2016 Colorado Revised Statutes
Title 12 - Professions and Occupations
Article 42.5 - Pharmacists, Pharmacy Businesses, and Pharmaceuticals
Part 1 - General Provisions
§ 12-42.5-102. Definitions
As used in this article, unless the context otherwise requires or the term is otherwise defined in another part of this article:
(1) "Administer" means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other method.
(2) "Advertise" means to publish or display information about prescription prices or drugs in any medium.
(3) "Anabolic steroid" has the same meaning as set forth in section 18-18-102 (3), C.R.S.
(3.5) "Authorized distributor of record" means a wholesaler with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. For purposes of this subsection (3.5), an ongoing relationship is deemed to exist between a wholesaler and a manufacturer when the wholesaler, including any affiliated group of the wholesaler as defined in section 1504 of the federal "Internal Revenue Code of 1986", complies with the following:
(a) The wholesaler has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship; and
(b) The wholesaler is listed on the manufacturer's current list of authorized distributors of record, which list is updated by the manufacturer on no less than a monthly basis.
(3.7) "Biological product" has the same meaning as "biological product", as defined in 42 U.S.C. sec. 262 (i) (1).
(4) "Board" means the state board of pharmacy.
(5) "Bureau" means the drug enforcement administration, or its successor agency, of the United States department of justice.
(6) "Casual sale" means a transfer, delivery, or distribution to a corporation, individual, or other entity, other than a consumer, entitled to possess prescription drugs; except that the amount of drugs transferred, delivered, or distributed in such manner by any registered prescription drug outlet or hospital other outlet shall not exceed ten percent of the total number of dosage units of drugs dispensed and distributed on an annual basis by such outlet.
(6.5) "Chain pharmacy warehouse" means a physical location for prescription drugs that serves as a central warehouse and performs intracompany sales or transfers of prescription drugs to a group of chain pharmacies or other chain pharmacy warehouses that are under common ownership or control. Notwithstanding any other provision of this article, a chain pharmacy warehouse receiving distributions on behalf of, or making distributions to, an intracompany pharmacy need not be an authorized distributor of record to be part of the normal distribution channel.
(7) (a) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device:
(I) As the result of a practitioner's prescription drug order, chart order, or initiative, based on the relationship between the practitioner, patient, and pharmacist in the course of professional practice; or
(II) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing.
(b) "Compounding" also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
(8) "Controlled substance" shall have the same meaning as in section 18-18-102 (5), C.R.S.
(9) "Delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration.
(10) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or similar or related article that is required under federal law to bear the label,"Caution: federal law requires dispensing by or on the order of a physician." "Device" also includes any component part of, or accessory or attachment to, any such article, whether or not the component part, accessory, or attachment is separately so labeled.
(11) "Dispense" means to interpret, evaluate, and implement a prescription drug order or chart order, including the preparation of a drug or device for a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to or use by a patient.
(12) "Distribution" means the transfer of a drug or device other than by administering or dispensing.
(13) (a) "Drug" means:
(I) Substances recognized as drugs in the official compendia;
(II) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in individuals or animals;
(III) Substances, other than food, intended to affect the structure or any function of the body of individuals or animals; and
(IV) Substances intended for use as a component of any substance specified in subparagraph (I), (II), or (III) of this paragraph (a).
(b) "Drug" does not include devices or their components, parts, or accessories.
(13.5) "FDA" means the federal food and drug administration.
(14) "Generic drug type" means the chemical or generic name, as determined by the United States adopted names (USAN) and accepted by the federal food and drug administration (FDA), of those drug products having exactly the same active chemical ingredients in exactly the same strength and quantity.
(15) "Hospital" means a general hospital or specialty hospital having a license or certificate of compliance issued by the department of public health and environment.
(16) "Hospital satellite pharmacy" means a satellite that registers pursuant to section 12-42.5-117 (10) for the purpose of administration of drugs to patients while being treated in the facility.
(16.5) "Interchangeable", in reference to a biological product, means:
(a) "Interchangeable" or "interchangeability", as determined by the FDA pursuant to 42 U.S.C. sec. 262 (k) (4); or
(b) That the FDA has deemed the biological product therapeutically equivalent to another biological product, as set forth in the latest edition or supplement of the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the "Orange Book".
(17) "Intern" means a person who is:
(a) (I) Enrolled in a professional degree program of a school or college of pharmacy that has been approved by the board;
(II) Currently licensed by the board to engage in the practice of pharmacy; and
(III) Satisfactorily progressing toward meeting the requirements for licensure as a pharmacist;
(c) A graduate of an approved professional degree program of a school or college of pharmacy or a graduate who has established education equivalency by obtaining a board-approved foreign pharmacy graduate certification and who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or
(d) A qualified applicant awaiting examination for licensure as a pharmacist or meeting board requirements for licensure.
(18) "Labeling" means the process of preparing and affixing a label to any drug container, exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or regulation.
(19) "Location" means the physical confines of an individual building or at the same address.
(19.5) "Long-term care facility" means a nursing facility, as defined in section 25.5-4-103 (14), C.R.S., that is licensed pursuant to section 25-1.5-103, C.R.S.
(20) "Manufacture" means to cultivate, grow, or prepare by other process drugs for sale to wholesalers or other persons entitled to purchase drugs other than the ultimate user, but "manufacture" does not include the compounding and dispensing of a prescription drug pursuant to a prescription order.
(20.5) "Manufacturer's exclusive distributor" means a person who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to the manufacturer's prescription drug but who does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug. To be considered part of the normal distribution channel, as defined in section 12-42.5-301 (6), a manufacturer's exclusive distributor shall be an authorized distributor of record.
(21) "Nonprescription drug" means a drug that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the law and rules of this state and the federal government.
(22) "Nuclear pharmacy" means a specialized pharmacy that deals with the preparation and delivery of radioactive material as defined in section 25-11-101, C.R.S.
(23) "Official compendia" means the official United States pharmacopeia, national formulary, homeopathic pharmacopoeia of the United States, or any supplements thereto.
(24) "Order" means:
(a) A prescription order that is any order, other than a chart order, authorizing the dispensing of a single drug or device that is written, mechanically produced, computer generated and signed by the practitioner, transmitted electronically or by facsimile, or produced by other means of communication by a practitioner to a licensed pharmacy or pharmacist and that includes the name or identification of the patient, the date, the symptom or purpose for which the drug is being prescribed, if included by the practitioner at the patient's authorization, and sufficient information for compounding, dispensing, and labeling; or
(b) A chart order, which is an order for inpatient drugs or medications that are to be dispensed by a pharmacist, or by a pharmacy intern under the direct supervision of a pharmacist, and administered by an authorized person only during the patient's stay in a hospital, medical clinic operated by a hospital, ambulatory surgical center, hospice, or long-term care facility. The chart order shall contain the name of the patient and the medicine ordered and such directions as the practitioner may prescribe concerning strength, dosage, frequency, and route of administration.
(25) "Other outlet" means:
(a) A hospital that does not operate a registered pharmacy, a rural health clinic, a federally qualified health center, as defined in section 1861 (aa) (4) of the federal "Social Security Act", 42 U.S.C. sec. 1395x (aa) (4), a family planning clinic, an acute treatment unit licensed by the department of public health and environment, a school, a jail, a county or district public health agency, a community health clinic, a university, or a college that:
(I) Has facilities in this state registered pursuant to this article; and
(II) Engages in the compounding, dispensing, and delivery of drugs or devices;
(b) An ambulatory surgical center licensed pursuant to part 1 of article 3 of title 25, C.R.S., a medical clinic operated by a hospital, or a hospice licensed pursuant to part 1 of article 3 of title 25, C.R.S., that:
(I) Has facilities in this state registered pursuant to this article; and
(II) Engages in the compounding, dispensing, and delivery of drugs or devices for administration to patients while being treated in the facility; or
(c) A telepharmacy outlet.
(26) "Patient counseling" means the oral communication by a pharmacist or intern of information to the patient or caregiver in order to improve therapy by ensuring proper use of drugs and devices.
(27) "Pharmaceutical care" means the provision of drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. In addition to the preparation, dispensing, and distribution of medications, "pharmaceutical care" may include assessment and evaluation of the patient's medication-related needs and development and communication of a therapeutic plan with defined outcomes in consultation with the patient and the patient's other health care professionals to attain the desired outcome. This function includes efforts to prevent, detect, and resolve medication-related problems for individual patients. "Pharmaceutical care" does not include prescriptive authority; except that a pharmacist may prescribe only over-the-counter medications to a recipient under the "Colorado Medical Assistance Act" as authorized pursuant to section 25.5-5-322, C.R.S.
(28) "Pharmacist" means an individual licensed by this state to engage in the practice of pharmacy.
(29) "Pharmacist manager" means an individual, licensed in this state as a pharmacist, who has direct control of the pharmaceutical affairs of a prescription drug outlet, and who is not the manager of any other prescription drug outlet.
(29.5) "Pharmacy buying cooperative warehouse" means a permanent physical location that acts as a central warehouse for prescription drugs and from which sales of prescription drugs are made to an exclusive group of pharmacies that are members or member owners of the buying cooperative operating the warehouse.
(30) "Pharmacy technician" means an unlicensed person who performs those functions set forth in paragraph (b) of subsection (31) of this section under the supervision of a pharmacist.
(31) "Practice of pharmacy" means:
(a) The interpretation, evaluation, implementation, and dispensing of orders; participation in drug and device selection, drug administration, drug regimen reviews, and drug or drug-related research; provision of patient counseling; and the provision of those acts or services necessary to provide pharmaceutical care in all areas of patient care;
(b) (I) The preparation, mixing, assembling, packaging, labeling, or delivery of a drug or device;
(II) Proper and safe storage of drugs or devices; and
(III) The maintenance of proper records for such drugs and devices; and
(c) The provision of a therapeutic interchange selection or a therapeutically equivalent selection to a patient if, during the patient's stay at a nursing care facility or a long-term acute care hospital licensed under part 1 of article 3 of title 25, C.R.S., the selection has been approved for the patient:
(I) In accordance with written guidelines and procedures for making therapeutic interchange or therapeutically equivalent selections, as developed by a quality assessment and assurance committee that includes a pharmacist licensed under this article and is formed by the nursing care facility or the long-term acute care hospital in accordance with 42 CFR 483.75 (o); and
(II) By one of the following health care providers:
(A) A physician licensed under article 36 of this title;
(B) A physician assistant licensed under section 12-36-107.4, if the physician assistant is under the supervision of a licensed physician; or
(C) An advanced practice nurse prescriber licensed as a professional nurse under section 12-38-111, registered as an advanced practice nurse under section 12-38-111.5, and authorized to prescribe controlled substances or prescription drugs pursuant to section 12-38-111.6, if the advanced practice nurse prescriber has developed an articulated plan to maintain ongoing collaboration with physicians and other health care professionals.
(32) "Practitioner" means a person authorized by law to prescribe any drug or device, acting within the scope of such authority.
(33) "Prescription" means the finished product of the dispensing of a prescription order in an appropriately labeled and suitable container.
(34) "Prescription drug" means a drug that:
(a) Is required by any applicable federal or state law or rule to be dispensed only pursuant to an order;
(b) Is restricted by any applicable federal or state law or rule to use by practitioners only; or
(c) Prior to being dispensed or delivered, is required under federal law to be labeled with one of the following statements:
(I) "Rx only"; or
(II) "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
(35) "Prescription drug outlet" or "pharmacy" means any pharmacy outlet registered pursuant to this article where prescriptions are compounded and dispensed. "Prescription drug outlet" includes, without limitation, a compounding prescription drug outlet registered pursuant to section 12-42.5-117 (9) or specialized prescription drug outlet registered pursuant to section 12-42.5-117 (11).
(36) "Refill" means the compounding and dispensing of any drug pursuant to a previously executed order.
(36.3) "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding repackaging or labeling completed by the pharmacist responsible for dispensing product to the patient.
(36.5) "Repackager" means a person who repackages prescription drugs.
(37) "Sample" means any prescription drug given free of charge to any practitioner for any reason except for a bona fide research program.
(38) "Satellite" means an area outside the prescription drug outlet where pharmaceutical care and services are provided and that is in the same location.
(39) "Supervision" means that a licensed pharmacist is on the location and readily available to consult with and assist unlicensed personnel performing tasks described in paragraph (b) of subsection (31) of this section. If the unlicensed person is a pharmacy technician located at a registered telepharmacy outlet, the licensed pharmacist need not be physically present at the telepharmacy outlet as long as the licensed pharmacist is connected to the telepharmacy outlet via computer link, video link, and audio link, or via other telecommunication equipment of equivalent functionality, and is readily available to consult with and assist the pharmacy technician in performing tasks described in paragraph (b) of subsection (31) of this section.
(39.5) (a) "Telepharmacy outlet" means a remote pharmacy site that:
(I) Is registered as an other outlet under this article;
(II) At the time of registration, is located more than twenty miles from the nearest prescription drug outlet and from any other telepharmacy outlet registered under this article;
(III) Is connected via computer link, video link, and audio link, or via other functionally equivalent telecommunication equipment, with a central pharmacy that is registered under this article; and
(IV) Has a pharmacy technician on site who, under the remote supervision of a licensed pharmacist located at the central pharmacy, performs the tasks described in paragraph (b) of subsection (31) of this section.
(b) The board may adopt rules as necessary to specify additional criteria for a telepharmacy outlet that the board deems necessary.
(39.7) "Therapeutic interchange" means the substitution of one drug for another drug with similar therapeutic effects.
(40) "Therapeutically equivalent" or "equivalent" means those compounds containing the identical active chemical ingredients of identical strength, quantity, and dosage form and of the same generic drug type, which, when administered in the same amounts, will provide the same therapeutic effect as evidenced by the control of a symptom or disease.
(41) "Ultimate user" means a person who lawfully possesses a prescription drug for his or her own use, for the use of a member of the person's household, or for use in administering to an animal owned by the person or a member of his or her household.
(42) (a) "Wholesale distribution" means distribution of prescription drugs to persons or entities other than a consumer or patient.
(b) "Wholesale distribution" does not include:
(I) Intracompany sales or transfers of prescription drugs, including a transaction or transfer between a division, subsidiary, parent, or affiliated or related company under common ownership or control of an entity;
(II) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons or during a state or national declaration of emergency;
(III) The sale or transfer of a drug for medical reasons by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
(IV) The distribution of prescription drug samples by a manufacturer's representative;
(V) Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with 21 CFR 203.23;
(VI) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed practitioners for office use;
(VII) A retail pharmacy's delivery of prescription drugs to a patient or patient's agent pursuant to the lawful order of a licensed practitioner;
(VIII) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy or pharmacies from or with another pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets;
(IX) The direct sale, purchase, distribution, trade, or transfer of a prescription drug from a manufacturer to an authorized distributor of record to one additional authorized distributor of record but only if an authorized distributor of record that purchases a prescription drug from an authorized distributor of record that purchased the prescription drug directly from the manufacturer:
(A) Provides the supplying authorized distributor of record with a verifiable statement that the product is unavailable from the manufacturer; and
(B) Receives a verifiable statement from the supplying authorized distributor of record that the product was purchased directly from the manufacturer;
(X) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs where the common carrier does not store, warehouse, or take legal ownership of the prescription drug;
(XI) The sale or transfer from a retail pharmacy or chain pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer or to a third-party returns processor;
(XII) The sale or transfer of compounded drugs compounded by a retail pharmacy as defined in subsection (7) of this section and as authorized by section 12-42.5-119 (6) (b);
(XIII) The transfer of prescription drugs within Colorado purchased with public funds by the department of public health and environment, created in section 25-1-102, C.R.S., or a district or county public health agency, created pursuant to section 25-1-506, C.R.S., and procured by a physician licensed in Colorado who is either the executive director or the chief medical officer appointed pursuant to section 25-1-105, C.R.S., or a public health director or medical officer of a county or district public health agency selected pursuant to section 25-1-508 (5) (c) (I), C.R.S. The transfers may only be made to the department of public health and environment pursuant to the Colorado medical license of the executive director or chief medical officer, a district or county public health agency pursuant to the Colorado medical license of the public health director or medical officer, or a physician licensed in Colorado.
(XIV) The distribution of naloxone;
(XV) The distribution, donation, or sale by a manufacturer or wholesaler of a stock supply of epinephrine auto-injectors to public schools or nonpublic schools for emergency use by designated school personnel in accordance with the requirements of section 22-1-119.5, C.R.S., or to other entities for emergency use in accordance with the requirements of article 47 of title 25, C.R.S.
(43) "Wholesaler" means a person engaged in the wholesale distribution of prescription drugs to persons, other than consumers, who are entitled to possess prescription drugs, including: Repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses; manufacturers' exclusive distributors; authorized distributors of record; drug wholesalers or distributors; independent wholesale drug traders; pharmacy buying cooperative warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.
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