Skip to main content

503b Facilities

Meaning

These facilities refer to outsourcing facilities operating under Section 503(b) of the Federal Food, Drug, and Cosmetic Act, which produce sterile drug products for office-use compounding or for distribution to licensed practitioners. In hormonal health, these sites often prepare custom sterile injectable or compounded hormone preparations when commercial availability is limited or specific dosing adjustments are clinically necessary. Understanding their compliance status is crucial for ensuring product integrity and patient safety when administering specialized endocrine treatments.