Chapter LIII

A. Unless otherwise allowed by law, drugs dispensed on prescription to a patient shall not be accepted for return, exchange, or re-dispensing by any pharmacist or pharmacy after such drugs have been removed from the pharmacy premises where they were dispensed. B. When a patient o…

A. The pharmacist shall conduct, participate in, and support medical and pharmaceutical research appropriate to the goals, objectives, and resources of the facility. B. The pharmacist shall ensure the development of policies and procedures for the appropriate use of investigation…

A. Veterinary prescription drugs are prescription medications for animal use prescribed by a licensed veterinarian pursuant to a valid veterinarian-client-patient relationship and dispensed by a licensed pharmacist to the veterinarian's client, for a legitimate medical purpose, t…

A. In the interest of public health, safety, and welfare, the board may, from time to time, restrict the sale of certain devices to be dispensed only by a licensed pharmacist after a legitimate medical need has been demonstrated. A legitimate medical need includes the prevention …

A. Definitions. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section: Chart Order -a lawful order entered on the electronic or paper chart or medical record of an inpatient or resident of an institutional facility by a practitioner …

A. The receiving pharmacist is responsible for verification of the authenticity of the prescription. B. The dispensing pharmacist is responsible for the accuracy of the medications or devices dispensed. Notes La. Admin. Code tit. 46 , § LIII-2513 Promulgated by the Department of …

A. A prescription issued solely on the results of answers to an electronic questionnaire, in the absence of a documented patient evaluation including a physical examination, is issued outside the context of a valid physician-patient relationship, and is not a valid prescription. …

A. Prescription dispensing means the issuance, by a licensed pharmacist, of one or more doses of medication in a suitable container, properly labeled for subsequent administration, and shall consist of the following procedures or practices: 1. receiving and interpretation of the …

A. Prescription Refills 1. Limitations on Number of Refills a. The refilling of a prescription for a drug listed in Schedule II is prohibited. b. A prescription for a drug listed in Schedule III or IV may be refilled up to five times if so indicated at the time issued. c. A presc…

A. Using sound professional judgment, a pharmacist may refill adequate medication for a quantity not to exceed a 30-day supply when an emergency for medication has been adequately demonstrated and the prescribing practitioner is not available. The 30-day supply limitation shall n…

A. Prescription Transfer Requirements 1. Prescriptions for Controlled Dangerous Substances a. The transfer between pharmacies of a prescription or prescription information for controlled substances is permissible in conformance with 21 CFR Part 1306 . 2. Prescriptions for Drugs O…

A. A prescription for a drug other than a controlled dangerous substance listed in Schedules II through IV shall expire one year after the date written. B. A prescription for a controlled dangerous substance shall expire: 1. 90 days after the date of issue if the drug is listed i…

A. An appropriate label shall be affixed to a proper container, and shall bear the following minimum information: 1. pharmacy's name, address, and telephone number; 2. prescription number; 3. authorized prescriber's name; 4. patient's name; 5. date dispensed; 6. drug name and str…

A. Prepackaging is the preparation of medication in a unit-of-use container by a pharmacist in a pharmacy prior to the receipt of a prescription for ultimate prescription dispensing by a pharmacist in Louisiana. B. Labeling. The label on the prepackaged container shall contain th…

A. Purpose. The rules of this Subchapter describe the requirements of minimum current good compounding practices for the preparation of drug formulations by Louisiana-licensed pharmacists, pharmacy interns, pharmacy technicians, and pharmacy technician candidates for dispensing a…

A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section. Biological Safety Cabinet -a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, an…

A. Compounding Practices. Compounded medications may be prepared using prescription medications, over-the-counter medications, chemicals, compounds, or other components. 1. A pharmacy shall have written procedures as necessary for the compounding of drug preparations to assure th…

A. Given the current public health emergency relative to the misuse and abuse of opioid derivatives, public health officials have strongly recommended the widespread availability of naloxone and other opioid antagonists to addicts and their caregivers as well as first responders …

A. Words not defined in this Chapter shall have their common usage and meaning as stated in the Merriam Webster's Collegiate Dictionary-Tenth Edition, as revised, and other similarly accepted reference texts. As used in this Chapter, the following terms shall have the meaning asc…

A. Classification 1. Controlled substances are specifically identified by reference, as provided in R.S. 40:961 et seq., or its successor, and 21 CFR §1308 et seq., or its successor. Schedules I, II, III, IV, and V shall, unless and until added to pursuant to R.S. 40:961 et seq.,…

A. The following drugs or substances are added to Schedule I of the Louisiana Uniform Controlled Dangerous Substances Law, R.S. 40:961 et seq.: 1. bromazolam. Notes La. Admin. Code tit. 46 , § LIII-2704 Promulgated by the Department of Health, Office of Public Health, LR 45 , Pro…

A. Every person who conducts research with, manufactures, distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within this state, including third-party logistics providers, or who proposes to engage in the research, manufacture, distributi…

A. Application for Initial Issuance of CDS License 1. An individual or other entity desiring to obtain a Louisiana CDS license shall complete the application form supplied by the board and submit it with the required attachments and appropriate fees, as set forth in R.S. 40:972 a…

A. Upon receipt of a properly completed application and appropriate fees from a qualified applicant, the board shall issue a Louisiana CDS license to the applicant, unless the board intends to deny the application. B. The board may deny an application for the issuance or renewal …

A. The board may refuse to renew a CDS license, or may suspend or revoke an existing CDS license, if the licensee has violated, or been found guilty of violating, any federal or state laws or regulations relating to controlled substances. B. Violations Committee 1. Informal Heari…

A. A licensee shall provide effective controls and procedures to guard against theft or diversion of controlled substances. In evaluating the overall security system of a licensee or applicant, the board may consider any of the following factors: 1. the type of activity conducted…

A. Storage Areas 1. Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedule I or II shall be stored in one of the following secure storage areas: a. Where small quantities permit, a sa…

A. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet. B. Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and …

A. All Schedule II-V controlled substances that will be temporarily stored at the freight forwarding facility shall be either: 1. stored in a segregated area under constant observation by designated responsible individual(s); or 2. stored in a secured area that meets the requirem…

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. 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. 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. 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. As used in this Chapter, the following terms shall have the meaning ascribed to them unless the context clearly indicates otherwise. Administer or Administration - the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means…

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,…