South Carolina Board of Pharmacy

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Permits and Registrations Requirements and Permit Information

IN-STATE PERMITS

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, wholesalers, manufacturers, and distributors. A Non-Dispensing Drug Outlet Permit requires a consultant pharmacist, unless the facility is engaged in manufacturing, wholesaling, or distributing.

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.

OUT-OF-STATE PERMITS

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/Manufacturer 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 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.

OWNERSHIP, NAME AND LOCATION CHANGES

Change of Ownership: A new application and organization chart (pre & post changes) must be submitted for a change in ownership of 50% or more. A less than 50% change requires written notification of the date of the transaction, the name(s), and percentage of change in ownership of the new owner(s).

Name Change: A Change of name for a facility requires a new application and application fee. The change or addition of a doing business as (dba) name requires a written request to change or add a dba name.

Change of Location:

Change of City: A change in location from one city to another requires a new application and application fee.

Same City: If relocating within the same city, a Relocation Application fee is required. In-state permits which are relocation within the same city will be inspected after the relocation.

CONTROLLED SUBSTANCE REGISTRATION

Controlled Substances: All in-state and out-of-state facilities that dispense or distribute controlled substances into the state of South Carolina must obtain a S.C. Controlled Substances Registration from the SCDHEC Bureau of Drug Control and a Federal DEA Registration. For in-state applicants, neither the S.C. Controlled Substances Registration nor the Federal DEA Registration will be issued until after the correct Board of Pharmacy permit has been issued; however, you may submit all of the applications to the respective agencies at the same time, indicating that the State permit number is pending.

The application for controlled substance registration is on the S.C. Department of Health and Environmental Control website: https://scdhec.gov/health-regulation/drug-control-register-verify/new-registrations

Prescription Monitoring Program: All SC-permitted pharmacies must also register with SCDHEC-Bureau of Drug Control Prescription Monitoring Program. If you do not dispense controlled substances, you must request an exemption from PMP reporting requirements. Contact PMP at scripts@dhec.sc.gov or (803) 896-0688.

ADDITIONAL INFORMATION

IN-STATE
  • 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.
  • 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.
  • 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

    https://scdhec.gov/health-regulation/drug-control-register-verify/drug-control-related-topics

NON-RESIDENT
  • Processing time for a non-resident applications are 3-6 months.
  • The Pharmacist-In-Charge or the Permit Holder must attend an Application Review Committee meeting in person, at the Board's office. 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.