Agency Profile

503B Compounding Pharmacy

503B Compounding Pharmacy, United States

Overview

Description: 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy serves hospitals, surgery centers, clinics, and licensed healthcare providers by delivering compliant, scalable compounded pharmaceuticals without patient-specific prescriptions. Operating under cGMP standards and subject to FDA inspection, the facility focuses on batch consistency, sterility assurance, regulatory compliance, and supply chain reliability.

Sponsorship in October 2026



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