reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-505 - Proceedings against Licensed EMS Practitioner, Certified Ambulance Operators, Licensed EMS Practitioner Applicants or Certified Ambulance Operator Applicants

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  commission may direct the bureau to deny, revoke, suspend, probate, limit,
				  reprimand, fine or restrict any certification or license to practice as a
				  licensed EMS practitioner or certified ambulance operator; or otherwise
				  discipline an individual in accordance with
				  R.S.
				  40:1133.7 and
				  R.S.
				  40:1133.18.
1. In accordance with
				  R.S.
				  40:1133.9, the commission, through the
				  bureau, may obtain an injunction without bond forbidding any person from
				  violating or continuing to violate any of the applicable provisions of Part II
				  of Chapter 5-C of Title 40 of the Revised Statutes. This injunction shall not
				  be subject to release upon bond.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-507 - Proceedings Involving Students Enrolled in EMS Education Programs

Current through Register Vol. 50, No. 6, June 20, 2024
A. The commission
				  may direct the bureau to deny, revoke, suspend, probate, limit, reprimand,
				  fine, or restrict any student enrolled in EMS education programs, or otherwise
				  discipline a student enrolled in EMS education programs or attempting to enroll
				  in EMS education programs as part of its duties and responsibilities in
				  regulating the practice of EMS in Louisiana and in overseeing the
				  administration of the curriculum and operation of EMS education programs in the
				  state of Louisiana.
B. Every
				  student enrolled or attempting to enroll in EMS education programs subjected to
				  the proceedings set forth in this Section, shall be afforded an opportunity for
				  a hearing before the commission or its duly appointed hearing officer or
				  committee.
C. Information obtained
				  by the commission that an EMS student enrolled or attempting to enroll in EMS
				  education programs is or has engaged in any conduct prescribed by
				  R.S.
				  40:1133.7, shall be received in a form
				  prescribed by the commission. However, nothing shall, prohibit the bureau or
				  commission from acting upon an allegation of wrongdoing learned of or submitted
				  by other means. This information may be furnished by any person, staff, agency,
				  or by the commission.
D. Grounds
				  for proceedings against a student enrolled or attempting to enroll in EMS
				  education programs are:
1. all of the grounds
				  for disciplinary proceedings against a person, individual or licensed EMS
				  practitioner, as applicable, listed in Subsection D of
				  §
												505 of this Chapter;
				  or
2. has been denied a request to
				  enroll in EMS education programs or has been denied a license to practice in
				  any healthcare field or had such privileges revoked, suspended, or otherwise
				  restricted.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-509 - Disciplinary Process and Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A. The provisions of the Administrative
				  Procedure Act shall govern proceedings on questions of violation of
				  R.S.
				  40:1131.1 et seq., as re-enacted and amended.
1. A disciplinary proceeding, including the
				  formal hearing, is less formal than a judicial proceeding. It is not subject to
				  strict rules and technicalities, but must be conducted in accordance with
				  considerations of fair play and constitutional requirements of due
				  process.
2. The purpose of a
				  disciplinary proceeding is to determine contested issues of law and fact;
				  whether the individual did certain acts and, if he or she did, whether those
				  acts violated the provisions or requirements of this Part; and to determine the
				  appropriate disciplinary action.
3.
				  Any disciplinary action shall also be forwarded to all applicable licensing
				  agencies and/or required reporting entities.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-510 - Disciplinary Process and Procedure Limitations on Disciplinary Proceedings by the Commission

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless a
				  special law is applicable, no disciplinary proceeding of any kind may be
				  initiated by the bureau or commission as follows.
1. If the nature of the complaint is based on
				  negligence or gross negligence, no proceeding may be initiated after two years
				  from discovery by the complainant. However, under no circumstances shall such a
				  proceeding be initiated more than five years from the date of the act of
				  omission.
2. If the nature of the
				  complaint is based on an intentional act or omission, no proceeding may be
				  initiated after two years from discovery by the complainant. However, under no
				  circumstances shall such a proceeding be initiated more than five years from
				  the date of the act or omission.
3.
				  If the nature of the complaint is based on fraud, no proceeding may be
				  initiated after two years from discovery by the complainant.
4. If the nature of the complaint is based on
				  a license or rules violation, no proceeding may be initiated after five years
				  form the date of the act or omission.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-511 - Formal Disciplinary Action

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				  decision to initiate formal disciplinary proceedings is made if one or more of
				  the following conditions exist:
1. the
				  complaint is sufficiently serious;
2. the individual fails to respond to the
				  commission's correspondence concerning the complaint;
3. the individual's response to the
				  commission's letter or investigative demand is not convincing that no action is
				  necessary;
4. an informal approach
				  is used, but fails to resolve all of the issues.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-513 - Formal Hearing

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  commission has the authority, granted by
				  R.S.
				  40:1133.4, to bring administrative
				  proceedings against licensed EMS practitioners, applicants for licensure,
				  individuals seeking enrollment or progression in an approved EMS education
				  program, certified ambulance operators and individuals practicing EMS without
				  licensure or certification. The commission and the individual are the parties
				  to the proceeding. The individual has the right to appear and be heard, either
				  in person or by counsel; the right of notice, a statement of what accusations
				  have been made; the right to present evidence and to cross-examine; and the
				  right to have witnesses subpoenaed.
B. Notice and Service
1. The chair or a designee fixes a time and
				  place for a hearing.
2. At least 30
				  days prior to the date set for the hearing, a copy of the charges and a notice
				  of the time and place of the hearing, shall be sent to the individual
				  respondent by any means authorized for such purpose by this Part.
3. At least 20 working days prior to the
				  scheduled hearing date, the individual shall respond in writing as to his or
				  her intention to appear or not appear at the scheduled hearing. At least 20
				  working days prior to the scheduled hearing date, the individual shall also
				  file with the commission a written response to the specific allegations
				  contained in the notice of charges. Allegations not specifically answered shall
				  be deemed admitted.
4. If the
				  individual does not appear, in person or through counsel, after proper notice
				  has been given, the individual has waived these rights and the commission may
				  proceed with the hearing without the presence of the individual.
5. An individual who fails without a valid
				  continuance to appear at two consecutive meetings after being validly served
				  with a notice to appear, as set forth in Subsection B of this Section, at each
				  may be summarily suspended for such reason. Any such suspension shall continue
				  until the individual appears for a hearing before the commission, opportunity
				  for which shall be afforded at the next regularly scheduled meeting
				  thereof.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-515 - Appeal from Commission Decision

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any person whose license has been revoked,
				  suspended, denied, or otherwise disciplined by the commission shall have the
				  right to have the proceedings of the commission reviewed by the court having
				  jurisdiction over the commission, provided that such appeal is made within 30
				  days after the date indicated on the registered mail receipt of the written
				  notice of the commission's decision. The commission's decision is enforceable
				  in the interim unless the court orders a stay.
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1133.4(A)(8),
					 R.S.
					 40:1133.5(9), and
					 R.S.
					 40:2017.10.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXVIII - Emergency Medical Services Professionals › Subpart 1 - Rules of Procedure › Chapter 5 - Disciplinary Proceedings; Alternative to Disciplinary Proceedings › Section XXXVIII-517 - Reinstatement of License

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Application for reinstatement of a suspended or surrendered license shall be in
				  writing.
B. The application for
				  reinstatement of a suspended license certification does not require the
				  satisfaction of all of the requirements for initial licensure. However, the
				  requirements of this Part, as determined by the commission or bureau shall be
				  met.
C. Prior to reinstatement of a
				  license previously suspended (except for nonpayment of fees), a hearing or
				  conference is held before the commission to afford the applicant with the
				  opportunity to present evidence that the cause for the revocation or suspension
				  no longer exists and to provide an opportunity for the commission to evaluate
				  changes in the person or conditions. In certain situations, the license may be
				  reinstated by consent order or settlement order. The burden of proof is on the
				  applicant to prove that conditions that led to the suspension no longer exist
				  and/or no longer affect the applicant's ability to practice safely. If
				  reinstatement is granted, a period of probation with stipulations may be
				  imposed.
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1133.4(A)(8),
					 R.S.
					 40:1133.5(9), and
					 R.S.
					 40:2017.10.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 1 - General Provisions › Section XXXIV-101 - Authority

Current through Register Vol. 50, No. 6, June 20, 2024
A. These rules of
				practice and procedure are promulgated in accordance with the Louisiana
				Administrative Procedure Act. All rule making and hearing procedures of this
				board are conducted according to the Louisiana Administrative Procedure
				Act.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 1 - General Provisions › Section XXXIV-105 - Exemptions

Current through Register Vol. 50, No. 6, June 20, 2024
A. Distribution
				does not include:
1. intra-company
				distribution to licensed drug or device distributors physically located in
				Louisiana;
2. the distribution of a
				drug or device or an offer to distribute a drug or device by a charitable
				organization described in section
				501(c)(3) of the
				Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to
				the extent otherwise permitted by law;
3. the distribution of a drug or device or an
				offer to distribute a drug or device among hospitals or other health care
				entities that are under common ownership;
4. the distribution of a drug or device or an
				offer to distribute a drug or device for emergency medical reasons including
				transfers of drugs or devices by a retail pharmacy to another retail pharmacy
				to alleviate a temporary shortage that arises from delays in or interruptions
				of regular distribution schedules or a public health emergency
				declaration;
5. the dispensing of a
				drug or device pursuant to a prescription;
6. the distribution of drug or device samples
				by manufacturers' representatives or distributors' representatives;
7. the distribution of blood and blood
				components intended for transfusion; or
8. the distribution of legend drugs by retail
				pharmacies to licensed practitioners for office use where the annual dollar
				volume of legend drugs sold to licensed practitioners does not exceed five
				percent of the dollar volume of that retail pharmacy's annual legend drug
				sales.
9. the distribution of
				devices by manufacturers sales representatives during transportation to
				customers;
10. the distribution of
				a software utilized in a non-emergency, delayed patient monitoring system to be
				used in remote monitoring not intended to provide real time integrated data
				from a continuous or long-time, non-invasive patient monitoring device, and
				that has been previously approved by the appropriate federal agency; this
				exemption shall not be deemed to prohibit regulation in accordance with
				quarantine statutes.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-301 - Licensing, Renewal and Reinstatement Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board shall issue sub-types for
				distributors of legend drug and legend device licenses as follows:
1. standard distributors;
2. wholesale distributors; and
3. third-party logistics provider
				distributors.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-303 - Required Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				board requires the following from each applicant as part of the initial
				licensing procedure and as part of any renewal or reinstatement of such
				license:
1. the company name, physical
				distribution address, business address, and the name and contact information of
				the person for the facility or physical location of the applicant;
2. all trade or business names used by the
				applicant;
3. the mailing address,
				and the name and contact information of the person for regulatory compliance
				used by the applicant;
4. the type
				of ownership or form of business operation used by the applicant (i.e.,
				partnership, corporation, or sole proprietorship); if other than a natural
				person, the type of entity and the name of the state where formed;
5. the names of the owners of the applicant
				including the percentage of interest owned;
6. the name and contact information of the
				person appointed as the designated responsible party;
7. the names and titles of the directors and
				officers of the applicant;
8. a
				list of every state or territory, other than Louisiana, where the applicant
				holds a current license for wholesale drug or device distribution;
9. any other information which the board may
				require to determine qualification for obtaining, renewing, or reinstating a
				license.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-305 - Qualifications

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board shall
				consider the following factors in issuing an initial license, the renewal of an
				existing license, or reinstatement of a license to a person to engage in the
				distribution of drugs and devices:
1. any
				convictions of the applicant or designated responsible party under any federal,
				state, or local laws relating to drug samples, drug or device distribution,
				retail drug dispensing, or distribution of controlled substances;
2. any felony convictions of the applicant or
				designated responsible party under federal, state, or local laws;
3. the applicant's past experience in the
				manufacture or distribution of drugs or devices, including controlled
				substances;
4. the furnishing by
				the applicant of false or fraudulent information to the board;
5. suspension or revocation by federal,
				state, or local government of any license currently or previously held by the
				applicant, including a license to distribute or manufacture any drug or device,
				including controlled substances;
6.
				compliance with the licensing requirements under any previously granted
				licenses;
7. compliance with the
				requirements to maintain and/or make available to the state licensing
				authorities or to federal, state, or local law enforcement officials those
				records required to be maintained by drug or device distributors;
8. any other factors that the board considers
				relevant to and consistent with its function to protect public health and
				safety;
9. failure to timely comply
				with a request made by the board shall result in the termination of an
				application for license or renewal. The applicant may apply for reinstatement
				if timely done and in accordance with the requirements for reinstatement, as
				well as timely complying with the request made by the board.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-307 - Personnel

Current through Register Vol. 50, No. 6, June 20, 2024
A. Personnel
				employed in drug or device distribution shall have appropriate education and/or
				experience to assume responsibility for positions related to compliance with
				state licensing requirements.
B. A
				drug or device distributor licensed by the board shall be responsible for the
				acts and/or omissions of such personnel which are deemed in violation of the
				Louisiana statutes for drug or device distributors and board promulgated
				regulations. The board shall have the authority to proceed with disciplinary
				action and sanction its licensee for such acts and/or omissions of his
				personnel in violation of the statutes and/or regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-309 - Storage and Handling Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The following are required for the storage
				and handling of drugs or devices, and for the establishment and maintenance of
				drug or device distribution records by drug or device distributors and their
				officers, agents, representatives, and employees.
1. Facility. A facility at which drugs or
				devices are stored, warehoused, handled, held, offered, marketed or displayed
				shall:
a. be of suitable size and
				construction to facilitate cleaning, maintenance, and proper
				operations;
b. have storage areas
				designed to provide adequate lighting, ventilation, temperature, sanitation,
				humidity, space, equipment, and security conditions;
c. have a designed and clearly identified
				quarantine area for storage of drugs or devices that are outdated, damaged,
				deteriorated, misbranded, or adulterated, or that are in immediate or sealed,
				secondary containers that have been opened;
d. be maintained in a clean and orderly
				condition; and
e. be free from
				infestation by insects, rodents, birds, or vermin of any kind.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-311 - Drug or Device Distribution Recordkeeping

Current through Register Vol. 50, No. 6, June 20, 2024
A. Drug or device distributors shall
				establish and maintain perpetual inventories and records of all transactions
				regarding the receipt and distribution or other disposition of drugs or
				devices. These records shall include the following information:
1. source of the drugs or devices, the name
				and principal address of the seller or transferor, and the address of the
				facility or physical location from which the drugs or devices were
				shipped;
2. the identity and
				quantity of the drugs or devices received and distributed or disposed of;
				and
3. the dates of receipt and
				distribution of the drugs or devices.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-313 - Policy and Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A. Drug or
				device distributors shall establish, maintain, and adhere to written policies
				and procedures, which shall be followed for the receipt, security, storage,
				inventory, and distribution of drugs or devices, including policies and
				procedures for identifying, recording, and reporting losses or thefts, and for
				correcting all errors and inaccuracies in inventories including contraband or
				counterfeit drug or device information. Drug or device distributors shall
				include in their written policies and procedures the following:
1. a procedure whereby the oldest approved
				stock of a drug or device is distributed first. The procedure may permit
				deviation from this requirement if such deviation is temporary and
				appropriate;
2. a procedure to be
				followed for handling recalls and withdrawals of drugs or devices. Such
				procedure shall be adequate to deal with recalls and withdrawals due to:
a. an action initiated at the request of the
				Food and Drug Administration or other federal, state, or local law enforcement
				or other government agency, including the board;
b. any voluntary action by the manufacturer
				to remove defective or potentially defective drugs or devices from the market;
				or
c. any action undertaken to
				promote public health and safety by replacing of existing merchandise with an
				improved product or new package design;
3. a procedure to ensure that drug or device
				distributors prepare for, protect against, and handle any crisis that affects
				security or operation of any facility in the event of strike, fire, flood, or
				other natural disaster, or other situations of local, state, or national
				emergency;
4. a procedure to ensure
				that any outdated drugs or devices shall be segregated from other drugs or
				devices and either returned to the manufacturer or destroyed. This procedure
				shall provide for written documentation of the disposition of outdated drugs or
				devices. This documentation shall be maintained for three years after
				disposition of the outdated drugs;
5. a procedure to validate customer licenses,
				to review excessive or suspicious purchases, to inspect all incoming and
				outgoing shipments, and to monitor and record the temperature of product
				storage;
6. a procedure to notify
				the board, in writing, within three business days of discovering, or being in a
				position to have acquired such knowledge, of any theft or diversion of a drug
				or device;
7. a procedure to notify
				the board, in writing, within 24 hours of discovery, or being in a position to
				have acquired such knowledge, of any contraband, counterfeit, or misbranded
				drug or device in his possession, whether actual or constructive.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-315 - Organizational On-Site List

Current through Register Vol. 50, No. 6, June 20, 2024
A. Drug or
				device distributors shall establish and maintain an on-site list of owners,
				officers, directors, managers, and other persons in charge of drug or device
				distribution, storage, and handling, including a description of their duties
				and a summary of their qualifications.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XXXIV-321 - Inspection Alternatives

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				board, in its discretion, may accept a satisfactory inspection by the United
				States Food and Drug Administration (USFDA) or a state agency which the board
				determines to be comparable to that made by USFDA or the board.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 5 - Powers and Functions of the Board › Section XXXIV-505 - Rules of Order

Current through Register Vol. 50, No. 6, June 20, 2024
A. All meetings of
				the board shall be conducted in accordance with
Robert's Rules of
				Order
(Latest official edition).
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 5 - Powers and Functions of the Board › Section XXXIV-509 - Inspection Contracts

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board
				may contract with any person or agency it deems qualified to conduct any
				inspections or reinspections.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-701 - Complaint Initiations

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Complaints may be initiated by any person, including the state of Louisiana
				acting through any of its departments, or by the board on its own
				initiative.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-703 - Complaint Investigations

Current through Register Vol. 50, No. 6, June 20, 2024
A. Upon
				receipt of complaints or inquiries, the board shall take the following action.
1. The complaint or inquiry shall be received
				by the board office and assigned for investigation.
2. If the information in the complaint is
				insufficient, the board may request further information by either written
				correspondence or the board may cause an investigation to be made.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-705 - Complaint Withdrawals

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the
				complainant wishes to withdraw the complaint, the investigation and/or
				proceedings are not automatically terminated. The board may complete the
				investigation and/or proceedings in its own right and in the interest of public
				health, safety and welfare.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-707 - Hearings

Current through Register Vol. 50, No. 6, June 20, 2024
A. Notice of
				Hearings. The board shall formally charge the party against whom a complaint
				has been made when said complaint appears to be sufficient cause for suspension
				or revocation of a license, or other disciplinary sanction. At least 30 days
				prior to the date set for a public hearing, the formal charges and notice shall
				be sent by certified mail to the party against whom the complaint is made at
				his last known address on file with the board. The formal charges and notice
				shall conform to the requirements of the Administrative Procedure
				Act.
B. Disposition of Complaint.
				The board shall conduct such investigations, order such hearings, and take such
				other action as it finds necessary to make an intelligent decision on the
				complaint submitted for review.
C.
				Appearance. The party against whom the complaint has been made and upon notice
				being served, must appear at the date, time and place fixed for the
				hearing.
D. Default in Appearing.
				In the event the party against whom the complaint has been made fails to appear
				at the hearing provided for and also that notice has been given as to the
				hearing date, time and place, the party so failing to appear or otherwise
				obtain approval of the board for its absence shall be deemed to be in default
				and the evidence as received by the board at that time may be entered into the
				record and may be taken as true and the order of the board entered
				accordingly.
E. The procedure for
				notice, hearing and appeals, there from, shall be that of the Louisiana
				Administrative Procedure Act.
F.
				Hearing Procedure. The hearings called according to these rules and regulations
				shall be conducted by the board in accordance with the Administrative Procedure
				Act.
1. The chairman of the board or the
				vice-chairman in the absence of the chairman shall announce the title and
				docket number of the proceeding before the board. Attorneys and/or other
				representative of the accused party shall be recognized along with the
				representatives of the board and other proper parties.
2. The board's attorney and/or representative
				shall then present its evidence.
3.
				The accused or his attorney shall then be entitled to present its evidence
				subject to cross examination by the board's attorney and/or
				representative.
4. The board, after
				deliberation in executive session, may render a decision in the case by order,
				consent order, or default order.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-709 - Emergency Action

Current through Register Vol. 50, No. 6, June 20, 2024
A. If at any
				point the board finds that public health, safety, or welfare requires emergency
				action, and incorporates a finding to that effect in its order, the board is
				hereby given authority to obtain a restraining order from a judge of the
				appropriate court to suspend the license pending investigation or proceedings
				for disciplinary action. The order may be issued without bond. If the board
				seeks and obtains such a restraining order, the investigation and disciplinary
				action shall be commenced and completed as rapidly as possible.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-711 - Grounds for Disciplinary Action

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				After notice and hearing, the board may deny, revoke or suspend a license or
				otherwise sanction a licensee, for any of the grounds set forth in
				R.S.
				37:3474.1 or
				R.S.
				37:3474.2 and any of the following:
1. violation of any federal, state, or local
				law or regulation relating to drugs;
2. violation of any provision of this
				regulation;
3. commission of any
				act or engaging in a course of conduct which constitutes a clear and present
				danger to the public health and safety.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XXXIV-713 - Declaratory Statements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				board may issue a declaratory statement in response to any written request for
				clarification of the effect of the provisions of the state statutes for
				wholesale drug distribution, the regulations of the board, and/or other
				applicable legal authority regarding wholesale drug distribution industry, on a
				stated set of circumstances.
B. The
				declaratory statement shall be in writing and be issued by the board within a
				reasonable period of time taking into consideration the nature of the matter
				and circumstances involved.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 8 - Fees › Section XXXIV-801 - Fees

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board may
				collect the following fees:
1. initial
				license fee:
a. one license
				sub-type-$400;
b. two license
				sub-types-$425;
c. three license
				sub-types-$450;
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 9 - Proceedings for Enforcement Action › Section XXXIV-901 - Proceedings

Current through Register Vol. 50, No. 6, June 20, 2024
A. The board,
				through its compliance officer, may investigate, mediate, or initiate
				enforcement action or legal proceedings on behalf of the board with respect to
				charges initiated or information received by the board alleging that a
				non-licensee committed or engaged in any of the acts or offenses listed in
				R.S.
				37:3474.2.
B. Enforcement action is instituted by the
				board, acting through its compliance officer, filing charges against any
				non-licensee who commits or engages in any of the acts of offenses listed in
				R.S.
				37:3474.2.
C. Within 20 days of the boards filing of
				charges, the board shall mail a copy of said charges to the last known address
				of the non-licensee so charged.
D.
				All charges shall be heard by the board within 12 months after the date on
				which filed. This 12-month period may be extended for good cause
				shown.
E. The date, time and place
				for said hearing shall be fixed by the board and a copy of the charges,
				together with a notice of the date, time and place of the hearing, shall be
				personally served on or mailed to the last known address of the charged party,
				at least 30 days before the date fixed for hearing. At any hearing, the charged
				party shall have the right to appear in person, or by counsel, or both, to
				cross-examine witnesses in his defense, and to produce evidence and witnesses
				in his defense. If the charged party fails or refuses to appear at the hearing,
				the board may proceed to hear and determine the validity of the
				charges.
F. If, after such hearing,
				a majority of the board participating in the proceeding vote in favor of
				sustaining the charges, the board may take enforcement action against the
				charged party.
G. A charged party
				aggrieved by any enforcement action taken by the board may appeal therefrom,
				pursuant to the provisions of the Administrative Procedure Act.
H. All enforcement actions taken shall be
				published in the official journal of the board and may be released to other
				boards, agencies, or professional organizations relating to wholesale drug
				distribution, or to the news media.
I. The board, through its compliance officer,
				may make informal disposition by consent order, agreement, settlement, or
				default of any enforcement proceeding pending before it. Each such informal
				disposition shall have no force of effect until ratified by the board. Consent
				orders are considered enforcement actions.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 11 - Quarantine of Legend Drugs or Legend Devices › Section XXXIV-1101 - Order of Quarantine

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				boards inspector or executive director may issue an order of quarantine on
				site.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1301 - License Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. No
				person may engage in wholesale distribution of drug products in the state
				unless such person:
1.
a. is licensed by the state from which the
				drug product is distributed; or
b.
				if the state from which the drug product is distributed has not established a
				licensure requirement, is licensed by the appropriate federal official in
				accordance with federal regulation; and
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1303 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				chapter, the following terms are defined herein.
Exclusive Distributor
-the wholesale
				  distributor that directly purchased the product from the manufacturer and is
				  the sole distributor of that manufacturers product to a subsequent repackager,
				  wholesale distributor, or retail dispenser.
Illegitimate Product
-a product in which
				  credible evidence shows that it:
a. is
				counterfeit, diverted or stolen;
b.
				is intentionally adulterated such that the product would result in serious
				adverse health consequences or death to humans;
c. is the subject of a fraudulent
				transaction; or
d. appears
				otherwise unfit for distribution such that the product would be reasonably
				likely to result in serious adverse health consequences or death to humans.
Suspect Product
-a product for which there is
				  reason to believe it may be illegitimate.
Trading Partners
-a manufacturer, repackager,
				  wholesale distributor, or retail dispenser from whom a manufacturer,
				  repackager, wholesale distributor, or retail dispenser accepts direct ownership
				  of a product or to whom a manufacturer, repackager, wholesale distributor, or
				  retail dispenser transfers direct ownership of a product; or a third-party
				  logistics provider from whom a manufacturer, repackager, wholesale distributor,
				  or retail dispenser accepts direct possession of a product or to whom a
				  manufacturer, repackager, wholesale distributor, or retail dispenser transfers
				  direct possession of a product.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1305 - General Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				wholesale distributor shall not accept ownership of a product unless the
				previous owner provides the transaction history, transaction information, and a
				transaction statement for the product at the time of the transaction.
B. When a wholesale distributor purchases
				product, whether or not directly from a manufacturer, an exclusive distributor,
				or a repackager that purchased directly from a manufacturer, the wholesale
				distributor shall provide a transaction statement, transaction history, and/or
				transaction information in accordance with federal regulations at the time of
				each transaction in which the wholesale distributor transfers ownership of
				product to subsequent purchasers.
C. A wholesale distributor shall:
1. capture the transaction information,
				transaction history, and transaction statement for each transaction and
				maintain such information, history, and statement for not less than six years
				after the date of the transaction; and
2. maintain the confidentiality of the
				transaction information, transaction history, and transaction statement for a
				product in a manner that prohibits disclosure to any person other than the
				appropriate federal or state official except where required among trading
				partners.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1307 - Returns

Current through Register Vol. 50, No. 6, June 20, 2024
A. A wholesale
				distributor may return a nonsaleable product to the manufacturer or repackager,
				to the wholesale distributor from whom the product was purchased, or to a
				person acting on behalf of such a person, including a returns processor,
				without providing the transaction history, transaction information, and
				transaction statement for the product.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1309 - Requests for Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. In
				the event of a recall or for the purpose of investigating a suspect or an
				illegitimate product and upon a request by the appropriate federal or state
				official, a wholesale distributor shall, not later than one business day and
				not exceeding 48 hours after receiving the request for information, provide the
				applicable transaction information, transaction history, and transaction
				statement for the product.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  37:3461-3482.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1311 - Verification Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				wholesale distributor shall have systems in place to enable the wholesale
				distributor to comply with the following requirements.
1. Upon making a determination that a product
				in possession or control of a wholesale distributor is a suspect product, or
				upon receiving a request for verification from the appropriate federal official
				that has made a determination that a product within the possession of a
				wholesale distributor is a suspect product, a wholesale distribution shall:
a. quarantine the suspect product from
				product intended for distribution until the suspect product is cleared or
				dispositioned; and
b. promptly
				conduct an investigation to determine whether the suspect product is an
				illegitimate product, which shall includes validating any applicable
				transaction history and transaction information in the possession of the
				wholesale distributor and otherwise investigating to determine whether the
				product is an illegitimate product.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XXXIV-1313 - Federal Reporting

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any person
				who owns or operates an establishment that engages in wholesale distribution
				shall:
1. report to the appropriate federal
				official, on an annual basis on a schedule determined by the appropriate
				federal official:
a. each state by which the
				wholesale distributor is licensed and the appropriate state license number
				issued by the state to the wholesale distributor; and
b. the name, address, and contact information
				of each wholesale distributor facility at which, and all trade names under
				which, the wholesale distributor conducts business; and
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 15 - Third-party Logistics Providers › Section XXXIV-1501 - General Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. No
				third-party logistics provider may conduct distribution activities in the state
				unless each facility of the third-party logistics provider:
1.
a. is
				licensed by the state from which the drug or device is distributed by the
				third-party logistics provider; or
b. is licensed by the appropriate federal
				official in accordance with federal regulation, if the state from which the
				drug or device is distributed by the third-party logistics provider does not
				require licensure for third-party logistics providers;
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 15 - Third-party Logistics Providers › Section XXXIV-1503 - Federal Reporting

Current through Register Vol. 50, No. 6, June 20, 2024
A. Third -party
				logistics provider shall report to the appropriate federal official on an
				annual basis on a schedule determined by the appropriate federal official:
1. the state in which the third-party
				logistics provider facility is licensed and the appropriate state license
				number issued by the state to the third-party logistics provider; and
2. the name and address of the third-party
				logistics provider facility and all trade names under which the third -party
				logistics provider facility conducts business.