§ 12-280-103 — Definitions - rules
This text of Colorado § 12-280-103 (Definitions - rules) is published on Counsel Stack Legal Research, covering Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Text
As used in this article 280, unless the context otherwise requires or the term is otherwise defined in another part of this article 280:
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As used in this article 280, unless the
context otherwise requires or the term is otherwise defined in another part of this
article 280:
(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.
(2.5) Animal shelter has the meaning set forth in section 35-80-102.
(3) Approved treatment facility means an approved private or public
treatment facility, as described in section 27-81-102 (2) and (3), that adheres to the
standards set forth in section 27-81-106.
(4) Behavioral health entity means a behavioral health entity, as defined in
section 25-27.6-102 (6), licensed pursuant to article 27.6 of title 25.
(5) Biological product has the same meaning as set forth in 42 U.S.C. sec.
262 (i)(1).
(6) Board means the state board of pharmacy created in section 12-280-104.
(7) Bureau means the federal drug enforcement administration, or its
successor agency.
(8) 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 this
manner by any registered prescription drug outlet or any registered other outlet
shall not exceed ten percent of the total number of dosage units of drugs
dispensed and distributed or originally procured in any registered other outlet on an
annual basis by the outlet.
(8.5) Certification means a certification to practice as a pharmacy
technician issued by the board in accordance with section 12-280-115.5 (2) and
includes a provisional certification issued in accordance with section 12-280-115.5
(3).
(8.7) Certifying organization means a board-approved, nationally
recognized organization that certifies pharmacy technicians.
(9) Repealed.
(9.5) Chronic maintenance drug means a drug that:
(a) Is not an opioid or is not a controlled substance that is prohibited from
being dispensed without a prescription under the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. sec. 301 et seq., as amended; and
(b) Is prescribed to a patient to take on a recurring basis or is used as a life-saving rescue drug for a chronic condition.
(9.7) Community mental health clinic has the same meaning as set forth in
section 25-27.6-102 (9).
(10) (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.
(11) Controlled substance shall have the same meaning as in section 18-18-102 (5).
(12) Delivery means the actual, constructive, or attempted transfer of a
drug or device from one person to another, whether or not for consideration.
(13) 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.
(14) 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.
(15) Distribution means the transfer of a drug or device other than by
administering or dispensing.
(15.5) DQSA means the federal Drug Quality and Security Act, Pub.L. 113-54, as amended.
(16) (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 subsection (16)(a)(I), (16)(a)(II), or (16)(a)(III) of this section.
(b) Drug does not include devices or their components, parts, or
accessories.
(17) FDA means the federal food and drug administration.
(18) Generic drug type means the chemical or generic name, as determined
by the United States Adopted Names (USAN) Council and accepted by the FDA, of
those drug products having exactly the same active chemical ingredients in exactly
the same strength and quantity.
(19) Hospital means a general hospital or specialty hospital having a
license or certificate of compliance issued by the department of public health and
environment.
(20) Hospital satellite pharmacy means a satellite that registers pursuant
to section 12-280-119 (10) for the purpose of administration of drugs to patients
while being treated in the facility.
(21) 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.
(22) 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;
(b) 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
(c) A qualified applicant awaiting examination for licensure as a pharmacist
or meeting board requirements for licensure.
(22.5) Inventory function means any nondispensing-related activity that is
related to the management of inventory and that may be performed by nonlicensed
personnel under the supervision of a licensed pharmacist.
(23) 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.
(24) Location means the physical confines of an individual building or at
the same address.
(25) Long-term care facility means a nursing facility, as defined in section
25.5-4-103 (14), that is licensed pursuant to section 25-1.5-103.
(26) 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.
(27) Manufacturer or manufacturing drug outlet means a person who
manufactures drugs and includes a resident 503B outsourcing facility.
(27.5) Medications for opioid use disorder or MOUD means treatment for
an opioid use disorder using medications approved by the FDA for that purpose and
prescribed, dispensed, or administered in accordance with national, evidence-based
published guidance.
(28) 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.
(28.5) Nonresident 503B outsourcing facility means a facility that is
registered by the FDA, that is located outside the state, and that distributes
compounded drugs into the state without a prescription order.
(29) Nuclear pharmacy means a specialized pharmacy that deals with the
preparation and delivery of radioactive material as defined in section 25-11-101.
(30) Official compendia means the official United States pharmacopeia,
national formulary, homeopathic pharmacopoeia of the United States, or any
supplements thereto.
(31) 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 the directions the practitioner
may prescribe concerning strength, dosage, frequency, and route of administration.
(32) 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 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 community
mental health clinic, a behavioral health entity, an approved treatment facility, a
university, or a college that:
(I) Has facilities in this state registered pursuant to this article 280; and
(II) Engages in the compounding, dispensing, and delivery of drugs or
devices; or
(b) An ambulatory surgical center, a hospice, or a convalescent center, each
of which is licensed pursuant to part 1 of article 3 of title 25, or a medical clinic
operated by a hospital, each of which:
(I) Has facilities in this state registered pursuant to this article 280; and
(II) Engages in the compounding, dispensing, and delivery of drugs or devices
for administration to patients while being treated in the facility.
(c) Repealed.
(33) 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.
(34) Repealed.
(35) Pharmacist means an individual licensed by this state to engage in the
practice of pharmacy.
(35.5) Pharmacist care services means patient care activities provided by a
pharmacist, with or without dispensing a drug, that are intended to achieve
outcomes related to curing or preventing disease, eliminating or reducing a
patient's symptoms, or arresting or slowing the process of a disease. Pharmacist
care services includes efforts to prevent, detect, and resolve medication-related
problems.
(36) 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, except as provided in section 12-280-118 (1)(a), is not the
manager of any other prescription drug outlet.
(37) Repealed.
(38) Pharmacy technician or certificant means a person who is certified
by the board to practice as a pharmacy technician and includes a person issued a
provisional certification pursuant to section 12-280-115.5 (3).
(38.5) (a) Practice as a pharmacy technician means engaging in any of the
following activities involved in the practice of pharmacy, under the supervision and
delegation of a supervising pharmacist:
(I) Receiving and initially inputting new written, facsimile, or electronic
orders;
(II) Preparing, mixing, assembling, packaging, labeling, or delivering a drug
or device;
(III) Properly and safely storing drugs or devices;
(IV) Maintaining proper records for drugs and devices;
(V) Transferring prescriptions;
(VI) Gathering, documenting, and maintaining proper clinical and nonclinical
information from patients;
(VII) Replenishing automated dispensing devices without the need for
pharmacist verification as long as the pharmacy technician uses bar code
technology that checks the accuracy of the medication or a second pharmacy
technician performs the verification;
(VIII) Performing point-of-care testing and patient care technical tasks as
specifically trained for and delegated by a supervising pharmacist;
(IX) Other activities as authorized and defined by the board by rule;
(X) Redispensing a prescription drug pursuant to section 12-280-141 (9)(b)
and (9)(c); and
(XI) Requesting refill authorization from the prescriber or prescriber's agent
and receiving clarifying prescription information from the prescriber or prescriber's
agent.
(b) Practice as a pharmacy technician does not include activities or
services described in subsection (38.5)(a) of this section that are performed by
employees or personnel of a practitioner dispensing drugs to patients pursuant to
section 12-280-120 (6) or of a registered other outlet, which practitioner or other
outlet does not store, compound, dispense, or deliver controlled substances.
(39) 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; the provision of patient counseling; and
the provision of those acts or services necessary to provide pharmacist care
services 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 the drugs and devices;
(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, 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 280 and is formed by the nursing care facility or the long-term
acute care hospital in accordance with 42 CFR 483.75; and
(II) By one of the following health-care providers:
(A) A physician licensed under article 240 of this title 12;
(B) A physician assistant licensed under section 12-240-113; or
(C) An advanced practice registered nurse prescriber licensed as a
professional nurse under section 12-255-110, registered as an advanced practice
registered nurse under section 12-255-111, and authorized to prescribe controlled
substances or prescription drugs pursuant to section 12-255-112;
(d) The dispensing of chronic maintenance drugs pursuant to section 12-280-125.5 and board rules adopted in accordance with that section;
(e) Pursuant to a standing order or to a statewide drug therapy protocol
developed pursuant to section 12-280-125.7, the prescribing and dispensing of
post-exposure prophylaxis, as defined in section 12-280-125.7 (1)(d), for
nonoccupational exposure to HIV infection and preexposure prophylaxis, as defined
in section 12-280-125.7 (1)(e), and the ordering of lab tests in conjunction with
prescribing or dispensing the drugs;
(f) Providing care to patients pursuant to a collaborative pharmacy practice
agreement as defined in section 12-280-601;
(g) Exercising independent prescriptive authority:
(I) As authorized pursuant to section 25.5-5-322, only with regard to over-the-counter medications prescribed to recipients under the Colorado Medical
Assistance Act, articles 4 to 6 of title 25.5;
(II) In accordance with a collaborative pharmacy practice agreement as
defined in section 12-280-601 (1)(b);
(III) As authorized pursuant to sections 12-30-110 and 12-280-123 (3)
regarding opioid antagonists;
(IV) For drugs that are not controlled substances, drug categories, or devices
that are prescribed in accordance with the product's FDA-approved labeling and to
patients who are at least twelve years of age and that are limited to conditions that:
(A) Do not require a new diagnosis;
(B) Are minor and generally self-limiting; or
(C) Have a test that is used to guide diagnosis or clinical decision-making
and is waived under the federal Clinical Laboratory Improvement Amendments of
1988, Pub.L. 100-578, as amended; or
(V) For any FDA-approved product indicated for opioid use disorder in
accordance with federal law and regulations, including medications for opioid use
disorder, if authorized pursuant to part 6 of this article 280;
(h) Ordering and evaluating laboratory tests as related to medication
therapy;
(i) Performing limited physical assessments commensurate with education
and training;
(j) Performing other tasks delegated by a licensed physician;
(k) Providing treatment that is based on national, evidence-based published
guidance; and
(l) Dispensing or administering any FDA-approved product for opioid use
disorder in accordance with federal law and regulations, including medications for
opioid use disorder.
(40) Practitioner means a person authorized by law to prescribe any drug
or device, acting within the scope of the authority, including a pharmacist who is
participating within the parameters of a statewide drug therapy protocol pursuant
to a collaborative pharmacy practice agreement as defined in section 12-280-601
(1)(b), prescribing over-the-counter medications pursuant to section 25.5-5-322, or
prescribing an opioid antagonist pursuant to sections 12-30-110 and 12-280-123 (3).
(41) Prescription means the finished product of the dispensing of a
prescription order in an appropriately labeled and suitable container.
(42) 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.
(43) Prescription drug outlet or pharmacy means any pharmacy outlet
registered pursuant to this article 280 where prescriptions are compounded and
dispensed. Prescription drug outlet includes, without limitation, a specialized
prescription drug outlet registered pursuant to section 12-280-119 (11) and a
telepharmacy outlet.
(44) Refill means the compounding and dispensing of any drug pursuant to
a previously executed order.
(45) 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.
(46) Repackager means a person who repackages prescription drugs.
(46.5) Resident 503B outsourcing facility means a facility that is
registered by the FDA, that is located in the state, and that distributes compounded
drugs within the state.
(46.7) Rural independent pharmacy has the meaning set forth in section
10-16-102 (59.5).
(47) Sample means any prescription drug given free of charge to any
practitioner for any reason except for a bona fide research program.
(48) Satellite means an area outside the prescription drug outlet where
pharmacist care services are provided and that is in the same location.
(49) Supervision means that a licensed pharmacist is on the location and
readily available to consult with and assist certificants practicing as pharmacy
technicians as described in subsection (38.5) of this section or ancillary personnel
performing tasks at the direction of the licensed pharmacist, excluding tasks
described in subsection (38.5)(a) of this section but which tasks may include
delivery and proper and safe storage of drugs or devices. If the 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 subsection (38.5)(a) of this section.
(50) (a) Telepharmacy outlet means a remote pharmacy site that:
(I) Is registered as a prescription drug outlet or pharmacy under this article
280;
(II) Repealed.
(III) Is connected via computer link, video link, and audio link, or via other
functionally equivalent telecommunication equipment, with a central pharmacy
located in this state that is registered under this article 280; and
(IV) Has a pharmacy technician on site who, under the remote supervision of
a licensed pharmacist located at the central pharmacy in this state, performs the
tasks described in subsection (38.5)(a) of this section.
(b) (Deleted by amendment, L. 2022.)
(c) As used in this subsection (50):
(I) Repealed.
(II) Central pharmacy means a registered pharmacy outlet responsible for
overseeing the operation of a telepharmacy outlet.
(51) Therapeutic interchange means the substitution of one drug for
another drug with similar therapeutic effects.
(52) 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.
(52.5) Third-party logistics provider means a person that contracts with a
manufacturer to provide or coordinate warehousing, distribution, or other services
on behalf of a manufacturer but does not take title to a prescription drug or have
general responsibility to direct the prescription drug's sale or disposition.
(53) 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.
(54) (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 prescription drug that is not compounded or
prepackaged by the selling or transferring pharmacy, except as allowed pursuant
to section 12-280-120 (15)(b), for medical reasons by an in-state or unregistered
nonresident pharmacy to a separate in-state pharmacy under common ownership
with the selling or transferring in-state or unregistered nonresident 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) Repealed.
(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 of expired, damaged,
returned, or recalled prescription drugs to the original manufacturer or to a third-party returns processor;
(XII) Repealed.
(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, or a district or county public health agency, created pursuant to
section 25-1-506, 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 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). 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, or to other entities for emergency use in
accordance with the requirements of article 47 of title 25;
(XVI) 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
federal Internal Revenue Code of 1986, as amended, to a nonprofit affiliate of the
organization to the extent otherwise permitted by law.
(55) Wholesaler means a person engaged in the wholesale distribution of
prescription drugs to persons, other than consumers, that are authorized by law to
possess prescription drugs.
Related
Legislative History
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