reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 3 - Nonprofit Hospital Acquisitions: Authorization for the Attorney General to Review Nonprofit Hospital Acquisitions › Section XXV-311 - Notification of Pending Application and Public Hearing

Current through Register Vol. 50, No. 6, June 20, 2024
A. In accordance with
				R.S.
				40:2115.14:
1. within five working days of receipt of a
				completed application, the department shall notify all persons of record by
				first class United States mail of the filing of such application, and publish
				in the official journal of the parish where the hospital is located notice of
				the filing. The notice shall state the following:
a. that an application has been
				received;
b. the names of the
				parties to the agreement;
c. a
				description of the contents of the agreement; and
d. the date by which a person may submit
				comments about the application to the attorney general.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 3 - Nonprofit Hospital Acquisitions: Authorization for the Attorney General to Review Nonprofit Hospital Acquisitions › Section XXV-313 - Application Review

Current through Register Vol. 50, No. 6, June 20, 2024
A. In
				accordance with
				R.S.
				40:2115.14:
1. the attorney general shall, within 15 days
				after the date an application is received, determine if the application is
				complete for the purposes of review. If the department determines that an
				application is unclear, incomplete, or contains an insufficient basis upon
				which to provide a decision, the application shall be returned to the
				applicant;
2. if the attorney
				general determines that an application is incomplete, he shall notify the
				applicant within 15 days after the date the application was received, stating
				the reasons for his determination of incompleteness with reference to the
				particular questions for which a deficiency is noted;
3. if an application is returned to the
				applicant and the applicant will be resubmitting the application for further
				review, the filing fee shall remain deposited; and
4. if an application is returned and the
				applicant elects not to resubmit an amended application, the department shall
				return the filing fee submitted with the application less costs associated with
				the review process.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 3 - Nonprofit Hospital Acquisitions: Authorization for the Attorney General to Review Nonprofit Hospital Acquisitions › Section XXV-315 - Final Decision

Current through Register Vol. 50, No. 6, June 20, 2024
A. The attorney
				general shall review the completed application. Within 60 days after receipt of
				a completed application, the attorney general shall either:
1. approve the acquisition, with or without
				specific modifications; or
2.
				disapprove the acquisition.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 3 - Nonprofit Hospital Acquisitions: Authorization for the Attorney General to Review Nonprofit Hospital Acquisitions › Section XXV-317 - Reports and Ongoing Supervision of Certificates

Current through Register Vol. 50, No. 6, June 20, 2024
A. In accordance with
				R.S.
				40:2115.19, the parties to the agreement
				shall submit information and supporting data on an annual basis regarding the
				current status of the agreement, including information relative to the
				continued benefits, any disadvantages of the agreement, and sufficient
				information to evaluate whether any terms and conditions imposed by the
				department have been met or otherwise satisfied. Reports shall be due on or
				before the annual anniversary date of the approval. Parties are under a
				continuing obligation to provide the department with any change to the
				information contained in the application subsequent to the approval of the
				application. Such information shall be provided to the department in a timely
				fashion or within a reasonable time that such information is known to the
				parties. The attorney general may subpoena information and documents reasonably
				necessary to assure compliance.
B.
				The information and supporting data that must be submitted to the department
				shall include, but not be limited to, the following:
1. an update of all the information required
				in the application;
2. any change
				in the geographic territory that is served by the health care equipment,
				facilities, personnel, or services which are subject of the
				agreement;
3. a detailed
				explanation of the actual effects of the agreement on each party, including any
				change in volume, market share, prices, and revenues;
4. a detailed explanation of how the
				agreement has affected the cost, access, and quality of services provided by
				each party; and
5. any additional
				information requested by the department.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 3 - Nonprofit Hospital Acquisitions: Authorization for the Attorney General to Review Nonprofit Hospital Acquisitions › Section XXV-319 - Revocation

Current through Register Vol. 50, No. 6, June 20, 2024
A. If at any time,
				the attorney general receives information indicating that the acquiring person
				is not fulfilling the commitment to the affected community as provided for in
				R.S.
				40:2115.18, the attorney general shall hold a
				hearing upon 10 days notice to the affected parties.
1. If after the hearing the attorney general
				determines that the information is true, it may petition the Louisiana
				Department of Health and Hospitals to revoke the license issued to the
				purchaser.
2. Any action for
				license revocation shall be conducted in accordance with the provisions of
				R.S.
				40:2109 et seq., and the regulations
				promulgated thereunder.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-501 - Purpose

Current through Register Vol. 50, No. 6, June 20, 2024
A. These rules are
				adopted in accordance with the public interest of controlling health care costs
				and improving the quality of and access to health care. In that regard, the
				state has a responsibility to protect the public interest through direct
				supervision and control over the implementation of cooperative agreements,
				mergers, joint ventures, and consolidations among health care facilities for
				which certificates of public advantage are granted pursuant to the provisions
				of
				R.S.
				40:2254.1 through 2254.12.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  40:2254.1 et
				  seq.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-505 - Notice

Current through Register Vol. 50, No. 6, June 20, 2024
A. Health care
				facilities that are parties to a transaction shall give the attorney general at
				least 30 days written notice prior to the anticipated closing of the intended
				transaction. Depending on the parties or the transaction, the Attorney General,
				at his sole discretion, may allow a shorter notice period.
B. The written notice shall include all of
				the following information:
1. the names,
				addresses and telephone numbers of the parties to the intended
				transaction;
2. the names,
				addresses and telephone numbers of the attorneys or other persons who represent
				the parties in connection with the intended transaction;
3. a general description of the intended
				transaction and a description of the scope of the cooperation, merger, joint
				venture, or consolidation contemplated by the agreement;
4 a general description of the assets
				involved in the intended transaction and the intended use of the assets after
				the closing of the intended transaction, including any change in the ownership
				of tangible or intangible assets;
5. a general summary of all collateral
				transactions that relate to the intended transaction, including the names,
				addresses and telephone numbers of the parties involved in the collateral
				transactions; and
6. the
				anticipated completion date of the intended transaction.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-507 - Filing of Applications and Additional Documents

Current through Register Vol. 50, No. 6, June 20, 2024
A. Filing of Applications
1. Applications shall be filed by delivering
				an original and three copies to the director.
2. The filing date of a conforming
				application shall be the date the department determines the application to be a
				completed application.
3. No
				application shall be filed by facsimile machine.
4. Applications filed with the department
				become property of the state.
5.
				Applications shall be accompanied with the filing fee as determined by
				§309 in
				accordance with
				R.S.
				40:2254.12.
6. The application must include the contents
				of application.
7. The application
				shall be submitted to the attorney general on the forms provided and include
				the information requested therein.
8. The department may at any time request any
				other supplemental or additional documentation, disclosures, information, etc.,
				as it deems necessary to the evaluation. The applicant shall provide the
				information not later than 10 days after the date of the request.
9. The application must be in the following
				format.
a. Applications shall be submitted to
				the attorney general on the forms provided and in accordance with the
				instructions therein.
b. Trade
				secret information should be printed on goldenrod colored paper to assist in
				identifying material that may be considered exempt from the Louisiana Public
				Records Act.
c. Applications that
				do not comply with these rules shall not be accepted and will be returned to
				the applicant.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-509 - Fees

Current through Register Vol. 50, No. 6, June 20, 2024
A. Remittance of
				Fees
1. In accordance with
				R.S. 40:2254.12,
				fees shall be remitted with the application and reports as required by
				R.S.
				40:2254.11. Fees shall be reasonably related
				to the costs incurred by the department in considering the application,
				evaluating reports, and performing other necessary administrative
				duties.
2. Fees shall be remitted
				only by certified check, cashier's check, or bank money order, and made payable
				to the department.
3. The
				application fee shall be $50,000 and shall be due with the application. If the
				actual cost incurred by the department is greater, the applicant shall pay any
				additional amounts due as instructed by the department.
4. The fee due with the filing of the report
				as required by
				R.S 40:2254.11
				shall be $15,000. If the actual cost incurred by the department is greater, the
				parties involved shall pay any additional amounts due as instructed by the
				department.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-511 - Notification of Pending Application and Public Hearing

Current through Register Vol. 50, No. 6, June 20, 2024
A. In accordance with
				R.S.
				40:2254.4:
1. within five working days of receipt of a
				completed application, the department shall notify all persons of record by
				first class United States mail of the filing of such application, and publish
				in the official journal of the parish where the health care facilities are
				located notice of the filing. The notice shall state the following:
a. that an application has been
				received;
b. the names of the
				parties to the agreement;
c. a
				description of the contents of the agreement; and
d. the date by which a person may submit
				comments about the application to the attorney general.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-513 - Application Review

Current through Register Vol. 50, No. 6, June 20, 2024
A. In
				accordance with
				R.S.
				40:2254.4:
1. the attorney general shall, within 15 days
				after the date an application is received, determine if the application is
				complete for the purposes of review. If the department determines that an
				application is unclear, incomplete, or contains an insufficient basis upon
				which to provide a decision, the application shall be returned to the
				applicant;
2. if the attorney
				general determines that an application is incomplete, he shall notify the
				applicant within 15 days after the date the application was received, stating
				the reasons for his determination of incompleteness with reference to the
				particular questions for which a deficiency is noted;
3. if an application is returned to the
				applicant and the applicant will be resubmitting the application for further
				review, the filing fee shall remain deposited; and
4. if an application is returned and the
				applicant elects not to resubmit an amended application, the department shall
				return the filing fee submitted with the application less costs associated with
				the review process.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-515 - Action by Department

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				attorney general shall review the completed application. Within 90 days after
				receipt of a completed application or within one 90 day extension, the attorney
				general shall either:
1. approve the
				application, with or without specific modifications and issue a certificate;
				or
2. disapprove the application
				for a certificate.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-516 - Reconsideration

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the
				department denies an application and refuses to issue a certificate, a party to
				the agreement may request that the department reconsider its decision. The
				department shall then reconsider its decision in accordance with the provisions
				of
				R.S.
				40:2254.5.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  40:2254.1 et
				  seq.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-517 - Reports and Ongoing Supervision of Certificates

Current through Register Vol. 50, No. 6, June 20, 2024
A. In accordance with
				R.S.
				40:2254.11, the parties to the agreement
				shall submit information and supporting data on an annual basis regarding the
				current status of the agreement, including information relative to the
				continued benefits, any disadvantages of the agreement, and sufficient
				information to evaluate whether any terms and conditions imposed by the
				department have been met or otherwise satisfied. Reports shall be due on or
				before the annual anniversary date of the approval. Parties are under a
				continuing obligation to provide the department with any change to the
				information contained in the application subsequent to the issuance of a
				certificate of public advantage. Such information shall be provided to the
				department in a timely fashion or within a reasonable time that such
				information is known to the parties. The attorney general may subpoena
				information and documents reasonably necessary to assure compliance.
B. The information and supporting data that
				must be submitted to the department shall include, but not be limited to, the
				following:
1. an update of all the
				information required in the application;
2. any change in the geographic territory
				that is served by the health care equipment, facilities, personnel, or services
				which are subject of the agreement;
3. a detailed explanation of the actual
				effects of the agreement on each party, including any change in volume, market
				share, prices, and revenues;
4. a
				detailed explanation of how the agreement has affected the cost, access, and
				quality of services provided by each party; and
5. any additional information requested by
				the department.
Louisiana Administrative Code › Title 48 - PUBLIC HEALTH-GENERAL › Part XXV - Mergers, Acquisitions, and Re-Organization › Chapter 5 - Certificates of Public Advantage › Section XXV-519 - Revocation

Current through Register Vol. 50, No. 6, June 20, 2024
A. If at any time,
				the attorney general receives information indicating that agreement is not is
				not resulting in lower health care costs or greater access to or quality of
				health care than would occur in absence of the agreement as provided for in
				R.S.
				40:2254.6, the attorney general shall hold a
				hearing upon 120 days notice to the affected parties. Any action for
				certificate revocation shall be conducted in accordance with the provisions of
				RS. 40:2254.6.
B. Notwithstanding
				any other provision of this Part, any amendment or alteration to an approved
				cooperative, merger, or consolidation agreement and any material change in the
				operations or conduct of any party to a cooperative, merger, joint venture, or
				consolidation shall be considered a new agreement and shall not take effect or
				occur until the attorney general has approved the amendment, alteration, or
				change.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  40:2254.1 et
				  seq.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-101 - Authority [Formerly 49:1.0000]

Current through Register Vol. 50, No. 6, June 20, 2024
A. These regulations are adopted under the
				authority of Act 142 of 1936 as amended by Act 185 of 1942.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-103 - Mission [Formerly 49:1.0010]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The primary mission of the Food and Drug
				Control Program is to protect consumers by assuring that products regulated by
				it are safe and perform as they are labeled or advertised. To achieve these
				objectives, the Unit engages in six general types of regulatory activities:
1. setting standards for product com
				position, manufacture, performance, and labeling;
2. evaluating, prior to marketing, the safety
				and effectiveness of those products that must have premarket
				clearance;
3. conducting
				inspections, surveys and analyses to monitor compliance with statutory
				requirements, administratively set standards, conditions of approval,
				etc.;
4. initiating enforcement
				action where necessary to effect compliance with the laws and implementing
				regulations;
5. informing and
				educating industry and consumers about the requirements of Louisiana Food and
				Drug laws and regulations; and
6.
				investigating corn plaints by Louisiana consumers concerning the alleged
				adulteration and/or misbranding of foods, drugs, cosmetics and medical devices
				in commerce.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-105 - Scope [Formerly 49:1.0020]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				provisions of regulations promulgated under the State Food, Drug and Cosmetic
				Act with respect to the doing of any Act shall be applicable also to the
				causing of such Act to be done.
B.
				The definitions and interpretation of terms contained in
				Section
				602 of the Louisiana Food, Drug
				and Cosmetic Act shall be applicable also to such terms when used in
				regulations promulgated under that Act.
C. Any Louisiana citizen has a right to
				utilize the program's resources with respect to the following.
1. Request to see the files on any firm under
				inspection by the Food and Drug Control Program.
2. Obtain copies of any reports in the Food
				and Drug Control Program's files, except that proprietary information is not
				considered public information, e.g., a firm's product formula.
3. Address corn plaints to the Food and Drug
				Program about any product which is suspected of being defective in any way or
				which is suspected of having caused food poisoning or other injury.
4. Request information from the Food and Drug
				Program staff on products regulated by the Program. Proprietary information is
				the only information that cannot be divulged under this provision.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-107 - Definitions [Formerly 49:1.0030]

Current through Register Vol. 50, No. 6, June 20, 2024
Act-
Act 142 of 1936 as amended by Act 185 of
				  1942, unless the text clearly indicates a different meaning. All definitions
				  and interpretations of terms given in the Act shall be applicable also to such
				  terms when used in these regulations.
Analysis
-includes examinations and
				  tests.
Artificial Coloring
-coloring containing any
				  dye or pigment, which dye or pigment was manufactured by a process of synthesis
				  or other similar artifice, or a coloring which was manufactured by extracting a
				  natural dye or natural pigment from a plant or other material in which such dye
				  or pigment was naturally produced.
Artificial Flavoring
-a flavoring containing
				  any sapid or aromatic constituent, which constituent was manufactured by a
				  process of synthesis or other similar artifice.
Chemical Preservative
-any chemical which,
				  when added to foods, tends to prevent or retard deterioration thereof; but does
				  not include common salt, sugars, vinegars, spices or oils extracted from
				  spices, or substances added to food by direct exposure thereof to wood
				  smoke.
Open Container
-a container of rigid or
				  semi-rigid construction, which is not closed by a lid, wrapper or otherwise
				  (see Section 265).
Sell, Sale or Sold
(wherever used in these
				  regulations)-the sale; keeping, offering, or exposing for sale; having in
				  possession for sale, delivery or distribution within the state of any product
				  or article covered by the Act or these regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-109 - Cause of Act [Formerly 49:1.0035]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any regulation pertaining to the doing of
				any act shall also apply to the causing of such act to be done.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-111 - Labeling Claims [Formerly 49:1.0040]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The label or labeling of a product shall
				be deemed misleading if it makes a claim or statement concerning which there is
				a difference of opinion among experts, and fails to state that such a
				difference of opinion exists if there is a material weight of expert opinion
				contrary to the claim or statement.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-113 - Guaranty [Formerly 49:1.0050]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A guaranty or undertaking, referred to in
				Section
				640 of the Act, shall be
				considered to have been given by each person signing such guaranty or
				undertaking.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-115 - Guaranty for a Specified Shipment [Formerly 49:1.0060]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A guaranty or undertaking limited to a
				specific shipment or other delivery of an article shall be a part of, or shall
				be attached to, the invoice or bill of sale covering such shipment or
				delivery.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-115 - Limited Guaranty [Formerly 49:1.0070]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The limited form of guaranty or
				undertaking shall state that the person giving the guaranty or undertaking
				guarantees that no article listed therein is adulterated or misbranded within
				the meaning of the State Food, Drug and Cosmetic Act (naming the Act), or that
				it is not an article which may not be introduced into commerce under the
				provisions of
				Section
				640 of the Act and the guaranty
				shall bear the signature and post office address of the person giving the
				guaranty or undertaking.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-115 - General or Continuing Guaranty [Formerly 49:1.0080]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A guaranty or undertaking that is general
				or continuing in its application to any shipment or other delivery of an
				article, shall be considered as having been given at the date such article was
				shipped or delivered by the person giving the guaranty or
				undertaking.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-115 - General Guaranty, Effective Date [Formerly 49:1.0090]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The general, or continuing, form of
				guaranty or undertaking shall state that the article comprising such shipment
				or delivery made thereafter by the guarantor to, or on the order of, the person
				to whom the guaranty or undertaking is given (naming the person and giving his
				address) is guaranteed, as of the date of shipment or delivery, to be, on such
				date, not adulterated or misbranded within the meaning of the State Food, Drug
				and Cosmetic Act (naming the Act); or is not an article which may not be
				introduced into commerce under the provisions of
				Section
				640 of the Act, and shall bear
				the signature and post office address of the person giving the guaranty or
				undertaking.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-115 - General Guaranty, Expiration [Formerly 49:1.0100]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The application of a guaranty or
				undertaking, referred to in
				Section
				640 of the Act to any shipment or
				other delivery of an article, shall expire when such article, after shipment or
				delivery of an article, shall expire when such article, after shipment or
				delivery by the person who gave such guaranty or undertaking becomes
				adulterated or misbranded within the meaning of the Act, or becomes an article
				which may not, under the provisions of
				Section
				612 of said Act, be introduced
				into state commerce.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-117 - General Guaranty, Signatures [Formerly 49:1.0110]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A guaranty or undertaking, if signed by
				two or more persons, shall state that such persons severally guaranty the
				article to which it applies.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-119 - Use of the Term Labeling [Formerly 49:1.0120]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No representation or suggestion that an
				article is guaranteed under the State Food, Drug and Cosmetic Act shall be made
				in labeling.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-121 - Hearings [Formerly 49:1.0130]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Hearings prescribed in
				Section
				637 of the Act shall be private
				and informal.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-123 - Hearing, Statements [Formerly 49:1.0140]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Statements presented at such hearings
				shall be confined to matters relevant to the contemplated proceeding. Such
				statements may be presented by letter or in person by the person to whom the
				notice was given, or by his representative. In case such person holds a
				guaranty or undertaking referred to in
				Section
				640 of the Act, the guaranty or
				undertaking referred to in
				Section
				640 of the Act, the guaranty or
				undertaking, or a verified copy thereof, shall be submitted at the
				hearing.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-125 - Hearing, Request for Change in time or Place [Formerly 49:1.0150]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The time or
				place, or both, appointed in the notice affording opportunity for a hearing
				under Section 637 of the
				Act, may be changed, upon request, reasonably made, addressed to the State
				Health Officer, by the person to whom the notice has been given, or by his
				representative, if the request states reasonable grounds therefor.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-127 - Collection of Samples [Formerly 49:1.0160]

Current through Register Vol. 50, No. 6, June 20, 2024
A. When any officer or employee of the
				department collects a sample of food, drug, cosmetic or device, for examination
				and investigation under the Act, the sample is collected from a shipment or
				other lot of the article which is displayed, offered for sale, held, stored or
				transported in intrastate commerce, or is in or was received in intrastate
				commerce. Only samples so designated by an officer or an employee of the
				department shall be considered to be official samples.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-129 - Owner of the Lot [Formerly 49:1.0170]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The owner of a food, drug, or cosmetic, of
				which an official sample is collected, is the person who owns the shipment or
				other lot of the article from which the sample is collected.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-131 - Size of Samples [Formerly 49:1.0180]

Current through Register Vol. 50, No. 6, June 20, 2024
A. When an officer or employee of the
				department collects an official sample of a food, drug or cosmetic for analysis
				under the Act, he shall collect at least twice the quantity sufficient for
				analysis, unless:
1. the amount of the
				article available and reasonably accessible for sampling is less than twice the
				quantity so needed;
2. the cost of
				twice the quantity so needed exceeds $10;
3. the article is perishable; named on the
				label of the article, or his agent, and
4. the sample is collected from the owner of
				the article, or his agent, and such person is also the owner of the
				article;
5. the sample is collected
				from the owner of the article, or his agent, and such article bears no label,
				or, if it bears a label no person is named thereon; or
6. the analysis consists principally of rapid
				analytical procedures, organoleptic examination, or other field inspection
				examinations or tests, made at the place where the sample is collected or in a
				mobile or temporary laboratory.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-133 - Collection for Trial Samples [Formerly 40:1.0190]

Current through Register Vol. 50, No. 6, June 20, 2024
A. In addition to the quantity of sample
				prescribed above, the officer or employee shall, if practicable, collect as
				part of the sample such further amount of the article as may be necessary for
				use as an exhibit in the trial of any case that may arise under the Act based
				on the sample.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-135 - Reserved Samples [Formerly 49:1.0200]

Current through Register Vol. 50, No. 6, June 20, 2024
A.
1. Upon
				completion of analyses by the laboratory whereby it is established that any
				article subject to the provisions of the Act is adulterated, misbranded, or
				otherwise subject to the prohibitions of the Act, a sufficient amount of the
				sample (if any remains) shall be reserved as an exhibit in the trial of any
				case that may arise under the Act based on the sample. Upon written request, if
				any person named on the label of the article found adulterated, misbranded, or
				otherwise subject to the prohibitions of the Act, or owner thereof, or the
				attorney or agent of such person or owner shall be provided with a part of the
				sample for their analysis, if any remains, subject to the reservations above,
				except when:
a. the sample or remaining part
				thereof has, after collection become decomposed or otherwise fit for analysis;
				or
b. the request for a portion of
				the sample on which the trial action is based is not made within a reasonable
				time before the date the case is set for trial.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-137 - Collection for Trial Samples [Formerly 49:1.0210]

Current through Register Vol. 50, No. 6, June 20, 2024
A. When an official sample of a food, drug or
				cosmetic is the basis of a notice given under
				Section
				637 of the Act, or of a case
				under the Act, and the person who is a party to the case, has a right under
				§135 to a part of the sample, such person
				or his attorney or agent may obtain a part of the sample upon request, provided
				the request is accompanied by a written waiver of right from the owner thereof
				and from each person named on the label of the article who has not exercised
				his right under
				§135 The operation of this paragraph
				shall be subject to the exceptions, terms, and conditions prescribed in
				paragraph §
										135
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-139 - Collection for Trial Samples [Formerly 49:1.0220]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The head of the Food and Drug Division of
				the department is authorized to destroy or recommend for destruction:
1. any official sample when it has been
				determined that no analysis of the sample will be made:
2. any official sample, or part thereof, when
				it has been determined that no notice under
				Section
				637 of the Act, and no case under
				the Act, is or will be based on the sample;
3. any official sample, or part thereof, when
				the sample was the basis of a notice under
				Section
				637 of the Act, and when after
				opportunity for presentation of views following such notice, it has been
				determined that no other notice and no case under the Act, is or will be based
				on the sample:
4. any official
				sample or part there of when the sample was a basis of a case under the Act
				which has gone to final judgment; and when it has been determined that no other
				such case is or will be based on the sample;
5. any official sample or part thereof if the
				article is perishable;
6. any
				official sample or part thereof, when after collection such sample or part
				thereof has become decomposed or otherwise unfit for analysis;
7. that part of any official sample which is
				in excess of three times the quantity estimated by the laboratory as sufficient
				for analysis.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-141 - Seizure [Formerly 49:1.0230]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any food, drug or cosmetic which is
				adulterated or misbranded within the provisions of the Act, and which has been
				manufactured for sale or is held in possession with intent to sell, offer or
				expose for sale, or is sold, transported or delivered for sale within this
				state, shall be liable to seizure as provided in R.S. 40: 633. Any product so
				seized shall be disposed of as follows.
1.
				Released under bond for reconditioning or relabeling in accordance with Section
				632(c) of the Act, if after the analysis the product is found to be of such
				quality that it may be reconditioned or if the violation is one of misbranding
				that may be corrected by relabeling; provided that the reconditioning or
				relabeling; provided that the recondition or relabeling shall be done under the
				supervision of an officer or agent of the department.
2. Submitted to the court for a court order
				of condemnation and destruction in accordance with
				Section
				634 of the Act, if after analysis
				the product is found to be adulterated but is not of a perishable nature or
				cannot be reconditioned and the owner refuses to authorize its destruction. If
				a judgment of condemnation and destruction is rendered against the product, the
				same shall be disposed of by destruction or sale as the court may direct, but
				such goods shall not be sold contrary to the provisions of the Food, Drugs and
				Cosmetic Act, or of these regulations.
3. Condemned and destroyed in accordance with
				Section
				635 of the Act, if the material
				constitutes a nuisance as provided for in that section.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 1 - General Regulations › Section I-143 - Identification of Seized Goods [Formerly 49:1.0240]

Current through Register Vol. 50, No. 6, June 20, 2024
A. All goods placed under seizure shall be
				tabbed, marked or otherwise identified. The removal of such tags, marks or
				other identification by anyone other than an authorized officer or agent of the
				department is prohibited; and any such removal shall be considered prima facie
				evidence of intent to violate the law.
B. Such tags shall be removed only by the
				authorized officer or agent.
1. After analysis
				or examination has shown the goods to be not in violation of the law or these
				regulations; or
2. in accordance
				with an order of any court or competent jurisdiction; or
3. after the goods have been reconditioned or
				relabeled under bond and are no longer in violation of the Act.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-201 - Misbranding [Formerly 49:2.0000]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A food shall be deemed misbranded:
1. if any representation in the labeling is
				false or misleading with respect to another food;
2. if the food contains two or more
				ingredients and the designation of the food in the labeling is by a name which
				includes or suggests the name of one or more but not all ingredients even
				though the names of all ingredients are stated elsewhere in the
				labeling.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-203 - Label, Firm Name [Formerly 49:2.0010]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where the name which appears on the label
				of any food is not that of the manufacturer, the name shall be qualified by a
				phrase which reveals the connection such person has with the food, such as
				"Manufactured for and Packed by _", "Packed for _", "Distributed by", or other
				similar phrase which expresses the facts; Provided, the name of the actual
				manufacturer or packer shall be furnished to the department upon
				request.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-205 - Label, Principal Place of Business [Formerly 49:2.0020]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where a person manufactures, packs, sells,
				or distributes a food at a place other than his principal place of business,
				the label may state the principal place of business instead of the actual place
				where each package of such food was manufactured or packed or is to be
				distributed, if such statement is not misleading in any particular.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-207 - Label, Cannot Be Misleading [Formerly 49:2.0030]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The requirement that the label shall
				contain the name and place of business of the manufacturer, packer, seller, or
				distributor, shall not be considered to modify any requirement that the label
				shall not be misleading in any particular.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-209 - Quantity of Contents [Formerly 49:2.0040]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The statement of the quantity of the
				contents shall reveal the quantity of food in the packages, exclusive of
				wrappers and other material packed with such food.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-211 - Statement of Quantity of Contents [Formerly 49:2.0050]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The statement of the quantity of the
				contents shall be expressed in terms of weight, measure, numerical count, or a
				combination of numerical count and weight or measure, which are generally used
				by consumers to express quantity of such food and which give accurate
				information as to the quantity thereof. If no general consumer usage in
				expressing accurate information as to the quantity of such food exists, the
				statement shall be in terms of liquid measure if the food is liquid, or in
				terms of weight if the food is solid, semi -solid, viscous, or a mixture of
				solid and liquid.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 2 - Food Regulations › Section I-213 - U.S. Measure Quantity of Contents [Formerly 49:2.0060]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A statement of the quantity of the
				contents by weight shall be in terms of the avoirdupois pound and ounce. A
				statement of the quantity of the contents by liquid measure shall be in terms
				of the United States gallon of 231 cubic inches and of the quart, pint and
				fluid ounce sub-divisions thereof, and, except in case of frozen food which is
				offered for sale as such, shall express the volume at 68 degrees Fahrenheit (20
				degrees Centigrade). A statement of the quantity of the contents by dry measure
				shall be in terms of the United States bushel of 2150.43 cubic inches and of
				the peck, dry quart and dry pint subdivisions thereof; or in terms of the
				United States standard barrel and it subdivisions of third, half and three
				quarters barrel. However, in the case of export shipment, the statement may be
				in terms of system of weight or measure in common use in the country to which
				such shipment is exported.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.