§ 33.1. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   ASA CLASS I—A classification of patient status developed by the American Society of Anesthesiologists for a patient without systemic disease.

   ASA CLASS II—A classification of patient status developed by the American Society of Anesthesiologists for a patient with mild systemic disease.

   ASA CLASS III—A classification of patient status developed by the American Society of Anesthesiologists for a patient with severe systemic disease that limits activity but is not incapacitating.

   ASA CLASS IV—A classification of patient status developed by the American Society of Anesthesiologists for a patient with incapacitating systemic disease that is a constant threat to life.

   ASA CLASS V—A classification of patient status developed by the American Society of Anesthesiologists for a moribund patient not expected to survive 24 hours with or without operation.

   Act—The Dental Law (63 P. S. § §  120—130i), which regulates the licensure of dentists and dental hygienists and the practice of dentistry and practice as a dental hygienist in this Commonwealth.

   Auxiliary personnel—Persons who perform dental supportive procedures authorized by the act and this chapter under the general or direct supervision of a dentist.

   Board regulated practitioner—A dentist, dental hygienist, expanded function dental assistant or auxiliary personnel.

   Bureau—The Bureau of Professional and Occupational Affairs of the Commonwealth.

   Child abuse—A term meaning any of the following:

     (i)   A recent act or failure to act by a perpetrator which causes nonaccidental serious physical injury to a child under 18 years of age.

     (ii)   An act or failure to act by a perpetrator which causes nonaccidental serious mental injury to or sexual abuse or sexual exploitation of a child under 18 years of age.

     (iii)   A recent act, failure to act or series of acts or failures to act by a perpetrator which creates an imminent risk of serious physical injury to or sexual abuse or sexual exploitation of a child under 18 years of age.

     (iv)   Serious physical neglect by a perpetrator constituting prolonged or repeated lack of supervision or the failure to provide the essentials of life, including adequate medical care, which endangers a child’s life or development or impairs the child’s functioning.

   ChildLine—An organizational unit of the Department of Public Welfare which operates a 24-hour a day Statewide toll free telephone system for receiving reports of suspected child abuse, referring reports for investigation and maintaining the reports in the appropriate file.

   Continuing education certificate—A document prepared by the program sponsor which contains the title of the course, the dates attended or completed and the hours of education completed.

   Credit hour—A minimum unit of continuing education consisting of 60 minutes of instruction. Programs longer than 60 minutes will be credited in 30 minute increments.

   Dental clinic—A public or quasipublic institution operated not for profit which has as a primary purpose providing dental health care.

   Department—The Department of State of the Commonwealth.

   Direct supervision—Supervision by a dentist who examines the patient, authorizes the procedure to be performed, is physically present in the dental facility and available during performance of the procedure, and examines and takes full professional responsibility for the completed procedure.

   General supervision—In a dental facility, supervision by a dentist who examines the patient, develops a dental treatment plan, authorizes the performance of dental hygiene services to be performed within 90 days of the examination, and takes full professional responsibility for the performance of the dental hygenist. In facilities identified in §  33.205(c)(2) and (3) (relating to practice as a dental hygienist), general supervision is as defined in §  33.205(d)(2).

   Individual residing in the same home as the child—An individual who is 14 years of age or older and who resides in the same home as the child.

   Individual study—A course of continuing education offered by an approved program sponsor, which permits the participant to learn without interacting with an instructor or interactive learning methodologies and which requires a passing grade on a written examination or workbook.

   Perpetrator—A person who has committed child abuse and is a parent of the child, a person responsible for the welfare of a child, an individual residing in the same home as a child or a paramour of a child’s parent.

   Person responsible for the child’s welfare—A person who provides permanent or temporary care, supervision, mental health diagnosis or treatment, training or control of a child in lieu of parental care, supervision and control. The term does not include a person who is employed by or provides services or programs in a public or private school, intermediate unit or area vocational-technical school.

   Program sponsor—The party approved by the Board who is responsible for the development and presentation of the continuing dental education program.

   Recent acts or omissions—Acts or omissions committed within 2 years of the date of the report to the Department of Public Welfare or county agency.

   Serious mental injury—A psychological condition, as diagnosed by a physician or licensed psychologist, including the refusal of appropriate treatment, that does one or more of the following:

     (i)   Renders a child chronically and severely anxious, agitated, depressed, socially withdrawn, psychotic or in reasonable fear that the child’s life or safety is threatened.

     (ii)   Seriously interferes with a child’s ability to accomplish age-appropriate developmental and social tasks.

   Serious physical injury—An injury that causes a child severe pain or significantly impairs a child’s physical functioning, either temporarily or permanently.

   Sexual abuse or exploitation—The employment, use, persuasion, inducement, enticement or coercion of a child to engage in or assist another person to engage in sexually explicit conduct or a simulation of sexually explicit conduct for the purpose of producing a visual depiction, including photographing, videotaping, computer depicting or filming, of sexually explicit conduct or the rape, sexual assault, involuntary deviate sexual intercourse, aggravated indecent assault, molestation, incest, indecent exposure, prostitution, statutory sexual assault or other form of sexual exploitation of children.

   The provisions of this §  33.1 amended under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(j.1), (j.2) and (o) of the Dental Law (63 P. S. §  122(j.1), (j.2) and (o)).

   The provisions of this §  33.1 adopted April 4, 1949; amended June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended November 8, 1996, effective November 9, 1996, 26 Pa.B. 5410; corrected November 22, 1996, effective November 9, 1996, 26 Pa.B. 5700; amended August 11, 2000, effective August 12, 2000, 30 Pa.B. 4245. Immediately preceding text appears at serial pages (230645) to (230646) and (244918).

   Ripeness

   Petition for review of these regulations was dismissed as the association of dental hygienists’ allegations of direct and immediate harm did not establish the justiciability of a pre-enforcement challenge to this regulation. The association’s allegations of change in their work schedule, reduced availability of dental hygiene services, reduced income, possible unemployment and the uncertainty of the ongoing day-to-day operations of dental hygiene care are merely anticipatory, speculative and too remote to support a claim of direct and immediate harm. Pennsylvania Dental Hygienists’ Association v. State Board of Dentistry, 672 A.2d 414 (Pa. Cmwlth. 1996).

 Under 1 Pa. Code §  31.1 (relating to scope of part), 1 Pa. Code Part II (relating to general rules of administrative practice and procedure) is applicable to the activities of and proceedings before the Board.

 (a)  Following is the schedule of fees charged by the Board:

 (b)  For fees related to anesthesia permits, refer to §  33.339 (relating to fees for issuance of permits).

   The provisions of this §  33.3 issued under section 4 of The Dental Law (63 P. S. §  123); amended under section 3 (g.1) and 4(b) of The Dental Law (63 P. S. § §  122 (g.1) and 123(b)).

   The provisions of this §  33.3 adopted April 28, 1989, effective April 29, 1989, 19 Pa.B. 1840; amended March 22, 1991, effective March 23, 1991, 21 Pa.B. 1167; amended May 19, 1995, effective May 20, 1995, 25 Pa.B. 1950; amended June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; corrected June 30, 1995, effective July 1, 1995, 25 Pa.B. 2598; amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2547; amended June 5, 1998, effective June 6, 1998, 28 Pa.B. 2590; amended June 16, 2000, effective June 17, 2000, 30 Pa.B. 3046; amended April 30, 2004, effective May 1, 2004, 34 Pa.B. 2326; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2899. Immediately preceding text appears at serial pages (303900) and (303901).

 The address of the Board is State Board of Dentistry, Post Office Box 2649, Harrisburg, PA 17105-2649.

   The provisions of this §  33.41 adopted September 18, 1967; amended September 12, 1975, effective September 13, 1975, 5 Pa.B. 2396; reserved June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492. Immediately preceding text appears at serial pages (159385) to (159386).

   The provisions of this §  33.61 adopted December 14, 1990, effective December 15, 1990, 20 Pa.B. 6190; reserved June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492. Immediately preceding text appears at serial pages (159393) to (159394) and (167701).

Subchapter B. LICENSURE OF DENTISTS AND
DENTAL HYGIENISTS

Sec.

 (a)  Only persons holding a current license issued by the Board may practice dentistry or may practice as a dental hygienist in this Commonwealth.

 (b)  Only persons holding a certificate issued by the Board may practice as an expanded function dental assistant in this Commonwealth.

 (c)  To secure a license or certificate, an applicant shall satisfy the requirements of the act and of this subchapter.

 (d)  Applications for licensure or certification shall be made on forms supplied by the Board and shall be accompanied by the application fee in §  33.3 (relating to fees).

   The provisions of this §  33.101 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Dentists.

   (1)  Candidates for licensure as dentists shall show compliance with section 3(c) of the act (63 P. S. §  122(c)) which requires a diploma from an ‘‘approved institution or college,’’ by submitting certification of graduation from a dental school accredited or provisionally accredited by the Commission on Accreditation of the American Dental Association.

   (2)  Candidates for licensure who received their professional education outside the United States in a nonaccredited school may satisfy the education requirement by submitting their credentials to an accredited or provisionally accredited school and obtaining additional preclinical and clinical training that will lead to the awarding of the D.M.D. or D.D.S. degree by that school.

 (b)  Dental hygienists.

   (1)  Candidates for licensure as dental hygienists shall show compliance with section 3(d) of the act by submitting certification of graduation from a dental hygiene school accredited or provisionally accredited by the Commission on Accreditation of the American Dental Association, if the school’s dental hygiene course of study comprises a minimum of 2 years of at least 32 weeks of at least 30 hours each week or its equivalent.

   (2)  Candidates for licensure who received their professional education outside the United States in a nonaccredited school may satisfy the education requirement by submitting their credentials to an accredited or provisionally accredited school and obtaining additional training that will lead to the awarding of a degree in dental hygiene by that school.

 (c)  Expanded function dental assistants.

   (1)  Candidates for certification as expanded function dental assistants shall show compliance with section 3(d.1) of the act by submitting verification of one of the following:

     (i)   Graduation from an expanded function dental assisting program at a 2-year college or other institution accredited or provisionally accredited by an accrediting agency approved by the United States Department of Education Council on Postsecondary Accreditation which offers an Associate Degree.

     (ii)   Graduation from a dental hygiene school which required the successful completion of at least 75 hours of clinical and didactic instruction in restorative functions accredited or provisionally accredited by the Commission on Accreditation of the American Dental Association.

     (iii)   Completion of a certification program in expanded function dental assisting of at least 200 hours of clinical and didactic instruction from a dental assisting program accredited by one of the following:

       (A)   The Commission on Dental Accreditation of the American Dental Association.

       (B)   An accrediting agency approved by the United States Department of Education Council on Postsecondary Accreditation whose expanded function educational standards are approved by the Board.

   (2)  Candidates for certification who receive their professional education outside the United States or from a nonaccredited program may satisfy the education requirement by submitting their credentials to a program listed in paragraph (1) and obtaining additional training that will lead to the awarding of a degree by that school.

   (3)  This subsection does not apply to persons who are not required to meet the educational requirements under section (3)(d.1)(2) of the act.

   The provisions of this §  33.102 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Dentists. Candidates for licensure shall pass the National Board Dental Examination (written examination) and the Northeast Regional Board (NERB) Dental Examination (clinical examination).

 (b)  Dental hygienists. Candidates for licensure shall pass the National Board Dental Hygiene Examination (written examination) and the NERB Dental Hygiene Examination (clinical examination).

 (c)  Expanded function dental assistants. Candidates for certification shall pass a written examination acceptable to the Board.

 (d)  Additional requirement. The Board will recognize successful completion of the NERB Dental Examination or NERB Dental Hygiene Examination or the expanded function dental assistant examination approved by the Board for up to 5 years from the date scores are reported to the Board. After 5 years, the Board will accept passing scores on the examinations only if the candidate has been engaged in postgraduate training or in the practice of dentistry, as a dental hygienist or as an expanded function dental assistant in another jurisdiction.

   The provisions of this §  33.103 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Each new licensee is issued a wall certificate indicating initial licensure and a registration packet including a biennial renewal certificate and a wallet-size license card that show the expiration date of the license. Licenses expire on March 31 of each odd-numbered year, regardless of the date of issuance.

 (b)  Each new certificate holder is issued a wall certificate indicating initial certification and a registration packet including a biennial renewal certificate and a wallet-size certification card that show the expiration date of the certificate. Certificates expire on March 31 of each odd-numbered year, regardless of the date of issuance.

 (c)  Fees as prescribed by the Bureau of Professional and Occupational Affairs Fee Act (63 P. S. § §  1401-101—1401-501), shall be charged for duplicate wall certificates and biennial renewal documents. A duplicate will be issued only upon submission by the licensee or certificate holder of a notarized statement specifying why the original is unavailable and stating that the duplicate will be returned if the original is recovered.

   The provisions of this §  33.104 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Licenses and certificates are renewable for a 2-year period beginning April 1 of each odd-numbered year. The fee for the biennial renewal is set by the Board. See §  33.3 (relating to fees). Upon renewal, licensees and certificate holders receive new biennial renewal licenses or certificates, as appropriate, and wallet-size cards which include the expiration date.

 (b)  As a condition of biennial renewal, commencing with the 2001-2003 renewal period, licensees and certificate holders shall maintain current certification in infant, child and adult cardiopulmonary resuscitation and continuing education requirements specified in Subchapter F (relating to continuing dental education). Licensees and certificate holders shall certify their compliance with this subsection when renewing their licenses on and after April 1, 2001. Courses for certification in cardiopulmonary resuscitation (CPR) shall be substantially similar in content to the CPR courses offered by the American Heart Association and the American Red Cross and have a similar renewal period.

 (c)  Dentists and dental hygienists who fail to renew their licenses and expanded function dental assistants who fail to renew their certificates are prohibited from practicing their profession in this Commonwealth.

   The provisions of this §  33.105 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Dentists and dental hygienists who have failed to renew their licenses and expanded function dental assistants who have failed to renew their certificates may apply for reactivation on forms prescribed by the Board. The applicant for reactivation shall pay the current biennial renewal fee, provide evidence of current certification in cardiopulmonary resuscitation, and shall submit a notarized affidavit identifying the period of time in which the applicant did not practice in this Commonwealth. Effective with the 1999-2001 renewal period, licensees and certificate holders shall also complete the continuing education requirements for the renewal periods during which the license or certificate was not renewed.

 (b)  In addition to the requirements in subsection (a), an applicant for reactivation who has failed to renew for more than 5 years may be subject to reexamination under section 3.1(b) of the act (63 P. S. §  122.1.(b)).

 (c)  An applicant for reactivation who practiced in this Commonwealth without a current license or certificate shall pay a later renewal fee of $5 for each month or part of a month during which the unauthorized practice occurred, as provided in section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P. S. §  1401-225). In addition, the applicant shall pay the biennial renewal fee for each biennium during which unauthorized practice occurred. The payment of late fees and biennial renewal fees does not preclude the Board from taking disciplinary action against a dentist or dental hygienist who practice without a current license or an expanded function dental assistant who practice without a current certificate.

   The provisions of this §  33.106 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 Dentists, dental hygienists and expanded function dental assistants who are currently licensed or certified in another state or territory or in Canada may be granted licensure or certification in this Commonwealth if the credentials submitted meet the requirements of the act and of this subchapter. Licensure and certification by criteria approval will be granted only to applicants whose licensing boards confirm that they reciprocate with the Commonwealth. An applicant shall cause the licensing authority of each state where the applicant has practiced to submit to the Board a letter of good standing. The Board may grant a personal interview to resolve questions concerning an applicant’s qualifications.

   The provisions of this §  33.107 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 Dentists, dental hygienists and expanded function dental assistants who wish their licensure, certification or grades certified to another state shall pay the fee in §  33.3 (relating to fees).

   The provisions of this §  33.108 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  A licensee’s or certificate holder’s name on file with the Board shall be the name that appears on the license or certificate unless that name is legally changed, in which case the licensee or certificate holder shall report the change to the Board in writing within 10 days.

 (b)  A licensee or certificate holder who changes an address on file with the Board shall notify the Board in writing within 10 days. Licensees or certificate holders who do not comply with this subsection shall bear full responsibility for failure to receive correspondence, including biennial renewal notifications, from the Board or the Department.

 (c)  A licensee’s or certificate holder’s most recent name and address on file with the Board will be deemed the licensee’s or certificate holder’s official name and address for purposes of service of process and other legal papers.

   The provisions of this §  33.109 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Purpose and definitions.

   (1)  The following subsections implement the Volunteer Health Services Act (35 P. S. § §  449.41—449.50) and provide for the issuance of a volunteer license to a qualified individual who retires from active practice and seeks to provide professional services as a volunteer. A volunteer license authorizes the holder to practice only in an organized community-based clinic without remuneration.

   (2)  The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

   Approved clinic—

     (i)   An organized community-based clinic offering primary health care services to individuals and families who cannot pay for their care, to Medical Assistance clients or to residents of medically underserved areas or health professionals shortage areas.

     (ii)   The term includes a State health center, nonprofit community-based clinic and Federally qualified health center, as designated by Federal rulemaking or as approved by the Department of Health or the Department of Public Welfare.

   Unrestricted license—A license which is not restricted or limited by order of the Board under its disciplinary power.

 (b)  License. A volunteer license may be issued to a licensee or certificateholder of the Board who documents to the satisfaction of the Board that the licensee will practice without personal remuneration in approved clinics and meets one of the following conditions:

   (1)  Holds a currently renewed, active, unrestricted license, registration or certificate in this Commonwealth and retires from active practice at the time the licensee applies for a volunteer license.

   (2)  Retires from the active practice of dentistry, or as a dental hygienist or as an expanded function dental assistant in this Commonwealth in possession of an unrestricted license, registration or certificate which was allowed to lapse by not renewing it. A retired licensee, registrant or certificateholder shall meet any requirements of the act or the regulations pertaining to continued education or continued competency to be eligible for renewal.

 (c)  Applications. An applicant for a volunteer license shall complete an application obtained from the Board. In addition to providing information requested by the Board, the applicant shall provide:

   (1)  An executed verification on forms provided by the Board certifying that the applicant intends to practice exclusively:

     (i)   Without personal remuneration for professional services.

     (ii)   In an approved clinic.

   (2)  A letter signed by the director or chief operating officer of an approved clinic that the applicant has been authorized to provide volunteer services in the named clinic by the governing body or responsible officer of the clinic.

 (d)  Validity of license. A volunteer license shall be valid for the biennial period for which it is issued, subject to biennial renewal. During each biennial renewal period, the volunteer license holder shall notify the Board of any change in clinic or volunteer status within 30 days of the date of the change, or at the time of renewal, whichever occurs first.

 (e)  Biennial renewal. A volunteer license shall be renewed biennially on forms provided by the Board.

   (1)  As a condition of biennial renewal, the applicant shall satisfy the same continuing education requirements as the holder of an active, unrestricted license.

   (2)  The applicant shall be exempt from payment of the biennial renewal fee in §  33.3 (relating to fees).

 (f)  Return to active practice. A volunteer license holder who desires to return to active practice shall notify the Board and apply for biennial registration on forms provided by the Board.

 (g)  Disciplinary provisions. A volunteer license holder shall be subject to the disciplinary provisions of the act and this chapter. Failure of the licensee to comply with the Volunteer Health Services Act or this section may also constitute grounds for disciplinary action.

 (h)  Permits to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.

   (1)  A dentist who applies for a volunteer license under subsection (b) who holds a current permit to administer anesthetic modalities may also apply for reissuance of an unrestricted or restricted permit of the type issued to the dentist as an active licensee under §  33.333 (relating to types of permits).

   (2)  A retired dentist who applies under subsection (b)(1) and (2) for a volunteer license who, within 2 years of the date of application, held an unrestricted permit or a restricted permit I, may apply for reissuance of the permit, but shall be required to comply with §  33.336a (relating to requirements for unrestricted permit and restricted permit I) by completing:

     (i)   An attestation in accordance with §  33.336a(b).

     (ii)   ACLS/PALS certification in accordance with §  33.336a(c).

     (iii)   Continuing anesthesia education in accordance with §  33.336a(d).

   (3)  A retired dentist who applies under subsection (b)(1) and (2) for a volunteer license who, within 5 years of the date of application, held a restricted permit II may apply for reissuance of the permit, but shall be required to comply with §  33.337(b) (relating to requirements for restricted permit II) by providing:

     (i)   A statement containing the make, model and serial number of nitrous oxide/oxygen analgesia equipment.

     (ii)   A certification that the equipment is properly calibrated, maintained, contains a fail-safe system and is in working order.

     (iii)   An attestation that the applicant has written procedures for handling emergencies.

   (4)  A dentist who applies for a volunteer license who does not qualify for a permit under paragraphs (1)—(3) and who wishes to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia under §  33.332(a) (relating to requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia) shall satisfy the educational requirements of §  33.335(a)(1), §  33.336 or §  33.337(a) (relating to requirements for unrestricted permit; requirements for restricted permit I; and requirements for restricted permit II), as applicable.

   (5)  Volunteer license holders will not be subject to any fee for the issuance, reissuance or renewal of a permit under this subsection.

     (i)   Supervision. Volunteer dental hygienists shall meet the supervision requirements of §  33.205(c)(1) (relating to practice as a dental hygienist). Volunteer expanded function dental assistants shall meet the supervision requirements of section 2 of the act (63 P. S. §  121).

   The provisions of this §  33.110 issued under section 5 of the Volunteer Health Services Act (35 P. S. §  449.45); and section 3(o) of the Dental Law (63 P. S. §  122(o)); amended under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(o) and 130c(a)).

 (a)  The Board will give notice to temporary permit holders of the date, time and location of the first expanded function dental assistant certification examination. A temporary permit holder is required to register for and achieve a passing score on the examination.

 (b)  Failure to register or to sit for the examination (unless the Board grants a waiver under subsection (c)) shall be deemed a failure of the examination. Upon notice from the Board of the failure of the examination, the temporary permit holder shall immediately cease to practice as an expanded function dental assistant and shall return the temporary permit to the Board.

 (c)  The Board will grant a waiver to a temporary permit holder who has not been present at the examination, who provides the Board with documentation acceptable to the Board that illness or bereavement prevented the applicant from taking the examination as scheduled. A request for a waiver shall be filed with the Board within 10 days of the examination date. If a waiver is not granted, the temporary permit holder shall, upon notice, immediately cease practicing as an expanded function dental assistant and return the permit to the Board.

   The provisions of this §  33.114 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

   The provisions of this §  33.191 adopted September 12, 1975, effective September 13, 1975, 5 Pa.B. 2397; reserved June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492. Immediately preceding text appears at serial page (135705).

Subchapter C. MINIMUM STANDARDS OF CONDUCT
AND PRACTICE

Sec.

§ 33.201. Use of titles and other designations.

 (a)  Dentists, dental hygienists and expanded function dental assistants may use only the following titles when formally holding themselves out to the public as members of their respective professions:

   (1)  Dentists.

     (i)   ‘‘Doctor’’ or ‘‘Dr.’’ if the licensee’s name and a title permitted under subparagraph (ii) or (iii) follows immediately. The Board specifically prohibits the use of the word ‘‘Doctor’’ or its abbreviation except in combination with one of these titles.

     (ii)   ‘‘Dentist,’’ ‘‘Doctor of Dental Surgery,’’ ‘‘Doctor of Dental Medicine,’’ or a title such as ‘‘Orthodontist,’’ signifying a specialty recognized by the Board in which the dentist has advanced training in conformity with §  33.203(d)(1) (relating to advertising), when preceded by the licensee’s name.

     (iii)   ‘‘D.D.S.’’ or ‘‘D.M.D.,’’ when preceded by the licensee’s name.

   (2)  Dental hygienists.

     (i)   ‘‘Dental Hygienist’’ or ‘‘D. H.,’’ when preceded by the licensee’s name.

     (ii)   ‘‘Registered Dental Hygienist’’ or ‘‘R.D.H.,’’ when preceded by the licensee’s name.

   (3)  Expanded function dental assistants. ‘‘Expanded function dental assistant’’ or ‘‘EFDA’’ when preceded by the certificate holder’s name.

 (b)  In addition to the titles approved under subsection (a), licensees may use, in conjunction with their names, designations of advanced degrees earned from accredited institutions and designations of advanced professional status—such as diplomate or fellow.

 (c)  References in this section to the licensee’s or certificate holder’s name shall be interpreted to mean the name appearing on the licensee’s or certificate holder’s current license or certificate but to allow for the use of initials preceding the licensee’s or certificate holder’s surname.

   The provisions of this §  33.201 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Dentists may use a fictitious name that is not false, misleading or deceptive.

 (b)  Dentists who wish to practice under a fictitious name shall submit to the Board a fictitious name registration and the fee specified in §  33.3 (relating to fees). The dentist who submits the registration shall be associated with the facility and shall assume responsibility for compliance with this section. The owner of the facility, if different from the applicant, shall be identified on the registration.

 (c)  Changes in the ownership of a dental facility, changes in the designation of the responsible dentist, changes in the scope of practice or changes in professional staffing, shall be reported in writing within 10 days.

 (d)  Advertisements in any medium shall include the name, as it appears on the current biennial renewal certificate, and the degree—D.D.S. or D.M.D.—of at least one licensed dentist who is associated with the dental facility. The lettering for the name of the dentist shall be at least equal in size to the lettering used for the fictitious name. The dentist referred to in this subsection and the dentist who registered to use the name under subsection (b) shall be jointly responsible for the advertisement.

 (e)  A directory listing the names of the dentists practicing at that location shall be prominently displayed in the entrance or reception area of the dental facility.

 (f)  The names of dentists who have practiced under the fictitious name shall be maintained in the records of the dental facility for at least 5 years following their departure from the practice.

 (g)  The use of the name of a dentist no longer actively associated with the practice may be continued for up to 1 year.

 (h)  Dentists who are specialists under §  33.203(d)(1) (relating to advertising) may incorporate their area of specialization in their fictitious name. A specialist in one area may include another recognized specialty area, or a nonspecialty area, in a fictitious name (examples: a specialist in orthodontics using Central Orthodontics and Pediatric Dentistry or a specialist in periodontics using Central Periodontics and Cosmetic Dentistry) only if the specialist conspicuously discloses, in every medium in which the name is used, that specialty status does not extend to the other specialty or nonspecialty area.

 (i)  Dentists who are not specialists under §  33.203(d)(1) may incorporate any area of dentistry in their fictitious name, including the recognized specialties, only if the name, in every medium in which it is used, is accompanied by the conspicuous disclosure that services are provided by a general dentist.

 (j)  A fictitious name may not include the word ‘‘clinic’’ unless the name designates a public or quasipublic facility as defined in §  33.1 (relating to definitions).

 (k)  A fictitious name may not include the word ‘‘institute’’ unless the name designates an educational or research facility.

 (l)  A fictitious name may not, by the use of plurals or otherwise, misrepresent the number of dentists practicing at a facility or the number of dentists at the facility who are specialists under §  33.203(d)(1).

   The provisions of this §  33.202 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2547. Immediately preceding text appears at serial pages (223032) to (223034).

 (a)  Advertising is permitted to provide the public with a sufficient basis for making an informed selection of a dentist. For purposes of this section, the term ‘‘advertising’’ includes signs, letterheads, business cards, and printed or broadcast announcements of services to the public.

 (b)  Advertising that is false, misleading or deceptive is prohibited under section 4.1(a)(10) of the act (63 P. S. §  123.1(a)(10)). Advertising is false, misleading or deceptive if it does one or more of the following:

   (1)  Contains a material misrepresentation of fact, or omits a fact necessary to make the statement considered as a whole not materially misleading.

   (2)  Is likely to create an unjustified expectation about results the dentist can achieve.

   (3)  Compares the advertising dentist’s services with the services of other dentists unless the comparison can be factually substantiated.

 (c)  A dental advertisement in any medium shall contain the name of at least one dentist whose services are being advertised. Each dentist whose name appears in the advertisement shall assume responsibility for the advertisement and shall use the name that appears on the dentist’s current biennial renewal certificate. A dentist who advertises under a fictitious name shall comply with §  33.202 (relating to fictitious names).

 (d)  A dental advertisement in any medium may identify the dentist as a specialist in a particular area of dentistry, state that the practice is limited to a particular area of dentistry or merely designate the kinds of dental services available. In addition, the following shall be met:

   (1)  An advertisement may not hold out or imply that the dentist is a specialist in any area unless the conditions in subparagraphs (i) and (ii) are satisfied. Holding out as a specialist includes the use of the terms ‘‘specialist’’ and ‘‘limited to specialty of’’ or of words such as ‘‘endodontist’’ and ‘‘pediatric dentist,’’ which denote a practitioner of the dental specialties listed in subparagraph (i).

     (i)   The area must be recognized by the Board as a dental specialty. The Board has adopted the American Dental Association’s (ADA’s) standards for recognizing the following specialties:

       (A)   Dental public health.

       (B)   Endodontics.

       (C)   Oral and maxillofacial surgery.

       (D)   Oral pathology.

       (E)   Orthodontics.

       (F)   Pediatric dentistry.

       (G)   Periodontics.

       (H)   Prosthodontics.

     (ii)   The dentist shall have successfully completed a specialty training program approved by the ADA’s Commission on Dental Accreditation.

   (2)  A dentist who is a specialist in one area under paragraph (1) and advertises, in conjunction with the specialty, that services are provided in another recognized specialty area, or in a nonspecialty area (examples: a specialist in orthodontics announcing additional services in pediatric dentistry or a specialist in periodontics announcing additional services in placing dental implants) shall conspicuously disclose that specialty status does not extend to the other specialty or nonspecialty area.

   (3)  A specialist under paragraph (1) may not hold out or imply that general dentists associated with the practice are specialists.

   (4)  A dentist who is not a specialist under paragraph (1) may list the area in which the dentist practices or to which the practice is limited. If the advertisement identifies an area by a term that designates a recognized specialty under paragraph (1)(i), the advertisement shall conspicuously disclose that services are provided by a general dentist. For example, an advertisement that announces services in prosthodontics or oral surgery shall include the general dentist disclosure, whereas an advertisement that announces services such as crown and bridge work or extractions may omit the disclosure.

   (5)  Neither general dentists nor specialists may hold out or imply that a nonspecialty area of dentistry has specialty status. For example, dentists may not state that they specialize in or limit their practice to temporomandibular joint disorders or implantology but may announce services in, or a practice limited to diagnosing or treating temporomandibular joint disorders, or placing dental implants.

 (e)  A dental advertisement in any medium may contain the fees charged by the advertising dentist for dental services, as defined in subsection (k). If a minimum fee is advertised, the advertisement shall contain a statement disclosing that the advertised fee is the minimum fee charged for the advertised service and that the actual fee may vary depending on the degree of complexity involved in treatment. The disclosure statement shall be at least as prominent in the context of the advertisement as the fee information contained in the advertisement. If the fee information is verbal, the disclosure statement also shall be verbal and shall be at least equal to the fee information in volume, quality and duration. If the fee information is in writing, the disclosure statement also shall be in writing and shall be at least equal to the fee information in size, legibility and length.

 (f)  A dental advertisement in any medium may state that dental services, as defined in subsection (k), will be rendered free of charge.

 (g)  For at least 60 days following final publication or broadcast of an advertisement containing information about fees or free services, the advertising dentist shall neither increase the advertised fees nor charge fees for services advertised as free unless the advertisement specifically and conspicuously stated that the advertised fees or free services would be available for a shorter period of time. When a dental patient agrees, within the 60-day period or the period otherwise stated in the advertisement, to accept a treatment plan for services for which fees have been advertised, the advertising dentist may not charge a fee higher than the advertised fee, even if the services are rendered beyond the 60-day period or the period otherwise stated in the advertisement. When a dental patient

   agrees, within the 60-day period or the period otherwise stated in the advertisement, to accept a treatment plan for services advertised as free, the advertising dentist may not charge fees for services, even if the services are rendered beyond the 60-day period or the period otherwise stated in the advertisement.

 (h)  A dental advertisement in any medium may state the dentist’s office hours.

 (i)  A recorded copy of an advertisement on radio or television shall be retained for 1 year following the final broadcast of the advertisement. The dentist who is responsible for the advertisement under subsection (c) shall furnish the Board with a copy of the advertisement within 20 days of being requested to do so.

 (j)  If the narrator of a dental advertisement on radio or television is represented as a dentist, that person shall be the dentist so represented.

 (k)  This subsection contains definitions of some but not all of the various types of dental services for which fees may be advertised under subsection (e). Whenever a fee is advertised for one of the defined terms listed in paragraphs (1)—(10), the meaning of the term, as used in the advertisement, is at least as inclusive as the definition set forth in this subsection. These definitions will help ensure that commonly used terms for dental services convey the same meanings in advertisements, thus providing consumers with a better opportunity to compare fees for equivalent services.

   (1)  Examination. A study of the structures of the oral cavity, including the recording of the condition of the structures and the appropriate history. At a minimum, the study shall include the charting of caries; the notation of periodontal disease, occlusal discrepancies, and oral lesions; and a written diagnosis. If a dentist intends to render services in addition to the examination and to charge a separate fee for the additional services, the dentist shall disclose this separate fee to the patient before rendering the additional services.

   (2)  Treatment planning. A written statement of treatment recommendations following an examination and diagnosis. This statement shall include an itemized treatment recommendation and an itemized fee statement.

   (3)  Radiographs. X-rays of the hard and soft oral structures to be used as an aid to diagnosis.

   (4)  Oral prophylaxis. Scaling and polishing of teeth by a licensed dentist or dental hygienist.

   (5)  Restorative dentistry. Procedures involving restoration of tooth structure. The advertisement shall indicate type of restoration and materials to be used.

   (6)  Endodontics. Treatment of the dental pulp, its replacement with suitable material and associated surgery, if indicated.

   (7)  Orthodontics. Prevention and treatment of irregular dentition.

   (8)  Periodontics. Treatment of diseases of the hard and soft tissue surrounding and supporting the oral dentition, including curettage, root planing, surgery, splinting, equilibration and hygiene control procedures.

   (9)  Prosthodontics. Restoration and replacement of teeth and other oral structures by artificial devices, including:

     (i)   Fixed prosthetics. Crowns and bridges. The advertisement shall indicate the type of prosthesis and materials to be used.

     (ii)   Removable prosthetics. Partial and full dentures. The advertisement shall indicate type of prosthesis and materials to be used.

   (10)  Surgery. Surgical treatment of hard or soft tissues, extractions, and treatment of oral pathology, injuries, pain, dysfunction, deformities or other conditions of the oral cavity and its surrounding structures.

   The provisions of this §  33.203 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 Dental procedures shall be assigned to a competent person who the dentist deems appropriate as defined by and consistent with the act.

 (a)  Scope of professional practice. A dental hygienist may offer to perform or perform services that involve:

   (1)  Placement of antimicrobial cord.

   (2)  Periodontal probing, scaling, root planing, polishing or another procedure required to remove calculus deposits, accretions, excess or flash restorative materials and stains from the exposed surfaces of the teeth and beneath the free margin of the gingiva to the base of the junctional epithelium.

   (3)  Evaluation of the patient to collect data to identify dental hygiene care needs.

   (4)  The application of fluorides and other recognized topical agents for the prevention of oral diseases.

   (5)  Conditioning of teeth for and application of sealants.

   (6)  Taking of impressions of the teeth for athletic appliances.

 (b)  Prohibition against independent practice. A dental hygienist is prohibited from establishing or maintaining an office or other workplace for the provision of dental hygiene services separate or independent from the office or other workplace in which the supervision of a dentist is provided.

 (c)  Practice sites. A dental hygienist may engage in professional practice at the following sites under the supervision of a dentist as required in subsection (d):

   (1)  In dental facilities.

   (2)  In public or private institutions such as schools, hospitals, public health care agencies, nursing homes, mobile health units and homes for juveniles, the elderly and the handicapped.

   (3)  In institutions under the jurisdiction of Federal, State or local health agencies.

 (d)  Supervision.

   (1)  In subsection (c)(1) practice sites, the following apply:

     (i)   A dental hygienist may provide the professional service identified in subsection (a)(1) to patients in any ASA Class under the direct supervision of a dentist.

     (ii)   A dental hygienist may provide the professional services identified in subsection (a)(2) to ASA Class I patients under the general supervision of a dentist.

     (iii)   A dental hygienist may provide the professional services identified in subsection (a)(2) to ASA Class II—ASA Class V patients under the direct supervision of a dentist.

     (iv)   A dental hygienist may provide the professional services identified in subsection (a)(3)—(6) to patients in any ASA Class under the general supervision of a dentist.

   (2)  In subsection (c)(2) and (3) practice sites, a dental hygienist shall provide professional services under the general supervision of a dentist. For the purposes of this paragraph, general supervision is defined as supervision by a dentist who authorizes and takes full professional responsibility for the provision of the services. A single authorization may, when appropriate, apply to one or more classes or categories of students/patients.

   (3)  For professional services not identified in subsection (a)(1)—(6) or §  33.302 (relating to auxiliary personnel performing radiologic procedures), the dentist shall compare the listed services and the supervision required with the unlisted service and utilize the appropriate supervision. Supervision for noncomparable services shall be determined by the Board on a modality basis.

   (4)  Notwithstanding the supervision requirements in this subsection, a dental hygienist may provide oral health education and perform preliminary dental screenings in any setting without the supervision of a dentist.

   The provisions of this §  33.205 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

   Ripeness

   Petition for review of these regulations was dismissed as the association of dental hygienists’ allegations of direct and immediate harm did not establish the justiciability of a pre-enforcement challenge to this regulation. The association’s allegations of change in their work schedule, reduced availability of dental hygiene services, reduced income, possible unemployment and the uncertainty of the ongoing day-to-day operations of dental hygiene care are merely anticipatory, speculative and too remote to support a claim of direct and immediate harm. Pennsylvania Dental Hygienists’ Association v. State Board of Dentistry, 671 A.2d 1130 (Pa. Cmwlth. 1996).

 (a)  Scope of professional practice.

   (1)  An expanded function dental assistant may offer to perform or perform the following services:

     (i)   Placing and removing rubber dams.

     (ii)   Placing and removing matrices.

     (iii)   Placing and removing wedges.

     (iv)   Applying cavity liners and bases.

     (v)   Placing and condensing amalgam restorations.

     (vi)   Carving and contouring amalgam restorations.

     (vii)   Placing and finishing composite resin restorations and/or sealant material or both.

   (2)  Each of the professional services identified in paragraph (1) shall be performed under the direct supervision of a dentist.

 (b)  Prohibitions. An expanded function dental assistant may not:

   (1)  Examine, diagnose or plan treatment.

   (2)  Cut hard or soft tissue.

   (3)  Prescribe drugs, medicaments or lab authorizations.

   (4)  Approve the final occlusion.

   (5)  Perform pulp capping, pulpotomy and other endodontic procedures.

   (6)  Perform final placement/cementation of fixed and removable prosthetic appliances.

   (7)  Administer local anesthesia, parenteral or inhalational sedation, nitrous oxide analgesia or general anesthesia.

   (8)  Take impressions other than for study models or diagnostic casts.

 (c)  Supervision. Expanded function dental assistants shall perform under the direct supervision of a dentist. Direct supervision means that a dentist is in the dental office or treatment facility, personally diagnoses the condition to be treated, personally authorizes the procedure and remains in the dental office or treatment facility while the procedure is being performed by the expanded function dental assistant, and, before dismissal of the patient, evaluates the work performed by the expanded function dental assistant.

   The provisions of this §  33.205a amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  The name, address, telephone number and dental license number of the prescribing dentist shall appear on prescriptions for drugs, services or supplies.

 (b)  Noncompliance with subsection (a) will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)).

 (a)  When prescribing, administering or dispensing controlled substances as defined in section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-104), a dentist shall comply with, or cause compliance with, the following minimum standards:

   (1)  Scope of authority. A dentist may prescribe, administer or dispense a controlled substance only:

     (i)   In good faith in the course of the dentist’s professional practice.

     (ii)   Within the scope of the dentist-patient relationship.

     (iii)   In accordance with treatment principles accepted by a responsible segment of the profession.

   (2)  Dental examination and medical history. A dental examination shall be conducted and a medical history shall be taken before a dentist initially prescribes, administers or dispenses a controlled substance to a patient. The examination and medical history shall be complete enough to justify the prescription, administration or dispensation of the controlled substance. The examination shall focus on the patient’s dental problems, and the resulting diagnosis shall relate to the patient’s specific complaint. The patient’s dental record shall contain written evidence of the examination and medical history.

   (3)  Records.

     (i)   On each occasion when a controlled substance is prescribed, administered or dispensed to a patient, an entry shall be made in the patient’s dental record containing the following information:

       (A)   The name, quantity and strength of the controlled substance.

       (B)   The directions for use.

       (C)   The date of issuance.

       (D)   The condition for which the controlled substance was issued.

     (ii)   For the purpose of this subsection, health care facility records will be considered part of the patient’s dental record. A patient’s dental record that contains entries pertaining to the issuance of controlled substances shall be retained by the dentist for a minimum of 5 years following the date of the last entry of any kind in the record.

   (4)  Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate short-term prescription may be telephoned to a pharmacist. An emergency prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the dispensing pharmacist within 72 hours. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history as required by paragraph (2).

   (5)  Exception. This subsection, except for paragraph (1), does not apply when a controlled substance is prescribed, administered or dispensed to a patient in a health care facility regulated by the Department of Health or by the Department of Public Welfare.

 (b)  A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)).

 (c)  This section does not restrict or limit the applicability of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) or of another statute or regulation and does not relieve a dentist from complying with more stringent standards that may be imposed by another regulation or statute.

   The provisions of this §  33.207 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 (a)  When prescribing, administering or dispensing medications not included under §  33.207 (relating to prescribing, administering and dispensing controlled substances), dentists shall comply with, or cause compliance with, the following minimum standards:

   (1)  Scope of authority. A dentist may prescribe, administer or dispense medication only:

     (i)   In good faith in the course of the dentist’s professional practice.

     (ii)   Within the scope of the dentist-patient relationship.

     (iii)   In accordance with treatment principles accepted by a responsible segment of the profession.

   (2)  Dental examination and medical history. A dental examination shall be conducted and a medical history shall be taken before a dentist initially prescribes, administers or dispenses medication to a patient. The examination and medical history shall be complete enough to justify the prescription, administration or dispensation of the medication. The examination shall focus on the patient’s dental problems, and the resulting diagnosis shall relate to the patient’s specific complaint. The patient’s dental record shall contain written evidence of the examination and medical history.

   (3)  Records. On each occasion when medication is prescribed, administered or dispensed to a patient, an entry shall be made in the patient’s dental record containing the following information:

     (i)   The name, quantity and strength of the medication.

     (ii)   The directions for use.

     (iii)   The date of issuance.

     (iv)   The condition for which the medication was issued.

   (4)  Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate short-term prescription may be telephoned to a pharmacist. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history as required by paragraph (2).

 (b)  A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)).

   The provisions of this §  33.208 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 (a)  A dentist shall maintain a dental record for each patient which accurately, legibly and completely reflects the evaluation and treatment of the patient. A patient dental record shall be prepared and maintained regardless of whether treatment is actually rendered or whether a fee is charged. The record shall include, at a minimum, the following:

   (1)  The name and address of the patient and, if the patient is a minor, the name of the patient’s parents or legal guardian.

   (2)  The date of each patient visit.

   (3)  A description of the patient’s complaint, symptoms and diagnosis.

   (4)  A description of the treatment or service rendered at each visit and the identity of the person rendering it.

   (5)  Information as required in §  33.208 (relating to prescribing, administering and dispensing medications) and this section with regard to controlled substances or other medications prescribed, administered or dispensed.

   (6)  The date and type of radiographs taken and orthodontic models made, as well as the radiographs and models themselves. Notwithstanding this requirement, the dentist may release orthodontic models to the patient. This transaction shall be memorialized on a form which is signed by the patient. The signed form shall become part of the patient’s record.

   (7)  Information with regard to the administration of local anesthesia, nitrous oxide/oxygen analgesia, conscious sedation, deep sedation or general anesthesia. This shall include results of the preanesthesia physical evaluation, medical history and anesthesia procedures utilized.

   (8)  The date of each entry into the record and the identity of the person providing the service if not the dentist of record-for example, dental hygienist, expanded function dental assistant, dental assistant, and the like.

 (b)  A patient dental record shall be retained by a dentist for a minimum of 5 years from the date of the last dental entry.

 (c)  Within 30 days of receipt of a written request from a patient or a patient’s parents or legal guardian if the patient is a minor, an exact copy of the patient’s written dental record, along with copies of radiographs and orthodontic models, if requested, shall be furnished to the patient or to the patient’s new dentist. This service shall be provided either gratuitously or for a fee reflecting the cost of reproduction.

 (d)  The obligation to transfer records under subsection (c) exists irrespective of a patient’s unpaid balance for dental services or for the cost of reproducing the record.

 (e)  Dentists shall provide for the disposition of patient records in the event of the dentist’s withdrawal from practice, incapacity or death in a manner that will ensure their availability under subsection (c).

 (f)  The components of a patient dental record that are prepared by a dentist or an agent and retained by a health care facility regulated by the Department of Health or the Department of Public Welfare shall be considered a part of the patient dental record required to be maintained by a dentist, but shall otherwise be exempt from subsections (a)—(e). The components of a patient dental record shall contain information required by applicable Department of Health and Department of Public Welfare regulations—see, for example, 28 Pa. Code §  141.26 (relating to patient dental records)—and health care facility bylaws.

 (g)  This section does not restrict or limit the applicability of recordkeeping requirements in § §  33.207 and 33.208 (relating to prescribing, administering and dispensing controlled substances; and prescribing, administering and dispensing medications).

 (h)  A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)).

   The provisions of this §  33.209 amended under sections 3(c) and 11.2(a) of the Dental Law (63 P. S. § §  122(o) and 130c(a)).

   The provisions of this §  33.209 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 12, 2000, effective May 13, 2000, 30 Pa.B. 2359; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (266034) to (266036).

   Patient’s Complaint

   The State Board of Dentistry’s findings that the dentist failed to properly record the parents’ complaint was supported by substantial evidence, where, based on the expert testimony, the Board found that the dentist should have recorded the parents’ complaint that their son had black spots on his teeth or recorded ‘‘no complaints’’ on the child’s record, and where the Board stated that while the dentist recorded the child’s cavities, such an activity constituted a diagnosis, which is a separate recording requirement. Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999).

 Dentists who administer or dispense drugs shall comply with the following standards:

   (1)  Each drug storage area shall be maintained in a clean and orderly condition.

     (i)   The storage area shall be dry, well ventilated and well lighted. Provision shall be made for adequate dust, humidity and temperature controls to ensure drug stability.

     (ii)   The storage area shall contain only drugs and related supplies and equipment which are necessary for the administration and dispensing of drugs to the dentist’s own patients.

     (iii)   Drugs in the storage area shall be accurately labeled. Until a drug is administered or dispensed to a dental patient, it shall be kept in the manufacturer’s original container showing the manufacturer’s lot number and the expiration date.

     (iv)   Drugs in the storage area shall be free from adulteration. Appropriate procedures shall be established to minimize the hazards of cross contamination.

     (v)   Outdated or deteriorated drugs shall be identified as such and shall be segregated in the storage area pending their return to the manufacturer or their appropriate disposal. The dentist shall maintain records reflecting the final disposition of these products.

   (2)  Controlled substances shall be stored in a substantially constructed, locked container such as a cabinet or safe. Access to the locked container where controlled substances are kept in order to clean, replenish supplies or perform other necessary functions shall be allowed only when a dentist is present and supervising.

   (3)  The dentist shall provide for the safe, secure and sanitary disposal of drug-containing refuse.

   (4)  This section prescribes minimum standards for the storage of drugs in dental offices. It does not relieve a dentist from complying with more stringent standards that may be imposed by another regulation or by statute.

   (5)  A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)).

 (a)  Dentists. Unprofessional conduct, as defined in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)), includes the following conduct by a dentist:

   (1)  Knowingly or negligently employing as a dentist, dental hygienist or expanded function dental assistant a person whose license or certificate is not current or has been suspended or revoked.

   (2)  Failing to carry out supervisory responsibility with regard to auxiliary personnel or dental residents/interns.

   (3)  Delegating to a person duties that the dentist knows, or has reason to know, the person is not competent to perform or not authorized to perform.

   (4)  Withdrawing dental services after a dentist-patient relationship has been established so that the patient is unable to obtain necessary dental care in a timely manner.

   (5)  Physically, sexually or verbally abusing a patient.

   (6)  Unnecessarily exposing a patient to ionizing radiation.

   (7)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control or to ensure that auxiliary personnel and other supervisees follow these Federal guidelines.

   (8)  Failing to provide necessary dental care to a patent in a timely manner or to apprise the patient of the need for the care.

   (9)  Failing to make available to a patient, within 30 days of a request, information sufficient to enable the patient to complete an insurance form.

 (b)  Dental hygienists. Unprofessional conduct, as defined in section 4.1(a)(8) of the act includes the following conduct by a dental hygienist:

   (1)  Practicing as a dental hygienist without the supervision of a dentist.

   (2)  Performing a service that the dental hygienist knows, or has reason to know, the hygienist is not competent to perform or not authorized to perform.

   (3)  Physically, sexually or verbally abusing a patient.

   (4)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control.

   (5)  Unnecessarily exposing a patient to ionizing radiation.

 (c)  Expanded function dental assistants. Unprofessional conduct, as defined in section 4.1(a)(8) of the act includes the following conduct by an expanded function dental assistant:

   (1)  Practicing as an expanded function dental assistant without the direct supervision of a dentist.

   (2)  Performing a service that the expanded function dental assistant is not competent or not authorized to perform.

   (3)  Physically, sexually or verbally abusing a patient.

   (4)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control.

   (5)  Providing ionizing radiation in violation of §  33.302 (relating to auxiliary personnel performing radiologic procedures).

   The provisions of this §  33.211 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 As used in section 4.1(a)(2) of the act (63 P. S. §  123.1(a)(2)), the phrase ‘‘misleading, deceptive, untrue or fraudulent representations’’ includes the following conduct by dentists, dental hygienists and expanded function dental assistants:

   (1)  Misrepresenting or concealing a material fact in obtaining, renewing or seeking reinstatement of a license or certificate.

   (2)  Misrepresenting or concealing a material fact in obtaining payment for dental services.

   (3)  Writing a prescription for a controlled substance or other medication in the name of a person other than for whom the controlled substance or other medication is intended under § §  33.207 and 33.208 (relating to prescribing, administering and dispensing controlled substances; and prescribing, administering and dispensing medications).

   (4)  Falsifying a patient’s record regarding treatment or the issuance of a controlled substance or other medication.

   The provisions of this §  33.212 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

   The provisions of this §  33.212 adopted January 18, 1965; amended September 12, 1975, effective September 13, 1975, 5 Pa.B. 2397; reserved April 28, 1989, effective April 29, 1989, 19 Pa.B. 1840; amended June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 12, 2000, effective May 13, 2000, 30 Pa.B. 2359. Immediately preceding text appears at serial page (223045).

 (a)  Background. The safety of dental amalgams, specifically, whether the mercury in amalgams causes or contributes to a variety of health problems, has become a recurring issue in dentistry. The Board has neither the resources nor the mandate to make or endorse scientific findings on this issue. It is aware, however, of no conclusive evidence that the removal of amalgams will cure or ameliorate disorders other than those associated with confirmed allergic reactions to mercury. Nonetheless, nonallergic patients may request replacement of amalgam restorations in the belief, or merely the hope, that a medical condition will thereby disappear or improve. Dentists receiving these requests must make ethical and professional decisions compatible with the best interests of their patients.

 (b)  Purpose. Section 4.1(a)(8) and (9) of the act (63 P. S. §  123.1(a)(8) and (9)) authorizes the Board to take disciplinary action against licensees who engage in unprofessional conduct or commit acts of negligence, incompetence or malpractice. The replacement of amalgams may implicate both provisions by, for example, generating complaints of unnecessary or even harmful treatment. The Board therefore provides the following guidelines to assist its licensees in conforming their behavior to the requirements of the act. In a disciplinary action brought against a dentist for treatment associated with replacing amalgams, the Board will consider whether these guidelines were followed.

 (c)  Guidelines.

   (1)  The Board recommends that, before replacing amalgams in a nonallergic patient, the dentist:

     (i)   Explain to the patient the current status of research on the safety of dental amalgams.

     (ii)   Provide the patient with information on contraindications and costs associated with removal/replacement of amalgam restorations.

     (iii)   Advise a patient relying on third-party payment to ascertain whether the insurer will cover removal/replacement procedures.

     (iv)   Encourage a patient seeking amelioration of a medical condition to consult with a physician and, as appropriate, secure from the physician documentation of recommendations made to the patient.

     (v)   Memorialize in writing the disclosures made to the patient and the patient’s informed consent.

   (2)  The Board recognizes the right and duty of dentists to refuse to replace amalgam restorations when, in their professional judgment, this procedure would not be in the best interests of the patient.

   The provisions of this §  33.213 adopted January 18, 1965; amended Septemb