of the drugs such as Ketamine hydrochloride and Lorazepam are already on the U.S. FDA drug shortage list. Therefore, in order to meet the increasing demand for drugs for the treatment of patients on ventilator support, during COVID-19 pandemic, the U.S. FDA allowed registered outsourcing facilities to compound 13 commonly used hospital drugs.
Moreover, the U.S. FDA also released guidelines in which the FDA will not take action against outsourcing facilities. These guidelines include conditions such as outsourcing facilities manufacturing compounding drug that is essentially a copy of an approved drug. Thus, increase in the preference of outsourcing facilities by the U.S. FDA for the manufacture of drugs that are currently in shortage is expected to drive the U.S. 503B compounding pharmacies market growth over the forecast period.
Furthermore, key players are indulged in inorganic activities such as partnerships. They are also engaged in launching new products in order to overcome the drug shortages during the COVID-19 pandemic. This is expected to drive growth of the market over the forecast period. For instance, in July, 2020, Piramal Critical Care (PCC), a company headquartered in India, entered into a strategic partnership with Medivant Healthcare, a U.S. based pharmaceutical outsourcing facility, for addressing severe shortage of injectable drugs in hospitals across the U.S. The focus of the companies is mainly on the distribution of single–dose injectable drugs in all the U.S. approved states that have a severe shortage in the supply of drugs for the treatment of COVID-19 patients.
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Key Players In U.S. 503B Compounding Pharmacies Market
The “Global U.S. 503B Compounding Pharmacies Market” study report will provide a valuable insight with an emphasis on the global market. The major players in the market are Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, LLC, IntegraDose Compounding services, LLC, Wells Pharma of Houston, LLC, US Compounding Inc., and SCA Pharma
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The post U.S. 503B Compounding Pharmacies Market To Hit US$ 1,508.1 Million by 2028 At a CAGR of 7.3% during the forecast period (2021-2028) appeared first on Gatorledger.
The article discusses the growth and impact of the U.S. 503B compounding pharmacies market, projected to reach $1,508.1 million by 2028.
COVID-19 led to increased demand for compounding pharmacies due to drug shortages and FDA guidelines for outsourcing facilities.
Outsourcing facilities help address drug shortages by compounding essential hospital drugs, as permitted by the FDA during the pandemic.
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