C.R.S. Section 12-280-125
Substitution of prescribed drugs and biological products authorized

  • when
  • conditions

(1)

Intentionally left blank —Ed.

(a)

A pharmacist filling a prescription order for a specific drug by brand or proprietary name may substitute an equivalent drug product if the substituted drug product is the same generic drug type and, in the pharmacist’s professional judgment, the substituted drug product is therapeutically equivalent, is interchangeable with the prescribed drug, and is permitted to be moved in interstate commerce. A pharmacist making a substitution shall assume the same responsibility for selecting the dispensed drug product as he or she would incur in filling a prescription for a drug product prescribed by a generic name; except that the pharmacist is charged with notice and knowledge of the FDA list of approved drug substances and manufacturers that is published periodically.

(a.5)

Intentionally left blank —Ed.

(I)

A pharmacist filling a prescription order for a specific drug may substitute a drug in the same therapeutic class as long as the patient agrees to the substitution and the substitution is made to replace a drug that is on back order, to ensure formulary compliance with the patient’s health insurance plan, or, in the case of an uninsured patient, to lower the cost to the patient for the drug while maintaining safety.

(II)

This subsection (1)(a.5) does not authorize:

(A)

The substitution of biological products, narrow therapeutic index drugs, or psychotropic drugs; or

(B)

A substitution when the practitioner has indicated, in the manner described in subsection (2) of this section, that the pharmacist shall not substitute a drug in the same therapeutic class as the drug prescribed.

(b)

Intentionally left blank —Ed.

(I)

A pharmacist filling a prescription order for a specific biological product may substitute an interchangeable biological product for the prescribed biologic only if:

(A)

The FDA has determined that the biological product to be substituted is interchangeable with the prescribed biological product; and

(B)

The practitioner has not indicated, in the manner described in subsection (2) of this section, that the pharmacist shall not substitute an interchangeable biological product for the prescribed biological product.

(II)

Within a reasonable time after dispensing a biological product, the dispensing pharmacist or his or her designee shall communicate to the prescribing practitioner the specific biological product dispensed to the patient, including the name and manufacturer of the biological product. The pharmacist or designee shall communicate the information to the prescribing practitioner by making an entry into an interoperable electronic medical records system, through electronic prescribing technology, or through a pharmacy record that the prescribing practitioner can access electronically. Otherwise, the pharmacist or his or her designee shall communicate to the prescribing practitioner the name and manufacturer of the biological product dispensed to the patient using facsimile, telephone, electronic transmission, or other prevailing means except when:

(A)

There is no FDA-approved interchangeable biological product for the prescribed biological product; or

(B)

A refill prescription is not changed from the biological product dispensed on the prior filling of the prescription.

(III)

The pharmacy from which the biological product was dispensed must retain a written or electronic record of the dispensed biological product for at least two years after the substitution.

(IV)

This subsection (1)(b) does not apply to the administration of vaccines and immunizations as outlined in board rules.

(2)

Intentionally left blank —Ed.

(a)

If, in the opinion of the practitioner, it is in the best interest of the patient that the pharmacist not substitute an equivalent drug, a drug in the same therapeutic class, or an interchangeable biological product for the specific drug or biological product the practitioner prescribed, the practitioner may convey this information to the pharmacist in any of the following manners:

(I)

Initialing by hand or electronically a preprinted box that states “dispense as written” or “DAW”;

(II)

Signing by hand or electronically a preprinted box stating “do not substitute” or “dispense as written”; or

(III)

Orally, if the practitioner communicates the prescription orally to the pharmacist.

(b)

The practitioner shall not transmit by facsimile his or her handwritten signature, nor preprint his or her initials, to indicate “dispense as written”.

(3)

Intentionally left blank —Ed.

(a)

If a pharmacist makes a substitution pursuant to subsection (1) of this section, the pharmacist shall communicate the substitution to the purchaser in writing and orally, label the container with the name of the drug or biological product dispensed, and indicate on the file copy of the prescription both the name of the prescribed drug or biological product and the name of the drug or biological product dispensed in lieu of the prescribed drug or prescribed biological product.

(b)

The pharmacist is not required to communicate a substitution to patients in an inpatient setting or an outpatient infusion center.

(4)

Except as provided in subsection (5) of this section, the pharmacist shall not substitute a drug or interchangeable biological product as provided in this section unless the drug or interchangeable biological product substituted costs the purchaser less than the drug or biological product prescribed. The prescription shall be priced for a drug, other than a biological product, as if it had been prescribed generically.

(5)

If a prescription drug outlet does not have in stock the prescribed drug or biological product and the only equivalent drug, drug in the same therapeutic class, or interchangeable biological product in stock is higher priced, the pharmacist, with the consent of the purchaser, may substitute the higher priced drug or interchangeable biological product. This subsection (5) applies only to a prescription drug outlet located in a town, as defined in section 31-1-101 (13).

(6)

The board shall maintain on its website a link to the FDA resource, if one is available, that identifies all biological products approved as interchangeable with specific biological products.

Source: Section 12-280-125 — Substitution of prescribed drugs and biological products authorized - when - conditions, 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

§ 12-280-125’s source at colorado​.gov