US 503 Compounding Pharmacies Market Survey | TMR Research Detailed Study Analysis

In recent years, the drug-compounding industry has embraced United States laws, mandates, and regulatory requirements to ensure reliable, safe, and cost-effective medications to physicians and their patients. The Food and Drug Administration (FDA) has mandated two designations for pharmaceutical compounders that serve to balance patient-specific needs with the increasing demand for high-quality compounded drugs. These specialized entities are categorized as either 503A compounding pharmacies or 503B outsourcing facilities. This article provides a review of important similarities and differences; which will allow hospital systems, ambulatory care centers, and other healthcare organizations to make informed decisions in the interest of patient safety, medication effectiveness, and consumer satisfaction.

503A pharmacies are more closely related to what might be considered "traditional compounding pharmacies." They provide medications to fill individual patient-specific prescriptions. They are designated by the FDA for home use. Under Section 503A, only very limited amounts of batch drugs can be produced.

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It is important to note that preparations in 503A pharmacies, because they are customized, cannot be produced in large batches. This makes the medication more expensive. Ultimately, this cost is passed on to the patient, at times making much-needed medications cost-prohibitive.

US 503 Compounding Pharmacies Market – Notable Developments

Some of the key developments in the 503 compounding pharmacies market are given below:

  • In 2018, Letco Medical, L.L.C., a supplier of quality compounding pharmacy products, entered into exclusive partnership with Sweetgrass GxP, a company indulged in providing regulatory services for compounding pharmacies. Under the partnership, Letco Medical, L.L.C. announced the launch of Letco’s Regulatory Solutions Program, which addresses the critical compliance needs of compounding pharmacies.
  • In May 2020, Central Admixture Pharmacy Services, Inc. launched three new compounded sterile preparations for the ICU patients, which are short in supply.

US 503 Compounding Pharmacies Market – Drivers and Restraints

There are multiple factors that are helping the overall development of the global 503 compounding pharmacies market. One of the key driving factors for the growth of the global market is the increased drug shortages. The US Food and Drug Administration (FDA) defines shortage of drugs as a period when there is a high demand for the drug which exceeds its supply. There might be several different reasons for such drug shortage such as production delays, manufacturing issues, or issues surrounding the procuring raw materials for the product manufacturing among others. Such cases are expected to help the overall development of 503 compounding pharmacies market. Moreover, increasing number of product launches and approvals is expected to aid in the growth of the market over the forecast period.

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Growth of the U.S. 503B compounding pharmacies market may be hampered, owing to the increasing product recalls, and safety concerns associated with U.S 503B compounding drugs. The U.S. Food and Drug Administration (FDA) classified the contamination as Class II contamination i.e., the affected injections may cause medically reversible and adverse health consequences. Furthermore, the cost of the medicines and absence of reimbursement services are expected to hamper the growth of the market over the forecast period. Depending upon the product to be manufactured, the operating cost may be higher than the manufacturing cost of certain drugs, thus, making them costly as compared to the approved drugs available in the market.

US 503 Compounding Pharmacies Market – Geographical Outlook

Based on the regional segmentation, the US 503 compounding pharmacies market is spread across the regional segment of North America. The growth of the regional segment can be attributed to the presence of a highly developed and matured healthcare infrastructure. In addition to this, presence of key players operating in the region has also helped the overall development of global 503 compounding pharmacies market in the US.

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