Part XXXIII. Dental Health Profession

A. - B. ...

C. No more than 20 of the required 40 hours can be completed from the following:

1. - 2. ...

3. Repealed.

D. …

F. No credit will be given for activities directed primarily to persons preparing for licensure in Louisiana.

G. Dentists who are on staffs of hospitals accredited by the Joint Commission on Accreditation of Health Care Organizations may receive continuing education credit for those continuing education courses provided by said hospital.

H. Dentists will be awarded three clinical credit hours for successful completion of Cardiopulmonary Resuscitation Course "C", Basic Life Support for Healthcare Providers as defined by the American Heart Association or the Red Cross Professional Rescue Course. When being audited for compliance with cardiopulmonary resuscitation course completion, a photocopy of the CPR card evidencing successful completion of the course for each year shall be appended to the form.

I. Dentists who successfully complete certification courses in advanced cardiac life support continuing education will be awarded up to 16 hours of clinical continuing dental education. However, dentists completing the shorter recertification course in advanced cardiac life support will be awarded 3 hours of clinical continuing dental education.

J. In order to renew permits for the administration of deep sedation, parenteral sedation, and enteral sedation, each licensee shall complete a board approved course pertinent to the level of their sedation permit no less than once every five years.

1. Recertification for deep sedation or general anesthesia as required by the American Association of Oral and Maxillofacial Surgeons every five years shall satisfy this requirement.

K. Dentists successfully completing the calibration training for the administration of the clinical licensing examination administered by the Council of Interstate Testing Agencies (CITA) may be awarded up to 20 hours of clinical continuing education per each renewal period.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:760(8) and (13).

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Dentistry, LR 20:661 (June 1994), amended LR 21:569 (June 1995), LR 22:24 (January 1996), LR 22:1216 (December 1996), LR 23:1526 (November 1997), LR 24:1117 (June 1998), LR 25:510 (March 1999), LR 26:489 (March 2000), LR 30:2307 (October 2004), LR 32:244 (February 2006), LR 35:

A. - B. ...

C. No more than 12 of the required 24 hours can be completed from the following:

1. - 2. ...

3. Repealed.

D. - G. ...

H. Dental hygienists who are on staffs of hospitals accredited by the Joint Commission on Accreditation of Health Care Organizations may receive continuing education credit for those continuing education courses provided by said hospital.

I. Dental hygienists will be awarded three clinical credit hours for successful completion of Cardiopulmonary Resuscitation Course "C", Basic Life Support for Healthcare Providers as defined by the American Heart Association or the Red Cross Professional Rescue Course. When being audited for compliance with cardiopulmonary resuscitation course completion, a photocopy of the CPR card evidencing successful completion of the course for each year shall be appended to the form.

J. ...

K. Dental hygienists successfully completing the calibration training for the administration of the clinical licensing examination administered by the Council of Interstate Testing Agencies (CITA) may be awarded up to

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:760(8) and (13).

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Dentistry, LR 20:661 (June 1994), amended LR 21:570 (June 1995), LR 22:24 (January 1996), LR 22:1217 (December 1996), LR 23:1526 (November 1997), LR 24:1118 (June 1998), LR 25:510 (March 1999), LR 26:489 (March 2000), LR 30:2307 (October 2004), LR 32:245 (February 2006), LR 35:

§1615. Approved Courses

A. - B.2.c.ii. ...

C. Clinical credit will be given to programs dealing with the mechanical delivery of dental services as well as those addressing biological and psychological aspects of therapy such as pharmacology, nutrition, behavioral modification, etc., which are pertinent to the restoration and maintenance of oral health.

D. Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:760(8), and (13).

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Dentistry, LR 20:662 (June 1994), amended LR 22:24 (January 1996), LR 24:1118 (June 1998), LR 35:

Interested persons may submit written comments on these proposed Rule changes to C. Barry Ogden, Executive Director, Louisiana State Board of Dentistry, One Canal Place, Suite 2680, 365 Canal Street, New Orleans, LA 70130. Written comments must be submitted to and received by the board within 60 days of this notice. A request pursuant to R.S. 49:953(A)(2) for oral presentation, argument, or public hearing must be made in writing and received by the board within 20 days of the date of this notice.
C. Barry Ogden

Executive Director

There will be a one-time cost of $500 in FY 08-09 for publication of the proposed rule in the Louisiana Register and in a mass mailing which is sent to all licensees every summer.

II. ESTIMATED EFFECT ON REVENUE COLLECTIONS OF STATE OR LOCAL GOVERNMENTAL UNITS (Summary)

It is anticipated that the implementation o these rule changes will neither increase nor decrease revenues for the Louisiana State Board of Dentistry.

III. ESTIMATED COSTS AND/OR ECONOMIC BENEFITS TO DIRECTLY AFFECTED PERSONS OR NONGOVERNMENTAL GROUPS (Summary)

Dentists and dental hygienists are required to receive three hours of cardiopulmonary resuscitation training per year under current rules. Dentists and dental hygienists who pay for their Continuing Education credits will have reduced costs for such Continuing Education credits because they will be able to apply their three hours of cardiopulmonary resuscitation training per year towards their continuing education credits each year. Such dentists and hygienists will also benefit from having fewer demands on their time by using current cardiopulmonary resuscitation training towards their Continuing Education requirements.

A small number of dentists and hygienists work with the Council of Interstate Testing Agencies (CITA) to calibrate CITA licensing tests taken by new dentists and hygienists. Such dentists and dental hygienists who pay for their Continuing Education credits will have reduced costs for such Continuing Education credits because they will be able to apply up to 10 hours per year towards working on calibrating the CITA tests towards their continuing education credits each year. Such dentists and hygienists will also benefit from having fewer demands on their time by using time spent calibrating the CITA tests towards their Continuing Education requirements.

Dentists and dental hygienists will also benefit from having a wider range of approved Continuing Education subjects to study each year. The proposed rules add biological, psychological, pharmacological nutrition, and behavior modification aspect of therapy to the Approved Courses for Continuing Education.

IV. ESTIMATED EFFECT ON COMPETITION AND EMPLOYMENT (Summary)

There is no estimated effect on competition and employment.

Wholesale Drug Distributors

The Louisiana Board of Wholesale Drug Distributors proposes to amend LAC 46:XCI.103, 105, 301, 303, 305, 315, 317, 319, 321, 501, 503, 507, 509, 711, and 801 in accordance with the provisions of the Administrative Procedure Act, R.S. 49:950 et seq., and R.S. 37:3467 et seq., of the Louisiana Board of Wholesale Drug Distributors Practice Act. These proposed Rule amendments will assist the board in its ability to safeguard life and health and promote the welfare of the citizen of Louisiana by regulating wholesale distributors of legend drugs or devices in and into the state. The proposed Rule amendments have no known impact on family formation, stability, and autonomy as described in R.S. 49:972. The proposed amendments to the Rule are set forth below.

A. As used in this regulation, unless the context otherwise requires:

a. - c. …

d. it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of federal or Louisiana law or rule; or

ii. Repealed.

e. - g.i. …

ii. substituted wholly or in part thereof.

h. Repealed.

Blood―whole blood collected from a single donor and processed either for transfusion or further manufacturing.

Blood Components―that part of blood separated by physical or mechanical means.

Consumer or Patient―a person who is the end user of a drug or device.

* * *

* * *

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:381 (April 1992), amended LR 29:1479 (August 2003), LR 32:394 (March 2006), LR 34:874 (May 2008), LR 35:

§105. Wholesale Drug Distribution—Exemptions

A. Wholesale drug distribution does not include:

1. intra-company sales;

2. the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug or device for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organization;

3. the sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

4. the sale, purchase, or trade of a drug or device or an offer to sell, purchase, or trade a drug or device among hospitals or other health care entities that are under common control; for the purposes of this section common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise;

5. the sale, purchase, or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for emergency medical reasons; for purposes of this Section, emergency medical reasons include transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage that arises from delays in or interruptions of regular distribution schedules;

6. the dispensing of a drug or device pursuant to a prescription;

7. the distribution of drug samples by manufacturers' representatives or distributors' representatives; or

8. the sale, purchase, or trade of blood and blood components intended for transfusion.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 35:

A. Every wholesale drug or device distributor shall submit an initial application for a new license on a form furnished by the board and accompanied by the initial license fee.

1. - 2. …

B. All new licenses issued by the board shall expire on December 31 of the calendar year issued.

C. A license shall be renewed annually by timely submitting an application and the license renewal fee.

D. Each application for the renewal of the license must be made between October 1 and December 31 of each year on a form provided by the board.

1. If a license is not renewed on or before the expiration date, a person may apply for reinstatement of the expired license within one year by submitting an application, the license renewal fee, and the license reinstatement fee.

2. If a license is expired beyond one year, a person may apply for reinstatement of the expired license by submitting an application, the initial license fee, the license reinstatement fee, and if applicable, the initial inspection fee.

3. A person may not lawfully operate as a wholesale drug or device distributor in Louisiana until the expired license has been reinstated.

E. Licenses renewed annually between October 1 and December 31 shall expire on December 31 of the following calendar year.

F. Each license issued hereunder shall be displayed by the licensee in a conspicuous place at the licensed facility or physical location.

G. Out-of-state wholesale drug or device distributors licensed by the board must have on file at all times with the board a current copy of a valid certificate of registration or license for wholesale drug or device distribution as issued by the appropriate regulatory board or agency of the state in which the facility or physical location licensed with the board is located.

1. If the state in which the facility licensed with the board is located does not require the facility to be registered or licensed as a wholesale drug or device distributor and the facility or physical location is registered or licensed in the state in which it is located as a manufacturer of drugs or devices, a current copy of the valid manufacturer registration or license must be submitted to and maintained with the board.

2. If the state in which the facility or physical location licensed with the board is located does not require the facility or physical location to be registered or licensed as a wholesale drug or device distributor and/or the facility or physical location is not a registered/licensed manufacturing facility and the state in which the facility or physical location is located does not require any registration or licensure of the facility or physical location, a letter from the appropriate regulatory board or agency must be submitted to the board confirming such fact.

3. If the facility or physical location licensed with the board does not physically distribute and/or manufacture the drugs or devices that it owns or holds title to and/or the facility or physical location licensed with the board contracts with another facility for the warehousing and/or distribution of the drugs or devices and the state in which the facility or physical location licensed by the board is located does not require any registration or licensure of the facility or physical location, a letter from the appropriate regulatory board or agency confirming this fact and a current copy of the valid registration or license from the state in which the contracted facility is located must be submitted to the board.

H. Wholesale drug or device distributor applicants and licensees physically located and conducting operations in Louisiana shall provide a list of their wholesale drug or device distributors from whom they purchased and/or received a legend drug or device within the 12 months prior to application or renewal application; the list shall include, but not be limited to:

1. name of each wholesale drug or device distributor;

2. each wholesale drug or device distributor's business address and telephone number; and

3. each wholesale drug or device distributor's distribution address(es) from which the legend drug or device was shipped.

I. An initial application for a new license is valid for 180 days after receipt by the board. If the application is not completed, the application becomes void and any fees paid are non-refundable.

J. Requests for voluntary cancellation of a license made by a licensee must be made in writing and must include information such as, but not limited to, the date the request is effective and the reason for the voluntary cancellation of the license.

1. If the request for voluntary cancellation is made before the license has expired, the original unexpired license certificate must be returned to the board and no refund of any portion of the license fee(s) paid will be made by the board.

K. If a licensed in-state wholesale drug or device distributor has an additional off-site storage facility, the off-site storage facility may operate under the current wholesale drug or device distribution license held by the licensee as long as the off-site storage facility is in compliance with §309.A.1 of these regulations and has temperature monitoring and an alarm system and the off-site storage facility does not physically receive or distribute legend drugs or devices from its location.

L. A license shall not be issued by the board for any wholesale drug or device distributor to operate from or out of a dwelling, building, or property zoned as residential.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 29:1480 (August 2003), LR 32:396 (March 2006), LR 34:875 (May 2008), LR 35:

A. The board requires the following from each applicant as part of the initial licensing procedure and as part of any renewal or reinstatement of such license:

1. the name, full business address, and telephone number of the applicant;

2. all trade or business names used by the applicant;

3. addresses, telephone numbers, and the names of contact persons for the facility or physical location used by the applicant;

4. the type of ownership or form of business operation used by the applicant (i.e., partnership, corporation, or sole proprietorship); if other than a natural person, the type of entity and the name of the state where formed;

5. the names of the owners of the applicant including the percentage of interest owned;

6. the name of the person designated as the responsible party;

7. the names and titles of the directors and officers of the applicant;

8. a list of every state or territory, other than Louisiana, where the applicant holds a current license for wholesale drug or device distribution;

9. any other information which the board may require to determine qualification for obtaining, renewing, or reinstating a license.

B. Changes in any information required in this regulation shall be submitted in writing to the board within 60 days after such changes become effective. Failure to do so may result in disciplinary action being taken against the licensee.

C. A license shall be valid only for the person or the facility or physical location for which it is issued. Licenses are not transferable for change of location or change of ownership of the facility or physical location licensed by the board. Any such change shall require the submission of an application and fee for, and the issuance of, a new license by the board and the termination of the existing license.

D. Wholesale drug or device distributors with a place of business physically located in Louisiana must notify the board, in writing, within three business days of discovery of, or being in a position to have acquired such knowledge of, any theft or diversion of drugs or devices.

E. Wholesale drug or device distributors with a place of business physically located in Louisiana must notify the board, in writing, within 24 hours of discovery of, or being in a position to have acquired such knowledge of, any contraband, counterfeit, or misbranded drugs or devices in their possession whether actual or constructive.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 29:1480 (August 2003), LR 30:1481 (July 2004), LR 32:397 (March 2006), LR 35:

§305. Qualifications

A. - A.9. …

B. The board shall deny a license to an applicant if it determines that the issuing of such a license would not be in the interest of public health, safety or welfare.

C. The designated responsible party must have knowledge of the policies and procedures pertaining to operations of the applicant facility.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992), amended LR 32:398 (March 2006), LR 35:

A. Wholesale drug or device distributors shall establish and maintain an on-site list of owners, officers, directors, managers, and other persons in charge of wholesale drug or device distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 32:400 (March 2006), LR 35:

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 32:400 (March 2006), repealed LR 35:

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 32:401 (March 2006), repealed LR 35:

A. The board, in its discretion, may accept a satisfactory inspection by the United States Food and Drug Administration (USFDA) or a state agency which the board determines to be comparable to that made by USFDA or the board.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 32:401 (March 2006), LR 35:

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:385 (April 1992), amended LR 32:401 (March 2006), repealed LR 35:

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:385 (April 1992), amended LR 29:1481 (August 2003), LR 32:401 (March 2006), repealed LR 35:

Repealed.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:385 (April 1992), amended LR 32:401 (March 2006), repealed LR 35:

A. The board may contract with any person or agency it deems qualified to conduct any inspections or reinspections.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:385 (April 1992), amended LR 30:1481 (July 2004), LR 32:401 (March 2006), LR 35:

Chapter 7. Disciplinary Procedures

§711. Grounds for Disciplinary Action

A. After notice and hearing, the board may deny, revoke or suspend a license or otherwise sanction a licensee, for any of the grounds set forth in R.S. 37:3474.1 or R.S. 37:3474.2 and any of the following:

1. - 3. …

B. The authority of the board to impose a monetary penalty in a case is not to be affected by any other civil or criminal proceeding concerning the same violation, nor shall the imposition of a monetary penalty preclude the board from imposing other sanctions.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 32:403 (March 2006), LR 35:

A. The board may collect the following fees.

1. Initial License Fee—$200

2. License Renewal Fee—$200

3. Initial Inspection Fee—$100

4. Duplicate License Fee—$10

5. License Reinstatement Fee for licenses suspended, revoked, or expired—$200

6. License Verification Fee—$15

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 32:403 (March 2006), amended LR 35:

Interested parties may submit written comments to John Liggio, Executive Director, Louisiana Board of Wholesale Drug Distributors, 12046 Justice Avenue, Suite C, Baton Rouge, LA 70816. Comments will be accepted through the close of business on May 19, 2009. If it becomes necessary to convene a public hearing to receive comments in accordance with the Administrative Procedures Act, the hearing will be held on May 26, 2009, at 11 a.m. at the office of the Louisiana Board of Wholesale Drug Distributors, 12046 Justice Avenue, Suite C, Baton Rouge, LA.
Kimberly B. Barbier

Executive Assistant

There will be no costs or savings to state or local governmental units, except for those associated with publishing the rule amendment (estimated at $1,600―$800 in fiscal year 2009 and $800 in fiscal year 2010). Licensees will be informed of this rule change via the Board's regular newsletter or other direct mailings, which result in minimal costs to the Board.

II. ESTIMATED EFFECT ON REVENUE COLLECTIONS OF STATE OR LOCAL GOVERNMENTAL UNITS (Summary)

The proposed rules are estimated to increase the Board's self-generated revenues by an estimated $6,100 per year. An Initial Inspection Fee of $100 for the initial inspection of new applicant facilities located in Louisiana for approximately 30 new in-state license applications per year; a Duplicate License Fee of $10 for processing requests for duplicate license certificates for approximately 10 licensees per year; and a License Verification Fee of $15 for processing requests for verification of Louisiana licenses for approximately 200 requests per year.

III. ESTIMATED COSTS AND/OR ECONOMIC BENEFITS TO DIRECTLY AFFECTED PERSONS OR NONGOVERNMENTAL GROUPS (Summary)

Wholesale drug distributors will pay an estimated $6,100 per year in additional fees based on the proposed rule changes.

IV. ESTIMATED EFFECT ON COMPETITION AND EMPLOYMENT (Summary)

No impact on competition and employment is anticipated as a result of the proposed rule change.

Adult Residential Care Providers―Minimum Licensing Standards―Dementia Training Requirements

The Department of Health and Hospitals, Bureau of Health Services Financing proposes to amend LAC 48:I.6803, §§6851 and §6867 in the Medical Assistance Program as authorized by R.S. 36:254 and R.S. 40.2200.1-2200.5. This proposed Rule is promulgated in accordance with the provisions of the Administrative Procedure Act, R.S. 49:950, et seq.

In compliance with the directives of Act 433 of the 2006 Regular Session of the Louisiana Legislature, the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing adopted provisions governing the minimum licensing standards for adult residential care providers (ARCPs) (Louisiana Register, Volume 34, Number 12).

Act 571 of the 2008 Regular Session of the Louisiana Legislature directed the Department of Health and Hospitals to establish dementia training requirements for persons who are employed by adult residential care facilities and nursing facilities. In compliance with Act 571, the department proposes to amend the December 20, 2008 Rule governing the minimum licensing standards for ARCPs to incorporate dementia training requirements.

In compliance with Act 1183 of the 1999 Regular Session of the Louisiana Legislature, the impact of this proposed Rule on the family has been considered. It is anticipated that this proposed Rule will have a positive impact on family functioning, stability, and autonomy as described in R.S. 49:972 by assuring that ARCP staff have the training necessary to provide adequate care to residents diagnosed with dementia and related illnesses.

Title 48

PUBLIC HEALTH—GENERAL