South Carolina Board of Pharmacy
Permits and Registrations Required
For Permit Renewal: A completed application with required fees must be submitted and postmarked before June 1. After June 1, a penalty of $50.00 will be assessed.
Permits not renewed by June 30 will be assessed $10.00 a day until the permit is reinstated, plus the $50.00 penalty fee, and the new application fee.
A permit holder who allows a site to operate with a lapsed permit is in violation of § 40-43-83.
Existing permits become lapsed on June 30.
A Pharmacy Permit is required for any outlet 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 outlet 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.
If the outlet possesses, dispenses or stores controlled substances in South Carolina, a South Carolina Controlled Substances Registration from the South Carolina Department of Health and Environmental Control, Division of Drug Control and a Federal DEA Registration must be obtained prior to engaging in such activity. Neither the State Controlled Substances Registration nor the Federal DEA Registration will be issued until after the State Pharmacy or Drug Outlet 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.
A Medical Gases/Legend Devices Permit allows a facility to dispense to a patient or to a patient's agent medical gases and legend devices on the order of a licensed practitioner. A Medical Gases/Legend Devices Permit allows a Medical Director, Respiratory Therapist, Registered Nurse, or Consultant Pharmacist to be responsible and accountable for duties of the Consultant Pharmacist as provided in section 40-43-86 (C).
A Non-Resident Pharmacy Permit authorizes facilities outside of this State whose primary business is filling mail order prescriptions to engage in the sale, distribution, or dispensing of legend drugs or devices in this State.
A Non-Resident Wholesale Distributor Permit is required for all wholesalers, distributors and brokers that wish to do business in this state.
New permits are required for any Change of Ownership, Change of Pharmacy Name, or Change of Location from one city to another. Permits are not transferable and each location requires its own permit. Correctly completed applications for new permits or changes to existing permits must be received in the Board of Pharmacy office at least 45 days before the opening date of the facility or effective date of a change. An on-site inspection is required before a permit will be issued.
Permit Holders that are relocating their facility within the same city are required to submit a Relocation Application to the Board of Pharmacy office at least 45 days before the relocation occurs.
For additional information concerning the State Controlled Substances Registration, please contact Dianna McLees at (803) 896-0636.
(A) A pharmacy, at a minimum, shall:
(1) be of sufficient size to allow for the safe and proper storage of prescription drugs and for the safe and proper compounding and preparation of prescription drug orders;
(2) maintain an area designated for the provision of patient counseling services. This area must be designed to provide a reasonable expectation of privacy;
(3) maintain on file current drug reference materials. The references should enable the user to find information using the brand name, generic name, pharmacologic group, therapeutic group and synonym.
(4) update drug monographs monthly, which include the following prescribing information: actions, indications, contradictions, warning and precautions, drug interactions, adverse reactions, patient information, overdosage, administration and dosage.
(5) update this product information monthly:
- products grouped by dosage or strength;
- identical brand name products;
- distributor name;
- package sizes for all dosage forms;
- product identification;
- whether prescription or nonprescription;
- controlled substance schedule;
- combination products comparison;
- products with identical formulations.
(6) update new development information monthly:
(a) significant recent drug therapy developments;
(b) information on investigational agents;
(c) recent new product information and product listing changes.
(7) maintain a copy of Equivalent Drug Product Evaluations;
(8) have a current copy of the South Carolina Pharmacy Practice Act, South Carolina Controlled Substances Act and Regulations, South Carolina Drug Act, and South Carolina Board of Pharmacy Newsletter;
(9) maintain patient-oriented reference material for guidance in proper drug usage;
(10) maintain storage areas at temperatures which shall ensure the integrity of the drugs prior to their dispensing as stipulated by the USP/NF and/or the Manufacturer's or distributor's labeling.
(11) have access to a sink with hot and cold running water that is in the compounding area.
(12) have a pharmacist who, while on duty, is responsible for the security of the pharmacy department including provision of effective control against theft or diversion of drugs or devices, or both.
(13) have secured its pharmacy by either a physical barrier with suitable locks or an electronic barrier, or both, to detect entry at a time the pharmacist is not present. The barrier must be approved by the Board of Pharmacy before being put into use.
(14) display, when the pharmacy department is closed or in the absence of the licensed pharmacist, a sign stating 'Pharmacy Department Closed, Pharmacist Not On Duty' displayed during the absence of the licensed pharmacist.
(15) carry, utilize, and maintain according to manufacturer's specifications the equipment and supplies necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws;
(16) maintain the area and equipment in which prescriptions are compounded and dispensed in a clean and orderly condition and:
- the prescription department must be kept dry and well ventilated, free from obnoxious odors, and equipped with adequate lighting facilities;
- drugs, pharmaceuticals, and chemicals must be arranged in a neat, orderly manner, free from dust, insects, rodents, or any type of contamination;
- all outdated, damaged, defaced, or unlabeled drugs, pharmaceuticals, biologicals, and chemicals must be removed from active stock;
- pharmaceuticals and biologicals requiring refrigeration must be kept stored in a refrigerator at the specified temperature;
- all stocks and materials used in the compounding of prescriptions must be labeled and conform in purity and strength as required by law;
- the prescription counter area upon which prescriptions are compounded must be used for no other purpose than for compounding prescriptions;
- the prescription department shall maintain only such instruments, equipment, materials, drugs, pharmaceuticals, biologicals, chemicals, and medicines as are necessary in the compounding and dispensing of prescriptions and pharmaceutical preparations;
- all instruments, articles, and containers used in the compounding and dispensing of prescriptions and pharmaceutical preparations must be clean and free form all foreign substances;
- the sink, with hot water connection, of the prescription department must be used for no other purpose than for cleaning of instruments and materials used in the compounding and dispensing of prescriptions and medicines, or the cleansing of the hands of those preparing and compounding;
- all pharmacists, before compounding prescriptions, and supportive personnel assisting pharmacists, shall thoroughly cleanse their fingernails and wash their hands;
- the storing of drugs, medicines, pharmaceuticals, or consumable materials used in compounding and dispensing prescriptions and pharmaceutical preparations in the washroom or toilet of a pharmacy is prohibited.
(B) (1) No person may operate a pharmacy without a pharmacist-in-charge. The pharmacist-in-charge of a pharmacy must be designated in and sign the application for the pharmacy permit, and in each renewal thereof. A pharmacist may not serve as pharmacist-in-charge unless he is physically present in the pharmacy a sufficient amount of time to provide supervision and control. A pharmacist may not serve as pharmacist-in-charge for more than one pharmacy at any one time without written permission from the board.
(2) Each institutional pharmacy shall be directed by a pharmacist, hereinafter referred to as the pharmacist-in-charge who is licensed to engage in the practice of pharmacy in this State.
(3) The pharmacist-in-charge shall have the following responsibilities:
- establishing or implementing, or both, written policies and procedures for the provision of pharmacy services;
- assuring that all pharmacists, technicians, and interns employed at the pharmacy are currently licensed, certified, or registered and that interns and technicians wear proper identification while on duty;
(c) notifying the Board of Pharmacy immediately of any of the following changes:
- change of employment or responsibility as the pharmacist-in-charge;
- change of ownership of the pharmacy;
- change of address of the pharmacy; or
- permanent closing of the pharmacy.
(d) making or filing any reports required by state or federal laws and regulations;
(e) responding to the Board of Pharmacy regarding any violations brought to the pharmacist-in-charge's attention.
(4) The pharmacist-in-charge must be assisted by a sufficient number of licensed pharmacists and registered pharmacy technicians as may be required to competently and safely provide pharmacy services.
- The pharmacist-in-charge shall maintain and file with the Board of Pharmacy, on a form provided by the board, a current list of all pharmacy technicians assisting in the provision of pharmacy services.
(b) The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum, specify that pharmacy technicians are to be personally supervised by a licensed pharmacist who has the ability to control and who is responsible for the activities of pharmacy technicians, and that pharmacy technicians are not assigned duties that may be performed only by a licensed pharmacist. One pharmacist may not supervise more than two pharmacy technicians at a time; however, the number of pharmacy technicians does not include personnel in the prescription area performing only clerical functions including data entry up to the point of dispensing as defined in Section 40-43-30(14).
(c) For the purpose of dispensing by institutional pharmacies to institutional facility in-patients the pharmacist to technician ratio may not exceed a one to three employment ratio. The allowable employment ratio for a site is determined by comparing the number of pharmacists employed at the site to the number of pharmacy technicians employed at the site. The day to day operational pharmacist to technician personal supervision ratio is to be determined by the pharmacist-in-charge.
Link to Forms and Applications