Earlier this year, South Carolina enacted legislation requiring 503b Outsourcing Facilities to hold both an Outsourcing Facility License AND either a ManufacturerLicense or a Pharmacy License (depending on business activity). SC law now states:
An Outsourcing Facility permit is required if a facility compounds:
* sterile drugs without a prescription or
* sterile and non-sterile drugs without a prescription
and is registered with the FDA as a 503B Outsourcing Facility.
The outsourcing facility must also hold a current S.C. Pharmacy permit or current S.C. Non-dispensing Drug Outlet permit as a manufacturer.
Additional information and applications available on the South Carolina Board of Pharmacy webpage.