N.J. Admin. Code § 13:30-8.4A

Current through Register Vol. 56, No. 21, November 4, 2024
Section 13:30-8.4A - Administration of injectable pharmacologics
(a) For purposes of this section, the following words and terms shall have the following meanings, unless the context clearly indicates otherwise.

"Injectable pharmacologic" means any medication classified as a neurotoxin, adjuvant or therapeutic agent including, but not limited to, hyaluronic acid (such as Restylane<(R)>), fillers (such as collagen), Botulinum Toxin Type A (such as Botox<(R)>) or similar products that have been approved by the Federal Food and Drug Administration.

"Peri-oral area" means the gums, cheeks, jaws, lips and oral cavity and associated tissues.

(b) No dentist shall administer an injectable pharmacologic unless the minimum standards of training and procedure set forth in this section are satisfied.
(c) A dentist may administer an injectable pharmacologic for the cosmetic or functional enhancement of peri-oral tissue only in a dental treatment setting.
(d) A dentist may administer an injectable pharmacologic only after having completed a Board-approved post-doctoral course that is sufficient to prepare a dentist to satisfactorily administer injectable pharmacologics safely and effectively, as provided in (f) below. The course shall be offered at an accredited dental school, in a hospital-based program or in a college or university clinical setting.
(e) Notwithstanding (d) above, a dentist who holds a specialty permit in oral and maxillofacial surgery issued by the Board pursuant to 13:30-6.1 shall not be required to complete the Board-approved course set forth in (f) below prior to administering injectable pharmacologics.
(f) In order to obtain Board approval for a course on injectable pharmacologics, a course provider shall submit a course outline, including course content and objectives and the curriculum vitae of the instructor(s), for Board review and approval. The course outline shall indicate whether the training is visual, hands-on or lecture. An approved course shall be at least 21 hours in length and shall include instruction in the following:
1. Anatomy of head and neck;
2. Neurophysiology, including facial tissues, parasympathetic, sympathetic and peripheral nervous systems relative to peri-oral tissue, and facial architecture;
3. Patient selection, including indications and contraindications;
4. Pharmacological effects and contraindications, including potential drug interactions;
5. Management of complications; and
6. Informed consent.
(g) The course administrator shall issue a certificate of completion to a dentist who successfully completes the approved course.
(h) A dentist who desires to administer injectable pharmacologics shall submit to the Board, within 30 days of completing the course, a certified true copy of the certificate of course completion provided to the dentist by the course administrator.
(i) Prior to administering, dispensing or prescribing injectable pharmacologics to a patient, the dentist shall conduct an appropriate physical examination within the scope of dental practice, obtain a complete medical history, including the patient's previous medications, allergies and sensitivities and comprehensively assess the dental needs of the patient. The patient history shall be maintained in the patient's record for a period of not less than seven years. Specific notations on the use of injectable pharmacologics, including the type of agent, dosage, duration and any untoward reactions, shall be recorded in the patient record.
(j) A dentist shall not delegate the administration of an injectable pharmacologic, except to a licensed health care professional who is authorized pursuant to the laws and/or rules in this State governing the professional's health care practice to provide injections under the direction of a dentist.
(k) The use of injectable pharmacologics without first having met the minimum standards for training and the procedures contained in this section shall constitute a deviation from the acceptable standards of practice required of a licensee and may subject a dentist to the penalties set forth in 45:1-21 et seq.
(l) A dentist shall not advertise, offer or otherwise represent the provision of treatment or services related to injectable pharmacologics unless the dentist has completed the Board-approved course outlined in (f) above.
(m) Nothing in this section shall be construed to authorize a dentist to treat diseases, disorders or conditions that are outside the scope of the practice of dentistry, as defined in 45:6-19.

N.J. Admin. Code § 13:30-8.4A

New Rule, R.2011 d.281, effective 11/21/2011.
See: 42 N.J.R. 2575(a), 43 N.J.R. 3096(a).