reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LXXXIX - Water Well Contractors (Drillers) › Chapter 11 - Revocation; Hearings; Appeals › Section LXXXIX-1107 - Falsification of Documents

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Falsification of documents to evade regulations, as well as penalties for said
				falsifications, appear in
				R.S.
				38:3095, as follows.
1. No person shall, for the purpose of
				evading this Part or any rules, regulations or order made thereunder:
a. make or cause to be made any false entry
				or statement of fact in any report required to be made by this Part or by any
				rule, regulation or order made hereunder; or
b. make or cause to be made any false entry
				in any account, record, or memorandum kept by any person in connection with the
				provisions of this Part or of any rules, regulation or order made thereunder;
				or
c. remove out of the
				jurisdiction of the state, or destroy or mutilate, alter, or by any other
				means, falsify any book, record or other paper, pertaining to the matters
				regulated by this Part or by any rule, regulation or order made
				thereunder.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LXXXIX - Water Well Contractors (Drillers) › Chapter 11 - Revocation; Hearings; Appeals › Section LXXXIX-1109 - Appeals

Current through Register Vol. 50, No. 6, June 20, 2024
A. Appeals. An
				alleged violator may appeal any order of the department by requesting a
				hearing. The hearing request must be made to the department, in writing, within
				30 calendar days of the original order and must be sent by "Certified Mail-
				Return Receipt Requested". After receiving the request, the department will
				arrange a hearing to determine what other remedial action will serve to effect
				compliance with the rules and regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  38:3098-38:3098.8.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XCI - Drug and Device Distributors › Chapter 1 - General Provisions › Section XCI-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 XCI - Drug and Device Distributors › Chapter 1 - General Provisions › Section XCI-103 - Definition

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				regulation, unless the context otherwise requires:
Adulterated Drug or Device
-a drug or device
				  shall be deemed adulterated if:
a. it
				consists, in whole or in part, of any filthy, putrid, or decomposed substance;
				or
b.
i. it has been produced, prepared, packed, or
				held under unsanitary conditions whereby it may have been contaminated with
				filth, or whereby it may have been rendered injurious to health; or
ii. the methods used in, or the facilities or
				controls used for, its manufacture, processing, packing, or holding do not
				conform to or are not operated or administered in conformity with current good
				manufacturing practice to assure that the drug or device meets with the
				requirements of this part as to safety and has the identity and strength, and
				meets with the quality and purity characteristics which it purports or is
				represented to possess; or
c. its container is composed, in whole or in
				part, of any poisonous or deleterious substance which may render the contents
				injurious to health; or
d. it bears
				or contains, for purposes of coloring only, a color additive which is unsafe
				within the meaning of federal or Louisiana law or rule; or
e. it purports to be or is represented as a
				drug or device the name of which is recognized in an official compendium, and
				its strength differs from, or its quality or purity falls below, the standard
				set forth in the compendium. Such a determination as to strength, quality, or
				purity shall be made in accordance with the tests or methods of assay set forth
				in the compendium, or in the absence of or inadequacy of these tests or methods
				of assay, those prescribed under the authority of federal or state law or rule.
				No drug or device defined in an official compendium shall be deemed to be
				adulterated under this paragraph because it differs from the standard of
				strength, quality, or purity therefore set forth in the compendium, if its
				difference in strength, quality, or purity from the standard is plainly stated
				on its label;
f. it is not subject
				to Subparagraph e above and its strength differs from, or its quality or purity
				falls below that which it purports or is represented to possess; or
g. it is a drug or any substance has been:
i. mixed or packed therewith so as to reduce
				its quality or strength; or
ii.
				substituted wholly or in part thereof.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XCI - Drug and Device Distributors › Chapter 1 - General Provisions › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 3 - Drug and Device Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 5 - Powers and Functions of the Board › Section XCI-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 XCI - Drug and Device Distributors › Chapter 5 - Powers and Functions of the Board › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 7 - Disciplinary Procedures › Section XCI-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 XCI - Drug and Device Distributors › Chapter 8 - Fees › Section XCI-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 XCI - Drug and Device Distributors › Chapter 9 - Proceedings for Enforcement Action › Section XCI-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 board's 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 XCI - Drug and Device Distributors › Chapter 11 - Quarantine of Legend Drugs or Legend Devices › Section XCI-1101 - Order of Quarantine

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				board's 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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 13 - Wholesale Distributors › Section XCI-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 XCI - Drug and Device Distributors › Chapter 15 - Third-party Logistics Providers › Section XCI-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 XCI - Drug and Device Distributors › Chapter 15 - Third-party Logistics Providers › Section XCI-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.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 1 - Equal Delivery of Services › Section I-101 - Policy Statement

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  Department of Health and Human Resources (DHHR) reaffirms its policy for the
				  Equal Delivery of Services and will administer all programs and conduct its
				  business, either directly or indirectly, or through contractual or other
				  arrangements, in accordance with Title VI of the Civil Rights Act of 1964 (  42
				  U.S.C. 2000  et seq.), Title 45 of the Code of Federal Regulations, Part 80, as
				  amended through July 5, 1973, Section 504 of the Rehabilitation Act of 1973 as
				  amended (29 U.S.C.
				  706), and the agency's Statements of
				  Compliance.
1. No person shall, on the
				  grounds of race, color, national origin, or handicap, be excluded from
				  participation in, be denied the benefits of, or be subjected to discrimination
				  under any program or activity conducted in this agency. The Department of
				  Health and Human Resources will take appropriate action to insure that the
				  above will be implemented at all levels of administration.
2. The Secretary, Department of Health and
				  Human Resources, has overall responsibility for the policy and program
				  development under Title VI of the 1964 Civil Rights Act and Section 504 of the
				  Rehabilitation Act of 1973. Responsibility for the coordination and
				  implementation has been placed with the director of the Civil Rights
				  Bureau.
3. Any person who believes
				  that he or she, or any specific class of persons, has been subjected to
				  discrimination covered by Title VI or Section 504 of the Rehabilitation Act of
				  1973, as amended, may without fear of reprisal or coercion, file a written
				  complaint with the Civil Rights Bureau, 200 Riverside Mall, Room 102, Baton
				  Rouge, Louisiana 70821, or the Dallas Regional Office for Civil Rights, 1200
				  Main Tower, Dallas, Texas 75202.
4.
				  It is the policy of the Department of Health and Human Resources to resolve all
				  complaints alleging discrimination based on age, race, color, sex, handicap,
				  religion, national original and political belief in the provision of any agency
				  services. Any person who believes that he or she or any specific class of
				  persons have been subjected to discrimination in any agency program, may
				  personally or by a representative file a written complaint. The identity of the
				  complainants will be kept confidential except to the extent necessary for
				  conducting the investigation. Any act or acts of intimidation or retaliation
				  against any individual making a complaint shall be prohibited.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 1 - Equal Delivery of Services › Section I-103 - Applicability

Current through Register Vol. 50, No. 6, June 20, 2024
A. The policy shall
				  apply to all DHHR Offices providing financial, social or health care services.
				  The policy shall also apply to any agency providing these services whether
				  directly or indirectly or through contractual or other arrangements in
				  accordance with those provisions of federal and state laws which prohibit
				  discrimination in the delivery of services. This complaint procedure carries
				  out the regulations for: Title VI of the Civil Rights Act of 1964, Section 504
				  of the Rehabilitation Act of 1973 ( P.L. 97-35), and federal block
				  grants.
AUTHORITY NOTE:
					 Promulgated in accordance with Title VI of the Civil Rights Act of 1964;
					 Section 504 of the Rehabilitation Act of
					 1973.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 1 - Equal Delivery of Services › Section I-105 - Complaints

Current through Register Vol. 50, No. 6, June 20, 2024
A. A complaint may
				  be filed with DHHR-Civil Rights Bureau, DHHS-Office of Civil Rights or USDA at
				  the following addresses:
1. Department of
				  Health and Human Resources (DHHR), Office of the Secretary, Civil Rights
				  Bureau, 200 Riverside Mall, Suite 102, Baton Rouge, LA 70802.
2. Department of Health and Human Services
				  (DHHS), Regional Office for Civil Rights, 1200 Main Tower, Suite 1900, Dallas,
				  Texas 75202.
3. U.S. Department of
				  Agriculture, Office of the Secretary, Washington, D.C. 20250.
4. Those Food and Nutrition Service Program
				  complaints (FNS) administered by the Office of Family Services, including food
				  stamps, that allege discrimination but have other programmatic problems will be
				  referred to the Appeals Section, DHHR, Office of the Secretary.
5. Those Civil Rights complaints received by
				  the Appeals Section, DHHR, Office of the Secretary, will be referred to the
				  Civil Rights Bureau.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 2 - Louisiana Physician Order for Scope of Treatment › Section I-201 - Statement of Policy

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  Department of Health and Hospitals is committed to the following.
1. It is important for people to make health
				  care decisions before a medical crisis presents itself.
2. Health care planning is a process, rather
				  than a single decision, that helps individuals to consider the kind of care
				  they would want if they become seriously ill or incapacitated, and encourages
				  them to talk to their family members or legal representative about such
				  issues.
3. The Louisiana Physician
				  Order for Scope of Treatment "LaPOST" form documents the wishes of a qualified
				  patient in a physician order.
4.
				  The hallmarks of the LaPOST form are the following:
a. immediately actionable, signed physician
				  orders on a standardized form;
b.
				  orders that address a range of life-sustaining interventions as well as the
				  patient's preferred treatment for each intervention;
c. a brightly colored, clearly identifiable
				  form;
d. a form that is recognized,
				  adopted, and honored across treatment settings.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 2 - Louisiana Physician Order for Scope of Treatment › Section I-203 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. The definitions
				  found in
				  R.S.
				  40:1299.64.2 apply to this Rule.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1299.64.1-1299.64.6.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part I - General Administration › Subpart 1 - General › Chapter 2 - Louisiana Physician Order for Scope of Treatment › Section I-205 - LaPOST Form

Current through Register Vol. 50, No. 6, June 20, 2024
A. An individual
				  who desires to execute a LaPOST form must use the form created by the
				  Department of Health and Hospitals. The form may not be altered in layout or
				  style, without the express written permission of the Department of Health and
				  Hospitals.
B. The form to be used
				  for the Louisiana physician order scope of treatment, as provided in
				  R.S.
				  40:1299.64.1-64.6, can be found at
www.La-POST.org
.
C. The LaPOST form found at
www.La-POST.org
is the exclusive form that
				  shall be used to document the wishes of a qualified patient in a physician
				  order for scope of treatment under this Rule.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:1299.64.1-1299.64.6.