Published by Coherent Market Insights
Posted on September 14, 2021
4 min readLast updated: February 10, 2026
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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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The major drivers of U.S. 503B compounding pharmacies market include the increasing drug shortage and rising geriatric population in the U.S. For instance, according to a report by the U.S. Food and Drug Administration (FDA): Drug Shortages: Root Causes and Potential Solutions 2019, 56% of hospitals reported they had changed patient care or delayed therapy in light of drug shortages and 36.6% hospitals said they had rescheduled non-urgent or emergent procedures. Such scenarios lead to the use of readily available compounded medications, which is expected to boost growth of the U.S. 503B compounding pharmacies market. Additionally, according to a 2018 U.S. Census Bureau report, geriatric population in the U.S. is expected to reach 78.0 million in 2035 compared to the population of 76.4 million of people under the age of 18. This is also expected to boost the U.S. 503B compounding pharmacies market growth.
Market players are focusing on launch of products, which is expected to strengthen their position in the U.S. 503B compounding pharmacies market. For instance, in 2018 Athenex, Inc. launched two products for the oncology supportive therapy in its 503B (outsourced sterile preparations): Epinephrine (2 mg and 4 mg) in 250 mL in 0.9% Sodium chloride and Norepinephrine (4 mg and 8 mg) in 250 mL in 0.9% Sodium chloride.
Market players are adopting strategies such as mergers and acquisitions to expand their product portfolio. For instance, on September 10, 2020, SCA Pharma signed an agreement with Kit Check, an automated and intelligent medication management solutions. This led to the addition of Kit Check’s embedded radio frequency identification (RFID) tag to all of its products, further ensuring the safety of 503B compounding drugs.
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Detailed Segmentation:
U.S. 503B compounding pharmacies Market Drugs Market, By Molecule:
U.S. 503B compounding pharmacies Market Drugs Market, By Packaging:
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Market players are focusing on facility expansion to grow their market presence in U.S. 503B compounding pharmacies market. For instance, in 2017, Nephron Pharmaceuticals Corporation expanded its facility in West Columbia in an area of 36,000 square feet, by investing US$ 12.5 million which is expected to boost the growth potential of 503B compounding pharmacies market.
Major players operating in the U.S. 503B compounding pharmacies market include 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 FAQ Promotes U.S. 503B Compounding Pharmacies Market to Overcome Widespread Effects of COVID-19 Pandemic appeared first on Gatorledger.
The major drivers include the increasing drug shortage and the rising geriatric population in the U.S.
Market players are adopting strategies such as mergers and acquisitions, as well as facility expansions to grow their market presence.
Market players are focusing on the launch of new products to strengthen their position, with examples including Athenex, Inc.'s product launches in 2018.
Major players include Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, and others.
Conventional compounding pharmacies operate without the supervision of the FDA, while 503B pharmacies are regulated to ensure safety and efficacy.
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