reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1203 - Automated Medication System Registration

Current through Register Vol. 50, No. 6, June 20, 2024
A. Requirement for Registration
1. A pharmacy intending to supply medications
				for use within an automated medication system, as defined at
				R.S.
				37:1164, shall obtain an automated medication
				system (AMS) registration prior to engaging in such activity.
2. The placement of medications within an
				automated medication system in the absence of an AMS registration shall
				substantiate a violation of
				R.S.
				37:1241(A)(12) and shall
				subject the pharmacy to disciplinary action by the board.
3. A pharmacy intending to supply controlled
				substances for use within an automated medication system shall obtain a
				controlled dangerous substance (CDS) license in addition to the AMS
				registration. The pharmacy shall also obtain a federal registration from the
				U.S. Drug Enforcement Administration (DEA) prior to placing controlled
				substances within the automated medication system.
4. The placement of controlled substances
				within an automated medication system in the absence of an AMS registration,
				CDS license, and DEA registration shall substantiate a violation of
				R.S.
				37:1241(A)(12) and
				R.S.
				40:973 and shall subject the pharmacy to
				disciplinary action by the board.
5. The operation of a remote dispensing
				system without an AMS registration shall substantiate a violation of
				R.S.
				37:1241(A)(12) and shall
				subject the pharmacy to disciplinary action by the board.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1205 - Pharmacist-in-Charge Responsibilities

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				pharmacist-in-charge shall be a Louisiana-licensed pharmacist with the
				following responsibilities:
1. assuring that
				the system is in good working order and accurately provides the correct
				strength, dosage form, and quantity of the drug prescribed while maintaining
				appropriate recordkeeping and security safeguards.
2. establishment of a quality assurance
				program prior to implementation of a system and the supervision of an ongoing
				quality assurance program that monitors appropriate use and performance of a
				system, which is evidenced by policies and procedures developed by the
				pharmacist-in-charge.
3. define
				access to the system in policy and procedures of the pharmacy, in compliance
				with state and federal regulations.
4. assign, discontinue, or change access to
				the system.
5. ensure that access
				to the medications complies with state and federal regulations as
				applicable.
6. ensure that the
				system is stocked and restocked accurately and in accordance with established
				pharmacy policies and procedures.
7. maintain or have access to all records of
				documentation specified in this Chapter for two years or as otherwise required
				by law.
8. continuous monitoring
				and documentation of temperature in the drug storage areas including a
				mechanism to alert the pharmacist when defined parameters are out of range as
				well as an action plan to address such excursions. A pharmacys failure to
				document the integrity of the drug supply or remediate for excursions as
				appropriate shall substantiate a violation of
				R.S.
				37:1241(A)(18) and shall
				subject the pharmacy to disciplinary action by the board.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1207 - Pharmacist Review

Current through Register Vol. 50, No. 6, June 20, 2024
A. System shall
				be used in settings that ensure medication orders are reviewed by a pharmacist
				prior to administration and in accordance with established policies and
				procedures and good pharmacy practice. A policy and procedure shall be adopted
				for non-profile driven systems to retrospectively review medications orders
				which cannot be reviewed prior to medication administration.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1209 - Policies and Procedures (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1211 - Documentation

Current through Register Vol. 50, No. 6, June 20, 2024
A. Documentation as
				to type of equipment, serial number, content, policies and procedures and
				location shall be maintained in the pharmacy for review by the board. Such
				documentation shall include, but is not limited to:
1. name, address, and permit number of the
				pharmacy and the location where the system is operational;
2. manufacturers name and model;
3. quality assurance policies and procedures
				to determine continued appropriate use and performance of the system;
4. policies and procedures for system
				operation, safety, security, accuracy, patient confidentiality, access,
				controlled substances, data retention, definitions, downtime procedures,
				emergency or first dose procedures, inspection, installation requirements,
				maintenance security, quality assurance, medication inventory, staff education
				and training, system set-up, and malfunction procedures; and
5. security procedures sufficient to prevent
				unauthorized access or use, prevent the illegal use or disclosure of protected
				health information, and comply with any applicable federal or state
				regulations.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1213 - Records

Current through Register Vol. 50, No. 6, June 20, 2024
A. Records and
				electronic data kept by the system shall meet the following requirements:
1. all events involving access to the
				contents of the system shall be recorded electronically;
2. in the event controlled substances are
				stored in the system, the records shall include the positive identification (as
				defined in
				§1119 of this Part) of the personnel
				retrieving and administering the controlled substances to the
				patient;
3. these internal records
				shall be maintained for one year by the pharmacist-in-charge and shall be
				readily available to the board. Such records shall include:
a. identity of system accessed;
b. identification of the individual accessing
				the system;
c. type of
				transaction;
d. name, strength,
				dosage form, and quantity of the drug accessed;
e. name or identification number of the
				patient for whom the drug was ordered;
f. identification of the person stocking or
				restocking the medications in the system; and
g. such additional information as the
				pharmacist-in-charge may deem necessary.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1215 - Security System(s) (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1217 - Stocking and Restocking

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				stocking and restocking of medications and devices within an automated
				medication system shall be performed by a pharmacist, or in the alternative, a
				pharmacy intern, pharmacy technician, or pharmacy technician candidate under
				the supervision of a pharmacist.
B.
				When the pharmacy employs electronic product verification procedures as
				described within this Section, the stocking and restocking of medications and
				devices within an automated medication system may be performed by other
				licensed personnel approved by the pharmacist-in-charge without the necessity
				of direct pharmacist supervision.
1. A bar
				code verification, electronic verification, or similar verification process
				which prohibits any human intervention following pharmacist verification of the
				product may be utilized to assure the correct selection of drugs to be placed
				into an automated medication system.
2. The use of a bar code, electronic
				verification, or similar verification process shall require an initial quality
				assurance validation followed by ongoing quality assurance reviews at intervals
				no greater than 90 days since the previous review, all conducted by a
				pharmacist.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1219 - Packaging and Labeling (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1221 - Proof of Use (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1223 - Wasted, Discarded, or Unused Medications (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1225 - Inspection (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1227 - Out-of-State Pharmacies (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1229 - Violations; Penalties (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 12 - Automated Medication Systems › Section LIII-1231 - Revised Statutes and Louisiana Administrative Code (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.A.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 13 - Community Pharmacy › Section LIII-1301 - Definition

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
community pharmacy
is a pharmacy located in a
				non-institutional environment, and is licensed by the board to conduct
				professional pharmacy practice activities in the state of Louisiana.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 13 - Community Pharmacy › Section LIII-1303 - Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A community
				pharmacy permit shall be required to operate a pharmacy in this state, and to
				dispense prescription drugs to patients in Louisiana. The permit shall be
				applied for, and renewed, in the manner prescribed by the board in Chapter 11
				of these regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 13 - Community Pharmacy › Section LIII-1305 - Compliance

Current through Register Vol. 50, No. 6, June 20, 2024
A. A community
				pharmacy shall comply with all applicable federal and state pharmacy laws and
				regulations, including Chapter 11 of these regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1501 - Cross References

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				all regulations that apply to permitted hospital pharmacies concerning pharmacy
				practices and records not specifically stated in this Chapter, refer to
				Chapters 11 and 25 of this Part.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1505 - Hospital Pharmacy Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				hospital pharmacy permit shall be required to operate a pharmacy department
				located within a hospital for registered patients in a hospital. The permit
				shall be applied for, and renewed, in the manner prescribed by the board in
				Chapter 11 of this Part.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1511 - Prescription Drug Orders

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				pharmacist shall review the practitioner's medical order prior to dispensing
				the initial dose of medication, except in cases of emergency.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1512 - Hospital Pharmacy Prepackaging

Current through Register Vol. 50, No. 6, June 20, 2024
A. Prepackaging is the preparation of
				medication in a unit-of-use container by credentialed pharmacy personnel in a
				pharmacy prior to the receipt of a prescription or medical order for ultimate
				issuance by a pharmacist in Louisiana.
B. Labeling. The label on the prepackaged
				container shall contain the following minimum information:
1. drug name;
2. dosage form;
3. strength;
4. quantity dispensed when
				appropriate;
5. special storage
				requirements;
6. a unique pharmacy
				prepackage lot number which shall correspond to the following:
a. name of manufacturer and/or
				distributor;
b. manufacturer's lot
				or batch number;
c. date of
				preparation; and
d. verifying
				pharmacist's initials;
7. expiration date according to United States
				Pharmacopeia (USP) guidelines.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1513 - Labeling

Current through Register Vol. 50, No. 6, June 20, 2024
A. All drugs
				dispensed or compounded by a hospital pharmacy, intended for use within the
				facility, shall be dispensed in appropriate containers and adequately labeled
				as to identify patient name and location, drug name(s) and strength, and
				medication dose(s). Additionally, compounded preparations and sterile
				preparations shall be labeled with the expiration date or beyond-use date,
				initials of the preparer, and the pharmacist performing the final
				check.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1515 - Ambulance Service Drugs

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Hospital pharmacies that supply prescription drugs, including any controlled
				dangerous substances, to any authorized ambulance service or emergency medical
				service shall maintain proper records to ensure control, proper utilization,
				inventory, and accountability.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1517 - Pharmacist Absence/Drug Cabinet

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Pharmacist Absence. In the absence of a licensed pharmacist, admittance to the
				pharmacy by unauthorized persons is prohibited. When the pharmacy is closed, a
				pharmacist shall be on emergency call.
1.
				Within a veterinary teaching hospital owned or operated by a public university
				in this state, the pharmacist-in-charge shall approve policies and procedures
				detailing the person(s) authorized to access the pharmacy
				after-hours.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1519 - Drug Returns; Drug Disposal

Current through Register Vol. 50, No. 6, June 20, 2024
A. In a hospital with a permitted hospital
				pharmacy on site, unused drugs may be returned to the pharmacy for
				re-dispensing in accordance with good professional practice
				standards.
B. When a patient or his
				designee wishes to return previously dispensed prescription drugs to a pharmacy
				for disposal, the pharmacy shall inform the patient or his designee of the
				disposal mechanisms available to him. In the event the pharmacy elects to
				accept such previously dispensed products for disposal, the pharmacy shall
				comply with the following requirements.
1.
				From the time of receipt of such products until the time of disposal, the
				pharmacy shall quarantine such products to keep them separate from its active
				dispensing stock and shall take appropriate security measures to prevent the
				theft or diversion of such products.
2. The pharmacy shall comply with the
				provisions of  21 CFR § 1317  or its successor for the pharmacy's disposal of
				controlled substances and other non-hazardous waste pharmaceuticals.
3. The pharmacy shall comply with the
				provisions of  40 CFR § 261  or its successor for the pharmacy's disposal of
				hazardous waste pharmaceuticals.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1521 - Off-Site Pharmacy Services

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Availability. Pharmacy services may be procured contractually from outside the
				hospital for inpatient administration.
B. Contractual agreements shall provide for:
1. emergency-the pharmacy provider shall be
				available for on-call for emergency pharmacy services;
2. storage-adequate drug storage facilities
				shall be provided to the pharmacy provider;
3. labeling-prescription drugs supplied to
				hospital inpatients shall be properly labeled to ensure that adequate control,
				supervision, and recall of medication are monitored;
4. contractual pharmacy service-off-site
				contractual pharmacy services rendered to the hospital shall be in accordance
				with federal and state laws, rules, and regulations.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1523 - Outpatient Pharmacy Dispensing

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Hospital outpatient dispensing shall require a separate pharmacy permit for the
				specialty classification(s) under these regulations. All records including the
				annual inventory of controlled dangerous substances for the outpatient pharmacy
				shall be maintained and kept separate and apart from that of the inpatient
				pharmacy, as the outpatient pharmacy may not acquire drugs through the hospital
				pharmacy permit under the provisions of the Robinson-Patman Act,  15 U.S.C. §
										13(c).
B. Nothing in this Section
				shall prohibit the dispensing of certain prescriptions from the hospital
				pharmacy, as allowed under the Robinson-Patman Act,  15 U.S.C. §
										13, including:
1. dispensing to the hospital inpatient for
				use in his treatment at the hospital;
2. dispensing to the patient admitted to the
				hospital's emergency facility for use in the patient's treatment at that
				location;
3. dispensing to the
				hospital outpatient for personal use on the hospital premises;
4. dispensing in the context of a genuine
				take-home prescription, intended for a limited and reasonable time as a
				continuation of, or supplement to, the treatment that was administered at the
				hospital to the recipient while an inpatient, an outpatient, or an emergency
				facility patient if the patient needs that treatment; or
5. dispensing to the hospital's physicians,
				employees, or its students for their personal use or for the personal use of
				their dependents.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1525 - Hospital Off-Site Satellite Pharmacy

Current through Register Vol. 50, No. 6, June 20, 2024
A. Issuance and Maintenance of Permit
1. A hospital pharmacy may establish a
				hospital off-site satellite pharmacy within a facility bearing the same
				hospital license number as the facility housing the provider
				pharmacy.
2. The provider pharmacy,
				acting through its pharmacist-in-charge, shall make application for the
				satellite pharmacy permit using a form and process specified by the
				board.
3. The applicant shall pay
				the fee for the initial issuance and renewal as specified in
				R.S.
				37:1184.
4. Once issued, the satellite pharmacy permit
				shall expire at midnight on December 31 of each year, unless suspended or
				revoked earlier by the board.
5.
				The satellite pharmacy shall renew its permit using the form and process
				specified by the board.
6. The
				operation of a hospital off-site satellite pharmacy without a pharmacy permit,
				or with an expired permit, shall constitute a violation of
				R.S.
				37:1241(A)12.
7. In the event a provider pharmacy sustains
				a change of ownership sufficient to require a new pharmacy permit, the hospital
				off-site satellite pharmacy shall also obtain a new pharmacy permit.
8. In the event a provider pharmacy closes
				permanently and surrenders its permit, the hospital off-site satellite pharmacy
				shall also close and surrender its permit.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 15 - Hospital Pharmacy › Section LIII-1529 - Investigational Drugs

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where the
				hospital pharmacy is a participant in one or more investigational drug studies,
				the pharmacy may dispense investigational drug products as well as commercially
				available drug products to patients enrolled in a study, whether or not the
				patient is a registered patient of the hospital.
AUTHORITY NOTE:
				  Promulgated in accordance with R. S.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter A - General Requirements › Section LIII-1701 - Cross References

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				  all regulations that apply to permitted institutional pharmacies concerning
				  pharmacy practices and records not specifically stated in this Chapter, refer
				  to Chapter 11 of this Part.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter A - General Requirements › Section LIII-1703 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				  Chapter, the following terms shall have the meaning ascribed to them in this
				  Section:
Institutional Facility
-any organization
					 whose primary purpose is to provide a physical environment for a patient to
					 obtain health care services, including but not limited to a(n):
a. convalescent home;
b. nursing home;
c. extended care facility;
d. mental health facility;
e. rehabilitation center;
f. psychiatric center;
g. developmental disability center;
h. drug abuse treatment center;
i. family planning clinic;
j. penal institution;
k. hospice;
l. public health facility;
m. athletic facility.
Institutional Pharmacy
-that physical
					 portion of an
institutional facility
where drugs, devices, and
					 other materials used in the diagnosis and treatment of an injury, illness, and
					 disease are dispensed, compounded, and distributed and pharmacy primary care is
					 provided, and is permitted by the board and is devoted exclusively to providing
					 professional services to a patient in that institutional setting, other than a
					 hospital.
Long Term Care Facility
-a nursing home,
					 retirement center, mental care, or other facility or institution that provides
					 extended health care to a residential patient, including but not limited to
					 health care facilities licensed by the Department of Health.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter A - General Requirements › Section LIII-1705 - Institutional Pharmacy Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. An
				  institutional pharmacy permit shall be required to operate a pharmacy
				  department located within an institutional facility, other than a hospital or
				  penal institution, for residents or patients of that institutional facility.
				  The permit shall be applied for, and renewed, in the manner prescribed by the
				  board in Chapter 11 of this Part.
B. Pharmacies operated within a hospital
				  shall be operated in accordance with Chapter 15 of this Part.
C. Pharmacies operated within a correctional
				  center shall be operated in accordance with Chapter 18 of this Part.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter A - General Requirements › Section LIII-1707 - Drug Cabinet

Current through Register Vol. 50, No. 6, June 20, 2024
A. In the
				  absence of a licensed pharmacist, arrangements shall have been formulated in
				  advance by the pharmacist-in-charge to provide drugs for the residents/patients
				  by the use of drug cabinets. When the pharmacy is closed, a pharmacist shall be
				  on emergency call.
1. Emergency Use. A drug
				  cabinet is solely intended for the proper and safe storage of needed drugs when
				  the pharmacy is closed and shall be available for emergency use by authorized
				  facility personnel only.
2.
				  Security. The drug cabinet shall be a securely constructed and locked enclosure
				  located outside the permitted pharmacy area ensuring access by authorized
				  personnel only.
3. Inventory. The
				  pharmacist-in-charge shall be responsible for the selection and quantity of
				  drugs to be maintained in the drug cabinet and shall maintain a perpetual
				  inventory of any controlled dangerous substances. Medications shall be
				  available in quantities sufficient only for immediate therapeutic
				  needs.
4. Labeling. Medications
				  stored in a drug cabinet shall bear a label with the following minimum
				  information:
a. drug name;
b. dosage form;
c. strength;
d. name of manufacturer and/or
				  distributor;
e. manufacturer's lot
				  or batch number;
f. pharmacist's
				  initials; and
g. expiration date,
				  according to United States Pharmacopeia guidelines.
5. Accountability. Documented medical
				  practitioner's orders and proof of use shall be provided when any of the drug
				  cabinet inventory is utilized.
6.
				  Inspection. The pharmacy shall inspect medications stored in a drug cabinet
				  every 30 days, plus or minus five days.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter B - Emergency Drug Kits › Section LIII-1709 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				  Subchapter, the following terms shall have the meaning ascribed to them in this
				  Section:
Emergency Drug Kit (EDK)
-for long-term
					 care facilities or other board-approved sites, other than a hospital, means a
					 drug kit containing designated
emergency drugs
which may be
					 required to meet the immediate therapeutic needs of a resident or
					 patient.
Emergency Drugs
-those drugs which may be
					 required to meet the immediate therapeutic needs of patients and which are not
					 available from any other authorized source in sufficient time to prevent risk
					 of harm to patients or residents because of delay resulting from obtaining such
					 medications from such other source.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter B - Emergency Drug Kits › Section LIII-1711 - Emergency Drug Kit Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				  long-term care facility, institutional facility without an institutional
				  pharmacy, or other board-approved site, other than a hospital, that desires to
				  maintain an Emergency Drug Kit shall obtain an EDK permit from the
				  board.
B. Permit Application and
				  Requirements. Application for an EDK permit shall be made on a form provided by
				  the board.
1. The provider pharmacy shall
				  apply to the board for an EDK permit. The administrator of the applicant
				  facility shall also sign the application for said permit. Upon compliance with
				  the required provisions, the provider pharmacy shall be issued a permit by the
				  board for the provider pharmacy to establish and maintain an EDK in the
				  facility.
2. The provider pharmacy
				  shall be a Louisiana-licensed pharmacy.
3. Only one provider pharmacy shall be
				  assigned to and be responsible for each EDK.
4. EDK permits are institutional
				  facility-specific and not transferable.
5. A separate permit is required for each
				  EDK.
6. The original EDK permit
				  shall be readily retrievable at the provider pharmacy. A copy of the EDK permit
				  shall be maintained in the room where the EDK is located.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter B - Emergency Drug Kits › Section LIII-1713 - Emergency Drug Kit Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. Emergency Use. An EDK is solely intended
				  for the immediate therapeutic emergency needs of a resident or
				  patient.
B. Security. The EDK shall
				  be tamper-evident and shall be maintained in a secure enclosure located within
				  the institutional facility and shall be available for emergency use by
				  authorized personnel only.
C.
				  Exterior Identification and Labeling. The EDK shall be clearly labeled to
				  indicate that it is an emergency drug kit. In addition, the attached exterior
				  label shall have an inventory of contents and contact information of the
				  provider pharmacy.
D. Labeling.
				  Medications stored in an EDK shall bear a label with the following minimum
				  information:
1. drug name;
2. dosage form;
3. strength;
4. name of manufacturer and/or
				  distributor;
5. manufacturer's lot
				  or batch number; and
6. expiration
				  date, according to United States Pharmacopeia guidelines.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1715 - Purpose

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board may
				  issue a pharmacy permit for a drug abuse treatment center operating in the
				  state of Louisiana where drugs are dispensed and pharmacy primary care is
				  provided.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1717 - Cross References

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				  all regulations that apply to drug abuse treatment center pharmacies concerning
				  pharmacy practices not specifically stated in this subchapter, refer to Chapter
				  11 of this Part.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1719 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				  Subchapter, the following terms shall have the meaning ascribed to them in this
				  Section:
Administer or Administration
-the direct
					 application of a drug to the body of a patient or research subject by
					 injection, inhalation, ingestion, or any other means.
Authorized Personnel
-individuals who,
					 within the scope of their authority granted by mutual agreement of the
drug abuse treatment center
's pharmacist-in-charge and
					 director, are granted access to the
drug abuse treatment
					 center
's pharmacy department as part of his duties.
Dispense or Dispensing
-the interpretation,
					 evaluation, and implementation of a prescription drug order, including the
					 preparation and delivery of a drug or device to a patient or patient's agent in
					 a suitable container appropriately labeled for subsequent administration to, or
					 use by, a patient.
Dispense
necessarily includes a transfer of
					 possession of a drug or device to the patient or the patient's agent.
Drug Abuse Treatment Center
-any
					 establishment, facility, or institution, public or private, whether operated
					 for profit or not, which primarily offers, or purports to offer, maintain, or
					 operate facilities for the residential or outpatient diagnosis, care,
					 treatment, or rehabilitation of two or more non-related individuals, who are
					 patients as defined herein, excluding, however, any hospital or mental hospital
					 otherwise licensed by the Department of Health.
Patient or Client
-a person who is
					 dependent on, or otherwise suffering physically or mentally from the use of, or
					 abuse of, controlled dangerous substances and who requires continuing care of a
drug abuse treatment center
.
Perpetual Inventory
-a computer record of
					 inventory kept continuously up to date by detailed entries of all incoming and
					 outgoing items. This includes inventory on hand, purchases, and
					 dispensing.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1721 - Drug Abuse Treatment Center Pharmacy Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A drug abuse treatment center pharmacy
				  permit shall be required to operate a pharmacy department located within a drug
				  abuse treatment facility for patients of that facility. The permit shall be
				  applied for, and renewed, in the manner prescribed by the board in Chapter 11
				  of this Part.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1723 - Minimum Security Controls for Drug Abuse Treatment Centers

Current through Register Vol. 50, No. 6, June 20, 2024
A. Persons enrolled
				  in a drug abuse treatment center shall wait for their prescriptions in an area
				  physically separated from the controlled dangerous substance (CDS) storage and
				  dispensing area. This requirement shall be enforced by the drug abuse treatment
				  center physician(s), pharmacist(s), and employees.
B. All CDS used in a drug abuse treatment
				  center shall be securely locked and accessible to authorized personnel within
				  that facility only.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 17 - Institutional Pharmacy › Subchapter C - Drug Abuse Treatment Center Pharmacies › Section LIII-1725 - Records and Reports of Drug Abuse Treatment Centers

Current through Register Vol. 50, No. 6, June 20, 2024
A. All persons licensed by the Department of
				  Health to operate a drug abuse treatment center and who possess a Drug
				  Enforcement Administration (DEA) registration to purchase, possess, and use CDS
				  shall keep the following records:
1. records
				  of CDS received by approved persons, including date of receipt, name and
				  address of distributor, type and quantity of such drugs received, and the
				  signature of the individual receiving the CDS. A duplicate invoice or separate
				  itemized list furnished by the distributor will be sufficient to satisfy this
				  record requirement, provided it includes all required information and is
				  maintained in a separate file. In addition, duplicate copies of federal order
				  forms for CDS listed in Schedule II must be retained; and
2. records of CDS administered or dispensed,
				  including date of administration or dispensing, name of patient, signature of
				  person administering or dispensing, type and quantity of drug, and such other
				  information as may be required by state and federal laws and
				  regulations.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1801 - Correctional Center Pharmacy Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A correctional center pharmacy permit
				shall be required to operate a pharmacy located within a correctional center
				owned and/or operated by the Louisiana Department of Public Safety and
				Corrections or its successor (hereinafter "the department"), or a local law
				enforcement agency, to provide medications and pharmacy care for offenders
				residing in that correctional center or another correctional center owned and
				operated by the department or local law enforcement agency. The pharmacy in the
				correctional center may also provide medications and pharmacy care to offenders
				assigned to that facility and residing at home or another housing
				location.
B. In the event a
				pharmacy located within the state but outside a correctional center intends to
				provide medications and pharmacy care on a contractual basis to offenders
				residing in, or assigned to, a correctional center owned and/or operated by the
				department or local law enforcement agency that pharmacy shall first obtain a
				correctional center pharmacy permit.
C. In the event a nonresident pharmacy
				intends to provide medications and pharmacy care on a contractual basis to
				offenders residing in, or assigned to, a correctional center owned and/or
				operated by the department or local law enforcement agency, or to any offender
				in the custody of the department or local law enforcement agency shall first
				obtain a nonresident correctional center pharmacy permit, and further, shall
				comply with the provisions of this Chapter with the exception of acquiring a
				separate correctional center pharmacy permit.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1226.3.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1803 - Permit Application Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A. Application for Initial Issuance of Permit
1. The applicant for a correctional center
				pharmacy permit 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. 37:1184, to the board.
2.
				Once received by the board, an application for the permit shall expire one year
				thereafter. Fees attached to an expired application shall be forfeited by the
				applicant and deposited by the board.
3. The board shall not process applications
				received by facsimile, or that are incomplete, or submitted with the incorrect
				fees.
4. The applicant may be
				required to personally appear before the board or one of its committees prior
				to any decision on the permit application.
5. The applicant shall be required to submit
				to the criminal history record check process used by the board, unless waived
				by the board.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1805 - Maintenance of Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				correctional center pharmacy permit is valid only for the entity to whom it is
				issued and shall not be subject to sale, assignment or other transfer,
				voluntary or involuntary, nor shall a permit be valid for any premises other
				than the business location for which it is issued.
B. The owner of the pharmacy shall appoint a
				Louisiana-licensed pharmacist as the pharmacist-in-charge of the permit. The
				owner of the pharmacy and the pharmacist-in-charge shall comply with the
				provisions of
				Section
				1105 of this Part.
C. A pharmacy contemplating permanent closure
				of its prescription department shall comply with the provisions of
				§1133ofthisPart.
D. A pharmacy
				contemplating a change in ownership shall comply with the provisions of
				Section
				1135 of this Part.
E. A pharmacy contemplating a change in
				location shall comply with the provisions of
				§
										1137 of this Part.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1226.3.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1807 - Prescription Department Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The prescription department of a
				correctional center pharmacy shall comply with the minimum specifications
				identified in
				§1103 of this Part, and further, the
				specifications provided for the correctional center pharmacy permit may not be
				held or used by any other pharmacy permit.
B. To ensure adequate access to medications
				and pharmacy care, the prescription department of a correctional center
				pharmacy shall be open for business a minimum of 10 hours per week, with said
				business hours posted at the pharmacy entrance.
C. A pharmacist shall be on duty at all times
				during regular operating hours of the pharmacy. When the pharmacy is closed, a
				pharmacist shall be available for emergency calls.
D. In the absence of a pharmacist, there
				shall be no access to the prescription department.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1226.3.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1809 - Drug Distribution Control

Current through Register Vol. 50, No. 6, June 20, 2024
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 shall cooperate with the
				pharmacist-in-charge in meeting drug control requirements in ordering and
				accounting for drugs.
1. The
				pharmacist-in-charge shall maintain a written policy and procedure manual for
				the safe and efficient distribution of drug products and delivery of pharmacy
				care. A copy of the current version of the manual shall be available for board
				inspection upon request.
2. The
				pharmacist-in-charge shall be responsible for making and keeping pharmacy
				records in compliance with the provisions of
				Sections
				1119 of this Part.
3. The procurement, storage, security, and
				recordkeeping of controlled substances shall be in compliance with the
				provisions of Chapter 27 of this Part.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1811 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
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 drugs which may be
				  required to meet the immediate therapeutic needs of an offender and which are
				  not available from any other authorized source in sufficient time to prevent
				  risk of harm to the offender because of a delay resulting from obtaining such
				  medications from such other source.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1226.3.