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503(b) compounding facility
OUr Mission
The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503(B) in the FDCA. Under section 503(B), a compounder can become an “outsourcing facility.”
The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503(B).
Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (cGMP) requirements.