Chapter LIII

A. An employer's comprehensive employee screening program shall include the following. 1. Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal o…

A. Each commercial container of a controlled substance shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, shall bear a label complying with the requirement…

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 symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy ident…

A. On each bottle, multiple dose vial, or other commercial container of any controlled substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container. Notes L…

A. The symbol requirements of this Section apply to every commercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of and/or the customs territory of Louisiana. B. The symbol requirements of this Section do not apply to any com…

A. Persons Required to Keep Records and File Reports 1. Each licensee shall maintain the records and inventories and shall file the reports required by this Chapter, except as exempted by this Section. Any licensee who is authorized to conduct other activities without being regis…

A. General Requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of …

A. General Requirements 1. Every licensee required to keep records pursuant to this Section shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him. 2. Sep…

A. Reports from Manufacturers Importing Narcotic Raw Material 1. Every manufacturer which imports or manufactures from narcotic raw material (opium, poppy straw, and concentrate of poppy straw) shall submit information which accounts for the importation and for all manufacturing …

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. A licensee located in Louisiana engaged in the manufacture of controlled dangerous substances within Schedules I, II, III, IV, or V shall prepare a complete and accurate record of the date of manufacture, the theoretical and actual yields, the quantity used for quality control…

A. A distributor or third-party logistics provider handling controlled substances in Schedules I or II shall maintain complete and accurate records of the original copies of all order forms received and filled for orders of controlled substances within these schedules. This file …

A. Orders for Schedule I and II Controlled Substances 1. General Requirements. A licensee acquiring controlled substances in Schedules I and II shall maintain a file of the duplicate copies of all order forms used to obtain controlled substances within these schedules. Each dupli…

A. Practitioners Authorized to Issue Prescriptions. A prescription for a controlled substance may be issued only by an individual practitioner who is: 1. authorized by law to prescribe controlled substances, and includes the following: a. a physician; b. a dentist; c. a veterinar…

A. Location of Dispensing Activities. A pharmacist may dispense a prescription for a controlled substance pursuant to a valid prescription or order while in the usual course of his professional practice, but only within a prescription department in a pharmacy licensed by the boar…

A. Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the special agent in charge of the DEA in the area in which the person is located for authority and instructions to dispose of such substance.…

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. Distribution by Dispenser to Another Practitioner or Reverse Distributor 1. A dispenser may distribute (without being registered to distribute) a quantity of such controlled substance to: a. another practitioner for the purpose of general dispensing by the practitioner to pati…

A. The board may inspect any licensed facility or location of a licensed person including pertinent records for the purpose of determining compliance with the requirements of this Chapter and other state and federal laws and regulations related to controlled substances, subject t…

A. The board may place under seal all drugs or devices that are owned by or in the possession, custody, or control of a licensee at the time his license is suspended or revoked, for a licensee's failure to timely renew his license, or at the time the board refuses to renew his li…

A. All formal administrative hearings conducted by the board shall be conducted in accordance with the Louisiana Administrative Procedures Act, R.S. 49:950 et seq . , and § 2711 of this Chapter. Notes La. Admin. Code tit. 46 , § LIII-2757 Promulgated by the Department of Health a…

A. Council Eligibility 1. In accordance with R.S. 42:17.4 the council is eligible to conduct open public meetings via electronic means. B. Postings Prior to Meeting via Electronic Means 1. At least 24 hours prior to the electronic meeting, the council shall provide the following,…

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. 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. 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. 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. 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. 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. 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. 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…