2015 South Carolina Code of Laws
Title 40 - Professions and Occupations
CHAPTER 43 - SOUTH CAROLINA PHARMACY PRACTICE ACT
Section 40-43-86. Facility requirements for pharmacies; presence of pharmacist-in-charge; consultant pharmacists; prescription drug orders; transferring of prescriptions; substitution of drugs; label requirements; patient records and counseling; policies and requirements for automated systems; unlawful practices; sales to optometrists and home medical equipment providers; code of ethics; sale of poisons and returned medications; permit fees; compounding regulations and restrictions.

(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 at least quarterly, 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 at least quarterly:

(a) products grouped by dosage or strength;

(b) identical brand name products;

(c) distributor name;

(d) package sizes for all dosage forms;

(e) product identification;

(f) whether prescription or nonprescription;

(g) controlled substance schedule;

(h) combination products comparison;

(i) products with identical formulations.

(6) update new development information at least quarterly:

(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 or equivalent reference;

(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, or a person authorized by the pharmacist on duty or the pharmacist-in-charge, 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:

(a) the prescription department must be kept dry and well ventilated, free from obnoxious odors, and equipped with adequate lighting facilities;

(b) drugs, pharmaceuticals, and chemicals must be arranged in a neat, orderly manner, free from dust, insects, rodents, or any type of contamination;

(c) all outdated, damaged, defaced, or unlabeled drugs, pharmaceuticals, biologicals, and chemicals must be removed from active stock;

(d) pharmaceuticals and biologicals requiring refrigeration must be kept stored in a refrigerator at the specified temperature;

(e) all stocks and materials used in the compounding of prescriptions must be labeled and conform in purity and strength as required by law;

(f) the prescription counter area upon which prescriptions are compounded must be used for no other purpose than for compounding prescriptions;

(g) 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;

(h) all instruments, articles, and containers used in the compounding and dispensing of prescriptions and pharmaceutical preparations must be clean and free from all foreign substances;

(i) 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;

(j) all pharmacists, before compounding prescriptions, and supportive personnel assisting pharmacists, shall thoroughly cleanse their fingernails and wash their hands;

(k) 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.

Subsection (B)(1) does not apply to a college or university athletic department pharmacy.

(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:

(a) 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;

(b) notifying the Board of Pharmacy immediately of any of the following changes:

(i) change of employment or responsibility as the pharmacist-in-charge;

(ii) change of ownership of the pharmacy;

(iii) change of address of the pharmacy; or

(iv) permanent closing of the pharmacy;

(c) making or filing any reports required by state or federal laws and regulations;

(d) 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.

(a) 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 three pharmacy technicians at a time; through June 30, 2006, at least one of these three technicians must be state-certified, and after June 30, 2006, at least two of these three technicians must be state-certified. If a pharmacist supervises only one or two pharmacy technicians, these technicians are not required to be state-certified. Pharmacy technicians do 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.

(5) The pharmacist-in-charge shall develop or implement, or both, a procedure for proper management of drug recalls which may include, where appropriate, contacting patients to whom the recalled drug products have been dispensed.

(6) The pharmacist-in-charge of an institutional pharmacy shall establish or implement, or both, written policies and procedures for provision of drugs to the medical staff and other authorized personnel whenever a licensed pharmacist is not physically present in an institutional facility by use of night cabinets and/or by access to the pharmacy. A licensed pharmacist must be on call at all times.

(a) In the absence of a pharmacist, only specifically authorized personnel shall have access by key or combination to the night cabinets. Such enclosures, which are to be located outside of the pharmacy, must be sufficiently secure to prevent access by unauthorized persons.

(b) The pharmacist-in-charge, in conjunction with the appropriate committee of the institutional facility, shall develop inventory listings of those drugs to be included in the cabinet and determine who may have access and ensure that:

(i) the drugs are properly labeled;

(ii) only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements;

(iii) whenever access to the cabinet occurs, written practitioner's orders and proofs of use are provided;

(iv) all drugs therein are inventoried no less than once a week;

(v) a complete audit of all activity concerning the cabinet is conducted no less than once a month; and

(vi) written policies and procedures are established to implement the requirements of this section.

(c) If a drug is not available from floor supplies or night cabinets, and the drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from the pharmacy only by authorized personnel. Removal of a drug from the pharmacy must be recorded on a suitable form showing patient name, room number, name of drug, strength, amount, date, time, and signature of authorized personnel. The form must be left with the container from which the drug was removed and must be reviewed by a licensed pharmacist within seventy-two hours.

(d) For an institutional facility that does not have an institutional pharmacy, drugs may be provided for use by authorized personnel in emergency kits located at the facility. The kits must meet the following requirements:

(i) emergency kit drugs must be those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining the drugs from the other sources;

(ii) all emergency kit drugs must be provided and sealed by a pharmacist;

(iii) the supplying pharmacist and the medical staff of the institutional facility shall jointly determine the drugs, by identity and quantity, to be included in emergency kits;

(iv) emergency kits must be stored in secured areas to prevent unauthorized access, and to ensure a proper environment for preservation of the drugs within them;

(v) the exterior of each emergency kit must be labeled to clearly indicate that it is an emergency drug kit for use in emergencies only. The label shall contain a listing of the drugs contained in the kit, including name, strength, and quantity of the contents, and the name, address, and telephone number of the supplying pharmacist;

(vi) drugs must be removed from emergency kits only pursuant to a valid medical order;

(vii) whenever an emergency kit is opened, the supplying pharmacist must be notified and the pharmacist shall restock and reseal the kit within a reasonable time to prevent risk of harm to patients; and

(viii) the expiration date of an emergency kit is the earliest date of expiration of a drug or device supplied in the kit. Upon the occurrence of the expiration date, the supplying pharmacist shall replace the expired drug or device.

(C) Except for a pharmacy, wholesaler, or a permitted facility that supplies only oxygen, every holder of a permit from the board shall designate a pharmacist duly licensed by the Board of Pharmacy as a consultant pharmacist to be responsible for the duties as stated in this chapter at the permit holder's location. The consultant pharmacist shall sign a new or renewal application along with the permit holder and agree in writing to assume the responsibilities of consultant pharmacist.

(1) The consultant pharmacist must be consistent with the accepted standards of professional conduct and practice and responsible for compliance with all applicable laws and regulations including:

(a) establishing as applicable to the permit, policies, and procedures for the procurement, storage, compounding, dispensing, and distribution of drugs;

(b) establishing and supervising the recordkeeping system for the purchase, sale, possession, storage, safekeeping, and return of drugs;

(c) facilitating drug recalls and the removal of outdated and adulterated drugs;

(d) supervising all employees of the permit holder whose duties relate to the procurement, compounding, sale, distribution, and storage of drugs;

(e) acting as a drug information resource for the staff by bringing new and current drug information to their attention and being available by phone for questions;

(f) performing written monthly inspections that are readily available.

(2) The outgoing consultant pharmacist and the permit holder shall notify the board in writing within ten days of a change of consultant pharmacist.

(3) No designation of an individual as a consultant pharmacist or delegation of duties to a consultant pharmacist by a holder of a pharmacy permit shall relieve the permit holder of any of the permit holder's duties under state or federal laws or regulations.

(4) Emergency medical services licensed by the Department of Health and Environmental Control are exempt from permit fees and the provisions of this section requiring a consultant pharmacist to perform the duties set forth in this chapter at the permit holder's location, and the medical director or a consultant pharmacist may perform the duties of the consultant pharmacist pursuant to this chapter.

(5) A facility supplying durable medical equipment is exempt from the provisions of this section requiring a consultant pharmacist to perform the duties set forth in this chapter at the permit holder's location, and a medical director, respiratory therapist, registered nurse, or consultant pharmacist may perform the duties of the consultant pharmacist pursuant to this chapter.

(D) In addition to the duties and responsibilities contained in this section, a consultant pharmacist for an institutional facility shall review the record of each institutional resident receiving medication for potential adverse reactions, allergies, interactions, and laboratory test modification and advise the physician of any recommended changes in the medication regimen. This review must be conducted monthly and documented on the resident's medical record.

(E) A prescription drug order shall contain at a minimum, the:

(1) full name and address of the patient;

(2) name, address, telephone number, and degree classification of the prescriber; license number, and Drug Enforcement Agency registration number of the prescribing practitioner where required by law;

(3) date of issuance;

(4) name, strength, dosage form, and quantity of drug prescribed;

(5) directions for use;

(6) number of refills authorized. No prescription marked "PRN" or any other nonspecified number of refills may be refilled more than two years beyond the date it was originally written. Nothing in this subsection abridges the right of a pharmacist to refuse to fill or refill a prescription; and

(7) a written order signed by the prescriber, which shall bear the name of the patient; name, strength, and quantity of the drug or device prescribed; directions for use; date of issue; and, either rubber stamped, typed, printed by hand, or typeset, the name, address, telephone number, and degree classification of the prescriber; and, if a controlled substance is prescribed, the prescriber's federal registration number;

(8) only one drug and set of instructions for each blank, if preprinted;

(9) a chart order is exempt from the requirements of this subsection.

(F) A prescription drug order must be issued for a legitimate medical purpose by a practitioner acting within the course of legitimate professional practice. The prescription drug order must be received at the pharmacy as it was originally transmitted. Each prescription drug order becomes part of a permanent record and must be readily retrievable. The institutional pharmacist must review the physician's drug order, or a direct copy, prior to dispensing any drug (except for emergency use). Electronically transmitted prescription drug orders shall meet these requirements:

(1) must be sent only to a pharmacy of the patient's choice;

(2) must be received at the pharmacy as it was originally transmitted by facsimile or computer and shall include the name and address of the practitioner, the phone number for verbal confirmation, the time and date of transmission, and the name of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law;

(3) a pharmacist may dispense prescription drug orders transmitted electronically only when transmitted by an authorized practitioner or his designated agent;

(4) the pharmacist shall exercise professional judgment regarding the accuracy or authenticity of the transmitted prescription drug order consistent with existing federal or state laws and regulations;

(5) any alterations of electronic transfer of a prescription drug order or information constitutes an unlawful act which will be prosecuted by the Attorney General of this State;

(6) the prescribing practitioner may authorize his agent to transmit a prescription drug order orally or electronically to the pharmacy provided that the identity of the transmitting agent is included in the order.

(G)(1) The transfer of original prescription information for the purpose of dispensing refills is permissible between licensed or permitted pharmacies subject to these requirements:

(a) The transfer must be communicated directly between two pharmacists and not by one pharmacist accessing an information file containing data for several locations, unless all locations accessed are under common ownership or accessed pursuant to contractual agreement of the pharmacies.

(b) The transferring pharmacist shall void any remaining refills and so mark the face of the prescription retained by the transferring pharmacist or record information electronically.

(c) The transferring pharmacist shall record the name and address of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information on the reverse side of the transferred prescription or record information electronically.

(2) The transferring pharmacist shall record in writing the date of the transfer and the name of the pharmacist transferring the information or record information electronically.

(3) The transferring pharmacist shall record on the prescription transferred or record information electronically that the receiving pharmacist is authorized to dispense all remaining refills based on the original prescription, if such is the case.

(4) The pharmacist receiving the transferred prescription information shall record in writing or electronically the following:

(a) the word "transfer" on the face of the transferred prescription;

(b) any information required to be on a prescription, including:

(i) the date of issuance of the original prescription;

(ii) the date and time of transfer;

(iii) the pharmacy's name, address, and original prescription number from which the prescription information was transferred;

(c) the name of the transferring pharmacist;

(d) the manufacturer or brand name of drug dispensed; and

(e) documentation that the receiving pharmacist shall dispense refills based on the transferring pharmacist's certification under subsection (G)(3).

(5) The requirements of this section may be facilitated by use of a computer, data, or facsimile.

(6) All records pertinent to this section must be readily available.

(7) Both the original and transferred prescription drug order must be maintained for a period of two years from the date of last refill.

(8) The transfer must be in compliance with current state and federal laws on controlled substances.

(9) The transfer of prescription information for the purpose of dispensing authorized refills is permissible between pharmacies where all pharmacies are under common ownership and access prescription information through a common computerized data system, subject to subsection (G)(1)(c), (G)(2), (G)(5), (G) (6), (G)(7), and (G)(8).

(H)(1) Upon receiving a prescription for a brand name product, a registered pharmacist may in his professional judgment substitute an equivalent drug product as provided in this subsection.

(2) Every oral or written drug prescription shall provide an authorization from the practitioner as to whether or not an equivalent drug product may be substituted.

(3) A written prescription shall have two signature lines at opposite ends on the bottom of the form. Under the line at the left side shall be clearly printed the words "Dispense As Written". Under the line at the right side shall be clearly printed the words "Substitution Permitted". The practitioner shall communicate the instructions to the pharmacist by signing on the appropriate line. No written prescription is valid without the signature of the practitioner on one of these lines.

(4) An oral prescription from the practitioner shall instruct the pharmacist as to whether or not an equivalent drug product may be substituted. The pharmacist shall note the instructions on the file copy of the prescription and retain the prescription form for the period as prescribed by law.

(5) The pharmacist shall note the brand name or the manufacturer of the substituted drug dispensed on the file copy of a written or oral prescription or record this information electronically, or both. If a pharmacist substitutes a generic drug for a name brand prescribed drug when dispensing a prescribed medication, the brand name and the generic name of the drug and its manufacturer, with an explanation of "generic for" or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label.

(6) Substitution may not occur unless the pharmacist advises the patient or the patient's agent that the practitioner has authorized substitution and the patient, or patient's agent, consents. A Medicaid recipient whose prescription is reimbursed by the South Carolina Medicaid Program is deemed to have consented to the substitution of a less costly equivalent generic drug product.

(I)(1) All drugs dispensed for use by inpatients of a hospital or other health care facility, where the drug is not in the possession of the ultimate user prior to administration, shall meet these requirements:

(a) The label of a single unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

(i) the nonproprietary or proprietary name of the drug;

(ii) the route of administration, if other than oral;

(iii) the strength and volume, where appropriate, expressed in the metric system whenever possible;

(iv) the control number and expiration date;

(v) special storage conditions, if required.

(b) A log book must be maintained identifying the repackager, the name of the drug, the lot number, the manufacturer, the facility control number, the expiration date, the quantity, and the initials of the pharmacist.

(c) When a multiple-dose drug distribution system is utilized, including dispensing of single-unit packages, the drugs must be dispensed in a container to which is affixed a label containing the:

(i) patient's name;

(ii) date of dispensing;

(iii) nonproprietary or proprietary name of the drug dispensed, or both; and

(iv) strength, expressed in the metric system whenever possible.

(2) All drugs dispensed to inpatients for self-administration shall be labeled in accordance with item (4).

(3) If any drugs are added to parenteral solutions, these admixtures shall bear a distinctive label indicating:

(a) name of solution and volume of solution;

(b) patient's name;

(c) infusion rate;

(d) bottle sequence number or other system control method;

(e) name and quantity of each additive;

(f) date of preparation;

(g) beyond-use date and time of parenteral admixture;

(h) ancillary precaution labels; and

(i) identity of preparer and checking pharmacist.

(4) All drugs dispensed to ambulatory or outpatients shall contain a label affixed to the container in which the drug is dispensed including:

(a) the name and address of the pharmacy dispensing the drug;

(b) the name of the patient for whom the drug is prescribed;

(c) the name of the prescribing practitioner;

(d) such directions as may be stated on the prescription drug order;

(e) the date of dispensing;

(f) any cautions which may be required by federal or state law;

(g) the serial number of the prescription drug order;

(h) the name or initials of the dispensing pharmacist;

(i) the proprietary or generic name of the drug dispensed and its strength, if more than one strength of the drug is marketed;

(j) the brand name of the drug product dispensed or the generic name of the drug product dispensed and its manufacturer or labeler, either written in full or appropriately abbreviated;

(k) when dispensing a prescribed medication, if a pharmacist selects an equivalent drug product for a name-brand prescribed drug, the generic drug name must either be listed on the prescription label first followed by the name-brand prescribed drug, or this information must be affixed to the container on an auxiliary label.

(5) Drugs other than sample medication provided by a manufacturer to a prescriber for patient use shall meet all requirements of labeling.

(6) No radiopharmaceutical may be dispensed unless a label is affixed to the immediate container bearing:

(a) the standard radiation symbol;

(b) the words "Caution-Radioactive Material"; and

(c) the prescription number.

(7) No radiopharmaceutical may be dispensed unless a label is affixed to the outer or delivery container bearing the:

(a) standard radiation symbol;

(b) words "Caution-Radioactive Material";

(c) radionuclide and chemical form;

(d) activity and date and time of assay;

(e) volume if in liquid form;

(f) requested activity and the calibrated activity;

(g) prescription number;

(h) patient name or space for patient name. Where the patient's name is not available at the time of dispensing, a seventy-two hour exemption is allowed to obtain the name of the patient. No later than seventy-two hours after dispensing the radiopharmaceutical, the patient's name shall become a part of the prescription drug order to be retained for two years;

(i) name and address of the nuclear pharmacy;

(j) name of the practitioner; and

(k) lot number of the prescription.

(8) A package prepared by a pharmacist containing two or more drugs prescribed for a specific patient shall meet USP labeling requirements.

(J)(1) A pharmacy patient record system must be maintained by all pharmacies for patients for whom prescription drug orders are dispensed. The pharmacy patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The pharmacist shall make a reasonable effort to obtain, record, and maintain the:

(a) full name of the patient for whom the drug is intended;

(b) address and telephone number of the patient;

(c) patient's age or date of birth;

(d) patient's gender;

(e) list of all prescription drug orders obtained by the patient at the pharmacy during the two years immediately preceding the most recent entry showing the prescription number, name, and strength of the drug, the quantity and date received, the number of refills given, the date of each refill, the identity and quantity of each refill if different from the prescribed quantity, the identity of dispensing pharmacist and the name of the practitioner; and

(f) pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.

(2) The pharmacist shall make a reasonable effort to obtain information from the patient or the patient's agent regarding any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review. This information shall be recorded in the patient's record.

(3) A pharmacy patient record must be maintained for a period of not less than two years from the date of the last entry in the profile record. This record may be a hard copy or a computerized form.

(K) A pharmacist shall review the pharmacy patient record and each prescription drug order presented for dispensing for purposes of promoting therapeutic appropriateness by identifying:

(1) over-utilization or under-utilization;

(2) therapeutic duplication;

(3) drug-disease contraindications;

(4) drug-drug interactions;

(5) incorrect drug dosage or duration of drug treatment;

(6) drug-allergy interactions;

(7) clinical abuse/misuse.

Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, as appropriate, include consultation with the practitioner.

(L)(1) Upon receipt of a prescription drug order for a new medication and following review of the patient's pharmacy record, the pharmacist shall personally offer counseling to the patient or the patient's agent. Using his best professional judgment, the pharmacist's counseling shall include a discussion of those matters that the pharmacist considers appropriate for the patient or patient's agent in that particular situation.

The discussion must be in person, whenever practicable, or by telephone and shall include appropriate elements of patient counseling. The elements may include:

(a) the name and description of the drug;

(b) the dosage form, dose, route of administration, and duration of drug therapy;

(c) intended use of the drug and expected action;

(d) special directions and precautions for preparation, administration, and use by the patient;

(e) potentially serious side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(f) techniques for self-monitoring drug therapy;

(g) proper storage;

(h) prescription refill information;

(i) action to be taken in the event of a missed dose; and

(j) pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.

(2) Alternative forms of patient information may be used to supplement patient counseling when appropriate including, but not limited to, written information leaflets, pictogram labels, or video programs.

(3) Patient counseling is not required for inpatients or emergency department patients of a hospital or institution where other licensed health care professionals are authorized to administer the drug.

(4) A pharmacist is not required to counsel a patient or caregiver when the patient or caregiver refuses the consultation.

(M) Significant adverse drug reactions must be reported to the prescriber immediately upon discovery. Appropriate entry on the patient's record also must be made.

(N) Records of dispensing, which are readily retrievable within twenty-four hours, for all drugs or devices are to be made and kept by pharmacies for two years and shall include, but are not limited to:

(1) quantity dispensed for original and refills, if different from original;

(2) date of dispensing;

(3) serial number or equivalent if an institution;

(4) the identification of the pharmacist responsible for dispensing;

(5) name and manufacturer of drug dispensed if drug product selection occurs; and

(6) records of refills to date.

(O)(1) An up-to-date policy and procedure manual must be maintained by the pharmacist-in-charge that explains the operational aspects of an automated system and shall:

(a) include examples of all required output documentation provided by the automated system;

(b) outline steps to be followed when the automated system is not operational due to scheduled or unscheduled system interruption;

(c) outline regular and routine backup file procedure and file maintenance;

(d) outline audit procedures, personnel code assignments, and personnel responsibilities;

(e) provide a quality assurance mechanism for data entry validation.

(2) The automated system shall have the capability of producing sight-readable information on all original and refill prescription drug orders. The term "sight-readable" means that an authorized individual must be able to examine the record and read the information from the cathode ray tube (CRT), microfiche, microfilm, printout, or other method acceptable to the Board of Pharmacy.

The automated system shall provide on-line retrieval (via CRT display or hard-copy printout) of original prescription drug order information. The information shall include, but is not limited to, the prescription drug order requirements and records of dispensing.

The automated system shall have the capability of producing a printout of any prescription drug order data. The system shall provide a refill-by-refill audit trail for any specified strength and dosage form of any drug. The audit trail must be by printout and shall include the name of the prescribing practitioner, name and location of the patient, quantity dispensed on each refill, date of dispensing of each refill, name or identification code of the dispensing pharmacist, and unique identifier of the prescription drug order.

A facility maintaining centralized prescription records must be capable of sending a requested printout to the pharmacy within seventy-two hours.

(3) To maintain the confidentiality of patient records, the system shall have adequate security and systems safeguards to prevent unauthorized access, modification, or manipulation of pharmacy patient records. Once the drug has been dispensed, any alterations in prescription drug order data must be documented including the identification of the pharmacist responsible for the alteration.

(4) In the event of an unscheduled system interruption, sufficient patient data and prescription drug order data must be available to permit reconstruction of such data within a two-hour time period for the pharmacist to dispense drugs with sound professional judgment.

An auxiliary system shall be established for the documentation of refills if the automated data processing system is inoperative for any reason and to ensure that all refills are authorized by the original prescription drug order and that the maximum number of refills is not exceeded.

The auxiliary system shall be in place to provide for the maintenance of all necessary patient drug information until the automated system becomes operational. However, nothing in this subsection shall preclude the pharmacist from using professional judgment for the benefit of a patient's health and safety.

When the automated system is restored to operation, the information regarding prescription drug orders dispensed and refilled during the inoperative period must be entered into the automated system.

Routine backup systems and procedures (hard copy, copy, disc, etc.) must be in place and operational to ensure against loss of patient data.

In the event that permanent dispensing information is lost due to unscheduled system interruption, the Board of Pharmacy must be notified within seventy-two hours of the loss or of the discovery of the loss.

(P) If a pharmacist receives a request for a prescription refill and the pharmacist is unable to obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a seventy-two hour supply of the prescribed medication if:

(1) the prescription is not for a controlled substance;

(2) the medication is essential to the maintenance of life or to the continuation of therapy;

(3) in the pharmacist's professional judgment, continuing the therapy for seventy-two hours will produce no undesirable health consequences or cause physical or mental discomfort;

(4) the pharmacist properly records the dispensing; and

(5) the dispensing pharmacist notifies the prescriber of the emergency dispensing within seventy-two hours after the one-time emergency refill dispensing.

(Q) Machines used in the prescription drug distribution process must be under the control of and are the responsibility of a licensed pharmacist.

Drugs brought into an institutional facility by a patient may not be administered unless they can be identified. If such drugs cannot be administered, then according to pharmacy procedures specified in writing, the drugs must be turned into the pharmacy which shall package and seal them and return them to an adult member of the patient's immediate family, or store and return them to the patient upon discharge.

Investigational drugs which are used within an institutional facility must be stored in and dispensed from the pharmacy only.

All information with respect to investigational drugs must be maintained in the pharmacy.

All drug storage areas must be routinely inspected by pharmacy personnel to ensure that no outdated or unusable items are present, and that all stock items are properly labeled and stored.

A written stop-order policy or other system must be established by the institutional pharmacists-in-charge to ensure that drug orders are not inappropriately continued.

There must be a written policy and procedure for providing pharmacy services in the event of a disaster. This shall be reviewed annually by all pharmacy staff members and so documented.

(R)(1) It is unlawful for a person, except a pharmacist licensed under this chapter and pursuant to the regulations of the board of pharmacy to:

(a) take, use, or exhibit the title "pharmacist", "druggist", "pharmacy", "drugstore", "drugs", "prescriptions", or any other title, sign, display, or declaration that tends to lead the public to believe that the person is engaged in the business of selling, compounding, or dispensing any prescription drugs; or

(b) have charge of, engage in, or carry on, for himself or another, the dispensing, compounding, or sale of any prescription drugs anywhere within this State.

(2) Except as prescribed by this chapter, it is unlawful for a person to practice as a pharmacist or to advertise or represent himself by a title, sign, display, declaration, or other item to be a pharmacist or to engage in, conduct, carry on, or be employed in the dispensing, compounding, or retailing of any prescription drugs within this State.

(3) Notwithstanding any other provision of law or regulation, pharmacies and apothecaries are permitted to advertise the retail price of all drugs sold by prescription.

(4) Those merchants selling varieties of health and beauty needs, including that class of personal care products and nonprescription drugs which do not require a prescription for sale at retail, may use and display the term "drug-sundries" in advertising, if these conditions are met:

(a) the word "drug-sundries" is a hyphenated word;

(b) the word "drug-sundries" must appear all on one line;

(c) the two parts of the word must be of equal size lettering, of the same color, and the same style print or script; and

(d) no effort may be made to mislead the public that there is a full drug and prescription service available.

(5) Nothing in this section authorizes the board to promulgate regulations concerning the prices of goods or drugs sold by outlets, the hours that the business may be operated, or the hours of work of the employees of the businesses.

(S) Licensed pharmacists may sell pharmaceutical agents, other than controlled substances as defined in Section 44-53-110, to optometrists who are diagnostically certified by the South Carolina Board of Examiners in Optometry for diagnostic purposes in the practice of optometry in accordance with Section 40-37-105(A). For these purposes, "pharmaceutical agent" means anesthetics, mydriatics, cyclopegics, miotics, dyes, and over-the-counter drugs.

Licensed pharmacists may sell pharmaceutical agents, other than Schedule I and Schedule II controlled substances as defined in Section 44-53-110, to optometrists who are therapeutically certified by the South Carolina Board of Examiners in Optometry for diagnostic and therapeutic purposes in the practice of optometry in accordance with Section 40-37-105(B).

(T) Duties that must be performed by a licensed pharmacist or a pharmacy intern or extern within the practice of pharmacy, to exclude Home Medical Equipment providers, include, but are not limited to:

(1) the interpretation and evaluation of medical orders;

(2) participation in drug and device selection;

(3) provision of patient counseling;

(4) performing drug regimen reviews;

(5) provision of pharmacy care; and

(6) receiving telephone or verbal medical orders from licensed practitioners.

A licensed pharmacist shall supervise the activities of a pharmacy technician to ensure all activities are performed completely, safely, and without risk of harm to patients.

(U) Nonprescription drugs may be sold by any retailer in their original, unbroken prepackaged containers and no rule or regulation shall be adopted by the Board of Pharmacy which shall require the sale of nonprescription drugs by a licensed pharmacist or in a pharmacy. However, nonprescription drugs may also be dispensed and profiled by pharmacists pursuant to a practitioner's prescription, and when dispensed in this manner by a pharmacist, the drug must be treated in all respects as a prescription drug and all prescription drug counseling and labeling requirements shall apply.

(V) A manufacturer or wholesaler shall supply insulin only to persons or entities that can legally possess prescription drugs.

(W) The American Pharmaceutical Association Code of Ethics will be adopted as the code of ethics for pharmacists in this State.

(X)(1) Physicians who are in charge or who directly supervise the operation of emergency rooms may dispense legend drugs in order to meet the immediate needs of the patient. The amount dispensed may not exceed an amount equal to a seventy-two hour supply. Records of drugs dispensed must be maintained. A valid physician-patient relationship shall exist between the emergency room physician and the patient before dispensing legend drugs in the emergency room.

(2) Physicians who are in charge of or who directly supervise the operation of college and university athletics department training rooms may dispense in the training room prescription drugs owned by the facility in order to meet the needs of the student-athletes participating in athletic department activities or programs. College and university athletic departments are exempt from Section 40-43-83, as it relates to the Board of Pharmacy and the requirement that each pharmacy must have a pharmacist-in-charge. Records of drugs dispensed must be maintained and properly accounted for by the athletic department physician. A valid physician-patient relationship must exist between the athletics department physician and the student-athlete before dispensing prescription drugs in the athletics department training room. Drugs dispensed by the athletic department physician must be properly labeled in accordance with federal and state law.

(Y) It is unlawful for a person to deliver prescription drugs to any permitted facility, at any time when the facility is not open for business, unless shipments are received by an authorized employee of the facility or into a secure area, or both.

(Z) A current record showing disposition of all restricted pharmaceutical preparations, such as federal legend drugs, exempt class V, insulin, controlled substances, poisons and any other drugs so designated by the board, dispensed or sold to physicians, dentists, veterinarians, pharmacies, hospitals, or other persons authorized by law to possess drugs restricted to sale on prescription only, must be maintained for two years in the prescription files or in the records of the permitted facility showing the name of the person to whom dispensed or sold, the name, strength, and quantity dispensed or sold, and the date of the transaction.

Every pharmacist or other person selling nonlegend poison must be satisfied that the purchase is made for legitimate purposes and keep a book on file in which must be recorded every sale of the following articles: arsenic and its preparations, all metallic cyanides and cyanides of potassium, tartar emetic, corrosive sublimate, aconite and alkaloids, and their salts, and hydrocyanic acid. The record shall exhibit the name of the person to whom the poison was sold and the purpose of purchase stated. The book or file must be kept at all times subject to inspection of the coroner of the county and the solicitor or inspector of the Board of Pharmacy or any other person as either of them may designate.

These above-named poisons, and oxalic acid, chloroform, or any other poisonous articles that may be added to the list by the board, must be securely labeled "Poison" when sold in the permitted facility.

Nothing in this section may be construed to apply to the filling of prescriptions written by physicians.

(AA) No pharmacist or permit holder shall reuse, sell, or offer for sale a prescription or other medication intended for internal or external use which has been returned unless the pharmacist accepting the medication determines in his best professional judgment that the strength, potency, and stability of the medication have not been adversely affected or contaminated.

(BB) Applicants and licensees must pay fees for new and renewed permits, licenses, registrations, and certifications. Fees shall be established and adjusted, as provided by Section 40-1-50. Among other things provided in this chapter, fees may be established by regulation and assessed for a:

(1) new pharmacy permit for renewal;

(2) new nondispensing drug outlet permit or permit renewal;

(3) new medical gases or legend devices drug outlet permit or permit renewal;

(4) new nonresident pharmacy permit or permit renewal;

(5) new out-of-state wholesale distributor permit or permit renewal;

(6) relocation permit within the same city;

(7) six-year intern certificate;

(8) application for complete licensure examination;

(9) application for licensure by score transfer;

(10) application for licensure by licensure transfer;

(11) pharmacist's license or license renewal; and

(12) pharmacy technician registration or registration renewal.

(CC)(1) The provisions of this subsection only apply to the compounding of medication by pharmacies permitted in the State of South Carolina.

(2) The following are the minimum current good compounding practices for the preparation of medications by pharmacists licensed in the State for dispensing or administering, or both, to humans or animals:

(a) Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable laws regulating the practice of pharmacy;

(b) Based on the existence of a pharmacist/patient/practitioner relationship and the presentation of a valid prescription, or in anticipation of prescription medication orders based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient medications that are commercially available in the market place;

(c) Pharmacists shall receive, store, or use drug substances for compounding that meet official compendia requirements, or of a chemical grade in one of the following categories: chemically pure (CP), analytical reagent (AR), American Chemical Society (ACS), or, if other than this, drug substances that meet the accepted standard of the practice of pharmacy;

(d) Pharmacists may compound drugs before receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/practitioner relationship, for all such products compounded at the pharmacy as required by the Board of Pharmacy;

(e) Pharmacists may not offer compounded medications to other pharmacies for resale; however, pharmacists may compound products based on an order from a practitioner for use by practitioners for patient use in institutional or office settings. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services, e.g., chemicals, devices, and information, when requested; however, they may not solicit business by promoting to compound specific drug products, e.g., like a manufacturer;

(f) The compounding of drugs in anticipation of receiving prescriptions without a historical basis or the distribution of compounded products without a patient/practitioner/pharmacist relationship is considered manufacturing.

(3) Pharmacists engaging in compounding shall maintain proficiency through current awareness and training. Continuing education shall include training in the art and science of compounding and the rules and regulations of compounding.

Pharmacy technicians may assist the pharmacist in compounding. The pharmacist is responsible for training and monitoring the pharmacy technician. The pharmacy technician's duties must be consistent with the training received.

Personnel engaged in the compounding of medications shall wear clean clothing appropriate to the operation being performed. Protective apparel, such as coats, jackets, aprons, gowns, hand or arm coverings, or masks must be worn as necessary to protect personnel from chemical exposure and medication or chemical contamination.

Only personnel authorized by the responsible pharmacist may be in the immediate vicinity of the drug compounding operation. A person shown at any time, either by medical examination or pharmacist determination, to have an apparent illness or open lesions that may adversely affect the safety or quality of a drug product being compounded must be excluded from direct contact with components, medication containers, closures, in-process materials, and medication products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of the products being compounded. All personnel who assist the pharmacists in compounding procedures must be instructed to report to the pharmacist any health conditions that may have an adverse effect on drug products.

(4) Pharmacists engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions that is maintained in a good state of repair for the placement of material and equipment. Sterile compounding must be performed in a separate area in compliance with Section 40-43-88.

Bulk medications and other chemicals or materials used in the compounding of medication must be stored in adequately labeled containers in a clean, dry, and temperature-controlled area or, if required, under proper refrigeration.

Adequate lighting and ventilation must be provided in all drug compounding areas. Potable water must be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to a compounded drug product. Adequate washing facilities, easily accessible to the compounding areas of the pharmacy, must be provided. These facilities shall include, but are not limited to, hot and cold water, soap or detergent, and air-dryers or single-use towels.

The area used for the compounding of drugs must be maintained in a clean and sanitary condition. It must be free of infestation by insects, rodents, and other vermin. Trash must be held and disposed of in a timely and sanitary manner. Sewage and other refuse in and from the pharmacy and immediate medication compounding areas must be disposed of in a safe and sanitary manner.

If sterile products are being compounded, the pharmacist shall comply with Section 40-43-88 as applicable to the procedure.

If radiopharmaceuticals are being compounded, the pharmacist shall comply with Section 40-43-87 as applicable to the procedure.

If drug products with special precautions for contamination, such as penicillin, are involved in a compounding procedure, appropriate measures, including either the dedication of equipment or meticulous cleaning of contaminated equipment before its use for the preparation of other drugs, must be utilized in order to prevent cross-contamination.

(5) Equipment and utensils used for compounding must be of appropriate design and capacity and stored in a manner to protect from contamination. In addition, all equipment and utensils must be cleaned and sanitized before use to prevent contamination that would alter the safety or quality of the drug product beyond that desired. The pharmacist is responsible for determining suitability for use. In the case of sterile compounding, the pharmacist shall comply with Section 40-43-88 as applicable to equipment and utensils.

Automatic, mechanical, electronic, or other equipment used in compounding must be routinely inspected, calibrated, if necessary, or checked to ensure proper performance.

The pharmacist shall ensure that the proper container is selected to dispense the finished compounded prescription, whether sterile or nonsterile.

(6) The pharmacist shall ensure that there are formulas and logs maintained either electronically or manually. Formulas must be comprehensive and include ingredients, amounts, methodology, and equipment, if needed, and special information regarding sterile compounding.

The pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate at each stage of the compounding procedure to conform to the formula being prepared. Any chemical transferred to a container from the original container must be labeled with the same information as on the original container and the date of transfer placed on the label.

The pharmacist shall establish and conduct procedures so as to monitor the output of compounded prescriptions, i.e., capsule weight variation, adequacy of mixing, clarity, pH of solutions, and, where appropriate, procedures to prevent microbial contamination of medications purported to be sterile.

(7) The pharmacist shall label any excess compounded product so as to reference it to the formula used and the assigned control number and the estimated beyond-use date based on the pharmacist's professional judgment, appropriate testing, or published data. The product must be stored appropriately.

At the completion of compounding the prescription, the pharmacist shall examine the prescription for correct labeling.

(8) The pharmacist shall keep records of all compounded products for a period of time as other prescriptions as required by the Board of Pharmacy. These records must be readily available for authorized inspection during the retention period at the establishment. These records are subject to duplication by photocopying or other means of reproduction as part of the inspection.

(DD) Unprofessional conduct includes, but is not limited to, the following acts by a pharmacist, permit holder, pharmacy technician, or the owner of a permitted facility:

(1) publishing or circulating false, misleading, or otherwise deceptive statements concerning the practice of pharmacy;

(2) attempting to circumvent the patient counseling requirements, or discouraging the patient from receiving patient counseling concerning their prescription drug orders;

(3) divulging or revealing to unauthorized persons patient information or the nature of professional pharmacy services rendered without the patient's express consent, or without order or direction of a court. Authorized persons include:

(a) a patient, or patient's agent, or another pharmacist acting on behalf of a patient;

(b) the practitioner who issued the prescription drug order;

(c) certified/licensed health care personnel who are responsible for the care of the patient;

(d) an inspector, agent, or investigator of the Board of Pharmacy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this State or the United States relating to drugs or devices and who is engaged in a specific investigation involving a designated person or drug;

(e) an agency of government charged with the responsibility of providing medical care for the patient upon written request by an authorized representative of the agency requesting the information;

(4) selling, giving away, or otherwise disposing of accessories, chemicals, or drugs or devices found in illegal drug traffic when the pharmacist knows or should have known of their intended use in illegal activities;

(5) engaging in conduct likely to deceive, defraud, or harm the public, or demonstrating a wilful or careless disregard for the health, welfare, or safety of a patient, or engaging in conduct which substantially departs from the standards of care ordinarily exercised by a pharmacist;

(6) selling a drug for which a prescription drug order from a practitioner is required without having received a prescription drug order for the drug;

(7) wilfully and knowingly failing to maintain complete and accurate records of all drugs received, dispensed, or disposed of in compliance with the federal laws and regulations and state laws and regulations;

(8) obtaining any remuneration by fraud, misrepresentation, or deception;

(9) using a system providing for the electronic transfer of information that infringes on a patient's freedom of choice as to the provider of pharmacy care.

(EE) Except as provided in subsection (S), it is unlawful for a person to possess, dispense, or distribute in this State, except on a prescription of a licensed practitioner, any drug or device, as defined in Section 39-23-20, bearing on its manufacturer's or distributor's original commercial container the legend, "Caution: Federal law prohibits dispensing without prescription", "Rx Only", "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian", or "Caution: Federal law restricts device for sale by or on the order of a _".

A person who violates this subsection is guilty of a misdemeanor and, upon conviction, must be fined not more than five hundred dollars or imprisoned not more than two years, or both.

(FF) The Department of Health and Environmental Control is exempt from the provisions of this section that prohibit a pharmacist from serving as a pharmacist-in-charge unless he is physically present in the pharmacy and that prohibits a pharmacist from serving as a pharmacist-in-charge for more than one pharmacy at a time, so that one pharmacist-in-charge may be designated by the department to serve more than one health district.

HISTORY: 1998 Act No. 366, Section 1; 1999 Act No. 76, Sections 6 to 12; 2000 Act No. 340, Sections 4, 9 and 10; 2002 Act No. 314, Sections 5, 6, 7; 2002 Act No. 356, Section 1, Part II.H(3); 2004 Act No. 251, Section 1; 2005 Act No. 18, Section 1; 2007 Act No. 49, Section 3.B; 2008 Act No. 353, Section 2, Part 4.A.