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) "Ante area" means an ISO 8 or greater area where personnel perform hand hygiene, garbing, and stage components. An ante area precedes a buffer area, provided:
(a) a buffer area must be separated by a wall from an ante area if high-risk preparations are compounded; and
(b) if only low-risk and medium-risk preparations are compounded, separating an ante room from a buffer area is recommended.
(3) "Aseptic preparation" means the technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.
(4) "Beyond-use date" or "BUD" means the date or time after which a compounded preparation is recommended not to be dispensed or used. The date is determined from the date or time the preparation is compounded.
(5) "Biological safety cabinet" or "BSC" means a containment unit suitable for the preparation of agents where there is a need for protection of the preparation, personnel, and environment, according to National Sanitation Foundation Standard 49.
(6) "Board" or "Board of Pharmacy" means the State Board of Pharmacy.
(7) "Brand name" means the proprietary or trade name placed upon a drug, its container, label, or wrapping at the time of packaging.
(8) "Buffer area" means an area where the primary engineering control is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding sterile preparations.
(9) "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).
(10) "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.
(11) "Class 100 environment" or "ISO 5" means an atmospheric environment which contains less than one hundred particles 0.5 microns in diameter per cubic foot of air.
(12) "Closed-system transfer device" or "CSTD" means a closed-system hazardous drug handling device comprising a number of interlocking parts for reconstituting, injecting, and administering doses of hazardous drugs.
(13) "Colony-forming unit" or "CFU" means an estimate of cell quantity.
(14) "Compounding" (sterile and nonsterile) 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 "nonsterile 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. The term "sterile compounding" does not include mixing, reconstituting, or other such acts with nonhazardous agents that are preformed in accordance with directions contained in approved labeling provided by the product's manufacturer for immediate use.
(15) "Compounded sterile preparation" or "CSP" means a compounded biologic, diagnostic, drug, nutrient, or radiopharmaceutical that must be sterile when administered to a patient. Among other things, CSPs include:
(a) aqueous bronchial and nasal inhalations;
(b) baths and soaks for live organs and tissues;
(c) injections, such as colloidal dispersions, emulsions, solutions, suspensions, among others;
(d) irrigations for wounds and body cavities;
(e) ophthalmic drops and ointments; and
(f) tissue implants.
(16) "Compounding aseptic containment isolator" or "CACI" means a completely enclosed isolating cabinet that makes use of airtight glove ports designed to protect the user from exposure to airborne drugs and other agents during the compounding and material transfer processes. A CACI also provides an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur in a CACI unless the air is first passed through a HEPA minimum, microbial retentive filter system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.
(17) "Compounding aseptic isolator" or "CAI" means a completely enclosed isolating cabinet that makes use of airtight glove ports designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a HEPA minimum, microbial retentive filter. A CAI is primarily used for nonhazardous drug preparations.
(18) "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.
(19) "Critical site" means an opening that provides a direct pathway between a CSP and the environment or any surface coming in contact with the preparation or environment.
(20) "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.
(21) "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.
(22) "Designated pharmacist" means an individual currently licensed by the Board of Pharmacy in this State who certifies internship training.
(23) "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.
(24) "Disinfectant" means an agent that frees from infection, usually a chemical agent but sometimes a physical one, and that destroys disease-causing pathogens or other harmful microorganisms but may not kill bacterial and fungal spores. It refers to substances applied to inanimate objects.
(25) "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.
(26) "Distribute" means the delivery of a drug or device other than by administering or dispensing.
(27) "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.
(28) "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.
(29) "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.
(30) "Enteral" means within or by way of the intestine.
(31) "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.
(32) "Expiration date" means the maximum time period that a manufactured, compounded, or repackaged product may be used based on specified storage requirements.
(33) "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.
(34) "First air" means the air exiting the HEPA filter in a unidirectional airstream that is essentially particulate-free.
(35) "Generic names" mean the official compendia names or United States Adopted Names (USAN).
(36) "Glove fingertip test" means a test where the gloved fingertips and thumb are lightly pressed into appropriate agar plates. The plates are incubated for an appropriate time period and at an appropriate temperature.
(37) "Hazardous drug" means a drug that has at least one of the following properties: carcinogenicity; teratogenicity or developmental toxicity; reproductive toxicity in humans; organ toxicity at low doses in humans or animals; genotoxicity; or new drugs that mimic existing hazardous drugs in structure or toxicity.
(38) "Health care provider" includes a pharmacist who provides health care services within the pharmacist's scope of practice pursuant to state law and regulation.
(39) "High-efficiency particulate arrestor" or "HEPA" means a type of air filter that must satisfy certain efficiency standards set by the United States Department of Energy. A filter that qualifies as a HEPA is subject to interior classifications.
(40) "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.
(41) "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.
(42) "Institutional consultant pharmacist" means a pharmacist licensed in this State who acts as a consultant for institutional facilities.
(43) "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.
(44) "ISO" means the International Organization for Standardization.
(45) "ISO 5 environment" means an atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100.
(46) "ISO 7 environment" means an atmospheric environment that contains fewer than 352,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 10,000.
(47) "ISO 8 environment" means an atmospheric environment that contains fewer than 3,520,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100,000.
(48) "Isolator" means a self-contained primary engineering control defined by having fixed walls, a floor, and a ceiling, and includes barriers such as gloves, sleeves, and air locks that separate transfers of materials into and out of the environment. The use of an isolator can be an alternative to a buffer area for sterile preparations.
(49) "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.
(50) "Laminar air flow workbench" or "LAFW" means a primary engineering control that uses an ISO 5 controlled environment created by a HEPA filter to retain airborne particles and microorganisms, and has horizontal air flow or vertical air flow.
(51) "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.
(52) "Manufacturer" means a person engaged in the manufacture of prescription drugs or devices.
(53) "Material safety data sheet" or "MSDS" means a resource that provides information concerning a chemical, including:
(a) the identity, physical and chemical characteristics, physical and health hazards, primary routes of entry, and exposure limits of the chemical;
(b) whether the chemical is a carcinogen;
(c) precautions for safe handling and use of the chemical;
(d) control measures;
(e) emergency and first aid procedures;
(f) the latter of the date the MSDS was prepared or last modified; and
(g) the name, address, and telephone number of the manufacturer, importer, or employer who distributes the MSDS.
(54) "Media-fill test" means a test to evaluate the aseptic technique of:
(a) compounding personnel; and
(b) a process to ensure that the process used can produce sterile preparation that has no microbial contamination.
(55) "Medical order" means a lawful order of a practitioner which may or may not include a prescription drug order.
(56) "Negative pressure" means a room or device that is at a lower pressure than adjacent space; the air flow moves into the room or device.
(57) "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.
(58) "Nonresident pharmacy" means a pharmacy located outside this State.
(59) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin.
(60) "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.
(61) "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.
(62) "Person" means an individual, sole-proprietorship, corporation, partnership, association, or any other legal entity including government.
(63) "Personal protective equipment" or "PPE" means a gown, glove, mask, hair cover, shoe cover, eye shield, and similar items intended to protect the compounder from hazards and minimize particle shedding.
(64) "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.
(65) "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.
(66) "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.
(67) "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.
(68) "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.
(69) "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".
(70) "Positive pressure" means a room or device with higher pressure than adjacent space so that air flow moves out of, rather than into, the room or device.
(71) "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.
(72) "Practitioner" means a physician, dentist, optometrist, podiatrist, veterinarian, or other health care provider authorized by law to diagnose and prescribe drugs and devices.
(73) "Preparation" means a drug or nutrient compounded in a licensed pharmacy or licensed health care facility.
(74) "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 or compounded preparations 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.
(75) "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.
(76) "Primary engineering control" or "PEC" means a device, such as a laminar airflow workbench or an isolator, or a room that provides an ISO 5 environment.
(77) "Process verification and validation" means the process:
(a) used to evaluate whether a preparation, service, or system meets specifications and fulfills its intended purpose; and
(b) of establishing evidence that provides a high degree of assurance that a preparation, service, or system accomplishes its intended requirements.
(78) "Product" means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. A product is accompanied by FDA-approved manufacturer labeling or a product package insert.
(79) "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.
(80) "Pyrogen" means a substance or agent that tends to cause a rise in body temperature or fever.
(81) "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.
(82) "Secondary engineering control" means a buffer area and an ante area that meet the designated ISO classification.
(83) "Segregated compounding area for compounding sterile product preparations" means a designated space:
(a) confined to a room or a demarcated area;
(b) restricted to preparing low-risk CSPs with a twelve hour or less beyond-use time;
(c) containing a device that provides unidirectional air flow of ISO 5 air quality;
(d) free of materials extraneous to sterile compounding; and
(e) not used for other activities or purposes.
(84) "Significant adverse drug reaction" means a drug-related incident that may result in serious harm, injury, or death to the patient.
(85) "Sterile pharmaceutical" means a dosage form devoid of viable microorganisms.
(86) "Sterility test" means a process designed to determine the presence of bacteria or fungi in or on a test device or solution.
(87) "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.
(88) "Velocity" means the displacement air flow across the line of demarcation between a buffer area into the ante area in a single room.
(89) "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.
(90) "Zone of turbulence" means the pattern of flow of air from the HEPA filter created behind an object placed within the LAFW pulling or allowing contaminated room air into the aseptic environment.
HISTORY: 1998 Act No. 366, Section 1; 1999 Act No. 76, Sections 1, 2; 2002 Act No. 314, Section 2; 2017 Act No. 11 (H.3438), Section 4, eff April 24, 2017; 2018 Act No. 143 (H.3926), Section 1, eff March 20, 2018.
Effect of Amendment
2017 Act No. 11, Section 4, added (2), definition of "Biological product"; added (28), definition of "Interchangeable biological product"; redesignated the paragraphs accordingly; and made other nonsubstantive changes.
2018 Act No. 143, Section 1, rewrote the section.