C.R.S. Section 12-280-103
Definitions

rules

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Repealed.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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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.

(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.

(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)

Intentionally left blank —Ed.

(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; and

(IX)

Other activities as authorized and defined by the board by rule.

(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)

Intentionally left blank —Ed.

(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 opiate antagonists; or

(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;

(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; and

(k)

Providing treatment that is based on national, evidence-based, published guidance.

(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 opiate 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.

(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)

Intentionally left blank —Ed.

(a)

“Telepharmacy outlet” means a remote pharmacy site that:

(I)

Is registered as a prescription drug outlet or pharmacy under this article 280;

(II)

At the time of registration, is located in an area of need;

(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)

“Area of need” means:

(A)

Any health facility licensed or certified by the department of public health and environment pursuant to section 25-1.5-103 (1); or

(B)

Any area where a demonstration of need is approved by the board.

(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)

Intentionally left blank —Ed.

(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.

Source: Section 12-280-103 — Definitions - rules, https://leg.colorado.gov/sites/default/files/images/olls/crs2023-title-12.pdf (accessed Oct. 20, 2023).

California:	Codes
Colorado:	C.R.S.
Nevada:	NRS
New York:	Laws
Oregon:	OAR, ORS
Texas:	Statutes
World:	Rome Statute, International Dictionary

C.R.S. Section 12-280-103 Definitions

(1)

(2)

(2.5)

(3)

(4)

(5)

(6)

(7)

(8)

(8.5)

(8.7)

(9)

(9.5)

(a)

(b)

(9.7)

(10)

(a)

(I)

(II)

(b)

(11)

(12)

(13)

(14)

(15)

(15.5)

(16)

(a)

(I)

(II)

(III)

(IV)

(b)

(17)

(18)

(19)

(20)

(21)

(a)

(b)

(22)

(a)

(I)

(II)

(III)

(b)

(c)

(23)

(24)

(25)

(26)

(27)

(28)

(28.5)

(29)

(30)

(31)

(a)

(b)

(32)

(a)

(I)

(II)

(b)

(I)

(II)

(c)

(33)

(34)

(35)

(35.5)

(36)

(37)

(38)

(38.5)

(a)

(I)

(II)

C.R.S. Section 12-280-103
Definitions