C.R.S. Section 12-280-141
Prescription drugs

  • automated pharmacy dispensing system
  • rules
  • definition

(1)

As used in this section, “automated pharmacy dispensing system” or “system” means a mechanical system that dispenses prescription drugs to a person interacting with a remote pharmacist and maintains related transaction information.

(2)

A prescription drug outlet may dispense prescription drugs through an automated pharmacy dispensing system in accordance with this section and rules promulgated by the board. A prescription drug outlet that operates an automated prescription drug dispensing system is solely responsible for the security, operation, and maintenance of the system and shall ensure that there is a pharmacist acting on behalf of the prescription drug outlet providing services to patients accessing prescription drugs through the system. The pharmacist may supervise the system through electronic means and is not required to be physically present at the site where the system is located.

(3)

A prescription drug outlet that dispenses prescription drugs through an automated pharmacy dispensing system shall:

(a)

Register the system with the board in accordance with rules promulgated by the board;

(b)

Require a pharmacist to perform all clinical services conducted as part of the dispensing process, including drug utilization review and consultation services;

(c)

Ensure that each system clearly displays the associated prescription drug outlet registration number and clear contact information for persons using the system to contact the prescription drug outlet;

(d)

Locate each system that dispenses controlled substances at the same location as a prescription drug outlet registered by the United States drug enforcement agency;

(e)

Maintain a record of each prescription drug dispensed from the automated pharmacy dispensing system, including the identity of the pharmacist responsible for verifying the accuracy of the dosage of the prescription drug dispensed, the directions for use of the prescription drug, and the counseling services, if any, provided to the individual to whom the prescription drug is dispensed;

(f)

Ensure that confidentiality of personal health information is maintained; and

(g)

Ensure that the system is accessible to persons with disabilities in compliance with the requirements of the federal “Americans with Disabilities Act of 1990”, 42 U.S.C. sec. 12101 et seq., as amended.

(4)

A prescription drug outlet may operate an automated pharmacy dispensing system in the same or in a different location than the prescription drug outlet. The automated pharmacy dispensing system must be:

(a)

Under the supervision and control of the prescription drug outlet;

(b)

Installed in a place and in a manner to ensure that a person is unable to remove the system from its location and any attempts to obtain access to the system without authorization are visible to the prescription drug outlet pharmacist, either through the direct view of the pharmacist or by real-time, audio-visual communication technology or audio-visual recording technology; and

(c)

Located in a secure location in:

(I)

The registered address of the prescription drug outlet;

(II)

The medical facility; or

(III)

The practice location of one or more practitioners.

(5)

An automated pharmacy dispensing system may only dispense prescription drugs upon the authorization of a pharmacist acting on behalf of the prescription drug outlet after the pharmacist has reviewed the prescription order and the patient’s profile for potential contraindications and adverse drug reactions.

(6)

Intentionally left blank —Ed.

(a)

A prescription drug outlet operating an automated pharmacy dispensing system shall develop, implement, and maintain written policies and procedures to ensure the proper, safe, and secure functioning of the system. The policies and procedures must, at a minimum, address:

(I)

Maintaining the security of the automated pharmacy dispensing system and any accompanying electronic verification process and ensuring the system and accompanying electronic verification process are in good working order;

(II)

Ensuring the accurate filling, stocking, restocking, and final verification of prescription drugs dispensed from the system;

(III)

Ensuring the sanitary operation of the system and the prevention of cross-contamination of cells, cartridges, containers, cassettes, and packages;

(IV)

Training of individuals authorized to access, stock, restock, and use the system;

(V)

Conducting routine and preventive maintenance of the system, including calibration of the system, if applicable;

(VI)

Removing expired, adulterated, misbranded, or recalled prescription drugs from the system;

(VII)

Ensuring that prescription drugs are stored under appropriate conditions and temperatures;

(VIII)

Preventing unauthorized individuals from accessing the system, including assigning, discontinuing, or modifying security access to the system;

(IX)

Identifying and recording the individuals who are responsible for filling, stocking, and restocking the system; and

(X)

Ensuring compliance with state and federal laws, including all applicable labeling, storage, and security requirements.

(b)

The prescription drug outlet shall annually review the written policies and procedures required pursuant to this subsection (6). The prescription drug outlet shall document its annual review of the policies and procedures, maintain the record of each review for at least two years, and make the review records available to the board upon request.

(c)

The prescription drug outlet operating an automated pharmacy dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of prescription drugs into and out of the system to ensure proper security, accuracy, and accountability.

(7)

The prescription drug outlet operating the automated pharmacy dispensing system is responsible for the operation, maintenance, and security of the system and shall label prescription drugs dispensed from the system in accordance with existing law that records each transaction made through the system.

(8)

A prescription drug outlet that operates inside the premises of a retail business shall only operate an automated pharmacy dispensing system during the hours that the prescription drug outlet is closed.

(9)

All prescription drugs stored in an automated pharmacy dispensing system are part of the inventory of the prescription drug outlet operating the system, and all prescription drugs dispensed from the system are considered to have been dispensed by the prescription drug outlet that operates the system.

(10)

The prescription drug outlet shall make all transaction information concerning each system under its operation readily available in a downloadable format for review and inspection by the board. A prescription drug outlet shall maintain the records for the period of time determined by rule of the board.

(11)

The board may promulgate rules as necessary to implement this section.

Source: Section 12-280-141 — Prescription drugs - automated pharmacy dispensing system - rules - definition, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-12.­pdf (accessed Oct. 20, 2023).

12‑280‑101
Public interest - rules 12‑280‑102
Applicability of common provisions 12‑280‑103
Definitions - rules 12‑280‑104
State board of pharmacy - creation - subject to review - repeal of parts 12‑280‑105
Membership of board - removal - compensation - meetings 12‑280‑106
Veterinary pharmaceutical advisory committee - creation - appointments - rules - repeal 12‑280‑107
Rules 12‑280‑108
Powers and duties - rules 12‑280‑109
Drugs, devices, and other materials 12‑280‑110
Publications 12‑280‑111
Malpractice claims information - not public - exception 12‑280‑112
Fees 12‑280‑113
Approval of schools 12‑280‑114
Licensure, certification, or registration - applicability - applications - licensure and certification requirements - rules 12‑280‑115
Exemptions from licensure - hospital residency programs - home renal dialysis - research companies 12‑280‑115.5
Certification of pharmacy technicians - requirements - provisional certification - criminal history record check - rules 12‑280‑116
Expiration and renewal of licenses, certifications, or registrations 12‑280‑117
Continuing education - exceptions - inactive status 12‑280‑117.5
Continuing education for pharmacy technicians - exceptions - inactive status 12‑280‑118
Prescription drug outlet under charge of pharmacist - rules 12‑280‑119
Registration of facilities - rules 12‑280‑120
Compounding - dispensing - sale of drugs and devices - rules - definition 12‑280‑121
Compounding drugs for office use by a veterinarian - rules - definitions 12‑280‑122
Limited authority to delegate activities constituting practice of pharmacy to pharmacy interns or pharmacy technicians 12‑280‑123
Prescription required - exception - dispensing opiate antagonists - selling nonprescription syringes and needles 12‑280‑124
Labeling - rules 12‑280‑125
Substitution of prescribed drugs and biological products authorized - when - conditions 12‑280‑125.3
Pharmacists’ authority - minor prescription adaptions 12‑280‑125.5
Pharmacists’ authority to dispense chronic maintenance drugs - rules - liability 12‑280‑125.7
Pharmacists’ authority to prescribe and dispense HIV prevention drugs - definitions - rules 12‑280‑126
Unprofessional conduct - grounds for discipline 12‑280‑127
Disciplinary actions 12‑280‑128
Judicial review 12‑280‑129
Unlawful acts - civil fines 12‑280‑130
Unauthorized practice - penalties 12‑280‑131
New drugs - when sales permissible 12‑280‑132
Advertising of prescription drug prices 12‑280‑133
Nonresident prescription drug outlet - registration 12‑280‑133.5
Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules 12‑280‑133.7
Third-party logistics providers - registration - denial, revocation, or suspension - rules 12‑280‑134
Records 12‑280‑135
Unused medication - licensed facilities - correctional facilities - reuse - definitions - rules 12‑280‑136
Confidential agreement to limit practice 12‑280‑137
Investigations of suspicious drugs 12‑280‑138
Patient counseling - pharmacists required to perform - patient may decline - rules 12‑280‑139
Insulin affordability program - record keeping - reimbursement - definitions 12‑280‑140
Emergency prescription insulin supply - eligibility - record keeping 12‑280‑141
Prescription drugs - automated pharmacy dispensing system - rules - definition 12‑280‑142
Epinephrine auto-injector affordability program - record keeping - reimbursement - definitions 12‑280‑201
Legislative declaration 12‑280‑202
Definitions 12‑280‑203
Pharmacy peer health assistance fund - rules 12‑280‑204
Eligibility - participants 12‑280‑205
Liability 12‑280‑206
Immunity 12‑280‑301
Definitions 12‑280‑303
Wholesaler registration requirements - rules 12‑280‑304
Record check 12‑280‑305
Restrictions on transactions 12‑280‑306
Records - pedigree - compliance with DQSA 12‑280‑307
Penalty 12‑280‑308
Manufacturer, agent, representative, or employee - drug cost information - required - definitions 12‑280‑401
Legislative declaration 12‑280‑402
Definitions 12‑280‑403
Prescription drug use monitoring program - registration required - applications - rules - appropriation - repeal 12‑280‑404
Program operation - access - rules - definitions 12‑280‑405
Prescription drug monitoring fund - creation - fee 12‑280‑406
Violations - penalties 12‑280‑407
Prescription drug outlets - prescribers - responsibilities - liability 12‑280‑408
Exemption - waiver 12‑280‑409
Examination and analysis of prescription drug monitoring program - recommendations to executive director 12‑280‑501
Written guidelines and procedures for making therapeutic interchange and therapeutically equivalent selections 12‑280‑502
Therapeutic interchange and therapeutically equivalent selections for nursing care facility or long-term acute care hospital patients - rules 12‑280‑601
Definitions 12‑280‑602
Collaborative pharmacy practice agreements - pharmacist requirements 12‑280‑603
Rules
Green check means up to date. Up to date

Current through Fall 2024

§ 12-280-141’s source at colorado​.gov