Rule 800 Colorado Medical Board For cosmetic Injectables
Anyone training in cosmetic injectables or offering them needs to be aware of Rule 800.
In Colorado, the practice of administering cosmetic injectables (such as Botox®, dermal fillers, and other injectable treatments) is governed by the Colorado State Medical Board and regulations surrounding the administration of medical procedures. The main regulation for the cosmetic injectable field falls under Rule 800 of the Colorado Medical Board, which outlines who can legally perform injectable treatments and the standards they must follow.
Key Highlights of Rule 800 for Cosmetic Injectables in Colorado:
Who Can Administer Injectables?
Only licensed healthcare professionals are authorized to perform cosmetic injectable procedures in Colorado. These include:
Physicians (MDs or DOs)
Nurses (Registered Nurses [RNs], Nurse Practitioners [NPs], and Nurse Anesthetists [CRNAs])
Physician Assistants (PAs)
Important: Although aesthetic providers, such as licensed aestheticians, may assist in the cosmetic and skincare field, they cannot administer injectables unless they are working under the supervision of a licensed physician or another qualified medical professional.
Supervision Requirements:
Injectable procedures must be performed under the supervision of a licensed medical professional. For non-physician professionals (such as RNs or PAs), they must have direct supervision or oversight from a licensed physician.
The level of supervision required (direct or indirect) depends on the type of procedure being performed and the individual’s qualifications and experience.
Training and Certification:
Healthcare professionals who wish to perform cosmetic injectables must undergo specialized training that includes both didactic and hands-on components. This training should be from an accredited program that meets the requirements of Colorado’s regulations. Here is a link to our training
Certification in injectables may be required, and ongoing education in new techniques and products is strongly recommended to stay compliant and up-to-date with the field.
Scope of Practice:
The scope of practice for cosmetic injectables depends on the practitioner’s training and qualifications. For example, a nurse practitioner (NP) or physician assistant (PA) may be able to perform Botox® and dermal filler treatments as part of their practice, but must adhere to the state's medical board rules and regulations.
Injectables should only be administered in a medical setting or by an appropriately qualified professional.
Documentation and Consent:
Before administering any injectable treatments, informed consent from the client or patient must be obtained, which includes explaining the risks, benefits, and expected results of the treatment.
Proper medical records must be kept, documenting each procedure and the consent process. This documentation must include details on the procedure performed, the amount of injectable product used, and the client’s response to treatment.
Medical Director and Oversight:
If non-physician practitioners (e.g., nurses, PAs) are performing injectable treatments, they must do so under the supervision of a licensed physician who acts as the medical director.
The medical director must ensure proper training, supervision, and compliance with safety and legal standards.
Scope of Injectable Treatments:
Rule 800 also specifies that only FDA-approved injectable treatments (such as Botox®, Dysport®, Restylane®, Juvederm®, etc.) may be used. Unapproved substances or off-label use must follow specific medical protocols and ensure patient safety.
Enforcement and Violations:
Violations of Rule 800 can result in disciplinary actions such as fines, suspension, or revocation of the medical professional’s license.
The Colorado Medical Board oversees complaints and investigations related to the improper practice of injectables.
In Colorado, cosmetic injectables are considered medical procedures and, therefore, must be administered by licensed healthcare professionals who meet the state's training, certification, and supervision requirements. Practitioners, including nurses, physician assistants, and others, must follow the guidance of the Colorado State Medical Board and Rule 800 to ensure patient safety and legal compliance.
If you are considering offering cosmetic injectables or seeking training, ensure you are fully compliant with all of the Colorado Medical Board's rules and have received appropriate education and supervision.
RULE 800
COLORADO BOARD OF MEDICAL EXAMINERS
RULES REGARDING THE DELEGATION AND SUPERVISION OF MEDICAL SERVICES TO UNLICENSED HEALTH CARE PROVIDERS PURSUANT TO SECTION 12-36-106(3)(l), C.R.S.
Skipping ahead to page 14 on this document it states:
Definition of “Medical-Aesthetic Services.” “Medical-Aesthetic Services” are medical services in the cosmetic or aesthetic field that constitute the practice of medicine. Such Medical-Aesthetic Services include, but are not limited to: (a) the use of a laser, radio-frequency device, intense pulsed light, or other technique that results in the revision, destruction, incision or other structural alteration of human tissue and/or for hair removal; and (b) the performance of injections of Botox, Collagen, Restylane, or any other substance injected for a primarily cosmetic purpose.
1. As with all delegated medical services, delegated Medical-Aesthetic Services must be of the type that a reasonable and prudent physician would find within the scope of sound medical judgment to delegate. Consequently, delegated Medical-Aesthetic Services should be routine, technical services, the performance of which do not require the special skills of a licensed physician.
2. Off-label use of medications or devices when performing delegated Medical-Aesthetic Services is generally prohibited unless:
A. the delegating physician has specifically authorized and delegated the off-label use, and
B. the off-label use is within generally accepted standards of medical practice.
C. General applicability of other sections. Except as explicitly provided in this Section VI of these Rules, all requirements set forth in other Sections of these Rules apply to delegation of Medical-Aesthetic Services.
D. Additional requirements. In addition to the other provisions of these Rules, the personal and responsible direction and supervision of delegatees performing Medical-Aesthetic Services must include the following:
1. The delegating physician and the delegatee must have a written agreement documenting and detailing the relationship. This written agreement is attached in Appendix A of these Rules. The written agreement as set forth in Appendix A must be available to the public at the site where the delegated medical services are performed.
2. The delegating physician must maintain a list of all delegatees to whom the physician has delegated Medical-Aesthetic Services. The list must include a comprehensive and specific list of the delegated Medical-Aesthetic Services the physician has authorized the delegatee to perform. The list shall be maintained with documentation of the delegatee’s qualifications to perform the Medical-Aesthetic Services as described in paragraph III(B) of these Rules. Upon request, all documentation maintained by the physician in accordance with this paragraph shall be provided to the Board.
3. The delegating physician is responsible for assuring the qualifications and competence of the delegatee to perform the delegated Medical-Aesthetic Services as follows:
a. Prior to authorizing a delegatee to perform any Medical-Aesthetic Services, the delegating physician must personally assess the qualifications and competence of the delegatee to perform the Medical-Aesthetic Services. This assessment must include a review the delegatee’s education and training as relevant to performance of the delegated medical service(s). Additionally, this assessment must include, but must not be limited to, initial over-the-shoulder monitoring of the delegatee’s performance of each delegated Medical-Aesthetic Service.
b. On at least an annual basis, the delegating physician must personally reassess the qualifications and competence of the delegatee to perform the Medical-Aesthetic Services. This reassessment must include, but must not be limited to, over-the-shoulder monitoring of the delegatee’s performance of each delegated Medical-Aesthetic Service.
c. The delegating physician must document the initial assessment and follow-up reassessments of the delegatee’s performance of the delegated Medical-Aesthetic Services. Upon request, the delegating physician must provide such documentation to the Board.
4. Medical-Aesthetic Services must be delivered within a facility appropriate to the delegated service provided and listed on the written agreement as set forth in Appendix A.
E. Physician-patient relationship for delegated Medical-Aesthetic Services. The delegating physician’s physician-patient relationship with a patient receiving delegated Medical-Aesthetic Services pursuant to these Rules need not comply with Section IV(E) of these Rules, but must include the following:
1. The delegating physician must ensure that each patient receives all information necessary to give appropriate informed consent for any Medical-Aesthetic Service and that such informed consent is timely documented in the patient’s chart.
2. All patients receiving a delegated Medical-Aesthetic Service must be informed that the delegating physician is available personally to consult with them or provide appropriate evaluation or treatment in relation to the delegated Medical-Aesthetic Services. Upon request, the delegating physician must timely and personally provide such consultation, evaluation or treatment.
3. The delegating physician must assure that the delegatee maintains appropriate patient charts for each patient receiving Medical-Aesthetic Services.
4. At least weekly, the delegating physician must monitor the quality of the services provided by the delegatee through such means as direct observation, review of care, review of outcomes, review of equipment, review of protocols and procedures and review of charts. The weekly monitoring must occur at the site where the delegated services are performed.