25,466 sections across 2,439 Louisiana regulatory chapters.
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1505 Public Display of Permits[formerly part of paragraph 6:192]
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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.
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1507 Permit Exemptions[formerly paragraph 6:193]
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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 …
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1509 Examination, Condemnation and Destruction of Unwholesome or Adulterated Drugs[formerly paragraph 6:194]
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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 s…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1511 Personnel[formerly paragraph 6:195]
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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 po…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1513 Building Construction[formerly paragraph 6:197]
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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.
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1515 Building Requirements[formerly paragraph 6:198-1]
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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 c…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1517 Equipment[formerly paragraph 6:199]
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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 i…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1519 Product Production and Quality Control[formerly paragraph 6:200]
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A. Production and control procedures shall include all reasonable precautions including the following to assure that the drugs produced have the safety, identity, quality, strength and purity they purport to possess: 1. [formerly paragraph 6:201-1] each significant step in the pr…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1521 Components[formerly paragraph 6:202]
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A. All components and other materials used in the manufacture, processing and packing of drug products, and materials necessary for building and equipment maintenance, shall upon receipt be stored and handled in a safe, sanitary and orderly manner to assure safety, purity and str…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1523 Product Containers and Their Components[formerly paragraph 6:203]
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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 dr…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1525 Laboratory Controls[formerly paragraph 6:204]
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A. Laboratory controls shall include the establishment of scientifically sound specifications, standards and test procedures to assure that the components, in-processed drugs and finished products conform to standards of identity, strength, quality and purity. Laboratory controls…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1527 2. [formerly paragraph 6:207-2] Expiration dates shall be related to storage conditions stated on the labeling wherever the expiration date appears.
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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 b…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1529 Expiration Dating[formerly paragraph 6:207]
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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. [f…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1531 Packaging and Labeling[formerly paragraph 6:208]
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A. Packaging and labeling operations shall be controlled to assure that only those products that have met the standards and specifications in their master production and control records shall be distributed; to prevent mix-ups between drugs during filling, packaging and labeling …
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1533 Records and Reports[formerly paragraph 6:209-1]
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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 incl…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1535 Distribution Records[formerly paragraph 6:209-3]
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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, dat…
Chapter 15. Current Good Manufacturing Practices in the Manufacture of Drugs-1537 Complaint Files[formerly paragraph 6:210]
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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…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-543 Radiation Survey Instruments
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A. The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each location where radioactive material is present to make physical radiation surveys as required by this Chapter and LAC 33:XV.430. Instrumentation required by this S…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-544 Leak Testing, Repair, Tagging, Opening, Modification, Replacement, and Records of Receipt and Transfer of Sealed Sources
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A. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing, repair, tagging, opening, or any other modification of any sealed source shall be performed only by persons specifically authorized to do so by the administrative …
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-545 Quarterly Inventory
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A. Each licensee and registrant shall conduct a quarterly physical inventory to account for all sealed sources and licensed or registered devices received or possessed under his or her license or registration, including devices containing depleted uranium. The records of the inve…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-546 Utilization Logs
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A. Each licensee or registrant shall maintain current logs, which shall be kept available for inspection by the department for three consecutive years from the date of the recorded event, showing for each source of radiation the following information: 1. a unique identification d…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-547 Inspection and Maintenance of Radiographic Exposure Devices and Storage Containers
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A. The licensee or registrant shall perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, source changers, and associated equipment prior to each day's use, or work shift, to ensure that: 1. th…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-548 Permanent Radiographic Installations
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A. Permanent radiographic installations having high-radiation area entrance controls of the type described in LAC 33:XV.436.A and B shall also meet the following requirements: 1. each entrance that is used for personnel access to the high radiation area shall have both visible an…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-549 Vehicle Identification
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A. The name of the licensee or registrant and the city or town where the licensee's or registrant's main business office is located shall be displayed with durable, clearly visible, and legible label on the sides of all vehicles used at temporary job sites.
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-550 Performance Requirements for Radiography Equipment
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A. Equipment serviced, maintained, or repaired by a licensee or registrant or used in industrial radiographic operations shall meet the following minimum criteria: 1. each radiographic exposure device, source assembly, or sealed source, and all associated equipment shall meet the…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-551 Notifications
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A. Each licensee or registrant shall provide a written report to the Office of Environmental Compliance within 30 days of the occurrence of any of the following incidents involving radiographic equipment: 1. unintentional disconnection of the source assembly from the control cabl…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-573 Conducting Industrial Radiographic Operations
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A. Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or, if the radiographer is a qualified instructor, a qualified radiographer trainee, as required …
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-575 Training and Testing
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A. No licensee or registrant shall permit any individual to act as a radiographer, as defined in this Chapter, until such individual completes the following requirements. 1. The individual shall receive training in the subjects outlined in LAC 33:XV.599.Appendix A, in addition to…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-576 Operating and Emergency Procedures
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A. The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following: 1. the handling and use of licensed sealed sources and radiographic exposure devices to be employed such that no individual is likely to be exposed to radiat…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-577 Personnel Monitoring Control
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A. No licensee or registrant shall permit an individual to act as a radiographer, instructor, or radiographer trainee unless, at all times during radiographic operations, each such individual wears, on the trunk of the body, a direct-reading pocket dosimeter, an operating alarm r…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-578 Reciprocity
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A. Reciprocal recognition by the department of an individual radiographer certification will be granted provided that: 1. the individual holds a valid certification in the appropriate category and class issued by another state or jurisdiction; 2. the requirements and procedures f…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-579 Certification Cards for Radiographers or Radiographer Trainees
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A. Issuance 1. An industrial radiographer or industrial radiographer trainee certification card shall be issued to each person who successfully completes the requirements of LAC 33:XV.575.A or B, respectively. 2. An industrial radiographer certification card shall contain the rad…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-585 Security
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A. During each radiographic operation, a radiographer or instructor shall maintain continuous direct, visual surveillance of the operation to protect against unauthorized entry into a radiation area or high radiation area, as defined in LAC 33:XV.Chapter 1, except: 1. where the h…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-586 Posting
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A. Notwithstanding any provisions in LAC 33:XV.452, areas in which radiography is being performed shall be conspicuously posted as required by LAC 33:XV.451.A and B.
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-587 Radiation Surveys and Survey Records
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A. No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation, as described in LAC 33:XV.543, is available and used at each site where radiographic exposures are made. B. A physical radiation survey shall be made after each radiog…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-588 Documents and Records Required at Temporary Job Sites and Applicable Field Stations
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A. Each licensee or registrant shall maintain copies of records required by this Chapter at the location specified in LAC 33:XV.326.E.1.k. Also, each licensee or registrant conducting industrial radiography at a temporary job site or applicable field station shall have the follow…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-589 Special Requirements and Exemptions for Enclosed Radiography
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A. Systems for enclosed radiography designed to allow admittance of individuals shall: 1. comply with all applicable requirements of this Chapter and LAC 33:XV.421, and if such system is a certified cabinet X-ray system, it shall comply with all applicable requirements of this Ch…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-590 Specific Requirements for Radiographic Personnel Performing Industrial Radiography
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A. At a job site, the following shall be supplied by the licensee or registrant: 1. at least one operable, calibrated survey instrument; 2. a current whole body personnel monitor (TLD or film badge) for each individual; 3. an operable, calibrated pocket dosimeter with a range of …
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-591 Prohibitions
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A. Industrial radiography performed with a sealed source which is not fastened to or contained in a radiographic exposure device, known as fishpole radiography, is prohibited unless specifically authorized in a license issued by the department. B. Exposure of a personnel monitori…
Chapter 15. D. A storage or use location is permanent if radioactive material is stored at the location for more than 90 days and any one or more of the following applies to the location:-599 Appendices A, B, and C
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Appendix A Subjects to be Covered during the Instruction of Radiographers A. Training provided to qualify individuals as radiographers in compliance with LAC 33:XV.575.A shall be presented on a formal basis. Subjects to be covered during instruction shall include the following to…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-332 Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas
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A. Except as provided in LAC 33:XV.333.B, each specific license shall expire at the end of the specified day in the month and year stated therein. B. Each licensee shall notify the Office of Environmental Compliance immediately, in writing, and request termination of the license …
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-333 Renewal of Licenses
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A. Applications for renewal of specific licenses shall be filed in accordance with LAC 33:XV.324. B. In any case in which a licensee, not less than 30 calendar days prior to expiration of his or her existing license, has filed an application in proper form for renewal or for a ne…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-334 Amendment of Licenses at Request of Licensee
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A. Applications for amendment of a license shall be filed in accordance with LAC 33:XV.324 and shall specify the respects in which the licensee desires his or her license to be amended and the grounds for such amendment.
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-335 Department Action on Applications to Renew or Amend
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A. In considering an application by a licensee to renew or amend his or her license, the department will apply the criteria set forth in LAC 33:XV.325, 326, 327, and 328 and in Chapters 5, 7, 13, and 20 of these regulations as applicable.
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-340 Transfer of Source or Byproduct Material
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A. No licensee shall transfer source or byproduct material except as authorized pursuant to this Section. B. Except as otherwise provided in the license and subject to the provisions of LAC 33:XV.340.C and D, any licensee may transfer source or byproduct material: 1. to the depar…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-341 Reporting Requirements for General and Specific Licenses
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A. Immediate Report. Each licensee shall notify the Office of Environmental Compliance by telephone at (225) 765-0160 in the manner provided in LAC 33:I.3923 as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actio…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-342 Records
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A. Each person who receives source or byproduct material in accordance with a license issued in accordance with these regulations shall keep records showing the receipt, transfer, and disposal of this source or byproduct material as follows. 1. The licensee shall retain each reco…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-350 Modification and Revocation of LicensesError! Bookmark not defined.
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A. The terms and conditions of all licenses shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to the act or by reason of rules, regulations, and orders issued by the administrative authority. B. Any licens…
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-351 Financial Assurance Arrangements
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A. Issuance of a license shall be dependent upon satisfactory evidence of financial assurance to ensure the protection of the public health and safety in the event of abandonment, default, or other inability of the licensee to meet the requirements of these regulations. Pursuant …
Chapter 15. D. Each licensee shall notify the Office of Environmental Compliance in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this Chapter.-361 Registration of Product Information
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A. Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the department for evaluation of radiation safety information about its product and for its registration. B. The request for review must be sent by an approp…