South Carolina 503b Outsourcing Facilities are now required to hold both an Outsourcing Facility License AND either a Manufacturer License or a Pharmacy License (depending on business activity).

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.

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