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S. 644
STATUS INFORMATION
General Bill
Sponsors: Senator Peeler
Document Path: l:\council\bills\nbd\11414ac11.docx
Introduced in the Senate on March 3, 2011
Currently residing in the Senate Committee on Medical Affairs
Summary: Pharmacy Permits
HISTORY OF LEGISLATIVE ACTIONS
Date Body Action Description with journal page number
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3/3/2011 Senate Introduced and read first time (Senate Journal-page 3)
3/3/2011 Senate Referred to Committee on Medical Affairs
(Senate Journal-page 3)
View the latest legislative information at the LPITS web site
VERSIONS OF THIS BILL
TO AMEND SECTION 40-43-30, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO THE DEFINITION OF TERMS USED IN THE SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO PLACE ALPHABETICALLY THE DEFINITIONS OF "CERTIFIED PHARMACY TECHNICIAN" AND "REVOCATION", TO REVISE THE DEFINITION OF "PHARMACY", AND TO DEFINE "REMOTE MEDICATION ORDER PROCESS"; AND BY ADDING SECTION 40-43-210 SO AS TO PROVIDE THE REQUIREMENTS AND PROCEDURES FOR AN ENTITY HOLDING A SOUTH CAROLINA PHARMACY PERMIT TO UTILIZE REMOTE MEDICATION PROCESSING.
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Section 40-43-30 of the 1976 Code is amended to read:
"Section 40-43-30. For purposes of this chapter:
(1) 'Administer' means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.
(2) 'Biological safety cabinet' means a containment unit suitable for the preparation of low-to-moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation Standard 49.
(3) 'Board' or 'Board of Pharmacy' means the State Board of Pharmacy.
(4) 'Brand name' means the proprietary or trade name placed upon a drug, its container, label, or wrapping at the time of packaging.
(5) 'Certified pharmacy technician' means an individual who is a registered pharmacy technician and who has completed the requirements provided for in Section 40-43-82(B).
(6) 'Chart order' means a lawful order from a practitioner for a drug or device for patients of a hospital or extended care facility, or such an order prepared by another person and signed by a practitioner either immediately or at another time, issued for a legitimate medical purpose within the practitioner's course of legitimate practice and including orders derived on behalf of a practitioner from a practitioner approved drug therapy management.
(6)(7) 'Class 100 environment' means an atmospheric environment which contains less than one hundred particles 0.5 microns in diameter per cubic foot of air.
(7)(8) 'Compounding' means the preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, or the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. The term compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.
(8)(9) 'Confidential information' means information maintained in a patient's records or which is communicated to a patient as part of patient counseling, which is privileged and may be released only to the patient, to those practitioners and pharmacists where, in the pharmacist's professional judgment, release is necessary to protect the patient's health and well being, and to other persons or governmental agencies authorized by law to receive such confidential information.
(9)(10) 'Cytotoxic agent' means a drug that has the capability of killing living cells.
(10)(11) 'Deliver' or 'delivery' means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration.
(11)(12) 'Designated agent' means a person employed by an authorized practitioner to transmit, either orally or electronically, a prescription drug order on behalf of the authorized practitioner to the pharmacist. The authorized practitioner accepts the responsibility for the correct transmission of the prescription drug order.
(12)(13) 'Designated pharmacist' means an individual currently licensed by the Board of Pharmacy in this State who certifies internship training.
(13)(14) 'Device' means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label: 'Caution: Federal law restricts this device for sale by or on the order of a ___________', the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; or 'Federal law prohibits dispensing without prescription'; or any products deemed to be a public health threat after notice and public hearing as designated by the board.
(14)(15) 'Dispense' means the transfer of possession of one or more doses of a drug or device by a licensed pharmacist or person permitted by law, to the ultimate consumer or his agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient. As an element of dispensing, the dispenser shall, before the actual physical transfer, interpret and assess the prescription order for potential adverse reactions or side effects, interactions, allergies, dosage, and regimen the dispenser considers appropriate in the exercise of his professional judgment, and the dispenser shall determine that the drug or device called for by the prescription is ready for dispensing. The dispenser shall also provide counseling on proper drug usage, either orally or in writing, as provided in this chapter. The actual sales transaction and delivery of a drug or device is not considered dispensing and the administration is not considered dispensing.
(15)(16) 'Distribute' means the delivery of a drug or device other than by administering or dispensing.
(16)(17) 'Drug' or 'medicine' means:
(a) articles recognized as drugs in an official compendium, or supplement to a compendium, including, but not limited to, USP/NF designated from time to time by the board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
(b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
(c) articles, other than food, or nonprescription vitamins intended to affect the structure or a function of the human body or other animals; and
(d) articles intended for use as a component of any articles specified in item (a), (b), or (c) of this subsection.
(17)(18) 'Drug regimen review' includes, but is not limited to, the following activities:
(a) evaluation of prescription drug orders and pharmacy patient records for:
(i) known allergies;
(ii) rational therapy-contraindications;
(iii) reasonable dose and route of administration; and
(iv) reasonable directions for use.
(b) evaluation of prescription drug orders and pharmacy patient records for duplication of therapy.
(c) evaluation of prescription drug orders and pharmacy patient records for interactions:
(i) drug-drug;
(ii) drug-food;
(iii) drug-disease, if available; and
(iv) adverse drug reactions.
(d) evaluation of prescription drug orders and pharmacy patient records for proper utilization, including over-utilization or under-utilization, and optimum therapeutic outcomes.
(18)(19) 'Drug therapy management' is that practice of pharmacy which involves the expertise of the pharmacist in a collaborative effort with the practitioner and other health care providers to ensure the highest quality health care services for patients.
(19)(20) 'Enteral' means within or by way of the intestine.
(20)(21) 'Equivalent drug product' means a drug product which has the same established name and active ingredients to meet the same compendia or other applicable standards, but which may differ in characteristics such as shape, scoring configuration, packaging, excipient (including colors, flavors, preservatives), and expiration time. Pharmacists may utilize as a basis for the determination of generic equivalency Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication.
(21)(22) 'Extern' means an individual currently enrolled in an approved college or school of pharmacy who is on required rotations for obtaining a degree in pharmacy.
(22)(23) 'Generic names' mean the official compendia names or United States Adopted Names (USAN).
(23)(24) 'Health care provider' includes a pharmacist who provides health care services within the pharmacist's scope of practice pursuant to state law and regulation.
(24)(25) 'Institutional facility' means an organization whose primary purpose is to provide a physical environment for patients to obtain health care services and shall not include those places where physicians, dentists, veterinarians, or other practitioners, who are duly licensed, engage in private practice.
(25)(26) 'Institutional pharmacy' means the physical portion of an institutional facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials, hereinafter referred to as 'drugs', used in the diagnosis and treatment of injury, illness, and disease and which is permitted by the State Board of Pharmacy.
(26)(27) 'Institutional consultant pharmacist' means a pharmacist licensed in this State who acts as a consultant for institutional facilities.
(27)(28) 'Intern' means an individual who is currently registered by certificate in this State to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist.
(28)(29) 'Labeling' means the process of preparing and affixing a label which includes all information required by federal and state law to a drug container exclusive of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device.
(29)(30) 'Manufacturing' of products means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, or from bulk chemicals, and includes any packaging or repackaging of the substances or labeling or relabeling of its container, if these actions are followed by the promotion and marketing of the drugs or devices for resale to pharmacies, practitioners, or other persons.
(30)(31) 'Manufacturer' means a person engaged in the manufacture of prescription drugs or devices.
(31)(32) 'Medical order' means a lawful order of a practitioner which may or may not include a prescription drug order.
(32)(33) 'Nonprescription drug' means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this State and the federal government.
(33)(34) 'Nonresident pharmacy' means a pharmacy located outside this State.
(34)(35) 'Parenteral' means a sterile preparation of drugs for injection through one or more layers of the skin.
(35)(36) 'Patient counseling' means the oral or written communication by the pharmacist to a patient or caregiver providing information on the proper use of drugs and devices.
(36)(37) 'Permit consultant pharmacist' means a pharmacist licensed in this State who acts as a consultant for a permit holder other than a pharmacy or institution.
(37)(38) 'Person' means an individual, sole-proprietorship, corporation, partnership, association, or any other legal entity including government.
(38)(39) 'Pharmacy care' is the direct provision of drug therapy and other pharmacy patient care services through which pharmacists, in cooperation with the patient and other health care providers, design, implement, monitor, and manage therapeutic plans for the purpose of improving a patient's quality of life. Objectives include cure of disease, elimination or reduction of a patient's symptomatology, arresting or slowing a disease process, or prevention of a disease or symptomatology. The process includes three primary functions:
(a) identifying potential and actual drug-related problems;
(b) resolving actual drug-related problems; and
(c) preventing potential drug-related problems.
(39)(40) 'Pharmacist' means an individual health care provider licensed by this State to engage in the practice of pharmacy. A pharmacist is a learned professional authorized to provide patient care services within the scope of his knowledge and skills.
(40)(41) 'Pharmacist-in-charge' means a pharmacist currently licensed in this State who accepts responsibility for the operation of a pharmacy in conformance with all laws pertinent to the practice of pharmacy and the distribution of drugs and who is in full and actual charge of the pharmacy and personnel.
(41)(42) 'Pharmacy' means a location for which a pharmacy permit is required and in which prescription drugs and devices are maintained, compounded, and dispensed for patients by a pharmacist. This definition includes a location where pharmacy-related services are provided by a pharmacist.
(42)(43) 'Pharmacy technician' means an individual other than an intern or extern, who assists in preparing, compounding, and dispensing medicines under the personal supervision of a licensed pharmacist and who is required to register as a pharmacy technician.
(43)(44) 'Poison' means:
(a) a drug, chemical, substance, or preparation which, according to standard works on medicine, materia medica, or toxicology, is liable to be destructive to adult human life in doses of sixty grains or less; or
(b) a substance recognized by standard authorities on medicine, materia medica, or toxicology as poisonous; or
(c) any other item enumerated in this chapter; or
(d) a drug, chemical, substance, or preparation which is labeled 'Poison'.
(44)(45) 'Practice of pharmacy' means the interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest; participation in drug and device selection, drug administration, prospective drug reviews, and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmacy care and drug therapy management; and responsibility for compounding and labeling of drugs and devices, (except labeling by a manufacturer, repackager, or distributor or nonprescription drugs and commercially packaged legend drugs and devices) proper and safe storage of drugs and devices and maintenance of proper records for them; or the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, education, management, and control of pharmacy.
(45)(46) 'Practitioner' means a physician, dentist, optometrist, podiatrist, veterinarian, or other health care provider authorized by law to diagnose and prescribe drugs and devices.
(46)(47) 'Prescription drug' or 'legend drug' means:
(a) a drug which, under federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements:
(i) 'Caution: Federal law prohibits dispensing without prescription';
(ii) 'Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian';
(iii) 'Rx only'; or
(b) a drug which is required by any applicable federal or state law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only;
(c) any drug products considered to be a public health threat, after notice and public hearing as designated by the board; or
(d) any prescribed compounded prescription is a prescription drug within the meaning of this act.
(47)(48) 'Prescription drug order' means a lawful order from a practitioner for a drug or device for a specific patient, issued for a legitimate medical purpose within the prescriber's course of legitimate practice and including orders derived from collaborative pharmacy practice.
(48)(49) 'Prospective drug use review' means a review of the patient's drug therapy and prescription drug order before dispensing the drug as part of a drug regimen review.
(50) 'Remote Medication Order Process' means any of the following activities performed from a remote location;
(a) receiving, interpreting, or clarifying medication orders;
(b) entering or transferring medication order data;
(c) performing prospective drug use review;
(d) obtaining substitution authorizations;
(e) interpreting and acting on clinical data;
(f) performing therapeutic interventions;
(g) providing drug information concerning medication orders or drugs; or
(h) authorizing the release of a medication for administration.
Remote medication order processing does not mean the dispensing of a prescription drug.
(51) 'Revocation' means the cancellation or withdrawal of a license, permit, or other authorization issued by the board either permanently or for a period specified by the board before the person is eligible to reapply. A person whose license, permit, or other authorization has been permanently revoked by the board is ineligible at any time in the future for a license or permit of any kind from the board.
(49)(52) 'Significant adverse drug reaction' means a drug-related incident that may result in serious harm, injury, or death to the patient.
(50)(53) 'Sterile pharmaceutical' means a dosage form devoid of viable micro-organisms.
(51)(54) 'Therapeutically equivalent' means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39-24-40.
(52)(55) 'Wholesale distributor' means a person engaged in wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; 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. 'Wholesale distributor' does not include:
(a) intracompany sales, being defined as a transaction or transfer between a division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity;
(b) the purchase or other acquisition by a hospital or other health care entity that is a member of a group-purchasing organization of a drug for its own use from the group-purchasing organization or from other hospitals or health care entities that are members of such organizations;
(c) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
(d) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control. For purposes of this section, 'common control' means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise;
(e) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons. For purposes of this section, 'emergency medical reasons' includes the transfer of legend drugs by a licensed pharmacy to another licensed pharmacy or a practitioner licensed to possess prescription drugs to alleviate a temporary shortage, except that the gross dollar value of the transfers may not exceed five percent of the total legend drug sales revenue of either the transferor or the transferee pharmacy during a consecutive twelve-month period;
(f) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription; or
(g) the sale, purchase, or trade of blood and blood components intended for transfusion.
(53) 'Revocation' means the cancellation or withdrawal of a license, permit, or other authorization issued by the board either permanently or for a period specified by the board before the person shall be eligible to apply anew. A person whose license, permit, or other authorization has been permanently revoked by the board shall never again be eligible for a license or permit of any kind from the board.
(54) 'Certified pharmacy technician' means an individual who is a registered pharmacy technician and who has completed the requirements provided for in Section 40-43-82(B)."
SECTION 2. Chapter 43, Title 40 of the 1976 Code is amended by adding:
"Section 40-43-210. (A) An entity may utilize remote medication order processing if the pharmacist performing the remote medication order processing has access to sufficient patient information necessary for prospective drug use review and approval of medication orders.
(B) The pharmacist may be employed or contracted by the entity.
(C) The pharmacist must be a licensed pharmacist in this State.
(D) An entity must have a written agreement or contract with the pharmacist which must:
(1) outline the services to be provided;
(2) delineate the responsibilities of each party, including compliance with federal and state laws and regulations governing the practice of pharmacy and state and federal medical privacy requirements;
(3) require that the parties adopt a policies and procedures manual;
(4) provide that the parties have access to or share a common electronic file such that the pharmacist performing remote medication order processing has sufficient patient information necessary for prospective drug use review and approval of medication orders.
(E) The pharmacist may be employed by a contractor of the entity to provide remote medication order processing outside this State if:
(1) the entity has a written agreement or contract with the contractor employing the pharmacist which must:
(a) require the contractor to have a South Carolina pharmacy permit;
(b) require the pharmacist-in-charge of the contractor to be a pharmacist licensed in this State;
(c) outline the services to be provided;
(d) delineate the responsibilities of each party, including compliance with federal and state laws and regulations governing the practice of pharmacy and state and federal medical privacy requirements;
(e) require that the parties adopt a policies and procedures manual; and
(f) provide that the parties have access to or share a common electronic file such that the pharmacist performing remote medication order processing has sufficient patient information necessary for prospective drug use review and approval of medication orders;
(2) the entity has a South Carolina pharmacy permit.
(F) A pharmacy using off-site order entry as provided for in this section shall comply with all applicable provisions of this chapter. However, nothing in this chapter may be construed to require remote medication order processing be performed from a permitted site.
(G) A policies and procedures manual must:
(1) be accessible to each party involved in remote medication order processing;
(2) be available for inspection by the board or an authorized agent of the department;
(3) outline the responsibilities of each party involved in remote medication order processing;
(4) when the pharmacist is not employed by the entity, include a current list of the name, address, telephone number, and license number of each pharmacist involved in remote medication order processing;
(5) include policies and procedures for:
(a) protecting the confidentiality and integrity of patient information by accessing secure networks;
(b) ensuring that a pharmacist performing prospective drug use review has access to appropriate drug information resources;
(c) ensuring that medical and nursing staff understand how to contact a pharmacist;
(d) maintaining records to identify the name, initials, or identification code of each person who performs a processing function for a medication order;
(e) complying with federal and state laws and regulations;
(f) operating or participating in a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
(g) reviewing the written policies and procedures and documenting the review every year.
(H)(1) The entity involved in remote medication order processing shall maintain a record that identifies the name, initials, or identification code of each person who performed a processing function for every medication order. The record must be available by medication order or by patient name.
(2) The record may be maintained in a common electronic file if the data processing system can produce a printout that identifies every person who performed a processing function for a medication order.
(3) The record must be readily retrievable for at least the past two years. The record must be available for inspection by the board or an authorized agent of the department.
(4) In operation of the off-site order entry, patient confidentiality and full compliance with HIPAA requirements must be observed at all times."
SECTION 3. This act takes effect upon approval by the Governor.
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