A bill

 

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ENACTING THE "DENTAL ADMINISTRATION OF NEUROMODULATORS ACT"; AND BY ADDING SECTION 40-15-217 SO AS TO AUTHORIZE THE BOARD OF DENTISTRY TO ISSUE PERMITS TO QUALIFIED LICENSEES FOR THE ADMINISTRATION OF NERUROMODULATORS, SUCH AS BOTOX, FOR COSMETIC AND NONCOSMETIC PURPOSES, TO PROVIDE REQUIREMENTS FOR RECEIVING, MAINTAINING, AND RENEWING SUCH PERMITS, AND TO PROVIDE SCOPE OF PRACTICE AND DELEGATION REQUIREMENTS, AMONG OTHER THINGS.

 

Be it enacted by the General Assembly of the State of South Carolina:

 

SECTION 1.  This act may be cited as the "Dental Administration of Neuromodulators Act".

 

SECTION 2.  Article 1, Chapter 15, Title 40 of the S.C. Code is amended by adding:

 

    Section 40-15-217. (A) For purposes of this section, "neuromodulator" means neuromodulators, such as Botox, that are derived from Clostridium botulinum or that are biosimilar to, or the bioequivalent of, such neuromodulators used in dental and facial esthetics.

    (B) A person licensed to practice dentistry by the board may obtain a permit from the board that authorizes him to administer neuromodulators in the region of the oral cavity and associated adjacent structures, to include the oral and maxillofacial regions, subject to the provisions of this section. The board shall issue and renew such a permit to a dentist who complies with the provisions of this section. Such permits are valid for one year and are renewable.

    (C) A dentist seeking an initial permit or the renewal of a permit to administer neuromodulators pursuant to this section shall apply to the board, pay applicable fees required by the board, and document that he:

       (1) is licensed and in good standing with the board;

       (2) successfully has completed a didactic and hands-on course of study in the injection of such neuromodulators in the region of the oral cavity and associated adjacent structures, to include the oral and maxillofacial regions. This course of study must be prescribed by the board in regulation and must include:

           (a) the pharmacology of injectable neuromodulators including, but not limited to, contraindications, potential side effects, injection techniques, and appropriate injection sites for the condition being treated;

           (b) applicable storage and sterility requirements;

           (c) necessary resuscitative techniques and equipment in the event of an unexpected adverse outcome; and

           (d) other requirements that the board considers necessary.

    (D) In addition to the provisions of subsection (C), a dentist shall satisfy the following requirements in order to maintain and renew a permit to administer neuromodulators:

       (a) document ongoing continuing education and competency for performing the procedures authorized in this section, provided such continuing education coursework must be approved by the American Dental Association or the American Medical Association;

       (b) maintain documentation acceptable to the board regarding his training, education, credentials, and qualifications before undertaking to perform procedures authorized in this section and make this documentation available to the board upon request;

       (c) limit the use of neuromodulators to the injection of resorbable materials only;

       (d) establish a bona fide dentist-patient relationship prior to the injection of any neuromodulator for either cosmetic or noncosmetic purposes;

       (e) create and maintain a record for each patient that includes, at a minimum, the following information for each injection:

           (i) informed consent;

           (ii) diagnosis or description of condition to be treated;

           (iii) record of anatomical location of injection site by means of photograph or diagram;

           (iv) dosage administered; and

           (v) manufacturer lot number for the neuromodulator used;

       (f) adhere to the FDA and manufacturer's guidelines for storage, reconstitution, administration, and management of unused product to ensure patient safety; and

       (g) only inject neuromodulators in an appropriate clinical setting that:

           (i) ensures sterility and resuscitative capabilities; and

           (ii) has written policies and procedures in place governing these procedures.

    (E) A dentist may delegate the act of administering neuromodulators for cosmetic use to an advanced practice registered nurse (APRN) pursuant to the practice agreement executed by and between the APRN and the dentist. Noncosmetic use is nondelegable and must be performed by the dentist. In no case may the dentist delegate the administration of neuromodulators to dental hygienists or unlicensed personnel.

    (F) Patient safety is the responsibility and priority for any dentist engaged in the injection of neuromodulators, whether for cosmetic or noncosmetic purposes.

    (G) Dentists performing procedures involving neuromodulators are subject to all applicable provisions of the Dental Practice Act, these regulations, and any applicable policies adopted by the board.

 

SECTION 3.  This act takes effect upon approval by the Governor.

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