reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1303 - Plans Review [formerly paragraph 6:168]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Plans for the construction of new ice
				plants and cold storage plants and rooms, or for major changes in existing
				plants, shall be submitted to the state health officer for approval.
				Construction, or improvements, shall not begin before approval of the state
				health officer is obtained.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1305 - Building Construction: Ice Plants, Cold Storage Plants or Cold Storage Rooms [formerly paragraph 6:169]

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Storage in any basement, room or receptacle which is subject to sewerage or
				waste water backflow, or in any place having defective drain pipes or
				appliances, is prohibited. Floors shall be constructed of tight, sound, smooth
				material, free from cracks and easily cleanable. The cold storage rooms shall
				be constructed and maintained to prevent entrance of rodents, in accordance
				with Part V (Disease Vector Control) of this Code.
B. All cold storage rooms shall be properly
				lighted by natural or artificial means.
C. No new ice plant shall hereafter be
				constructed nor shall major alterations be made to existing ice plants without
				the prior written approval of, and unless in accordance with plans and
				specifications approved in advance by the state health officer.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1307 - Potable Water Supply [formerly paragraph 6:170]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The water supply used by an artificial ice
				plant to make ice shall meet the requirements of Part XII of this Code for safe
				water supplies.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1309 - Cross Connections [formerly paragraph 6:171]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Physical connections between a potable
				water supply and a water of unknown or questionable quality are
				prohibited.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1311 - Sewage Disposal [formerly paragraph 6:172]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Sewage disposal facilities shall be
				provided in compliance with Part XIII of this Code.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1313 - Toilet and Lavatory Facilities [formerly paragraph 6:173]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Every artificial ice plant and cold
				storage plant shall be provided with toilet and hand washing facilities for
				employees as required by LAC 51:XIV.411, titled "Minimum Plumbing Fixtures".
				Handwashing facilities shall be located conveniently to all toilet facilities.
				These facilities shall be kept clean. Toilet room doors shall be
				self-closing.
AUTHORITY NOTE:
				  Promulgated in accordance with provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  40:601 et seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1315 - Air Blowers [formerly paragraph 6:174]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The air intake of air blowers used at
				artificial ice plants shall be so located and protected as to ensure the use of
				a safe and clean air supply.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1317 - Outside Entrances [formerly paragraph 6:175]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Outside doors shall be
				self-closing.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1319 - Permits [formerly paragraph 6:176]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Cold storage and ice plants must obtain
				permits from the state health officer, in accordance with Part I of this
				Code.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1321 - Employee Health [formerly paragraph 6:177]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The requirements of Part I, §117, and Part
				II, §501-503 C shall be met.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1323 - Spitting [formerly paragraph 6:178]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Spitting in the ice plant and cold storage
				rooms is prohibited.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1325 - Cleanliness [formerly paragraph 6:179]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Floors of the brine rooms, ice storage and
				cold storage rooms, toilets and all other appurtenances shall be kept clean.
				Employees working on brine tanks or in ice storage rooms shall wear rubber
				boots, which shall be worn in these areas only.
B. [formerly paragraph 6:180] Cold storage
				plants shall be kept free from rust, growths, molds and slime.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1327 - Storage of Meats and Foods [formerly paragraph 6:181]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Meats and foods shall not be placed in
				direct contact with ice, or upon the flooring of cold storage rooms. Bins,
				racks or other receptacles used for the storage of meats and foods shall be
				kept in a sanitary condition.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1329 - Ice Removal from Cans [formerly paragraph 6:182]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Submerging or spraying of ice cans for
				removal of ice cakes in other than potable water is prohibited.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1331 - Transportation, Distribution and Storage of Ice [formerly paragraph 6:183]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Ice intended for
				human or domestic consumption shall not be placed on streets, sidewalks, roads
				or alleys, or transported through such streets, sidewalks, roads or alleys,
				unless protected in a sanitary manner.
1.
				[formerly paragraph 6:184] Trucks and other vehicles from which ice is sold or
				delivered, and all factories, shops, storerooms, pantries and other places
				where ice is handled for sale, service or consumption, shall be thoroughly
				clean and in a sanitary condition, and shall be kept free from all dirt, dust,
				trash or any other substance or matter which is liable to become mixed with or
				enter into the ice or anything prepared with ice, so as to contaminate or
				render it unclean or insanitary.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1333 - Grinding, Crushing and Packaging of Ice [formerly paragraph 6:185]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Crushed or
				ground ice intended for human consumption or use shall be crushed or ground and
				packaged in a sanitary manner so as to prevent contamination by filth, foreign
				material, dust, insects, rodent filth such as hairs, droppings, etc.
1. [formerly part of paragraph 6:185] The
				crushing or grinding and packaging of ice on wagons, trucks or other vehicles
				used to deliver ice to be used for human or domestic consumption is strictly
				prohibited.
2. [formerly part of
				paragraph 6:185] Ice intended to be used for human or domestic consumption
				shall be thoroughly washed before being placed in the crusher or grinder. The
				facilities for crushing or grinding and packaging of ice shall be located in a
				satisfactorily enclosed building or structure, and shall be maintained in a
				sanitary condition so that the ice will be protected from dust, dirt, flies,
				insects, rust and other contaminating sources during the grinding or crushing
				and packaging operations.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1335 - Records [formerly paragraph 6:186]

Current through Register Vol. 50, No. 6, June 20, 2024
A. It shall be the duty of every person, firm
				or corporation operating a cold storage plant to keep an accurate record of the
				receipts and withdrawals of all goods stored therein. All goods stored in such
				an establishment shall be identified by a code or lot number, which number
				shall be entered in the record book at the time such goods are accepted for
				cold storage. The state health officer shall have free access to these records
				at any reasonable time during working hours.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1337 - Unwholesome Food [formerly paragraph 6:187]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No article of food shall be placed in cold
				storage if it shows evidences of decomposition, such as, but not limited to,
				spoilage, rodent defilement, insect infestations, chemical or pesticide
				contamination, filth and foreign object contamination, swollen cans, etc., or
				of other conditions which would make it unfit for food.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1341 - Sale of Cold Storage Goods; Prohibited "Fresh" Food Claims [formerly paragraph 6:189]

Current through Register Vol. 50, No. 6, June 20, 2024
A. It
				shall be a violation of the state sanitary code to sell or offer or expose for
				sale uncooked articles of food which have been held in cold storage without
				advising or notifying persons purchasing, or intending to purchase, such
				articles of food that they have been held in cold storage; and it shall be
				unlawful to represent or advertise as "fresh," articles of food which have been
				held in cold storage.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 13 - Cold Storage and Ice Plants › Section VI-1343 - Transfer of Cold Storage Goods; Prohibited Return to Cold Storage [formerly paragraph 6:190]

Current through Register Vol. 50, No. 6, June 20, 2024
A. It
				shall be a violation of the sanitary code to return to cold storage any article
				of food which has once been released from storage, except that nothing in these
				regulations shall be construed as preventing the transfer of goods from one
				cold storage plant to another; provided, such goods are refrigerated at a
				temperature of 45°F or lower during such transfer; and, provided further, that
				such transfer is not made for the purpose of evading any provision.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1501 - Definitions [formerly paragraph 6:191]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless otherwise specifically provided
				herein, the following words and terms used in this Part of the sanitary code,
				and all other Parts which are adopted or may be adopted, are defined for the
				purposes thereof as follows.
Active Ingredient
-any component which is
				  intended to furnish pharmacological activity or other direct effect in the
				  diagnosis, care, mitigation, treatment or prevention of disease or to affect
				  the structure of any function of the body of man or other animals. The term
				  shall include other components which may undergo chemical change in the
				  manufacture of the drug or be present in the finished product in a modified
				  form intended to furnish the specified activity or effect.
Batch
-a specific quantity of a drug that
				  has uniform character and quality within specified limits, and is produced
				  according to a single manufacturing order.
Component
-any ingredient intended for use
				  in the manufacture of drugs in dosage form, including those that may appear in
				  the final product.
Factory
-see Chapter 1,
				  §101 of this Part.
Inactive Ingredient
-any component other
				  than an Active Ingredient present in a drug.
Lot
-a batch or any portion of a batch of a
				  drug or, in the case of a drug manufactured in a continuous process, an amount
				  of drug product in a unit of time or quantity in a manner that assures its
				  uniformity and in either case which is identified by a distinctive lot and has
				  uniform character and quality within specified limits.
Lot Numbers or Control Numbers
-any
				  distinctive combination of letters or numbers, or both from which the complete
				  history of the manufacture, control, packaging and distribution of a batch or
				  lot of drug can be determined.
Materials Approval Unit
-any organizational
				  element having the authority and responsibility to approve or reject
				  components, in processing materials, packaging components and final
				  products.
Strength
-
a. the concentration of the drug substance (for example: w/w,
				  w/v or unit dose/volume basis); and/or
b. the potency, that is the therapeutic activity of the drug
				  substance as indicated by appropriate laboratory test or by adequately
				  developed or clinically controlled data expressed (for example: in terms of
				  units by reference to a standard).
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1503 - Permits [formerly paragraph 6:192]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No person shall operate any factory or
				process or repackage any drug within the state of Louisiana, without first
				applying for, paying the required fee and obtaining a permit to operate, issued
				by the state health officer.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1505 - Public Display of Permits [formerly part of paragraph 6:192]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Every establishment regulated by this Part
				shall have displayed, at all times, in a place designated by the state health
				officer, a permit to operate.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1507 - Permit Exemptions [formerly paragraph 6:193]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The following shall be exempt from the
				above permit procedures.
1. [formerly
				paragraph 6:193-1] Pharmacies that are operating under applicable state laws
				regulating the dispensing of prescription drugs and that do not manufacture,
				prepare, propagate, compound or process drugs for sale other than in the
				regular course of the profession of pharmacy including the dispensing and
				selling of drugs at retail.
2.
				[formerly paragraph 6:193-2] Hospitals, clinics and public health agencies
				which maintain establishments in conformance with any applicable state laws
				regulating the practice of pharmacy and medicine and which are regularly
				engaged in dispensing prescription drugs, other than human blood products, upon
				prescription of practitioners, licensed by law to administer such drug for
				patients under the care of such practitioners in the course of their
				professional practice; practitioners who are licensed by law to prescribe or
				administer drugs and who manufacture, prepare, propagate, compound or process
				drugs solely for use in the course of their professional practice; and
				manufacturers of harmless inactive ingredients which are excipients, colorings,
				flavoring, emulsifiers, lubricants, preservatives or solvents that become
				components of drugs.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1509 - Examination, Condemnation and Destruction of Unwholesome or Adulterated Drugs [formerly paragraph 6:194]

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Samples of drugs and drug components may be taken and submitted to a state
				approved laboratory by the state health officer for examination as often as he
				deems necessary for the detection of unwholesomeness or adulteration. The state
				health officer may condemn and forbid the sale of, or cause to be removed or
				destroyed, any drug which he deems unwholesome or adulterated.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of §258(B) of Title 36, and
				  Chapters 1 and 4 of Title 40 of the Louisiana Revised Statutes of 1950. See in
				  particular,
				  R.S.
				  40:4(A)(1)(a) and
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1511 - Personnel [formerly paragraph 6:195]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The personnel responsible for directing
				the manufacture and control of the drug shall be adequate in number, and in
				education, training and experience, or combination thereof, to assure that the
				drug has the safety, identity, strength, quality and purity that it purports to
				possess. All personnel shall have capabilities commensurate with their assigned
				functions, a thorough understanding of the manufacturing and control functions
				they perform and adequate information concerning the reason for application of
				pertinent provisions of this Part to their respective functions.
B. [formerly paragraph 6:196] Any person
				shown at any time (either by medical examination or supervisory observation) to
				have an apparent illness or open lesion that may adversely affect the safety or
				quality of drugs, shall be excluded from direct contact with drug products
				until the condition is corrected. All employees shall be instructed to report
				to supervisory personnel any condition that may have an adverse affect on drug
				products.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of §258(B) of Title 36, and
				  Chapters 1 and 4 of Title 40 of the Louisiana Revised Statutes of 1950. See in
				  particular,
				  R.S.
				  40:4(A)(1)(a) and
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1513 - Building Construction [formerly paragraph 6:197]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Buildings shall be maintained in a clean
				and orderly manner and shall be of a size and construction to comply with the
				requirements of §107-109 of this Part, and of Part XIV (Plumbing) of this
				code.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of §258(B) of Title 36, and
				  Chapters 1 and 4 of Title 40 of the Louisiana Revised Statutes of 1950. See in
				  particular,
				  R.S.
				  40:4(A)(1)(a) and
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1515 - Building Requirements [formerly paragraph 6:198-1]

Current through Register Vol. 50, No. 6, June 20, 2024
A. [formerly paragraph 6:198-1] Buildings
				shall provide space for:
1. [formerly
				paragraph 6:198-1 (1)] orderly placement of equipment and materials to minimize
				the possibility of contamination;
2. [formerly paragraph 6:198-1 (2)] the
				receipt, storage and withholding from use of components pending sampling,
				identification and testing prior to release by the materials approval unit for
				manufacturing or packaging;
3.
				[formerly paragraph 6:198-1 (3)] the holding of rejected components prior to
				distribution to preclude the possibility of their use in manufacturing or
				packaging procedures for which they are unsuitable;
4. [formerly paragraph 6:198-1 (4)] the
				storage of components, containers, packing materials and labeling;
5. [formerly paragraph 6:198-1 (5)] any
				manufacturing and processing operation performed;
6. [formerly paragraph 6:198-1 (6)] any
				packing or labeling operation;
7.
				[formerly paragraph 6:198-1 (7)] storage of finished product;
8. [formerly paragraph 6:198-1 (8)] control
				and production laboratory operations.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1517 - Equipment [formerly paragraph 6:199]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Equipment used for the manufacture,
				processing, packing, labeling, holding, testing or control of drugs shall be
				maintained in a clean and orderly manner and shall be of suitable design, size,
				construction and location to facilitate cleaning, maintenance and operation of
				its intended purpose. The equipment shall:
1.
				[formerly paragraph 6:199-1] be constructed so that all surfaces that come into
				contact with a drug product shall not be reactive, additive or absorptive so as
				to alter the safety, identity strength, quality or purity of the drug or its
				components beyond established requirements;
2. [formerly paragraph 6:199-2] be
				constructed so that any substance required for operation of the equipment, such
				as lubricant or coolants, do not contact drug products so as to alter the
				safety, identity, strength, quality or purity of the drug or its components
				beyond the established requirements;
3. [formerly paragraph 6:199-3] be
				constructed and installed to facilitate adjustment, disassembly, cleaning and
				maintenance to assure the reliability of control procedure's uniformity of
				production and exclusion from the drugs of contamination from previous and
				current operations that might affect the safety, identity, strength, quality or
				purity of the drug or its components beyond established requirements;
4. [formerly paragraph 6:199-4] be of
				suitable type, size and accuracy for any testing, measuring, mixing, weighing
				or other processing of storage operations. The regulations in this Part permit
				the use of precision automatic, mechanical or electronic equipment in the
				production and control of drugs when inspection and checking procedures are
				used to assure proper performance.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1523 - Product Containers and Their Components [formerly paragraph 6:203]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Specifications,
				test methods, cleaning procedures and when indicated, sterilization procedures
				shall be used to assure that containers, closures and other component parts of
				drug packages are suitable for their intended use. Containers for parenteral
				drugs, drug products or drug components shall be cleansed with water which has
				been filtered through a non-fiber releasing filter. Product containers and
				their components shall not be reactive, additive or absorptive so as to alter
				the safety, strength, identity, quality or purity of the drug or its components
				beyond the official or established requirements, and shall provide protection
				against external factors that can cause the deterioration or contamination of
				the drug.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1527 - Stability [formerly paragraph 6:206]

Current through Register Vol. 50, No. 6, June 20, 2024
A. There shall be assurance of the stability
				of the finished drug products. This stability shall be:
1. [formerly paragraph 6:206-1] determined by
				reliable, specific test methods;
2.
				[formerly paragraph 6:206-2] determined on products in the same container
				closure system in which they are marketed;
3. [formerly paragraph 6:206-3] determined on
				any dry drug product that is to be reconstituted at the time of dispensing (as
				directed in its labeling) as well as on the reconstituted product;
4. [formerly paragraph 6:206-4] recorded and
				maintained in such a manner that the stability data may be utilized in
				establishing product expiration dates.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1529 - Expiration Dating [formerly paragraph 6:207]

Current through Register Vol. 50, No. 6, June 20, 2024
A. To assure that the drug product liable to
				deterioration meets appropriate standards of identity, strength, quality and
				purity at the time of use, the label of all such drugs shall have suitable
				expiration dates which relate to the stability test performed on the product.
1. [formerly paragraph 6:207-1] Expiration
				dates appearing on the drug product label shall be justified by readily
				available data from stability studies such as described in §1527
2. [formerly paragraph 6:207-2] Expiration
				dates shall be related to storage conditions stated on the labeling wherever
				the expiration date appears.
3.
				[formerly paragraph 6:207-3] When the drug is marketed in the dry state for use
				in preparing a liquid product, the label shall bear expiration date and
				information for the reconstituted product as well as an expiration date for the
				product.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1533 - Records and Reports [formerly paragraph 6:209-1]

Current through Register Vol. 50, No. 6, June 20, 2024
A. To assure uniformity from batch to batch,
				a master production and control record for each drug product and each batch
				size of drug product shall be independently checked, reconciled, dated and
				signed or initialed by a second. The master production and control record shall
				include:
1. [formerly paragraph 6:209-1 (1)]
				the name of the product, description of the dosage form and a specimen of the
				copy of each label and all other labeling associated with the retail or bulk
				unit, including copies of such labeling signed or initialized and dated by the
				person or persons responsible for the approval of such labeling;
2. [formerly paragraph 6:209-1 (2)] the name
				and weight or measure of each active ingredient per dosage unit, or per unit of
				weight or measure of the finished drug, and statement of the total weight or
				measure of any dosage unit;
3.
a. [formerly paragraph 6:209-1 (3)] a
				complete list of ingredients designated by names or codes to indicate any
				special quality characteristic;
b.
				an accurate statement of the weight or measure of each ingredient, regardless
				of whether it appears in the finished product. Reasonable variations may be
				permitted in the amount of components necessary in the preparation in dosage
				form, provided that provisions for such variations are included in the master
				production and control record;
c. a
				statement of theoretical weight or measure at various stages of processing and
				a statement of theoretical yield;
4. [formerly paragraph 6:209-1 (4)] a
				description of the containers, closures and packaging and finishing
				materials;
5. [formerly paragraph
				6:209-1 (5)] manufacturing and control instructions, procedures and
				specifications, special notations and precautions to be followed.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1535 - Distribution Records [formerly paragraph 6:209-3]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Finished goods warehouse control and
				distribution procedures shall include a system by which the distribution of
				each lot of drug can be readily determined to facilitate its recall if
				necessary. Records within the system shall contain the name and address of the
				consignee, date and quantity shipped and lot or control number of the drug.
				They shall be kept for two years after the batch has been completed or one year
				after the expiration of the drugs, whichever is longer.
B. [formerly paragraph 6:209-4] To assure the
				quality of the product, finished goods warehouse control shall also include a
				system whereby the oldest stock is distributed first whenever
				possible.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs › Section VI-1537 - Complaint Files [formerly paragraph 6:210]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Records shall be maintained of all written
				and oral complaints regarding each product. An investigation of each complaint
				shall be made in accordance with Part I of this Code. The record of each
				investigation shall be maintained for at least two years after the distribution
				of the drug has been completed or one year after the expiration date, whichever
				is longer.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1701 - Definitions [formerly paragraph 6:211]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless otherwise specifically provided
				herein, the following words and terms used in this Part of the sanitary code,
				and all other Parts which are adopted or may be adopted, are defined for the
				purposes thereof as follows.
Drug Wholesaler or Drug Distributor
-any
				  person or establishment that distributes drugs other than to the ultimate
				  consumer.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1703 - Permits [formerly paragraph 6:212]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No person shall operate as a drug
				wholesaler, drug distributor or operate a drug warehouse within the state of
				Louisiana without first applying for, paying required fee and obtaining a
				permit to operate issued by the state health officer. Operating without such
				permit is a violation of this Code.
B. Every establishment regulated by this Part
				shall have displayed at all times a permit to operate.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1705 - Buildings [formerly paragraph 6:213]

Current through Register Vol. 50, No. 6, June 20, 2024
A. All buildings shall be maintained in a
				clean and orderly manner approved by the state health officer and shall be
				large enough and constructed and located in a way to facilitate cleaning and
				maintenance of good storage conditions of drugs and drug products.
B. [formerly paragraph 6:214] All buildings
				shall be well lighted and ventilated.
C. [formerly paragraph 6:215] All floors,
				walls, ceilings, tables and other fixtures shall be constructed of such
				materials that they may be readily cleaned.
D. [formerly paragraph 6:216] All buildings
				shall be free of flies, rats, mice and other vermin. All insecticides and
				pesticides used shall be approved by the state health officer.
E. [formerly paragraph 6:217] All buildings
				shall provide locker facilities for employee clothing and belongings. Provide
				washing facilities equipped with hot and cold water under pressure, delivered
				through a mixing faucet. Soap and sanitary towels or air dryer shall be
				provided at each lavatory.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1707 - Premises [formerly paragraph 6:218]

Current through Register Vol. 50, No. 6, June 20, 2024
A. All grounds where buildings are located
				shall be properly graded to provide a natural drainage, thus preventing an
				accumulation of stagnant water and other material.
B. [formerly paragraph 6:219] No litter,
				waste or refuse shall be allowed to accumulate in and around the building or
				yards. Waste shall be removed and disposed of in an approved manner.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1709 - Water Supply [formerly paragraph 6:220]

Current through Register Vol. 50, No. 6, June 20, 2024
A. An ample supply of potable water (Part
				XII) under pressure shall be provided on the premises for drinking, cleaning,
				washing or other purposes. Such water supply shall not be connected to any
				other supply.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics › Chapter 17 - Drug Distributors, Drug Wholesalers and Drug Storage Warehouses › Section VI-1711 - Records [formerly paragraph 6:221]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Readily retrievable records shall be
				maintained which will show the disposition of all prescription items. Such
				records shall be retained for two years.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S. 40:601 et
				  seq.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VII - Dairy Products Regulations › Chapter 1 - Milk and Dairy Products › Section VII-103 - Local Ordinances

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Parishes and municipalities may adopt local milk ordinances provided that such
				ordinances do not conflict with and are not less restrictive than the PMO, this
				Code, or state statutes pertaining to milk and further provided that such
				ordinances have been reviewed and approved by the state health officer prior to
				adoption.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S.
				  40:5(2)(3)(5)(7) (15)(17),
				  R.S.
				  40:922, and
				  R.S.
				  40:925.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VII - Dairy Products Regulations › Chapter 1 - Milk and Dairy Products › Section VII-105 - Severability Clause

Current through Register Vol. 50, No. 6, June 20, 2024
A. If
				any provision of this Part, or the application of such provision to any person
				or circumstance, shall be held invalid, the remainder of this Part, or the
				application of such provision to persons or circumstances other than those as
				to which it is held invalid, shall not be affected thereby.
AUTHORITY NOTE:
				  Promulgated in accordance with the provisions of
				  R.S.
				  40:4(A)(1)(a). Also see
				  R.S.
				  40:5(2)(3)(5)(7) (15)(17)
				  and
				  R.S.
				  40:922.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VII - Dairy Products Regulations › Chapter 1 - Milk and Dairy Products › Section VII-107 - Standard of Identity

Current through Register Vol. 50, No. 6, June 20, 2024
A. All
				dairy products sold in the state shall conform with the standards of identity
				(definitions, specifications and requirements) contained in this Section, 21
				USC
				§321 a,  21 CFR Part 130,  21 CFR Part 131, 21 CFR Part 133,  21 CFR Part 135  or  21 CFR Part 184, determined by the state
				health officer, to be applicable to the specific product. A product shall not
				be in compliance with a standard of identity when :
1. the product contains ingredients that are
				not provided for in the standard, unless the ingredient is an incidental
				additive;
2. the product fails to
				contain one or more ingredients required by the definition and standard;
				or
3. the product contains an
				ingredient or component not within the limitation of the definition or
				standard.
Louisiana Administrative Code › Title 51 - PUBLIC HEALTH-SANITARY CODE › Part VII - Dairy Products Regulations › Chapter 1 - Milk and Dairy Products › Subchapter A - Required Permits › Section VII-109 - Permits

Current through Register Vol. 50, No. 6, June 20, 2024
A. Operators of
				  dairy farms, receiving stations, transfer stations, dairy plants (including
				  frozen dessert manufacturing plants, filled dairy products processing plants,
				  anomalous milk and milk products processing plants, anomalous dairy products
				  processing plants, imitation milk and milk products processing plants,
				  single-service containers and closures for milk and milk products manufacturing
				  plants, milk tank truck cleaning facilities, finished dairy product
				  depots/transfer points and milk tank trucks) that are domiciled within the
				  state shall obtain a permit to operate from the state health officer prior to
				  beginning operation. Bulk milk tank truck operators/samplers and dairy plant
				  receivers/samplers shall obtain a permit from the state health officer prior to
				  performing the duties associated with those positions. Only a person who
				  complies with the requirements of this Part shall be entitled to receive or
				  retain a permit from the state health officer.
B. Persons applying for permits shall
				  complete and sign all forms for permit application and pay any and all fees
				  required by the state health officer.
C. Such a permit may be temporarily suspended
				  by the state health officer upon violation by the holder of any of the terms of
				  these regulations, or for interference with the state health officer in the
				  performance of his duties, or may be revoked after an opportunity for a hearing
				  by the state health officer upon serious or repeated violations.
AUTHORITY NOTE:
					 Promulgated in accordance with the provisions of
					 R.S.
					 40:4(A)(1)(a). Also see
					 R.S.
					 40:5(2)(3)(5)(7) (15)(17)
					 and
					 R.S.
					 40:922.