Permits and Registrations Requirements and Permit Information
Correctly completed applications for new permits must be received in the Board of Pharmacy office at least 45 days before the opening date of the facility. An on-site inspection is required before a permit will be issued.
A Pharmacy Permit is required for any facility located in South Carolina that dispenses drugs requiring a prescription or order from a practitioner licensed to prescribe drugs. A permit holder and a pharmacist-in-charge must be designated on every pharmacy permit application.
A Non-Dispensing Drug Outlet Permit is required for any facility located in South Carolina that administers and/or stores legend drugs. Facilities requiring a Non- Dispensing Drug Outlet Permit include, but are not limited to clinics. A Non-Dispensing Drug Outlet Permit requires a consultant pharmacist.
A Federally-Qualified Health Center (FQHC) Drug Outlet Permit is required for FQHC delivery sites to store, administer and distribute patient-specific labeled medications received from a permitted FQHC pharmacy or contracted pharmacy. This permit requires a consultant pharmacist.
A Medical Gases/Legend Devices Permit allows a facility to dispense to a patient, or a patient's agent, medical gases and/or legend devices on the order of a licensed practitioner. This permit requires a consultant who is a SC-licensed Practitioner, respiratory therapist, registered nurse, or pharmacist to be responsible and accountable for duties of the Consultant Pharmacist as provided in section 40-43-86 (C).
An EMS Non-Dispensing Drug Outlet Permit is required for EMS, First Responders and Medical Transport companies storing and administering oxygen and legend drugs to patients.
An Outsourcing Facility Permit is required for 503B outsourcing facilities registered with the FDA. The facility must also have either a current Pharmacy permit or a Non- dispensing Drug Outlet permit.
A Wholesale Distributor Permit is required for a facility to engage in the wholesale distribution of prescription drugs and/or devices to permitted facilities and licensed practitioners. Entities requiring a Wholesale Distributor Permit include, but are not limited to: repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.
A Manufacturer/Repackager Permit is required for a facility to engage in the manufacturing of prescription drugs or devices, including any packaging or repackaging of the drugs and/or devices and/or labeling or re-labeling of containers.
Narcotic Treatment Program Satellite
A Narcotic Treatment Program is required fa narcotic treatment facility to store, administer and dispense legend drugs.
A Narcotic Treatment Program is required fa narcotic treatment facility to store, administer and dispense legend drugs.
A Central Fill Permit is required for a facility to engage in the business of central filling prescriptions and to engage in the sale, distribution, or dispensing of legend drugs or devices.
A Third-Party Logistics Provider Permit is required for a facility to provide or otherwise coordinate warehousing, or other logistics services, of drugs and/or devices in interstate commerce on behalf of a manufacturer, wholesale distributor or dispenser of drugs and/or devices. A 3PL Provider does not take ownership of the drugs and/or devices and is not responsible for the sale and/or distribution of the drugs and/or devices to permitted facilities and/or licensed practitioners.
A Health System Non-Dispensing Drug Outlet Permit is required for a hospital owned health system, which stores and administers legend drugs and or devices, to operate multiple facilities.
A Non-Resident Pharmacy Permit authorizes facilities outside of this State to dispense legend drugs and/or devices in this State. The pharmacist-in-charge does not have to be licensed in South Carolina. A South Carolina Controlled Substance Registration with South Carolina Department of Health and Environmental Control or DHEC-Bureau of Drug Control, is required to distribute controlled substances into the state. For additional information, please visit the controlled substance section at the end of this page.
A Non-Resident Wholesale/Distributor Permit is required for all wholesalers, distributors, manufacturers, and repackagers of legend drugs and/or devices. A South Carolina Controlled Substance Registration with South Carolina Department of Health and Environmental Control or DHEC-Bureau of Drug Control is required to distribute or take possession of controlled substances. For additional information, please visit the controlled substance section at the end of this page.
A Non-Resident Manufacturer/Repackager Permit is required for a facility to engage in the manufacturing of prescription drugs or devices, including any packaging or repackaging of the drugs and/or devices and/or labeling or re-labeling of containers. A Non-Resident Central Fill Permit is required for a facility to engage in the business of central filling prescriptions and to engage in the sale, distribution, or dispensing of legend drugs or devices in this State.
A Non-Resident Central Fill Permit is required for a facility to engage in the business of central filling prescriptions and to engage in the sale, distribution, or dispensing of legend drugs or devices in this State.
A Non-Resident Virtual Manufacturer Permit is required for a facility located outside the geographic boundaries of South Carolina must obtain a Non-Resident Manufacturer/Repackager Permit as a Virtual Manufacturers for any company that sells their own legend drug products and/or medical devices but outsources the manufacturing (uses contract manufactures) and distribution operations.
A Non-Resident Virtual Wholesale Permit is required for a facility located outside the geographic boundaries of South Carolina must obtain a Non-Resident Wholesale Distributor Permit as a Virtual Wholesale/Distributors when the business entity arranges for the distribution of a legend drug or device, without taking actual possession of the legend drug or device, and contracts with others for the distribution, purchase and sale. The facility will use other wholesalers or 3PL's to distribute the product(s).
A Non-Resident Medical Gas/Legend Device Permit is required to dispense to a patient, or a patient's agent, medical gases and legend devices (DME) on the order of a licensed practitioner.
A Non-Resident Third Party Logistics Provider Permit is required for any entity that distributes, but does not take ownership nor have responsibility to direct the sale or disposition of legend drugs and/or devices on behalf of outsourcing facilities, manufacturers and/or wholesale distributors.
A Non-Resident Outsourcing Facility Permit is required for 503B outsourcing facilities registered with the FDA to distribute into this State. The facility must also have a current South Carolina Non-resident Pharmacy permit or a Non-resident Wholesale/Distributor/Manufacturer permit.
A Non-Resident Non-Dispensing Pharmacy Permit is required for remote medication order processing. The facility must be in compliance with South Carolina Board of Pharmacy's Policies and Procedures 147. The Pharmacist-In-Charge of the facility must be a South Carolina licensed Pharmacist.
Anything regarding controlled substances is regulated by the South Carolina Department of Health and Environmental Control or DHEC-Bureau of Drug Control. (803) 896-0636
- All applications submitted to the Board will expire after one year.
- For any application, the listed Pharmacist-In-Charge may not currently be serving as Pharmacist-In-Charge at another facility without prior authorization from the Board.
- Facilities/entities owned 100% by a South Carolina licensed Practitioner do not require a Board of Pharmacy permit. If that facility/entity is not owned 100% by a South Carolina licensed Practitioner, they are required to have a Non-Dispensing Drug Outlet permit to be able to store and administer legend drugs and/or devices. Facilities not owned 100% by a South Carolina licensed Practitioner cannot dispense, only store and administer.
- Processing time for a non-resident applications are 3-6 months.
- Regulation 99-43(G)(3)(b) requires the Pharmacist-In-Charge and/or the Permit Holder to appear before the Non-Resident Application Review Committee to answer questions about all aspects of the applicant's operations. This appearance shall be in lieu of an in-person inspection of the applicant's facility and is designed to provide the Board with information that would typically be obtained during an in-person inspection. Applicants will be notified by email of the time and date of the meeting for which they are scheduled. All requested information and emailed confirmation are required prior to the meeting date.
- During the meeting the appropriate individual(s) will be asked questions regarding their submitted application and supporting documents as well as questions pertaining to the day to day business. Most questions asked are similar to common inspection questions.
- The Non-Resident Non-Dispensing Pharmacy permit is the only permit that requires the Pharmacist-In-Charge to be a South Carolina licensed Pharmacist.
- All applications submitted to the Board have a one year expiration date before the applications are withdrawn. At that time the facility would need to re-apply.
- The Board requires that an operational inspection conducted within the last two years be submitted as part of the application. Opening inspections are not considered operational.