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 SC Board of Pharmacy webpage. 

Is your business operating in a compliant manner? Let LicenseLogix check your blind spots before the authorities do. Contact your account manager or get a free quote today!