If a compounder chooses not to register as an outsourcing facility and
qualify for the exemptions under section 503B, the compounder could qualify for
the exemptions under section 503A of the FDCA. Otherwise, it would be subject to
all of the requirements in the FDCA applicable to conventional manufacturers.
FDA anticipates that state boards of pharmacy will continue their oversight and
regulation of the practice of pharmacy, including traditional pharmacy
compounding. The Agency also intends to continue to cooperate with State
authorities to address pharmacy compounding activities that may be violative of
the FDCA.
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