reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1813 - Emergency Drug Kit Permit

Current through Register Vol. 50, No. 6, June 20, 2024
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 pharmacy shall
				apply to the board for the permit.
2. The applicant 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.
3. 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.
4. The
				board shall not process applications received by facsimile, or that are
				incomplete, or submitted with the incorrect fees.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1815 - Emergency Drug Kit Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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, the attached exterior label
				shall identify the inventory of contents as well as contact information for the
				correctional center pharmacy responsible for maintaining the kit.
C. Medications stored in an EDK shall bear a
				label with the following minimum information:
1. drug name;
2. dosage form;
3. drug strength;
4. name of manufacturer and/or
				distributor;
5. manufacturer's lot
				or batch number; and
6. expiration
				date, according to relevant standards from the United States Pharmacopeia
				(USP).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1817 - Drug Donations to Correctional Center Pharmacies

Current through Register Vol. 50, No. 6, June 20, 2024
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 individual authorized to do so by the correctional
				center pharmacy.
2. An inventory
				list of the drugs being donated shall accompany the drugs received in the
				correctional center pharmacy; the list shall contain, at a minimum, the name
				and strength of the drug, the quantity received, and expiration date. The
				correctional center pharmacy receiving the donated drugs shall maintain this
				list as an acquisition record.
3.
				The correctional center pharmacy shall not knowingly accept the donation of any
				expired drugs. In the event expired drugs are received by a correctional center
				pharmacy, the pharmacist-in-charge shall destroy them as required by
				law.
4. the patient's name,
				prescription number, and any other identifying marks shall be obliterated from
				the packaging prior to its receipt in the penal pharmacy;
5. the drug name, strength, and expiration
				date shall remain on the medication package or label.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 18 - Correctional Center Pharmacy › Section LIII-1819 - Medication Use Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
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 the facility shall be packaged in
				appropriate containers that comply with the relevant standards of the
				USP.
C. The compounding of drug
				preparations shall comply with the relevant standards of the USP, as well as
				the provisions of
				Sections
				2531 of this Part.
D. All drugs dispensed by the pharmacy,
				intended for use within the correctional center, shall be labeled as to
				identify the offender's name and location as well as the drug name and
				strength. Further, compounded preparations shall include the expiration date or
				beyond-use date, initials of the preparer, and initials of the pharmacist
				performing the final check on the label.
E. Drugs dispensed by the correctional center
				pharmacy may be returned to that correctional center pharmacy for reuse, in
				accordance with good professional practice procedures, subject to the following
				limitations.
1. Drugs returned to the
				pharmacy for re-use shall not be further distributed to another
				entity.
2. Drugs that may be
				dispensed only to patients registered with the drug manufacturer in accordance
				with federal Food and Drug Administration (FDA) requirements shall not be
				accepted for return or re-dispensed.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1901 - Cross References

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				all regulations that apply to permitted nuclear pharmacies concerning pharmacy
				practices not specifically stated in this Chapter, refer to Chapter
				11.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1903 - 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.
Nuclear Pharmacy
-a board-approved facility
				  limited to procuring, possessing, compounding, or dispensing
radiopharmaceuticals
or any interventional drug used in
				  conjunction with nuclear medicine procedures. This definition shall not apply
				  to hospital nuclear medicine departments and nuclear medicine clinics operating
				  under the auspices of a licensed practitioner of medicine.
Radiation
-any electromagnetic or ionizing
radiation
including gamma rays, X-rays, alpha and beta
				  particles, high-speed electrons, neutrons, protons, and other nuclear
				  particles.
Radioactive Material
-any solid, liquid, or
				  gas that emits
radiation
spontaneously.
Radiopharmaceutical
-a drug that is a
radioactive material
and includes any drug that is intended to
				  be made radioactive, as defined by the appropriate federal
				  agency.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1905 - Nuclear Pharmacy Permit Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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 License.
2. Nuclear Pharmacist-in-Charge. A
				pharmacist-in-charge of a nuclear pharmacy operation shall be a qualified
				nuclear pharmacist, as defined in §1907, and shall be responsible for the
				entire nuclear pharmacy operation.
3. Structural Requirements. A nuclear
				pharmacy shall provide adequate space separate and apart from other areas
				commensurate with the scope of service and with the following space
				requirements.
a. Dispensing Area. The
				radiopharmaceutical compounding or preparation area shall be separate and apart
				from other facility areas and shall be not less than 300 square feet, which may
				include storage and decay areas. The pharmacy area shall be sufficient to
				provide a work environment for the safe handling, compounding, and dispensing
				of radiopharmaceuticals. This area shall be separate and inaccessible to
				non-pharmacy personnel.
b. Delivery
				and Receipt Area. An area designated for the delivery and receipt of materials
				requiring after-hours handling by non-pharmacy personnel. This area shall be
				separate from the dispensing area of the pharmacy.
c. Storage Area. A storage area sufficient to
				maintain the scope and content of unused and returned material for decay and
				disposal commensurate with the compounding and dispensing requirements of the
				facility.
d. Maintenance. A nuclear
				pharmacy shall be well maintained, clean, orderly, lighted, and properly
				ventilated.
e. Plumbing. A sink
				equipped with hot and cold running water shall be located within the nuclear
				pharmacy. A sink located in a pharmacy lavatory or restroom shall not be
				sufficient to satisfy this requirement.
4. Equipment. There shall be adequate
				equipment commensurate with the scope of services required and provided by the
				facility.
5. Supplies. There shall
				be adequate supplies commensurate with the compounding and dispensing needs of
				the facility, as well as any other services provided for by the facility,
				including appropriate shielding and safety devices and any other supplies
				necessary for the safe and legal transport of materials compounded or dispensed
				from the facility. There shall be appropriate supplies for the safe handling
				and disposal of used and unused material by employees and staff of the
				facility. The appropriateness of personal protective equipment shall be
				reviewed on an annual basis.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1907 - Qualified Nuclear Pharmacist

Current through Register Vol. 50, No. 6, June 20, 2024
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 Accreditation Council for Pharmacy Education (ACPE) or board-approved
				continuing education on those applications and procedures specific to nuclear
				pharmacy.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1909 - Labeling

Current through Register Vol. 50, No. 6, June 20, 2024
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;
				and
5. the amount of radioactive
				material contained, in the appropriate unit of measure.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 19 - Nuclear Pharmacy › Section LIII-1911 - Quality Control and Quality Assurance

Current through Register Vol. 50, No. 6, June 20, 2024
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 pharmacy.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2101 - Cross References

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				all regulations that apply to permitted charitable pharmacies concerning
				pharmacy practices not specifically stated in this Chapter, refer to Chapter
				11.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2103 - 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.
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 patients. For the purposes of
				  the Louisiana Administrative Code and the Pharmacy Practice Act, a
charitable pharmacy
may at times also be referred to as a
provisional permitted pharmacy
.
Qualified Patients
-those patients who are
				  without sufficient funds to obtain medications as determined by strict
				  screening guidelines based on needs assessment.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2105 - Charitable Pharmacy Permit Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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 Code under 26 U.S.C.
				§501 (c)(3), or its successor.
B. Compliance. The charitable pharmacy shall
				be in compliance with applicable federal, state, and local laws and/or
				regulations pertaining to the practice of pharmacy.
C. Guidelines. Strict screening guidelines
				based on needs assessment shall be developed by the charitable pharmacy to
				determine who is eligible as a qualified patient.
D. Review. All screening guidelines, needs
				assessments, and revisions shall be submitted to the board upon
				request.
E. Patient Dispensing.
				Prescriptions filled in a charitable pharmacy may only be dispensed to
				qualified patients of that pharmacy.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2107 - Prescription Drug Samples

Current through Register Vol. 50, No. 6, June 20, 2024
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 qualified patients of that
				charitable pharmacy; and
2. the
				prescription drug samples are possessed in compliance with the Federal
				Prescription Drug Marketing Act of 1987, 21 U.S.C.
				§301 et seq., or its
				successor.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2109 - Medication Transfers

Current through Register Vol. 50, No. 6, June 20, 2024
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 permitted charitable pharmacy
				for relabeling and dispensing to indigent patients, free of charge, pursuant to
				a valid prescription order.
1. The
				pharmacist-in-charge of the permitted charitable pharmacy shall be responsible
				for determination of suitability of the product for reuse.
a. No product where integrity cannot be
				assured shall be accepted for re-dispensing by the pharmacist.
b. A re-dispensed prescription medication
				shall be assigned the expiration date stated on the package.
c. No product shall be re-dispensed more than
				one time.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 21 - Charitable Pharmacy › Section LIII-2111 - Prohibitions

Current through Register Vol. 50, No. 6, June 20, 2024
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.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2301 - Purpose

Current through Register Vol. 50, No. 6, June 20, 2024
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
				state of Louisiana where prescription drugs are dispensed and/or pharmacy care
				is provided to residents of the state of Louisiana. This includes, but is not
				limited to, pharmacies providing goods and services via U.S. mail carrier,
				commercial carrier, the Internet, and/or directly to Louisiana
				residents.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2303 - Nonresident Pharmacy Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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 pharmacy doing business
				in Louisiana by dispensing and delivering prescription drugs and devices to
				offenders in the custody of the Louisiana Department of Public Safety and
				Corrections or local law enforcement agency shall obtain and maintain a
				nonresident correctional center pharmacy permit, and further, shall comply with
				the provisions of Chapter 18 of this Part, with the single exception of the
				necessity for acquiring a separate correctional center pharmacy
				permit.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2305 - Nonresident Pharmacy Permit Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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 position of each officer and director of a corporation or of
				the owners, if the pharmacy is not a corporation.
B. The nonresident pharmacy shall pay an
				annual permit fee as defined by the Board.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2307 - Pharmacist-in-Charge

Current through Register Vol. 50, No. 6, June 20, 2024
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 pharmacist license;
b. possession of an active license in the
				state in which the pharmacy is located, and further, said license shall not
				have any restrictions which prohibit the position of
				pharmacist-in-charge;
c. active
				practice as a pharmacist for a minimum of two years under the jurisdiction of
				any board of pharmacy in the United States; and
d. the completion of the affidavit of
				responsibility and duties described in Subsection J of this Section.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2309 - Applicable Laws and Regulations

Current through Register Vol. 50, No. 6, June 20, 2024
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.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2311 - Inspection

Current through Register Vol. 50, No. 6, June 20, 2024
A. The facilities
				and records of the nonresident pharmacy shall be subject to inspection by the
				board or its designated agent(s).
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2313 - Records

Current through Register Vol. 50, No. 6, June 20, 2024
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 inspection by the board. The pharmacy permit holder
				or the pharmacist-in-charge shall produce within 72 hours any information,
				documentation, and/or records requested by the board.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2315 - Counseling Services

Current through Register Vol. 50, No. 6, June 20, 2024
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, plus other numbers available for
				use, shall be printed on each container of drugs dispensed to Louisiana
				residents. The toll-free telephone number shall have sufficient extensions to
				provide reasonable access to incoming callers.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2317 - Nonresident Pharmacy Closure Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
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
				holder shall surrender the pharmacy permit to the board upon closure.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 23 - Nonresident Pharmacy › Section LIII-2319 - Jurisdiction

Current through Register Vol. 50, No. 6, June 20, 2024
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 constitutes doing business in Louisiana.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter A - Durable Medical Equipment › Section LIII-2401 - 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.
Durable Medical Equipment
					 (DME)
-technologically sophisticated medical devices that may be used
					 in a residence, including the following:
a. oxygen and oxygen delivery system;
b. ventilators;
c. respiratory disease management devices;
d. continuous positive airway pressure (CPAP)
					 devices;
e. electronic and computerized wheelchairs and seating
					 systems;
f. apnea monitors;
g. transcutaneous electrical nerve stimulator (TENS)
					 units;
h. low air loss cutaneous pressure management
					 devices;
i. sequential compression devices;
j. feeding pumps;
k. home phototherapy devices;
l. infusion delivery devices;
m. distribution of medical gases to end users for human
					 consumption;
n. hospital beds;
o. nebulizers; and
p. other similar equipment as determined by rule.
Legend
-an instrument, apparatus,
					 implement, machine, contrivance, implant, or other similar or related article,
					 including any component part or accessory, which is required under federal law
					 to bear the label, "Caution: federal or state law requires dispensing by or on
					 the order of a physician" and/or "Rx Only," or any other designation required
					 under federal law.
Legend Drug
-
a. any substance recognized as a drug in the official
					 compendium, or supplement thereto, designated by the board for use in the
					 diagnosis, cure, mitigation, treatment or prevention of diseases in humans or
					 animals;
b. any substance intended for use in the diagnosis, cure,
					 mitigation, treatment or prevention of disease in humans or other animals;
					 or
c. any substance other than food intended to affect the
					 structure or any function of the body of humans or other animals.
Medical Gas
-compressed oxygen and liquid
					 oxygen intended for human consumption.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter A - Durable Medical Equipment › Section LIII-2403 - Durable Medical Equipment (DME) Permit

Current through Register Vol. 50, No. 6, June 20, 2024
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)
				  permit from the board.
B. A DME
				  permit shall authorize the permit holder to procure, possess and provide legend
				  devices to the patient or end user; however, the DME permit shall not authorize
				  the permit holder to procure, possess, or provide any prescription or legend
				  drugs.
C. The board shall not issue
				  a DME permit to any person or other entity that has not registered with the
				  Louisiana Secretary of State to conduct business within the state.
D. Licensing Procedures
1. A person or other entity desiring to
				  obtain a DME permit shall complete the application form supplied by the board
				  and submit it with any required attachments and the application fee to the
				  board.
2. The applicant shall
				  provide a complete street address reflecting the location where the applicant
				  will hold the equipment and engage in the activity for which the permit is
				  acquired. The board shall not issue more than one permit for the same physical
				  space.
3. The board shall not
				  process applications received by facsimile, or that are incomplete, or
				  submitted with the incorrect fee.
4. A person or other entity who knowingly or
				  intentionally submits a false or fraudulent application shall be deemed to have
				  violated
				  R.S.
				  37:1241(A)(2).
5. Once issued, the DME permit shall expire
				  on August 31 of every year. No person or other entity shall engage in the
				  provision of DME with an expired DME permit.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter A - Durable Medical Equipment › Section LIII-2405 - Standards of Practice

Current through Register Vol. 50, No. 6, June 20, 2024
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, allow for equipment maintenance
				  work space, and contain sufficient space for the storage and retrieval of all
				  required records.
2. The provider
				  shall maintain the facility in a clean, orderly and sanitary condition at all
				  times.
3. The facility shall be
				  equipped with a functioning lavatory with hot and cold running water, or in the
				  alternative, hand washing appliances or waterless hand cleaner are
				  available.
4. The facility shall
				  comply with all local and state building laws and fire codes.
5. The provider shall comply with all
				  requirements from the United States Pharmacopeia (USP), the federal Food and
				  Drug Administration (FDA), federal Department of Transportation (DOT) and
				  Occupational Safety and Health Administration (OSHA) relative to the storage,
				  packaging, labeling and shipping of DME including medical gases.
6. The provider shall staff the facility with
				  an adequate number of qualified personnel to properly render DME services in
				  the manner prescribed by law.
7.
				  The provider shall make services continuously available without interruption
				  when such services are essential to the maintenance of life or when the lack of
				  services might reasonably cause harm.
8. The provider shall implement and maintain
				  written procedures for handling complaints, and further, shall maintain a
				  complaint file documenting all complaints and their resolution.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter A - Durable Medical Equipment › Section LIII-2407 - Exemptions

Current through Register Vol. 50, No. 6, June 20, 2024
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. occupational therapists;
4. optometrists;
5. physical therapists;
6. physicians;
7. podiatrists;
8. respiratory therapists;
9. speech pathologists;
10. veterinarians;
11. distributors;
12. home health agencies;
13. hospice programs;
14. hospitals;
15. long term care facilities;
16. manufacturers; and
17. pharmacies.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter B - Special Event Pharmacy Permit › Section LIII-2411 - Special Event Pharmacy Permit

Current through Register Vol. 50, No. 6, June 20, 2024
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 based on special conditions as requested by
				  the applicant and imposed by the board in cases where certain requirements or
				  standards of practice may be waived.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1223.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter B - Special Event Pharmacy Permit › Section LIII-2413 - General Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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
				  patient for later use upon the order of a practitioner with prescriptive
				  authority.
2. In the absence of a
				  Louisiana controlled dangerous substance (CDS) license, the holder of a special
				  event pharmacy permit shall not procure or possess any controlled dangerous
				  substances.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter B - Special Event Pharmacy Permit › Section LIII-2415 - Standards of Practice

Current through Register Vol. 50, No. 6, June 20, 2024
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 and proper storage of prescription
				  drugs and, if applicable, controlled dangerous substances;
b. all areas where drugs and devices are
				  stored shall be dry, well-lighted, well ventilated, and maintained at
				  temperatures which will ensure the integrity of drugs prior to their dispensing
				  as stipulated by the United States Pharmacopeia (USP) and/or manufacturers or
				  distributors product labeling unless otherwise indicated by the
				  board;
c. the pharmacy shall be
				  secured by either a physical barrier with suitable locks and/or an electronic
				  barrier to detect entry at a time when the pharmacist is not present;
				  and
d. prescription and other
				  patient healthcare information shall be maintained in a manner that protects
				  the integrity and confidentiality of such information.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter C - Telepharmacy Services › Section LIII-2421 - Purpose

Current through Register Vol. 50, No. 6, June 20, 2024
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
				  evolve, with changing patterns of distribution of the workforce, certain parts
				  of the state have experienced a shortage of pharmacists, which can adversely
				  impact access to pharmacist care.
C. In an effort to improve access to
				  pharmacist care and pharmacy services, the board has determined it appropriate
				  to establish standards for the operation and regulation of telepharmacy
				  services.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter C - Telepharmacy Services › Section LIII-2423 - 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.
Central Pharmacy
-a permitted pharmacy in
					 Louisiana that supervises a telepharmacy dispensing site.
Still Image Capture
-a specific image
					 captured electronically from a video or other image capture device.
Store and Forward
-a video or still image
					 record which is saved electronically for future review.
Telepharmacy Dispensing Site
-a permitted
					 pharmacy supervised by a central pharmacy that offers pharmacy services using a
					 telepharmacy system.
Telepharmacy System
-a system that monitors
					 the dispensing of prescription drugs and provides for related drug use review
					 and patient counseling services by an electronic method which shall include the
					 use of the following types of technology:
a. audio and video;
b. still image capture; and
c. store and forward.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter C - Telepharmacy Services › Section LIII-2425 - Telepharmacy Dispensing Site

Current through Register Vol. 50, No. 6, June 20, 2024
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 to the board and a waiver to the mileage restriction is deemed
				  appropriate.
2. A telepharmacy
				  dispensing site permit shall authorize the permit holder to procure and possess
				  prescription and non-prescription drugs and devices and:
a. hold such items for immediate
				  administration directly to a patient pursuant to an order from a lawful
				  prescriber;
b. dispense such items
				  to a patient for later use upon the order of a practitioner with prescriptive
				  authority; or
c. distribute such
				  items to another entity with lawful authority to procure and possess such
				  items.
3. In the event
				  the telepharmacy dispensing site intends to procure and possess any controlled
				  substances, that pharmacy shall first obtain a Louisiana controlled dangerous
				  substance license as well as the federal registration from the U.S. Drug
				  Enforcement Administration.
4. The
				  telepharmacy dispensing site shall operate using a telepharmacy system under
				  the control of its supervising central pharmacy.
5. A central pharmacy may supervise no more
				  than two telepharmacy dispensing sites, and all such sites must be located
				  within the state of Louisiana.
6.
				  The minimum staffing requirement for a telepharmacy dispensing site shall be a
				  Louisiana-licensed certified pharmacy technician with at least two years of
				  experience as a Louisiana-licensed certified pharmacy technician and with
				  demonstrated proficiency in operating the telepharmacy system used in the
				  telepharmacy dispensing site.
7. A
				  pharmacist shall approve each prescription before it is taken away from the
				  telepharmacy dispensing site.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter D - Remote Processor Pharmacy › Section LIII-2431 - Purpose

Current through Register Vol. 50, No. 6, June 20, 2024
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.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter D - Remote Processor Pharmacy › Section LIII-2433 - 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.
On-Site Pharmacy
-a permitted pharmacy
					 which utilizes remote processing services from a remote processor
					 pharmacy.
Remote Processing Services
-the processing
					 of a medical order or prescription drug order by one permitted pharmacy on
					 behalf of another permitted pharmacy, including:
a. receipt, interpretation, or clarification
				  of an order;
b. data entry and
				  information transfer;
c.
				  interpretation of clinical data;
d.
				  performance of drug utilization review; and
e. provision of drug information concerning a
				  patients drug therapy; provided, however, that remote processing does not
				  include the physical preparation or physical transfer of drugs.
Remote Processor
-a pharmacy holding a
					 remote processor pharmacy permit and provides remote processing services for
					 another permitted pharmacy,
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter D - Remote Processor Pharmacy › Section LIII-2435 - General Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
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 substances.
3. The holder of a remote processor pharmacy
				  permit shall not be eligible to acquire a Louisiana controlled dangerous
				  substance license or a federal registration from the U.S. Drug Enforcement
				  Administration.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter D - Remote Processor Pharmacy › Section LIII-2437 - Standards of Practice

Current through Register Vol. 50, No. 6, June 20, 2024
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 in compliance with the
				  Louisiana
Sanitary Code
.
3. The pharmacy shall be secured by either a
				  physical barrier with suitable locks and/or an electronic barrier to detect
				  entry by any unauthorized personnel.
4. Prescription and other patient healthcare
				  information shall be maintained in a manner that protects the integrity and
				  confidentiality of such information.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2440 - Preamble; Warning; Consultation Suggested (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1046.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2443 - Marijuana Products

Current through Register Vol. 50, No. 6, June 20, 2024
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, nor may such misbranded and/or adulterated products be
				  dispensed by any marijuana pharmacy.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2449 - Marijuana Pharmacy Personnel (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1046.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2451 - Operation of Marijuana Pharmacy

Current through Register Vol. 50, No. 6, June 20, 2024
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 marijuana pharmacy shall not dispense marijuana from, obtain marijuana from,
				  or transfer marijuana to, a location outside of the state of
				  Louisiana.
C. A marijuana pharmacy
				  shall not obtain, cultivate, deliver, transfer, transport, sell or dispense
				  marijuana except:
1. it may acquire marijuana
				  from an authorized producer pursuant to the provisions of
				  R.S.
				  40:1046; and
2. it may dispense and sell marijuana to a
				  patient with a recommendation/prescription/order for such marijuana or the
				  patients caregiver.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2453 - Security Requirements for Marijuana Pharmacies (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1046.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2455 - Reportable Security Events

Current through Register Vol. 50, No. 6, June 20, 2024
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 law enforcement authorities; and
2. the board.