C.R.S. Section 12-280-133.5
Nonresident 503B outsourcing facility

  • registration
  • requirements
  • denial, revocation, or suspension
  • rules

(1)

A nonresident 503B outsourcing facility shall not conduct the business of distributing compounded prescription drugs in this state without first registering with the board as a nonresident 503B outsourcing facility. A nonresident 503B outsourcing facility shall apply for a nonresident 503B outsourcing facility registration on a form furnished by the board and shall submit the following to the board with the application:

(a)

Proof that the facility is actively registered with the FDA as a 503B outsourcing facility and is actively licensed, permitted, or registered in the state in which it is a resident;

(b)

The location, names, and titles of all principal entity officers and the name of the pharmacist in charge of the operations of the facility;

(c)

Verification that the facility complies with all lawful directions and requests for information from the FDA and from the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, as well as with all requests for information made by the board pursuant to this section;

(d)

A copy of the most recent inspection report resulting from an inspection conducted by the FDA; and

(e)

Any other information the board deems necessary to carry out the purpose of this section.

(2)

A nonresident 503B outsourcing facility shall:

(a)

Maintain at all times a valid, unexpired license, permit, or registration to operate the 503B outsourcing facility in compliance with the laws of the state in which it is a resident; and

(b)

Comply with the requirements of the “Federal Food, Drug, and Cosmetic Act”, 21 U.S.C. sec. 301 et seq., as amended, or the DQSA or with FDA regulations implementing either act.

(3)

The board may deny, revoke, or suspend a nonresident 503B outsourcing facility registration if:

(a)

The facility fails to comply with this section or with any rule promulgated by the board;

(b)

The FDA has revoked or refused to renew the nonresident 503B outsourcing facility’s FDA registration for failing to comply with the requirements of the “Federal Food, Drug, and Cosmetic Act”, 21 U.S.C. sec. 301 et seq., as amended, the DQSA, or FDA regulations implementing either act or the facility’s FDA registration has expired or is no longer active; or

(c)

The state in which the nonresident 503B outsourcing facility resides has revoked or refused to renew the facility’s license, permit, or registration for failing to comply with the laws of that state or the facility’s license, permit, or registration in another state has expired or is no longer active.

(4)

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

Source: Section 12-280-133.5 — Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - 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

§ 12-280-133.5’s source at colorado​.gov