The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, 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 503B.
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.
503A is patient-specific compounding, where product is made exclusively for one patient on a one-time basis. Generally, products compounded under the 503A umbrella have shorter shelf lives, as they are for immediate administration or use.
Signed into law November 21, 1997 by the Food, Drug and Cosmetic Act, Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FD&C Act requiring FDA approval prior to marketing (section 505), compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)), and labeling with adequate directions for use (section 502(f)(1)) States primarily regulate pharmacies that qualify for the exemptions
Compounding must be performed by a licensed pharmacist in a licensed pharmacy or Federal facility, or by licensed physician. Patient-specific anticipatory compounding is permitted in limited quantities. All requirements for bulk drug substances used to compound must be in place.
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