C.R.S. Section 12-280-303
Wholesaler registration requirements

  • rules

(1)

A wholesaler that resides in this state must register with the board before engaging in the wholesale distribution of prescription drugs in this state. A wholesaler that does not reside in this state must be registered in this state prior to engaging in the wholesale distribution of prescription drugs in this state.

(2)

Intentionally left blank —Ed.

(a)

The board may adopt rules to approve an accreditation body to evaluate a wholesaler’s operations to determine compliance with professional standards and any other applicable laws and to perform inspections of each facility and location where the wholesaler conducts wholesale distribution operations.

(b)

An applicant for a registration shall pay any fee required by the accreditation body or the board and comply with any rules promulgated by the board.

(c)

The board shall not issue or renew a registration to a wholesaler who does not comply with this part 3.

(3)

Intentionally left blank —Ed.

(a)

An applicant for a wholesaler registration shall provide to the board the following information, and any other information deemed appropriate by the board, on a form provided by the board:

(I)

The name, full business address, and telephone number of the applicant;

(II)

The trade and business names used by the applicant;

(III)

The addresses, telephone numbers, and names of the contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs;

(IV)

The type of ownership or operation of the applicant;

(V)

The names of the owner and the operator of the applicant, including:

(A)

The name of each partner if the applicant is a partnership;

(B)

The name and title of each officer and director, the name of the corporation, and the state of incorporation, if the applicant is a corporation;

(C)

The name of the limited liability company, if the applicant is a limited liability company, and the name of the parent company, if any, and the state of incorporation or formation of both; or

(D)

The name of the sole proprietor and the business entity if the applicant is a sole proprietorship;

(VI)

A list of the licenses, registrations, or permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs; and

(VII)

The name of the applicant’s designated representative for the facility, the fingerprints of the designated representative, and a personal information statement for the designated representative that includes information as required by the board, including but not limited to the information in subsection (5) of this section.

(b)

A registrant shall complete and return a form approved by the board at each renewal period. The board may suspend or revoke the registration of a wholesaler if the board determines that the wholesaler no longer qualifies for a registration.

(4)

Prior to issuing a wholesaler registration to an applicant, the board, the regulatory oversight body from another state, or a board-approved accreditation body may conduct a physical inspection of the facility at the business address provided by the applicant. Nothing in this subsection (4) precludes the board from inspecting a wholesaler.

(5)

The designated representative of an applicant for a wholesaler registration shall:

(a)

Be at least twenty-one years of age;

(b)

Have at least three years of full-time employment history with a pharmacy or a wholesaler in a capacity related to the dispensing and distribution of and the record keeping related to prescription drugs;

(c)

Be employed by the applicant in a full-time managerial position;

(d)

Be actively involved in and aware of the actual daily operation of the wholesaler;

(e)

Be physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including, but not limited to, sick leave and vacation leave;

(f)

Serve in the capacity of a designated representative for only one applicant or wholesaler at a time, except where more than one registered wholesaler is co-located in the same facility and the wholesalers are members of an affiliated group as defined by section 1504 of the federal “Internal Revenue Code of 1986”, as amended;

(g)

Not have any convictions under federal, state, or local law relating to wholesale or retail prescription drug distribution or a controlled substance, as defined in section 18-18-102 (5);

(h)

Not have any felony convictions pursuant to federal, state, or local law; and

(i)

Update all of the information required in this part 3 whenever changes occur.

(6)

A wholesaler shall obtain a registration for each facility it uses for the distribution of prescription drugs.

Source: Section 12-280-303 — Wholesaler registration requirements - rules, 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

§ 12-280-303’s source at colorado​.gov