Chapter LIII

A. Each dispenser shall submit to the board information regarding each prescription dispensed for a controlled substance or drug monitored by the program. B. Each dispenser shall submit the required information by electronic means no later than the next business day after the dat…

A. The information submitted for each prescription shall include data relative to the identification of the following elements of the transaction, or alternative data as identified in the board's program user manual. To the extent possible, the data shall be transmitted in the fo…

A. The board shall retain a minimum of five years of prescription monitoring information for review by persons authorized to access such information. B. The board shall archive all prescription monitoring information not available for direct or indirect access up to 10 years. C. …

A. A dispenser who fails to submit prescription monitoring information to the board as required shall be referred to the appropriate professional licensing, certification, or regulatory agency for administrative sanctions as deemed appropriate by that agency. Notes La. Admin. Cod…

A. The following persons may access prescription monitoring information in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar protected health information under federal and state law and regulation: 1. persons autho…

A. Authorized users of prescription monitoring information, and their delegates, shall comply with the following requirements to register with the board, in order to receive the appropriate credentials to access prescription monitoring information. 1. a. A prescriber or dispenser…

A. Prescribers and dispensers as well as their delegates, once properly registered, may solicit prescription monitoring information from the program concerning their patients, or for verifying their prescription records. The program may require such users to certify the legitimac…

A. If the program receives evidence of inappropriate or unlawful use or disclosure of prescription monitoring information by an authorized user or his delegate, the program shall refer that user to the appropriate professional licensing, certification, or regulatory agency for ad…

A. The program shall provide prescription monitoring information to public or private entities, whether located in or outside the state, for public research, policy, or educational purposes, but only after removing information that identifies or could reasonably be used to identi…

A. The board shall report to the appropriate legislative oversight committee on a periodic basis, but in no case less than annually, the cost benefits and other information relevant to policy, research, and education involving controlled substances and other drugs of concern moni…

A. The board shall, in consultation with and upon recommendation of the advisory council, design and implement an evaluation component to identify cost benefits of the prescription monitoring program and other information relevant to policy, research, and education involving cont…

A. The following terms shall have the meaning ascribed to them in this Section: Audited Financial Statement -Repealed. Notes La. Admin. Code tit. 46 , § LIII-3001 Promulgated by the Department of Health, Board of Pharmacy, LR 47 591 ( 5/1/2021 ), Amended LR 48 2105 ( 8/1/2022 ). …

A. A pharmacy benefit manager, as defined at R.S. 40:2863 , shall obtain and maintain a pharmacy benefit manager permit from the board prior to conducting business in Louisiana if it administers, develops, maintains, performs, or provides one or more of the pharmacy services enum…

A. Application for Initial Issuance of Permit 1. The board shall develop an application form suitable for the pharmacy benefit manager permit. The board may revise that application form on its own initiative in order to collect the information it deems necessary to properly evalu…

A. Person. The board has jurisdictional authority over the person practicing pharmacy, assisting in the practice of pharmacy, operating a pharmacy, or otherwise licensed, registered, certified, or permitted by the board. A person is as defined in R.S. 37:1164(33) of the Pharmacy …

A. A summons shall represent a complaint of an alleged violation directed to a respondent. B. Hearing Notice. The board shall initiate a hearing by issuing a notice summons. The notice summons shall be forwarded to the respondent commanding his presence to appear before the board…

A. Method. Service of a summons shall be made either by regular, registered, or certified mail, with a return receipt requested, or board or court designated process servers confected by tendering the summons to the respondent personally or domiciliary at the last known address. …

A. The board may proceed with a hearing in the event the respondent fails to appear after due notice was perfected or a diligent effort had been made to perfect service on the respondent at the last known address of record. Notes La. Admin. Code tit. 46 , § LIII-307 Promulgated b…

A. Several complaints may be joined or incorporated and the respondents may be joined in the same or similar complaints based on the same or similar acts or transactions that are connected in a common plan or scheme. Notes La. Admin. Code tit. 46 , § LIII-309 Promulgated by the D…

A. Scope of Chapter. The rules of this Chapter interpret, implement, and provide for the enforcement of R.S. 37:1744 and R.S. 37:1745 , or their successors, requiring disclosure of a pharmacist's financial interest in another health care provider to whom or to which the pharmacis…

A. As used in this Chapter, the following terms have the meaning ascribed to them by this Section. Board -the Louisiana Board of Pharmacy. Financial Interest -a significant ownership or investment interest established through debt, equity, or other means and held, directly or ind…

A. A pharmacist or pharmacy shall not knowingly and willfully make, or offer to make, any payment, directly or indirectly, overtly or covertly, in cash or in kind, to induce another person to refer an individual to the pharmacist for the furnishing, or arranging for the furnishin…

A. Any arrangement or scheme, including cross-referral arrangements, which a pharmacist or pharmacy knows or should know has a principal purpose of ensuring or inducing referrals by the pharmacist to another health care provider, which, if made directly by the pharmacist or pharm…

A. Proportionate Return on Investment. Payments or distributions by an entity representing a direct return on investment based upon a percentage of ownership, shall not be deemed a payment prohibited by R.S. 37:1745(B) , or its successor, or § 3105 of these regulations. B. Genera…

A. Hearings may be held jointly to assure a fair due process hearing. Any alleged violations may be consolidated for an administrative hearing of respondents. Notes La. Admin. Code tit. 46 , § LIII-311 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 1…

A. Any violation of, or failure of compliance with, the prohibitions and provision of § 3105 of this Chapter shall be deemed a violation of the Pharmacy Practice Act, R.S. 37:1161 et seq., providing cause for the board to sanction a person culpable of such violation. Notes La. Ad…

A. Mandatory Disclosure. A pharmacist or pharmacy shall not make any referral of a patient outside the pharmacist's or pharmacy's group practice for the provision of health care items or services by another health care provider in which the referring pharmacist has a financial in…

A. Required Contents. The disclosure required by § 3113 of this Chapter shall be made in writing, shall be furnished to the patient, or the patient's authorized representative, prior to or at the time of making the referral, and shall include: 1. the pharmacist's or pharmacy's na…

A. Effect of Violation. Any violation of, or failure of compliance with, the prohibitions and provision of § 3113 of this Chapter shall be deemed a violation of the Pharmacy Practice Act, R.S. 37:1161 et seq., providing cause for the board to sanction a pharmacist or pharmacy cul…

[Name of Pharmacist/Group] [Address] [Telephone Number] DISCLOSURE OF FINANCIAL INTEREST As Required by R.S. 37:1744 and LAC 46:LIII.613-615 TO:_________________ DATE:____________________ _________________________________ (Name of Patient to Be Referred) _________________________…

A. A severance of complaints is permitted when a fair due process hearing will not be satisfied. Otherwise, complaints may be heard jointly. Notes La. Admin. Code tit. 46 , § LIII-313 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 198…

A. Hearing Motions. Motions are directed to the board or presiding officer for particular relief or action before, during, or after a hearing and shall be in writing when applicable, and allege specifically the grounds upon which the relief is based, and filed with the board five…

A. A board member or special counsel may be recused by one's own motion because of an inability to contribute to a fair and impartial hearing or may be recused by a majority vote of the board members present based on the following grounds: 1. prejudicial or personal interest in a…

A. Upon request by either respondent or special counsel or by direction of the hearing officer, witnesses shall be sequestered and not allowed in the hearing chambers or permitted to discuss their testimony with other witnesses. Notes La. Admin. Code tit. 46 , § LIII-319 Promulga…

A. The sanctions imposed by the board pursuant to R.S. 37:1241 of the Pharmacy Practice Act shall be based on the following guidelines. 1. Nature. The nature or seriousness of the violation. 2. Degree. The degree of culpability, knowledge and/or intent, or the responsibility to h…

A. Upon the receipt of a written complaint, board staff shall initiate and conduct an investigation. 1. Grounds. The investigative report shall be reviewed by board-designated staff and forwarded to the violations committee or legal counsel to determine sufficient grounds for pro…

A. Purpose. Board-designated staff shall receive reports and complaints and review and evaluate findings to determine the nature and disposition of the alleged violation(s). The alleged violation(s) may then be directed to: 1. violations committee for informal hearing; 2. violati…

A. Impairment. Impairment means a condition that causes an infringement on the ability of an individual to practice, or assist in the practice of, pharmacy sufficient to pose a danger to the public. Impairment may be caused by, but is not limited to, alcoholism, substance abuse o…

A. Authority. The board shall provide a formal administrative hearing pertaining to the proprietary rights or privilege to practice pharmacy, or operate a pharmacy, or hold a certificate or registration, in accordance with the Administrative Procedure Act, R.S. 49:950 et seq., wi…

A. In the event any rule, sentence, clause, or phrase or any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect t…

A. Hearing Officers 1. Administrative Hearing Officer. The presiding hearing officer may be the board president, a vice-president, or other individual appointed by the president or his successor. The hearing officer has the responsibility to conduct a fair and impartial proceedin…

A. Respondents and/or their legal counsel in matters pending before the board may be directed by the presiding administrative hearing officer to appear at a pre-hearing conference to consider the simplification of the issues, admission of facts, or stipulations to documents which…

A. Respondents may enter into consent agreements with the board on any matter pending before the board. A consent agreement is not final until the board approves the consent agreement by majority vote of the administrative jury. If the consent agreement is rejected in full or par…

A. An opening statement by legal or special counsel may present a brief position comment with an outline of evidence to be offered. Respondent or respondent's legal counsel may present an opening defense position statement. Notes La. Admin. Code tit. 46 , § LIII-337 Promulgated b…

A. Testimony Received. Testimony shall be received under oath administered by the presiding hearing officer, the executive director, or other staff or board member designated by the hearing officer. B. Evidence Introduction. All parties shall be afforded an opportunity to present…

A. Closing arguments may be made by respondent in proper person or by legal counsel followed by closing arguments from prosecuting legal or special counsel. Notes La. Admin. Code tit. 46 , § LIII-341 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:…

A. The board's decision shall be based on finding(s) of fact and conclusion(s) of law. The board's decision shall be based on a preponderance of the evidence presented at a formal hearing, together with the board's determination of any appropriate sanctions, by an affirmative maj…

A. The board, in their discretion and based upon lack of evidence, may orally dismiss at an open hearing a pending matter or parts thereof. Notes La. Admin. Code tit. 46 , § LIII-345 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988…

A. A complete record of all formal hearing proceedings shall be transcribed, maintained, and available upon written request with sufficient costs of the preparation of the transcript for a minimum of three years from the date the pertinent order(s) is final. Notes La. Admin. Code…

A. A failure of a respondent or witness to comply with a board order, after being duly served, constitutes contempt and the board may petition a court of competent jurisdiction to rule the witness or respondent in court to show cause why he should not be held in contempt of court…