Chapter LIII

A. The pharmacist-in-charge shall be responsible for the safe and efficient procurement, receipt, storage, distribution, control, accountability, and patient administration and management of all drugs used in the correctional center. The administration and staff of the facility s…

A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Emergency Drug Kit (EDK) -a container holding designated emergency drugs which may be required to meet the immediate therapeutic needs of an offender. Emergency Drugs -those d…

A. A correctional center pharmacy located outside a correctional center intending to use one or more emergency drug kits within the correctional center shall first obtain an EDK permit from the board. B. Application for Initial Issuance of Permit 1. The correctional center pharma…

A. The EDK shall be tamper-evident, shall be maintained in a secure enclosure located within the correctional center, and shall be available for emergency use by authorized personnel only. B. The EDK shall be clearly labeled to indicate it is an emergency drug kit, and further, t…

A. A correctional center pharmacy may accept the donation of a prescription drug, except a controlled substance, previously dispensed to another patient provided the following procedures are satisfied. 1. The physical transfer of the donated drug shall be accomplished by an indiv…

A. The pharmacist shall review the practitioner's medical order or prescription prior to dispensing or otherwise provide access to the initial dose of the medication, except in cases of emergency. B. All drugs dispensed by the pharmacy or held for administration to offenders at t…

A. For all regulations that apply to permitted nuclear pharmacies concerning pharmacy practices not specifically stated in this Chapter, refer to Chapter 11. Notes La. Admin. Code tit. 46 , § LIII-1901 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 1…

A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Nuclear Pharmacy -a board-approved facility limited to procuring, possessing, compounding, or dispensing radiopharmaceuticals or any interventional drug used in conjunction wi…

A. A nuclear pharmacy permit shall be required to operate a nuclear pharmacy department. The permit shall be applied for, and renewed, in the manner prescribed by the board in Chapter 11 of these regulations. 1. A nuclear pharmacy shall have a Louisiana Radioactive Material Licen…

A. A qualified nuclear pharmacist shall be a currently licensed pharmacist in the state of Louisiana who is listed on a Louisiana Radioactive Material License. B. Continuing Education. Nuclear pharmacists shall obtain at least five hours of the total required hours of Accreditati…

A. Immediate Container. The immediate container that comes into direct contact with the radiopharmaceutical shall be labeled with: 1. the standard radiation symbol; 2. the words "Caution-Radioactive Material"; 3. the prescription control number; 4. the name of the radionuclide; a…

A. Quality control of radiopharmaceuticals is required on all radiopharmaceuticals compounded in a nuclear pharmacy. Appropriate quality assurance procedures shall be developed and followed for the procurement, compounding, and dispensing of all pharmaceuticals in a nuclear pharm…

A. For all regulations that apply to permitted charitable pharmacies concerning pharmacy practices not specifically stated in this Chapter, refer to Chapter 11. Notes La. Admin. Code tit. 46 , § LIII-2101 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, L…

A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Charitable Pharmacy -the practice of pharmacy at a site where prescriptions are dispensed by a charitable organization free of charge to appropriately screened and qualified p…

A. A charitable pharmacy permit shall be required to operate a pharmacy in the state to dispense free prescription drugs to qualified patients in Louisiana. This permit shall only be granted to an organization qualified as a charitable organization by the U.S. Internal Revenue Co…

A. A charitable pharmacy shall not sell, purchase, or trade prescription drug samples. B. A charitable pharmacy shall only possess and dispense prescription drug samples if the following conditions are satisfied: 1. the prescription drug samples are dispensed at no charge to qual…

A. In facilities licensed by the Department of Health and Hospitals where United States Pharmacopeia (USP) storage requirements can be assured, prescription drugs, except controlled dangerous substances, dispensed in unit dose or in individually sealed doses may be transferred to…

A. A charitable pharmacy shall not purchase, possess, trade, distribute, or dispense controlled dangerous substances. B. A charitable pharmacy shall not be operated, or in any way associated, with any for-profit pharmacy permitted in this state or any other jurisdiction. Notes La…

A. Nonresident pharmacies shall comply with the provisions of this Chapter in order to be and remain permitted to operate in Louisiana as a nonresident pharmacy. B. This Chapter applies to any place physically located outside the state of Louisiana that provides services in the s…

A. The nonresident pharmacy shall hold a current pharmacy permit in good standing in the state in which it is located. B. Each pharmacist dispensing drugs into Louisiana shall be licensed as a pharmacist in good standing in the state where he practices. C. Every nonresident pharm…

A. The nonresident pharmacy shall apply for a permit and annual permit renewals on forms provided by the board. The board may require such information as reasonably necessary to carry out the provisions of R.S. 37:1232 , including, without limitation, the name, address, and posit…

A. The opportunity to accept an appointment as the pharmacist-in-charge (PIC) of a pharmacy is a professional privilege. The following requirements are attached to a PIC privilege. 1. The acquisition of the PIC privilege shall require: a. possession of an active Louisiana pharmac…

A. Louisiana pharmacy laws and regulations shall be applicable to regulate the practice of pharmacy for that portion of the nonresident pharmacy's Louisiana pharmacy practice or operation. Notes La. Admin. Code tit. 46 , § LIII-2309 Promulgated by the Department of Health and Hos…

A. The facilities and records of the nonresident pharmacy shall be subject to inspection by the board or its designated agent(s). Notes La. Admin. Code tit. 46 , § LIII-2311 Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effect…

A. Records shall be maintained for not less than two years. B. The pharmacy shall maintain records of drugs dispensed to Louisiana residents in such a manner so as to be identifiable, readily retrievable, and available upon request. Said records shall be made available for inspec…

A. The pharmacy shall maintain an incoming toll-free telephone number for use by Louisiana consumers during regular office hours. Readily available telephone counseling services shall be provided that are consistent with the reasonable standard of due care. This telephone number,…

A. Notice. Notice shall be afforded the board not less than 10 days prior to the anticipated closure date of a nonresident pharmacy. Said notice shall include the location of all transferred prescription files for Louisiana residents. B. Permit. The nonresident pharmacy permit ho…

A. Nonresident pharmacies soliciting, receiving, and dispensing and delivering prescription drugs and devices, including controlled dangerous substances as defined in 21 USC § 1 , et seq. and 21 CFR 1 et seq., or their successors, and delivered to residents in Louisiana constitut…

A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Durable Medical Equipment (DME) -technologically sophisticated medical devices that may be used in a residence, including the following: a. oxygen and oxygen delivery system; …

A. No person or other entity shall sell, rent or provide, or offer to sell, rent or provide, directly or indirectly, to consumers in this state any durable medical equipment, legend devices, and/or medical gas until such person has obtained a durable medical equipment (DME) permi…

A. The DME provider shall not furnish any legend device or medical gas to a patient without a prescription or medical order from a licensed practitioner with prescriptive authority. B. General Requirements 1. The provider shall establish a suitable facility to house the equipment…

A. The credentialing requirements of this Subchapter shall not apply to the following persons or entities unless such persons or entities have separate business entities engaged in the business of providing DME to patients at their home: 1. chiropractors; 2. dentists; 3. occupati…

A. For good cause shown, the board may issue a special event pharmacy permit when the scope, degree, or type of pharmacy practice or service to be provided is of a special, limited, or unusual nature as compared to a regular pharmacy service. The permit to be issued shall be base…

A. Authority and Limitation 1. A special event pharmacy permit shall authorize the permit holder to procure and possess prescription and non-prescription drugs and devices, and hold such items for immediate administration directly to a patient and/or dispense such items to a pati…

A. General Requirements 1. The special event pharmacy shall be of sufficient size and shall contain sufficient fixtures, equipment, and supplies commensurate with the scope of practice for that pharmacy, provided: a. the pharmacy shall be of sufficient size to allow for the safe …

A. As market forces continue to adversely impact community pharmacies, some pharmacies have or will close permanently. In certain parts of the state, such closures create critical access issues for citizens in need of pharmacy services. B. As the pharmacy workforce continues to e…

A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section. Central Pharmacy -a permitted pharmacy in Louisiana that supervises a telepharmacy dispensing site. Still Image Capture -a specific image captured electronically from a vid…

A. General Requirements 1. At the time of its opening, there shall be no other pharmacies licensed by the board within 15 miles (driving distance) of the location of the telepharmacy dispensing site. This mileage restriction shall not apply if a demonstration of need is presented…

A. The purpose of this Subchapter is to establish standards for the operation and regulation of remote processor pharmacies to be located within the state of Louisiana. Notes La. Admin. Code tit. 46 , § LIII-2431 Promulgated by the Department of Health and Hospitals, Board of Pha…

A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section. On-Site Pharmacy -a permitted pharmacy which utilizes remote processing services from a remote processor pharmacy. Remote Processing Services -the processing of a medical o…

A. Authority and Limitations 1. A remote processor pharmacy permit shall authorize the permit holder to engage in remote processing services. 2. A remote processor pharmacy permit shall not authorize the procurement or possession of any prescription medications or any controlled …

A. Environmental Standards 1. The remote processor pharmacy shall be of sufficient size and shall contain sufficient fixtures, equipment, and supplies commensurate with the nature and scope of practice for that pharmacy. 2. The pharmacy shall be well-lighted, well ventilated and …

A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section: Administer -the direct application of marijuana to the body of a qualifying patient by ingestion or any other means. Advertisement -Repealed. Agent -an authorized person wh…

A. Exclusive Source 1. The exclusive source of marijuana products shall be the producers licensed for that activity by LDH . 2. Repealed. 3. Marijuana products from any other source shall be deemed misbranded and/or adulterated and shall not be received by any marijuana pharmacy …

A. The board shall develop and configure a pharmacy permit designated as a marijuana pharmacy permit. B. The dispensing of marijuana for therapeutic purposes shall be limited to those pharmacies holding a marijuana pharmacy permit issued by the board , and only when that permit i…

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

A. No person may operate a marijuana pharmacy without a marijuana pharmacy permit issued by the board , and further, that permit shall be in active or restricted status. A pharmacist shall be on duty at all times during the regular open hours of the marijuana pharmacy . B. A mari…

A. Upon becoming aware of discrepancies identified during inventory, diversion, theft, loss, or unauthorized destruction of any marijuana, or of any loss or unauthorized alternation of records related to marijuana or patients, a pharmacy shall immediately notify: 1. appropriate l…

A. Environmental Standards 1. The prescription department shall be of sufficient size commensurate with the nature and scope of practice. The space occupied by the prescription department shall be restricted to authorized personnel only, as determined by the pharmacist -in-charge…

A. Prescription Drugs or Devices. A prescription drug or device is a medication or mechanism that may only be dispensed by a pharmacist on the order of a licensed practitioner and shall bear the "Rx Only" notation or any other designation of similar import required by law on the …