reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter E - Recordkeeping Requirements › Section LIII-2733 - Inventory Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  General Requirements. Each inventory shall contain a complete and accurate
				  record of all controlled substances on hand on the date the inventory is taken,
				  and shall be maintained in written, typewritten, or printed form at the
				  registered location. An inventory taken by use of an oral recording device
				  shall be promptly transcribed. Controlled substances shall be deemed to be "on
				  hand" if they are in the possession of or under the control of the licensee,
				  including substances returned by a customer, ordered by a customer but not yet
				  invoiced, stored in a warehouse on behalf of the licensee, and substances in
				  the possession of employees of the licensee and intended for distribution as
				  complimentary samples. A separate inventory shall be made for each registered
				  location and each independent activity registered, except as provided in this
				  Section. In the event controlled substances in the possession or under the
				  control of the licensee are stored at a location for which he is not
				  registered, the substances shall be included in the inventory of the registered
				  location to which they are subject to control or to which the person possessing
				  the substance is responsible. The inventory may be taken either as of opening
				  of business or as of the close of business on the inventory date and that
				  option shall be indicated on the inventory.
B. Initial Inventory Date. Every person
				  required to keep records shall take an inventory of all stocks of controlled
				  substances on hand on the date he first engages in the manufacture,
				  distribution, or dispensing of controlled substances, in accordance with this
				  Section as applicable. In the event a person commences business with no
				  controlled substances on hand, he shall record this fact as the initial
				  inventory.
C. Biennial Inventory
				  Date. After the initial inventory is taken, the licensee shall take a new
				  inventory of all stocks of controlled substances on hand at least every two
				  years. The biennial inventory may be taken on any date which is within two
				  years of the previous biennial inventory date.
1. Exception
a. Pharmacies shall take a new inventory of
				  all stocks of controlled substances on hand every year; the annual inventory
				  may be taken on any date which is within one year of the previous annual
				  inventory date.
b. Pharmacies shall
				  take a new inventory on the following occasions:
i. arrival of a new
				  pharmacist-in-charge;
ii. discovery
				  of any substantial loss, disappearance, or theft of controlled
				  substances;
iii. departure of a
				  pharmacist-in-charge; and
iv.
				  permanent closure of a pharmacy.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter E - Recordkeeping Requirements › Section LIII-2735 - Continuing Records

Current through Register Vol. 50, No. 6, June 20, 2024
A. General
				  Requirements
1. Every licensee required to
				  keep records pursuant to this Section shall maintain on a current basis a
				  complete and accurate record of each such substance manufactured, imported,
				  received, sold, delivered, exported, or otherwise disposed of by him.
2. Separate records shall be maintained by a
				  licensee for each registered location except as provided in §2731. B In the
				  event controlled substances are in the possession or under the control of a
				  licensee at a location for which he is not registered, the substances shall be
				  included in the records of the registered location to which they are subject to
				  control or to which the person possessing the substance is
				  responsible.
3. Separate records
				  shall be maintained by a licensee for each independent activity for which he is
				  registered, except as provided in Subsection B of this Section.
4. In recording dates of receipt,
				  importation, distribution, exportation, or other transfers, the date on which
				  the controlled substances are actually received, imported, distributed,
				  exported, or otherwise transferred shall be used as the date of receipt or
				  distribution of any documents of transfer (e.g., invoices or packing
				  slips).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2739 - Manufacture

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee
				  located in Louisiana engaged in the manufacture of controlled dangerous
				  substances within Schedules I, II, III, IV, or V shall prepare a complete and
				  accurate record of the date of manufacture, the theoretical and actual yields,
				  the quantity used for quality control, the identity of batch numbers or other
				  appropriate identification, and the quantity of any product reworked for any
				  reason for each manufactured batch of controlled dangerous substances or each
				  manufactured batch of drugs in which a controlled dangerous substance was used
				  as a raw material.
B. The licensee
				  shall maintain manufacturing records in such a manner that the identity of a
				  batch of controlled dangerous substances finished product can be matched to the
				  identity of the controlled dangerous substance raw material used to make that
				  product.
C. The licensee shall
				  maintain any other such records as are necessary to account for all controlled
				  dangerous substances used in the manufacturing process.
D. A building where manufacturing takes place
				  shall be maintained in a clean and orderly manner and shall be of a suitable
				  size, construction, and location to facilitate cleaning, maintenance,
				  processing, and packing, labeling, or storing of legend drugs pursuant to
				  federal and state requirements.
E.
				  All manufacturers shall employ security precautions by ensuring controlled
				  access to premises to avoid drug diversion, including adequate legend drug
				  storage, alarm system security, and adequate lighting and protection of the
				  premises.
F. Finished products,
				  warehouse control, and distribution procedures shall include a system by which
				  the distribution of each lot of drug can be readily determined to facilitate
				  its recall if necessary. Records within the system shall contain the name and
				  address of the consignee, date and quantity shipped, and the lot or control
				  number of the drug. Records shall be retained a minimum of two years after the
				  distribution of the drug has been completed, or for one year after the
				  expiration date of the drug, whichever is longer.
G. To assure the quality of the finished
				  product, warehouse control shall include a system whereby the oldest approved
				  stock is distributed first.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2741 - Distribution

Current through Register Vol. 50, No. 6, June 20, 2024
A. A distributor or
				  third-party logistics provider handling controlled substances in Schedules I or
				  II shall maintain complete and accurate records of the original copies of all
				  order forms received and filled for orders of controlled substances within
				  these schedules. This file shall be kept separate from the licensee's other
				  business and professional records and shall be kept in this file a minimum of
				  two years from the date the order was filled.
B. A distributor or third-party logistics
				  provider handling controlled substances in Schedules III, IV, and V shall
				  maintain complete and accurate records of all distributions for a minimum of
				  two years from the date of each distribution. These records shall contain the
				  full name, address, and registration number, if any, of the recipient, the
				  common or established name of the controlled substance, its dosage, form, and
				  strength, amount, and date of distribution.
C. A distributor or third-party logistics
				  provider shall not sell or distribute drugs or drug devices except to a person
				  or facility authorized by law or regulation to procure or possess drugs or drug
				  devices.
D. A distributor or
				  third-party logistics provider shall maintain and follow a written procedure to
				  assure the proper handling and disposal of returned goods.
E. A distributor or third-party logistics
				  provider shall maintain a written policy for handling recalls and withdrawals
				  of products due to:
1. any voluntary action
				  on the part of the manufacturer;
2.
				  the direction of the Food and Drug Administration, or any other federal, state,
				  or local government agency; or
3.
				  replacement of existing merchandise with an approved product with a new package
				  design.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2745 - Prescriptions

Current through Register Vol. 50, No. 6, June 20, 2024
A. Practitioners
				  Authorized to Issue Prescriptions. A prescription for a controlled substance
				  may be issued only by an individual practitioner who is:
1. authorized by law to prescribe controlled
				  substances, and includes the following:
a. a
				  physician;
b. a dentist;
c. a veterinarian;
d. a physician assistant;
e. an advanced practice registered
				  nurse;
f. an optometrist;
				  or
g. a medical psychologist (but
				  no narcotics);
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2749 - Disposal of Controlled Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any person in possession of any controlled
				  substance and desiring or required to dispose of such substance may request
				  assistance from the special agent in charge of the DEA in the area in which the
				  person is located for authority and instructions to dispose of such substance.
				  The request should be made as follows:
1. if
				  the person is a licensee, he shall list the controlled substance or substances
				  which he desires to dispose of on DEA Form 41, and submit three copies of that
				  form to the special agent in charge in his area; or
2. if the person is not a licensee, he shall
				  submit to the special agent in charge a letter stating:
a. the name and address of the
				  person;
b. the name and quantity of
				  each controlled substance to be disposed of;
c. how the applicant obtained the substance,
				  if known; and
d. the name, address,
				  and registration number, if known, of the person who possessed the controlled
				  substances prior to the applicant, if known.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2751 - Distributions and Transfers of Controlled Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A. Distribution by Dispenser to Another
				  Practitioner or Reverse Distributor
1. A
				  dispenser may distribute (without being registered to distribute) a quantity of
				  such controlled substance to:
a. another
				  practitioner for the purpose of general dispensing by the practitioner to
				  patients, provided that:
i. the receiving
				  practitioner is authorized to dispense that controlled substance;
ii. the distribution is recorded by the
				  dispenser and the receiving practitioner, in accordance with §2735. B of this
				  Chapter;
iii. a DEA 222 order form
				  is used as required for controlled substances listed in Schedule II;
				  and
iv. the total number of dosage
				  units of all controlled substances distributed by the dispenser pursuant to
				  this Section during each calendar year shall not exceed 5 percent of the total
				  number of dosage units distributed and dispensed by the dispenser during the
				  same calendar year;
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter G - Administrative Procedures › Section LIII-2753 - Inspections

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board may
				  inspect any licensed facility or location of a licensed person including
				  pertinent records for the purpose of determining compliance with the
				  requirements of this Chapter and other state and federal laws and regulations
				  related to controlled substances, subject to the limitations identified in
				  R.S.
				  40:988.B and
				  R.S.
				  40:988.C.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter G - Administrative Procedures › Section LIII-2755 - Seizures

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board may
				  place under seal all drugs or devices that are owned by or in the possession,
				  custody, or control of a licensee at the time his license is suspended or
				  revoked, for a licensee's failure to timely renew his license, or at the time
				  the board refuses to renew his license.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter G - Administrative Procedures › Section LIII-2757 - Hearings

Current through Register Vol. 50, No. 6, June 20, 2024
A. All formal
				  administrative hearings conducted by the board shall be conducted in accordance
				  with the Louisiana Administrative Procedures Act,
				  R.S.
				  49:950 et seq
.
, and
				  §2711 of this Chapter.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter A - General Operations › Section LIII-2903 - Authority for Program Operation (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1004.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter A - General Operations › Section LIII-2905 - Authority to Engage Staff (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1179.F(6).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter A - General Operations › Section LIII-2907 - Authority to Contract with Vendors (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1012.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter A - General Operations › Section LIII-2909 - Advisory Council (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1005.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter B - Data Collection › Section LIII-2911 - Reporting of Prescription Monitoring Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each dispenser shall submit to the board
				  information regarding each prescription dispensed for a controlled substance or
				  drug monitored by the program.
B.
				  Each dispenser shall submit the required information by electronic means no
				  later than the next business day after the date of dispensing.
C. If the dispenser is unable to submit
				  prescription information by electronic means, he may apply to the board for a
				  waiver. The board may grant a waiver to that requirement; if so, the waiver
				  shall state the format and frequency with which the dispenser shall submit the
				  required information. The waiver shall expire one year after the date of issue,
				  unless terminated sooner by the board.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter B - Data Collection › Section LIII-2913 - Required Data Elements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  information submitted for each prescription shall include data relative to the
				  identification of the following elements of the transaction, or alternative
				  data as identified in the board's program user manual. To the extent possible,
				  the data shall be transmitted in the format established by the American Society
				  for Automation in Pharmacy (ASAP) Telecommunications Format for Prescription
				  Monitoring Programs Standard Version 4.2 or a successor.
1. Prescriber information:
a. last and first name of
				  prescriber;
b. United States Drug
				  Enforcement Administration (DEA) registration number, and suffix if applicable,
				  or in the alternative, the national provider identifier (NPI) number, as issued
				  by the United States Centers for Medicare and Medicaid Services
				  (CMS).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter B - Data Collection › Section LIII-2914 - Record Retention of Prescription Monitoring Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board shall
				  retain a minimum of five years of prescription monitoring information for
				  review by persons authorized to access such information.
B. The board shall archive all prescription
				  monitoring information not available for direct or indirect access up to 10
				  years.
C. The board may remove and
				  destroy prescription monitoring information in excess of 10 years.
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1006(G).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter B - Data Collection › Section LIII-2915 - Failure to Report Prescription Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. A dispenser who fails to submit
				  prescription monitoring information to the board as required shall be referred
				  to the appropriate professional licensing, certification, or regulatory agency
				  for administrative sanctions as deemed appropriate by that agency.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter C - Access to Prescription Monitoring Information › Section LIII-2917 - Authorized Direct Access Users of Prescription Monitoring Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. The following
				  persons may access prescription monitoring information in the same or similar
				  manner, and for the same or similar purposes, as those persons are authorized
				  to access similar protected health information under federal and state law and
				  regulation:
1. persons authorized to
				  prescribe or dispense controlled substances or drugs of concern, and their
				  delegates, for the purpose of providing medical or pharmaceutical care for
				  their patients, or for verifying their prescription records;
2. designated representatives from the
				  professional licensing, certification, or regulatory agencies of this state or
				  another state charged with administrative oversight of those professionals
				  engaged in the prescribing or dispensing of controlled substances or other
				  drugs of concern;
3. designated
				  representatives from the Louisiana Medicaid program regarding Medicaid program
				  recipients;
4. designated
				  representatives of the board or any vendor or contractor establishing or
				  maintaining the prescription monitoring program;
5. a medical examiner or coroner, or a
				  delegate thereof, for the purpose of investigating an individuals
				  death;
6. a licensed substance
				  abuse addiction counselor providing services as part of a state-licensed
				  substance abuse or addiction treatment program;
7. an epidemiologist with the Louisiana
				  Department of Health for the purpose of assisting the board in analyzing
				  prescription monitoring information in order to conduct public health
				  evaluations to support public policy and education pursuant to an agreement
				  with the board;
8. prescription
				  monitoring programs, electronic health information systems, and pharmacy
				  information systems located in other states, territories, federal districts,
				  and federal jurisdictions, through a secure interstate data exchange system or
				  health information exchange system approved by the board, but only in
				  compliance with the provisions of
				  R.S.
				  40:1007(G).
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter C - Access to Prescription Monitoring Information › Section LIII-2919 - Registration Procedures for Authorized Direct Access Users

Current through Register Vol. 50, No. 6, June 20, 2024
A. Authorized users of prescription
				  monitoring information, and their delegates, shall comply with the following
				  requirements to register with the board, in order to receive the appropriate
				  credentials to access prescription monitoring information.
1.
a. A
				  prescriber or dispenser, excluding veterinarians, shall be automatically
				  registered as a participant in the program and shall authenticate their
				  identity through an online process in order to activate their
				  account.
b. An agency applicant
				  shall file an application with the program, using the form supplied by the
				  program for that purpose.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter C - Access to Prescription Monitoring Information › Section LIII-2921 - Methods of Access to Prescription Monitoring Information and Audit Trail Information

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Prescribers and dispensers as well as their delegates, once properly
				  registered, may solicit prescription monitoring information from the program
				  concerning their patients, or for verifying their prescription records. The
				  program may require such users to certify the legitimacy of their inquiry prior
				  to furnishing the requested information.
B. Designated representatives from agencies
				  charged with administrative oversight of prescribers and dispensers of
				  controlled substances may solicit prescription monitoring information and audit
				  trail information from the program concerning specific investigations of
				  prescribers or dispensers. The program may require such users to certify the
				  legitimacy of their inquiry prior to furnishing the requested information.
C. Designated representatives of
				  the Louisiana Medicaid program, once properly registered, may solicit
				  prescription monitoring information from the program concerning specific
				  recipients. The program may require such users to certify the legitimacy of
				  their inquiry prior to furnishing the requested information.
D. Designated representatives of the board,
				  or any vendor or contractor establishing or maintaining the program, once
				  properly registered, may solicit prescription monitoring information from the
				  program for the purpose of establishing or maintaining the program's
				  database.
E. Upon receipt of one of
				  the following methods of application by local, state, out-of-state, or federal
				  law enforcement or prosecutorial officials, including judicially-supervised
				  specialty courts within the criminal justice system that are authorized by the
				  Louisiana Supreme Court, the program may provide prescription monitoring
				  information and audit trail information:
1. a
				  court order or court-ordered warrant, or a subpoena or summons issued by a
				  judicial officer;
2. a grand jury
				  subpoena; or
3. an administrative
				  request, including an administrative subpoena or summons, a civil or an
				  authorized investigative demand, or similar process authorized under law,
				  provided by law enforcement to the board, and further, provided all of the
				  following:
a. the information sought is
				  relevant and material to a legitimate law enforcement inquiry;
b. the request is specific and limited in
				  scope to the extent reasonably practicable in light of the purpose for which
				  the information is sought;
c.
				  de-identified information, or limited information that does not identify or
				  could not reasonably lead to the identification of an individual patient, could
				  not reasonably be used.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter C - Access to Prescription Monitoring Information › Section LIII-2923 - Unlawful Use or Disclosure of Prescription Monitoring Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the program
				  receives evidence of inappropriate or unlawful use or disclosure of
				  prescription monitoring information by an authorized user or his delegate, the
				  program shall refer that user to the appropriate professional licensing,
				  certification, or regulatory agency for administrative sanctions as deemed
				  appropriate by that agency.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter D - Reports › Section LIII-2925 - Release of Prescription Monitoring Information to Other Entities

Current through Register Vol. 50, No. 6, June 20, 2024
A. The program
				  shall provide prescription monitoring information to public or private
				  entities, whether located in or outside the state, for public research, policy,
				  or educational purposes, but only after removing information that identifies or
				  could reasonably be used to identify prescribers, dispensers, and individual
				  patients or persons who received prescriptions from prescribers.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter D - Reports › Section LIII-2927 - Legislative Oversight

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  board shall report to the appropriate legislative oversight committee on a
				  periodic basis, but in no case less than annually, the cost benefits and other
				  information relevant to policy, research, and education involving controlled
				  substances and other drugs of concern monitored by the program.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 29 - Prescription Monitoring Program › Subchapter D - Reports › Section LIII-2929 - Program Evaluation

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  board shall, in consultation with and upon recommendation of the advisory
				  council, design and implement an evaluation component to identify cost benefits
				  of the prescription monitoring program and other information relevant to
				  policy, research, and education involving controlled substances and drug
				  monitored by the prescription monitoring program.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1011.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 30 - Pharmacy Benefit Managers › Section LIII-3001 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. The following
				terms shall have the meaning ascribed to them in this Section:
Audited Financial Statement
-Repealed.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1253.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 30 - Pharmacy Benefit Managers › Section LIII-3003 - Pharmacy Benefit Manager Permit

Current through Register Vol. 50, No. 6, June 20, 2024
A. A pharmacy benefit manager, as defined at
				R.S.
				40:2863, shall obtain and maintain a pharmacy
				benefit manager permit from the board prior to conducting business in Louisiana
				if it administers, develops, maintains, performs, or provides one or more of
				the pharmacy services enumerated in
				R.S.
				40:2868 in the state or that affects one or
				more beneficiaries of a pharmacy benefit management plan, as defined at
				R.S.
				40:2863, administered by the pharmacy benefit
				manager.
B. A pharmacy benefit
				manager permit shall authorize the permit holder to administer pharmacy benefit
				management services.
C. The board
				shall not issue a pharmacy benefit manager permit to any person or other entity
				which has not yet registered with the Louisiana Secretary of State to conduct
				business within the state.
D. A
				pharmacy benefit manager permit is not transferable from the original owner.
				The permit shall not be subject to sale, assignment or other transfer,
				voluntary or involuntary. Moreover, in the event the ownership of the pharmacy
				benefit manager changes by 50 percent or more after the initial issuance of the
				permit, the ownership will be deemed sufficiently different as to require a new
				pharmacy benefit manager permit. The continued operation of a pharmacy benefit
				manager permit after its ownership has changed by 50 percent or more shall
				constitute sufficient basis for the board to issue a finding for the operation
				of a pharmacy benefit manager without a valid permit, in violation of
				R.S.
				40:2865.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1253.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 30 - Pharmacy Benefit Managers › Section LIII-3005 - Permitting Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Application for Initial Issuance of Permit
1.
				The board shall develop an application form suitable for the pharmacy benefit
				manager permit. The board may revise that application form on its own
				initiative in order to collect the information it deems necessary to properly
				evaluate an applicant.
2. The board
				shall not process applications received by facsimile, or that are incomplete,
				or submitted with the incorrect fee.
3. Once received by the board, an application
				for the permit shall expire one year thereafter.
4. In the event any information contained in
				the application or accompanying documents changes after being submitted to the
				board and before the issuance of the permit, the applicant shall immediately
				notify the board in writing and provide corrected information.
5. The applicant may be required to
				personally appear before the board or any of its committees prior to any
				decision on the permit application.
6. Upon approval of the application, the
				board shall issue the pharmacy benefit manager permit to the
				applicant.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter A - General Information › Section LIII-3101 - Scope and Purpose of Chapter [Formerly Section 2701]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Scope of Chapter. The rules of this
				  Chapter interpret, implement, and provide for the enforcement of
				  R.S.
				  37:1744 and
				  R.S.
				  37:1745, or their successors, requiring
				  disclosure of a pharmacist's financial interest in another health care provider
				  to whom or to which the pharmacist refers a patient and prohibiting certain
				  payments in return for referring or soliciting patients.
B. Declaration of Purpose; Interpretation and
				  Application. Pharmacists owe a fiduciary duty to patients to exercise their
				  professional judgment in the best interests of their patients in providing,
				  furnishing, recommending, or referring patients for health care items or
				  services. The purpose of these rules and the laws they implement is to prevent
				  payments by or to a pharmacist as a financial incentive for the referral of
				  patients to a pharmacist or other health care provider for healthcare services
				  or items. These rules shall be interpreted, construed, and applied so as to
				  give effect to such purposes and intent.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter B - Illegal Payments › Section LIII-3105 - Prohibition of Payments for Referrals [Formerly Section 2705]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A pharmacist or
				  pharmacy shall not knowingly and willfully make, or offer to make, any payment,
				  directly or indirectly, overtly or covertly, in cash or in kind, to induce
				  another person to refer an individual to the pharmacist for the furnishing, or
				  arranging for the furnishing, of any health care item or service.
B. A pharmacist or pharmacy shall not
				  knowingly and willfully solicit, receive, or accept any payment, directly or
				  indirectly, overtly or covertly, in cash or in kind, in return for referring a
				  patient to a health care provider for the furnishing, or arranging for the
				  furnishing, of any health care item or service.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter B - Illegal Payments › Section LIII-3107 - Prohibited Arrangements [Formerly Section 2707]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any arrangement or scheme, including
				  cross-referral arrangements, which a pharmacist or pharmacy knows or should
				  know has a principal purpose of ensuring or inducing referrals by the
				  pharmacist to another health care provider, which, if made directly by the
				  pharmacist or pharmacy would be a violation of §3113, shall constitute a
				  violation of §3113
AUTHORITY NOTE:
					 Promulgated in accordance with R.S. 38:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter B - Illegal Payments › Section LIII-3109 - Exceptions [Formerly Section 2709]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Proportionate Return on Investment.
				  Payments or distributions by an entity representing a direct return on
				  investment based upon a percentage of ownership, shall not be deemed a payment
				  prohibited by
				  R.S.
				  37:1745(B), or its
				  successor, or
				  §3105 of these regulations.
B. General Exceptions. Any payment,
				  remuneration, practice, or arrangement which is not prohibited by or unlawful
				  under §1128(b) of the Federal Social Security Act (Act),  42 U.S.C. §
											1320a-7b (b), or its successor, with respect to health care items or services for which
				  payment may be made under Title XVIII or Title XIX of the Act, including those
				  payments and practices sanctioned by the secretary of the United States
				  Department of Health and Human Services, through the Office of the Inspector
				  General, pursuant to §1128B(b)(3)(E) of the Act, through regulations
				  promulgated at  42 CFR §1001 . 952, or its successor, shall not be deemed a
				  payment prohibited by
				  R.S.
				  37:1745(B), or its
				  successor, or by
				  §3105 of these rules with respect to
				  health care items or services for which payment may be made by any patient or
				  private or governmental payor.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter B - Illegal Payments › Section LIII-3111 - Effect of Violation [Formerly Section 2711]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any violation of, or failure of compliance
				  with, the prohibitions and provision of
				  §3105 of this Chapter shall be deemed a
				  violation of the Pharmacy Practice Act,
				  R.S.
				  37:1161 et seq., providing cause for the
				  board to sanction a person culpable of such violation.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter C - Disclosure of Financial Interests in Third-Party Health Care Providers › Section LIII-3113 - Required Disclosure of Financial Interest [Formerly Section 2713]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Mandatory
				  Disclosure. A pharmacist or pharmacy shall not make any referral of a patient
				  outside the pharmacist's or pharmacy's group practice for the provision of
				  health care items or services by another health care provider in which the
				  referring pharmacist has a financial interest, unless, in advance of any such
				  referral, the referring pharmacist or pharmacy discloses to the patient, in
				  accordance with
				  §3113 of this Chapter, the existence
				  and nature of such financial interest.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter C - Disclosure of Financial Interests in Third-Party Health Care Providers › Section LIII-3115 - Form of Disclosure [Formerly Section 2715]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Required Contents. The disclosure required
				  by §3113 of this
				  Chapter shall be made in writing, shall be furnished to the patient, or the
				  patient's authorized representative, prior to or at the time of making the
				  referral, and shall include:
1. the
				  pharmacist's or pharmacy's name, address, and telephone number;
2. the name and address of the health care
				  provider to whom the patient is being referred by the pharmacist or
				  pharmacy;
3. the nature of the
				  items or services which the patient is to receive from the health care provider
				  to which the patient is being referred; and
4. the existence and nature of the
				  pharmacist's or pharmacy's financial interest in the health care provider to
				  which the patient is being referred.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter C - Disclosure of Financial Interests in Third-Party Health Care Providers › Section LIII-3117 - Effect of Violation ; Sanctions [Formerly Section 2717]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Effect of Violation. Any violation of, or
				  failure of compliance with, the prohibitions and provision of
				  §3113 of this Chapter shall be deemed a
				  violation of the Pharmacy Practice Act,
				  R.S.
				  37:1161 et seq., providing cause for the
				  board to sanction a pharmacist or pharmacy culpable of such
				  violation.
B. Administrative
				  Sanctions. In addition to the sanctions provided for by
				  R.S.
				  37:1241, upon proof of violation of
				  §3113 by a pharmacist or pharmacy, the
				  board may order that all or any portion of any amounts paid by a patient,
				  and/or by any third-party payor on behalf of a patient, for health care items
				  or services furnished upon a referral by the pharmacist or pharmacy in
				  violation of §3113, be refunded by the pharmacist or pharmacy to such patient
				  and/or third-party payor, together with legal interest on such payments at the
				  rate prescribed by law calculated from the date on which any such payment was
				  made by the patient and/or third-party payors.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 31 - Illegal Payments; Required Disclosures of Financial Interests › Subchapter C - Disclosure of Financial Interests in Third-Party Health Care Providers › Section LIII-3119 - Disclosure of Financial Interest [Formerly Section 2719]

Current through Register Vol. 50, No. 6, June 20, 2024
[Name of Pharmacist/Group]
[Address]
[Telephone Number]
DISCLOSURE OF FINANCIAL INTEREST
As Required by
					 R.S.
					 37:1744 and LAC 46:LIII.613-615
TO:_________________ DATE:____________________
_________________________________
(Name of Patient to Be Referred)
_________________________________
(Patient Address)
Louisiana law requires pharmacists and other health care
					 providers to make certain disclosures to a patient when they refer a patient to
					 another health care provider or facility in which the pharmacist has a
					 significant financial interest. [I am/we are] referring you, or the named
					 patient for whom you are legal representative, to:
__________________________________________________
(Name and Address of Provider to Whom Patient is
					 Referred)
to obtain the following health care services, products, or
					 items:
__________________________________________________
(Purpose of the Referral)
[I/we] have a financial interest in the health care
					 provider to whom we are referring you, the nature and extent of which are as
					 follows:
__________________________________________________
__________________________________________________
PATIENT ACKNOWLEDGEMENT
I, the above-named patient, or legal representative of such
					 patient, hereby acknowledge receipt, on the date indicated and prior to the
					 described referral, of a copy of the foregoing Disclosure of Financial
					 Interest.
________________________________________
Signature of Patient or Patient's Representative)
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 33 - Severability › Section LIII-3301 - Severability

Current through Register Vol. 50, No. 6, June 20, 2024
A. In the event any
				rule, sentence, clause, or phrase or any of these rules and regulations may be
				construed by any court of competent jurisdiction to be invalid, illegal,
				unconstitutional, or otherwise unenforceable, such determination or
				adjudication shall in no manner affect the remaining rules or portions thereof,
				and such remaining rules or portions thereof shall remain of full force and
				effect, as if such rule or portions thereof so determined, declared, or
				adjudged invalid or unconstitutional were not originally a part hereof. It is
				the intent of the Louisiana Board of Pharmacy to establish rules and
				regulations that are constitutional and enforceable so as to safeguard the
				health, safety, and welfare of the people of the state.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIV - Physical Therapy Examiners › Subpart 1 - Licensing and Certification › Chapter 1 - Physical Therapists and Physical Therapists Assistants › Subchapter A - Board Organization › Section LIV-103 - Board Domicile

Current through Register Vol. 50, No. 6, June 20, 2024
A.
					 Domicile. The board shall be domiciled in accordance with
					 R.S.
					 37:2403(A).
AUTHORITY NOTE:
						Promulgated in accordance with
						R.S.
						37:2403(A) and Act 535 of
						2009.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIV - Physical Therapy Examiners › Subpart 1 - Licensing and Certification › Chapter 1 - Physical Therapists and Physical Therapists Assistants › Subchapter A - Board Organization › Section LIV-107 - Officers

Current through Register Vol. 50, No. 6, June 20, 2024
A. The officers of
					 the board shall be a chairman and secretary-treasurer.
B. The chairman shall preside at all board
					 meetings and shall, when available, represent the board at official
					 functions.
C. The secretary
					 treasurer shall act in place of the chairman when the chairman is not present
					 or available.
D. The secretary
					 treasurer shall oversee board finances and present financial reports to the
					 board as requested and shall review and advise on board investments as directed
					 by the board.
E. Term. Officers of
					 the board shall be elected in accordance with the schedule set forth in
					 R.S.
					 37:2404(A) and shall serve a
					 one-year term or until the election of their successors. An officer elected to
					 a position vacated before the end of its term shall serve only for the
					 remainder of that term.
AUTHORITY NOTE:
						Promulgated in accordance with
						R.S.
						37:2404(A) and Act 535 of
						2009.