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503a Facilities

Meaning

503a Facilities are traditional compounding pharmacies that prepare patient-specific medications pursuant to a valid prescription, operating under the regulatory oversight of state boards of pharmacy. These facilities specialize in customizing hormonal formulations, such as bioidentical hormone replacement therapy, when a commercially available drug product does not meet an individual patient’s unique physiological needs. They must adhere to specific quality standards, primarily those outlined by the United States Pharmacopeia, and are distinct from larger-scale outsourcing facilities. The primary function is to provide personalized, non-commercial therapeutic solutions tailored to the prescriber’s specifications.