reglab/statecodes huggingface dataset:
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.510 - Review of records before release of batch

Current through June 11, 2024
Each licensee shall establish procedures for the review and approval of all records regarding production and control, including those for packaging and labeling before the release or distribution of any batch.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 4.1.8, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.520 - Investigation of unexplained discrepancies in batches

Current through June 11, 2024
1. A licensee shall immediately order a thorough investigation of any unexplained discrepancy or failure of a batch to meet any of its specifications, whether or not the batch has already been distributed.
2. The investigation must be undertaken by a competent and responsible person and must extend to other batches of the same drug and other drugs that may have been associated with the specific failure.
3. The licensee shall make a written record of the investigation, which must include the conclusions and following action.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.8.1-4.1.8.1.2, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.530 - Stability of finished drugs

Current through June 11, 2024
The stability of finished drugs must be ensured. The stability must be:
1. Determined by reliable, meaningful and specific methods of testing;
2. Determined on drugs in the same system of container and closure in which they are marketed;
3. Determined on any dry drug that is to be reconstituted at the time of dispensing (as directed on its labeling) as well as on the reconstituted drug.
4. Recorded and maintained in such a manner that the data on stability may be used to establish expiration dates for the drug.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.6-4.6.1.4, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.540 - Date of expiration of drugs

Current through June 11, 2024
1. To ensure that drugs liable to deterioration meet appropriate standards of identity, strength, quality and purity at the time of use, the label of all such drugs must show expiration dates which relate to stability tests performed on the drug.
2. Expiration dates appearing on the drug labeling must be justified by readily available data from stability studies described in NAC 585.530.
3. An expiration date must be related to the appropriate storage condition. The condition must be stated on the labeling wherever the expiration date appears.
4. When a drug is marketed in its dry state for use in preparing a liquid product, the label must bear information concerning the expiration date for the reconstituted product as well as the expiration date for the dry product.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.7-4.7.1.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.550 - Control of packaging, labeling operations

Current through June 11, 2024
1. A licensee shall control his or her packaging and labeling operations adequately to:
(a) Ensure that only drugs which meet the standards and specifications established in the master production and control records are distributed;
(b) Prevent mixups during filling, packaging and labeling operations;
(c) Ensure that correct labels and labeling are employed for drugs; and
(d) Identify each finished product with a lot number that permits determination of the history of the manufacture and control of the batch.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.560 - Labeling: Controls; disclosure

Current through June 11, 2024
1. A licensee shall include the following controls in his or her packaging and labeling operations:
(a) An inspection of the facilities before use to ensure that all drugs and materials which were previously used for packaging and labeling have been removed.
(b) The holding of labels and package labeling upon receipt, pending their review and proofing against an approved final copy by a competent and responsible person, to ensure that they are accurate regarding identity and content and are in conformity with the approved copy before they are released to inventory.
(c) The maintenance and storage of each type of label and package labeling, representing different products, strength, dosage forms or quantity of contents in a manner that will prevent mixups and provide proper identification.
(d) A suitable system for ensuring that only current labels and package labeling are retained and that stocks of obsolete labels and package labeling are destroyed.
(e) Restriction of access to labels and package labeling to authorized personnel.
(f) Avoidance of "gang" printing of cut labels, cartons or inserts where the labels, cartons or inserts are:
(1) For different products or different strengths of the same products; or
(2) Of the same size and have identical or similar format or color schemes.
(g) If "gang" printing is employed, added control procedures must be provided for. In devising these added controls, the licensee shall consider the problems related to sheet layout, stacking, cutting and handling during and after printing.
(h) Strict control of the package labeling issued for use with the drug. Such labeling must be carefully checked by a competent and responsible person for identity and conformity to the labeling specified in the production record for the batch. The record must identify the labeling and the quantities issued and used and must reasonably reconcile any discrepancy between quantities of the finished drug and the quantities of the issued labeling. All excess package labeling which bears lot numbers must be destroyed. If any significant, unexplained discrepancy occurs, the licensee shall carry out an investigation pursuant to NAC 585.520.
(i) Adequate examination or laboratory testing of representative samples of finished products after packaging and labeling to safeguard against any errors in the finishing operations and to prevent distribution of any batch until all required tests have been made.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.570 - Returned drugs

Current through June 11, 2024
1. A licensee shall identify any returned drugs as such and hold them for disposition as follows:
(a) If the conditions under which the returned drugs have been held, stored or shipped (before or during their return) or if the condition of the drugs, their containers, cartons or labeling as a result of the storing or shipping cast doubt upon the safety, identity, strength, quality or purity of the drugs, they must be destroyed or subjected to adequate examination or testing to ensure that they meet all appropriate standards or specifications before being returned to stock for warehouse distribution or repacking; or
(b) If the drugs are neither destroyed nor returned to stock, they may be reprocessed if the final product will meet all its standards and specifications and is approved by the Commissioner.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Records › Section 585.580 - Master record of drugs

Current through June 11, 2024
To ensure uniformity from batch to batch, a master record for each drug and each batch of drug must be prepared, dated and signed or initialed by a competent and responsible person and must be independently checked, reconciled, dated and signed or initialed by a second competent and responsible person. The master record must include:
1. The name of the drug, a description of the dosage form and a specimen or copy of each label and all other labeling associated with the retail or bulk unit, including copies of the labeling signed or initialed and dated by the person responsible for its approval.
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 complete list of ingredients, designated by names or codes sufficiently specific to indicate any special characteristic of quality, and the following information:
(a) An accurate statement of the weight or measure of each ingredient, regardless of whether it appears in the finished product, except that reasonable variations are permitted in the amount of components necessary in the preparation in dosage form if provisions for such variations are included in the master record;
(b) An appropriate statement concerning any calculated excess of an ingredient;
(c) An appropriate statement of theoretical weight or measure at various stages of processing; and
(d) A statement of the theoretical yield.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Records › Section 585.590 - Records of batches

Current through June 11, 2024
1. A licensee shall prepare a record containing complete information concerning the production and control of each batch of a drug which the licensee produces. He or she shall retain the record for at least 2 years after the distribution of the batch is complete or at least 1 year after the expiration date of the batch, whichever period is longer. The record must identify the specific labeling and lot numbers used on the batch and must be readily available during the retention period.
2. The record must include:
(a) An accurate reproduction of the appropriate master formula. The reproduction must be checked, dated and signed or initialed by a competent and responsible person.
(b) An entry for each significant step in the manufacturing, processing, packaging, labeling, testing and controlling of the batch, including:
(1) The date;
(2) The major equipment and lines employed;
(3) The specific identification of each batch of components used;
(4) The weights and measures of components and products used in processing;
(5) In-process and laboratory control results; and
(6) The identification of the person who actively performs and who directly supervises or checks that step in the operation.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Records › Section 585.600 - Records of distribution

Current through June 11, 2024
1. The procedures for warehouse control and distribution of finished goods must include a system by which the distribution of each lot of a drug can be readily determined to facilitate recall of a drug if necessary.
2. Records within the system must contain the name and address of the consignee, the date and quantity shipped and the lot number of the drug.
3. A licensee shall retain the records of distribution for at least 2 years after distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever period is longer.
4. To ensure the quality of the product, a licensee shall include in his or her warehouse control of finished goods a system whereby the oldest approved stock is distributed first whenever possible.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 6.4-6.4.2, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Records › Section 585.610 - Complaints

Current through June 11, 2024
1. A licensee shall maintain records of all written and oral complaints regarding each product and notify the Commissioner immediately upon the receipt of any complaint.
2. A licensee shall make an investigation of each complaint pursuant to NAC 585.520.
3. A licensee shall maintain the record of each investigation for at least 2 years after distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever period is longer.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 6.5-6.5.1.2, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Records › Section 585.620 - Confidentiality of records

Current through June 11, 2024
All records acquired or compiled by the Commissioner relating to formulas, processing procedures, earnings, revenue and other internal financial matters of any applicant or licensee are confidential and will not be revealed in whole or in part except:
1. For the necessary administration of NAC 585.010 to 585.640, inclusive; or
2. Upon the order of a court of competent jurisdiction.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 10.1-10.1.2, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Enforcement › Section 585.630 - Inspections

Current through June 11, 2024
1. The Commissioner will make an initial inspection of a licensee's plant before the license is granted. At least annually the Commissioner will make such additional inspections as he or she deems necessary for enforcement of chapter 585 of NRS and NAC 585.010 to 585.640, inclusive.
2. A licensee shall permit the Commissioner or his or her agent, after proper identification, to enter at any reasonable time any drug manufacturing, processing or packaging plant of the licensee within the State of Nevada to make an inspection to determine compliance with chapter 585 of NRS and NAC 585.010 to 585.640, inclusive. The licensee shall permit the Commissioner or the agent to examine the records of the establishment to obtain pertinent information.
3. After an inspection is made, the Commissioner will prepare a written report of the inspection and give a copy of the report to the licensee. Whenever the licensee is found not to be in compliance with NAC 585.010 to 585.640, inclusive, the Commissioner will take action pursuant to chapter 585 of NRS.
4. The Commissioner or his or her agent will pick up samples of finished drugs or their components from time to time and take the samples for testing at a laboratory approved by the Commissioner. Samples of finished drugs will be picked up and tested at least two times a year.
[Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 8.1-8.3, eff. 5-15-78]-(NAC A 9-17-82)
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Enforcement › Section 585.640 - Amygdalin, procaine hydrochloride: Verification of substances; appeal

Current through June 11, 2024
1. The Commissioner of Food and Drugs shall analyze any substance or formulation purporting or represented to be amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers to determine whether it is the substance licensed by the State Board of Health.
2. Any denial of a substance purporting or represented to be amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers may be appealed to the State Board of Health. The appeal must follow the Board's regulations governing procedures for seeking variances.
Bd. of Health, Licensing Reg. §§ 2.1 & 2.2, eff. 5-26-78
NRS 233B.050, 439.200
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › TAXATION OF AMYGDALIN AND PROCAINE HYDROCHLORIDE › Section 585.650 - Applicability

Current through June 11, 2024
NAC 585.660 and 585.670 apply to the substances amygdalin (laetrile) and procaine hydrochloride with preservatives and stabilizers (Gerovital H3) which are licensed for manufacture pursuant to NRS 585.495.
Tax Comm'n, Amygdalin and Procaine Hydrochloride Reg. part No. 1, eff. 2-5-82
NRS 360.090, 585.497
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › TAXATION OF AMYGDALIN AND PROCAINE HYDROCHLORIDE › Section 585.660 - Definitions

Current through June 11, 2024
As used in this section and NAC 585.670:
1. "Gross receipts" means the total amount of the sale of each substance, valued in money, whether received in money or otherwise, without a deduction for any of the following:
(a) The cost of the substance sold.
(b) The cost of the materials used, labor or service, or interest paid, or for losses or any other expense.
(c) The cost of marketing the substance.
(d) The cost of transporting the substance before its sale to the purchaser.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › TAXATION OF AMYGDALIN AND PROCAINE HYDROCHLORIDE › Section 585.670 - Reporting of gross receipts by manufacturers

Current through June 11, 2024
1. A manufacturer of these substances shall report his or her gross receipts based upon the manufacturer's designated sales price whether or not the revenue from the sales is actually received by the manufacturer in the quarter covered by the report or in a subsequent quarter. The manufacturer's report must be made on a form prescribed by the Nevada Tax Commission.
2. No allowance for nonpayment of the sales price by any purchaser may be deducted from the manufacturer's gross receipts.
3. Any sales of the substances to the manufacturer's subsidiaries must be included in the manufacturer's gross receipts at the sales price computed and charged to the subsidiaries without deduction for expenses incurred for intercorporate accounting or transactions.
4. Each manufacturer shall maintain accurate and complete records of all sales of the substances for at least 4 years.
Tax Comm'n, Amygdalin and Procaine Hydrochloride Reg. part No. 1, eff. 2-5-82
NRS 360.090, 585.497
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.700 - Definitions

Current through June 11, 2024
As used in NAC 585.700 to 585.840, inclusive, unless the context otherwise requires:
1. "Batch" means a specific quantity of a cosmetic which has a uniform character and quality within specified limits and is produced according to a single manufacturing order during a cycle of manufacture.
2. "Control number" means any distinctive combination of letters or numbers, or both, from which the complete history of the manufacturing, control, packaging and distribution of a lot can be determined.
3. "Licensee" means a person who is licensed by the Commissioner to manufacture, process or package cosmetics.
4. "Lot" means a batch or any portion of a batch of a cosmetic or, if the cosmetic is produced in a continuous process, any amount of the cosmetic produced in a unit of time or quantity in a manner that ensures its uniformity.
Comm'r of Food & Drugs, Cosmetics § 2, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.705 - Use, inspection of equipment

Current through June 11, 2024
A licensee may use precision, automatic or electronic equipment to manufacture, process or package cosmetics if the licensee adequately inspects and checks the equipment to ensure its proper performance.
Comm'r of Food & Drugs, Cosmetics § 3, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.710 - Qualifications of employees

Current through June 11, 2024
A licensee shall ensure that:
1. Employees who are responsible for directing the manufacture and control of a cosmetic have sufficient education, training and experience, or a combination thereof, to ensure that the cosmetic will have the safety, identity, quality and purity that it purports or is represented to possess.
2. Employees must have capabilities which are commensurate with their assigned duties, a thorough understanding of the manufacturing or control operations they perform, the appropriate training or experience and adequate information concerning the reasons for statutes and regulations relating to the manufacture of cosmetics.
Comm'r of Food & Drugs, Cosmetics § 4, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.715 - Exclusion of persons with illness or open lesions

Current through June 11, 2024
A licensee shall exclude from direct contact with any cosmetic 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 the cosmetic until the condition is corrected.
Comm'r of Food & Drugs, Cosmetics § 5, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.720 - Report on adverse effects

Current through June 11, 2024
A licensee shall instruct all of his or her employees to report to their supervisor any conditions that may have an adverse effect on any cosmetic.
Comm'r of Food & Drugs, Cosmetics § 6, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.725 - Buildings used to manufacture cosmetics: Condition; size, construction, location; separate rooms

Current through June 11, 2024
1. A licensee shall maintain in a clean and orderly condition the buildings used to manufacture cosmetics. The buildings must be of suitable size, construction and location to facilitate adequate cleaning, maintenance and proper operations in the manufacturing, processing, packing, labeling and storage of a cosmetic.
2. The licensee shall provide any separate rooms which are necessary to prevent a cosmetic product from being contaminated by another.
Comm'r of Food & Drugs, Cosmetics § 7, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.730 - Buildings used to manufacture cosmetics: Space

Current through June 11, 2024
A licensee shall use buildings to manufacture cosmetics which have adequate space for:
1. The orderly placement of equipment and materials to minimize the risk of contamination and confusion between different components, materials in process, packaging materials or labeling materials.
2. The storage of components, containers, packaging materials and labeling materials.
3. Any manufacturing and processing operation.
4. Any packaging or labeling operation.
5. The storage of finished products.
6. The control of production and laboratory operations.
Comm'r of Food & Drugs, Cosmetics § 8, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.735 - Buildings used to manufacture cosmetics: Lighting, facilities; water; sewage disposal

Current through June 11, 2024
A licensee shall provide in a building used to manufacture cosmetics:
1. Adequate lighting of at least 50 foot-candles, and ventilation and screening, if necessary, to:
(a) Minimize the contamination of products by extraneous adulterants, including the cross-contamination of one product by dust or particles or ingredients arising from the manufacture, storage or handling of another product;
(b) Minimize the dissemination of micro-organisms from one area to another; and
(c) Maintain suitable conditions for the storage of components, materials in process and finished cosmetics.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.740 - Equipment

Current through June 11, 2024
1. A licensee shall maintain in a clean and orderly condition all equipment used in the manufacturing, processing, packaging, labeling, holding, testing or controlling of cosmetics. The equipment must be of a suitable design, size, construction and location to facilitate cleaning, maintenance and operation for its intended purpose.
2. Any equipment must:
(a) Be constructed so that all surfaces which come into contact with a cosmetic are not reactive, additive or absorptive in a way which alters the safety, quality or purity of the cosmetic;
(b) Be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance and to ensure uniformity of production and the exclusion from the cosmetics of contaminants from previous and current operations that might affect the safety and quality of the cosmetics; and
(c) Be of a suitable type, size and accuracy for any testing, measuring, mixing, weighing or other processing or storage.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.745 - Submission, approval of plan to construct, remodel plant

Current through June 11, 2024
1. If, after December 16, 1982, a plant for manufacturing cosmetics is constructed or extensively remodeled, or an existing structure is converted for such a use, an applicant must submit plans to the Commissioner for his or her approval before the work is begun.
2. The plans must include:
(a) The layout and arrangement of the plant;
(b) The materials to be used in construction; and
(c) The location, size and type of any fixed equipment and facilities.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.750 - Procedures for production and control

Current through June 11, 2024
1. The procedures for the production and control of cosmetics which are adopted by a licensee must include all reasonable precautions, including those contained in this section, to ensure that the cosmetics which are produced will have the safety and quality which they purport or are represented to possess.
2. Each significant step in the manufacturing process, such as the selection, weighing or measuring of components, the addition of ingredients during the process and the determination of the finished yield, must be performed by a competent and responsible person. If these steps are controlled by precision, automatic, mechanical or electronic equipment, the proper performance of the equipment must be adequately checked by at least one competent and responsible person.
3. Each container, line and piece of equipment used during the production of a batch must be properly identified at all times to show accurately and completely its contents and, when necessary, the stage of the processing of the batch.
4. To minimize contamination and prevent confusion, all equipment, utensils and containers must be thoroughly and appropriately cleaned and properly stored. The identification marking for the previous batch must be removed between batches or at suitable intervals during a continuous production.
5. A licensee shall establish appropriate procedures:
(a) To minimize the cross-contamination of cosmetics while they are being manufactured or stored.
(b) For the review and approval of all records concerning production control, including those for packaging and labeling, before the release or distribution of any batch.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.755 - Components: Storage, handling; conformance with specifications

Current through June 11, 2024
1. A licensee shall store and handle in a safe, sanitary and orderly manner, all components and other materials used in the manufacturing, processing and packaging of cosmetics and all materials necessary for the maintenance of the buildings and equipment.
2. A licensee may not use any component until it has been identified and examined for conformance with the specifications of the product.
Comm'r of Food & Drugs, Cosmetics § 13, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.760 - Components: Examination; testing

Current through June 11, 2024
A licensee shall:
1. Visually examine each container of components before the components are used to detect any damage or contamination.
2. Appropriately examine samples of components which are susceptible to contamination by filth, insects or other extraneous contaminants.
3. Subject the final product to microbiological tests. The product shall not contain microorganisms that are objectionable.
4. Handle and store approved components in such a manner as to guard against their contamination by other cosmetics or components.
Comm'r of Food & Drugs, Cosmetics § 14, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.765 - Containers

Current through June 11, 2024
The containers which are used by the licensee for his or her products and their components must not be reactive, additive or absorptive so as to alter the safety or quality of the cosmetic. The containers must provide adequate protection against any element which can cause the deterioration or contamination of the cosmetic.
Comm'r of Food & Drugs, Cosmetics § 15, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.770 - Laboratory controls

Current through June 11, 2024
A licensee shall include in his or her laboratory controls, provisions for:
1. The establishment of scientifically sound and appropriate specifications and testing procedures to ensure the quality of the finished cosmetic.
2. Verifying the reliability and accuracy of the laboratory testing procedures and instruments which are used.
3. The retention of a properly identified sample of each finished cosmetic. The sample must be stored in a container which is identical to the container in which the cosmetic is marketed. The sample must contain at least twice the quantity necessary to perform all tests performed, except for net weight content, to ensure quality. The licensee shall retain the sample for at least 2 years.
4. The retention of complete records of all laboratory data relating to each lot for at least 1 year after the distribution of the lot is completed.
Comm'r of Food & Drugs, Cosmetics § 16, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.775 - Packaging and labeling

Current through June 11, 2024
1. A licensee shall control his or her packaging and labeling operations to:
(a) Ensure that only cosmetics which meet the standards and specifications established in the master record of production and control are distributed;
(b) Prevent confusion during filling, packaging and labeling operations;
(c) Ensure that correct labels and labeling materials are used; and
(d) Identify each finished product with a control number that permits the determination of the history of the manufacture and control of the batch.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.780 - Master record of production and control

Current through June 11, 2024
1. To ensure the uniformity of batches, a licensee shall prepare a master record of production and control for each cosmetic and each batch.
2. The record must be dated and signed or initialed by a competent and responsible person and must include:
(a) The name and weight or measure of each ingredient.
(b) A complete list of ingredients, designated by names or codes which are sufficiently specific to show any special characteristic of quality, including statements concerning:
(1) Any calculated amount of excess of an ingredient;
(2) The theoretical weight or measure at the various stages of processing; and
(3) The theoretical yield.
(c) A description of the containers, closures and packaging of finished materials.
(d) The instructions regarding manufacturing and control, and the procedures, specifications, and special notations and precautions to be taken.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.785 - Records of batches

Current through June 11, 2024
1. A licensee shall prepare a record which is readily available containing complete information concerning the production and control of each batch which he or she produces.
2. The licensee shall retain the record for at least 2 years after the distribution of the batch has been completed.
3. The record must:
(a) Identify the specific labeling and control numbers used on the batch; and
(b) Note the number that identified all of the documents concerning the production, control and history of the batch and all other control numbers associated with the batch.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.790 - Records of distribution of lots

Current through June 11, 2024
1. A licensee shall include in the procedures for the control and distribution of finished goods, a record system by which the distribution of each lot can be readily determined to facilitate the recall of a cosmetic, if necessary. The records must contain the name and address of the consignee, the date of each shipment, the quantity shipped and the lot or control number of the cosmetic. The licensee shall retain these records for at least 2 years after the distribution of the cosmetic has been completed.
2. The licensee shall establish a system whereby the licensee's oldest approved stock is distributed before newer stock is distributed, whenever possible.
Comm'r of Food & Drugs, Cosmetics § 20, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.795 - Records of complaints

Current through June 11, 2024
A licensee shall maintain records of all written and oral complaints he or she receives regarding each product and shall notify the Commissioner immediately upon the receipt of any such complaint.
Comm'r of Food & Drugs, Cosmetics § 21, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.800 - Qualifications of applicant for license

Current through June 11, 2024
The Commissioner will not issue a license pursuant to NRS 585.245 unless the applicant has satisfied the Commissioner that the applicant is competent and has adequate business experience to conduct the activity for which the application for a license is made.
Comm'r of Food & Drugs, Cosmetics § 22, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.805 - Application for license

Current through June 11, 2024
1. Any person who desires to operate a plant for the manufacture of cosmetics must submit to the Commissioner an application for a license.
2. The applicant must provide the Commissioner with complete information regarding the ownership of the plant and report promptly all significant changes in its ownership.
3. A corporate applicant must provide the Commissioner with the name and address of each of its officers and managers. An applicant who is not a corporation must provide the Commissioner with the name and address of each of the applicant's managerial employees. Each applicant must notify the Commissioner of any change in this information.
4. The applicant must:
(a) State the proposed hours of operation of the plant and notify the Commissioner of any change in the hours of operation.
(b) Submit the formula of the cosmetic he or she intends to manufacture, including all components, to the Commissioner for review and approval.
(c) Satisfy the Commissioner of his or her ability to meet the requirements of NAC 585.700 to 585.740, inclusive, of this regulation before the Commissioner will issue any license.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.810 - Denial, suspension, revocation of license

Current through June 11, 2024
1. The failure or refusal of an applicant or a licensee to comply with any applicable statutes or regulations is a ground for the denial, suspension or nonrenewal of a license.
2. The Commissioner will include in the notice of any denial, suspension, revocation or nonrenewal of a license the legal authority and reasons for the action. The Commissioner will send the notice to the applicant or licensee by certified mail within 10 days after the action is taken.
Comm'r of Food & Drugs, Cosmetics § 24, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.815 - Fees; renewal of license

Current through June 11, 2024
1. An applicant must pay an initial licensing fee of $300 to the Commissioner before a license will be issued. The Commissioner will prorate an initial licensing fee for the period from the date of the issuance of the license until the end of the fiscal year.
2. A license is effective until June 30 of the fiscal year in which it is issued and must be renewed by July 1 of each year. The renewal fee is $300. In certain cases, the Commissioner may prorate a renewal fee for part of a fiscal year. An application for the renewal of a license must be received by the Commissioner at least 30 days before the expiration of the license.
3. The fees collected pursuant to this section will not be refunded.
Comm'r of Food & Drugs, Cosmetics § 25, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.820 - Inspections

Current through June 11, 2024
1. The Commissioner will make an initial inspection of an applicant's plant before a license is granted and will make such an inspection at least annually. The Commissioner will make such additional inspections as he or she deems necessary for the enforcement of chapter 585 of NRS and this regulation.
2. The Commissioner will give to the licensee a written report of the findings of any inspection the Commissioner makes at the licensee's factory, warehouse or plant.
Comm'r of Food & Drugs, Cosmetics § 26 + part § 27, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.825 - Examination of records

Current through June 11, 2024
A licensee shall permit the Commissioner to examine the records of the establishment to obtain information which is pertinent to the licensee's operation.
Comm'r of Food & Drugs, Cosmetics part § 27, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.830 - Federal regulations adopted by reference

Current through June 11, 2024
Parts 700 to 740, inclusive, of Title 21 of the Code of Federal Regulations, as those regulations existed on April 1, 1982, are hereby adopted by reference. A copy of the volume containing these parts may be obtained by mail from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 979050, St. Louis, Missouri 63197-9000, or by telephone at (866) 512-1800, for the price of approximately $6.
Comm'r of Food & Drugs, Cosmetics § 28, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.835 - Exemptions

Current through June 11, 2024
1. A licensee may petition the Commissioner for an exemption from a particular provision of NAC 585.700 to 585.840, inclusive.
2. The petition must contain:
(a) The section for which the licensee requests the exemption; and
(b) Facts sufficient to show the Commissioner that, because of the harmless nature of the cosmetic the licensee manufactures, the section should not apply.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › COSMETICS › Section 585.840 - Severability

Current through June 11, 2024
If any provision of NAC 585.010 to 585.840, inclusive, or any application thereof to any person, thing or circumstance is held invalid, the Commissioner intends that the invalidity not affect the remaining provisions or applications to the extent that they can be given effect.
Comm'r of Food & Drugs, Cosmetics § 30, eff. 12-16-82
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 586 - Pesticides › GENERAL PROVISIONS › Section 586.005 - Definitions

Current through June 11, 2024
As used in this chapter, unless the context otherwise
				requires:
1. "Authorized commercial
			 applicator" has the meaning ascribed to it in
			 NRS
			 555.26157.
2. "Department" means the State Department of
			 Agriculture.
3. "Director" means
			 the Director of the Department.
4.
			 "Non-private applicator" has the meaning ascribed to it in
			 NRS
			 555.2657.
5.
			  "Private applicator" has the meaning ascribed to it in
			 NRS
			 555.2681.
6. "Restricted-use pesticide" has the meaning
			 ascribed to it in NRS 586.205. The term includes
			 any pesticide that contains any amount of strychnine or a salt of
			 strychnine.
Supplied in
				codification; A by Dep't of Agriculture by R045-03,
				9-24-2003;	A
				by
				R048-21A,
				eff. 12/16/2022
NRS 586.237
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.011 - Annual registration fee: Amount; deposit and use of portion of fee

Current through June 11, 2024
1. Each registrant must pay an annual
			 registration fee of $125 for each pesticide registered.
2. The Director will deposit, in a separate
			 account, $40 of each annual registration fee collected pursuant to subsection
			 1. The money in the account will be used to:
(a) Monitor and dispose of
			 pesticides;
(b) Protect groundwater
			 and surface water from contamination by pesticides; and
(c) Eradicate and control noxious
			 weeds.
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.015 - Restricted-use pesticides: Annual registration fee for seller

Current through June 11, 2024
Each person registering to sell restricted-use pesticides shall
				pay an annual registration fee of $25.
Added to NAC by Bd. of
				Agriculture by R097-99, 12-10-99, eff. 1-1-2000
NRS
				  561.105,
				  586.406
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.017 - Restricted-use pesticides: Distribution or sale

Current through June 11, 2024
1. A
			 restricted-use pesticide must only be distributed or sold by a person
			 registered to sell restricted-use pesticides.
2. A person registered to sell restricted-use
			 pesticides shall only distribute or sell a restricted-use pesticide to:
(a) An authorized commercial applicator,
			 non-private applicator or private applicator with the appropriate license or
			 certification to use or supervise the use of the type and quantity of the
			 restricted-use pesticide; or
(b)
			 The authorized representative of an authorized commercial applicator,
			 nonprivate applicator or private applicator with the appropriate license or
			 certification to use or supervise the use of the type and quantity of the
			 restricted-use pesticide.
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.018 - Restricted-use pesticides: Application by or under supervision of certified applicator

Current through June 11, 2024
A person shall not apply or otherwise use a restricted-use
				pesticide unless the person is:
1. An
			 authorized commercial applicator, non-private applicator or private applicator
			 with the appropriate license or certification to use the restricted-use
			 pesticide; or
2. A person under the
			 direct supervision of an authorized commercial applicator, non-private
			 applicator or private applicator who holds the appropriate license or
			 certification to use the restricted-use pesticide and the person under direct
			 supervision meets the requirements of
			 40 C.F.R. §
									171.201.
Added to NAC by Dep't of
				Agriculture by R045-03, eff. 9-24-2003;	A
				by
				R048-21A,
				eff. 12/16/2022
NRS 586.237 and
				  586.406
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.020 - Pesticides highly toxic to humans

Current through June 11, 2024
A pesticide which falls within any of the following categories
				when tested on laboratory animals is highly toxic to humans:
1. A pesticide which produces death in half
			 or more of the test animals of any species at a dosage of 50 milligrams or less
			 per kilogram of body weight when administered orally to 10 or more animals of
			 the species.
2. A pesticide which
			 produces death in half or more of the animals of any species at a dosage of 200
			 parts or less by volume of the gas or vapor per million parts by volume of air
			 when administered by continuous inhalation for 1 hour or less to 10 or more
			 animals of the species, if that concentration is likely to be encountered by
			 humans when the pesticide is used in any reasonably foreseeable
			 manner.
3. A pesticide which
			 produces death in half or more of the animals tested at a dosage of 200
			 milligrams or less per kilogram of body weight when administered by continuous
			 contact with the bare skin for 24 hours or less to 10 or more
			 animals.
Dep't of Agriculture,
				No. 86.01, eff. 7-1-56-NAC A 12-9-81
NRS
				  586.310,
				  586.401
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.030 - Coloration or discoloration of white pesticides

Current through June 11, 2024
1. The
			 white pesticides named in this section must be colored or discolored in
			 accordance with this section, except that any white pesticide which is intended
			 solely for use by a textile manufacturer or a commercial laundry, cleaner or
			 dyer as a mothproofing agent, which would not be suitable for such use if
			 colored and which will not come into the hands of the public when incorporated
			 into a fabric, is not required to be colored or discolored in accordance with
			 this section. The hues, values and chromas specified are those contained in the
			 Munsell Book of Color, Munsell Color Company, 10 East Franklin Street,
			 Baltimore, Maryland.
2. The
			 coloring agent must produce a uniformly colored product not subject to change
			 in color beyond the minimum requirements during ordinary conditions of
			 marketing and storage and must not cause the product to become less effective
			 or cause damage when used as directed or in accordance with commonly recognized
			 safe practice.
3. Sodium fluoride
			 and sodium fluosilicate must be:
(a) Colored
			 blue or green having a value of not more than 8 and a chroma of not less than
			 4; or
(b) Discolored to a neutral
			 lightness value not over 7.
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.040 - Sodium fluoroacetate: Sale, possession or use

Current through June 11, 2024
1. No
			 person may sell, possess or use sodium fluoroacetate (also known as "Compound
			 1080" and "1080"), other than:
(a) An
			 authorized commercial applicator, non-private applicator or private
			 applicator;
(b) A research or
			 chemical laboratory in its respective field; or
(c) A wholesaler or jobber of pesticides for
			 sale to the persons specified in paragraphs (a) and (b), or for
			 export.
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.080 - Expression of percentages; sliding scale prohibited

Current through June 11, 2024
The sliding scale method of expressing percentages must not be
				used. This does not forbid the use of a qualifying statement descriptive of the
				basic active material or materials, if the statement does not constitute an
				integral part of the percentage of total active ingredients.
Dep't of Agriculture,
				No. 86.07, eff. 7-1-56
NRS
				  586.401
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.100 - Arsenic: Label requirements

Current through June 11, 2024
The label of any pesticide containing arsenic as an active
				ingredient in any form must show the total amount of arsenic, expressed as
				metallic, and the amount of arsenic in water-soluble form, expressed as
				metallic, in addition to other required statements.
Dep't of Agriculture,
				No. 86.09, eff. 7-1-56-NAC A 12-9-81
NRS
				  586.401
Nevada Administrative Code › Chapter 586 - Pesticides › PESTICIDES GENERALLY › Section 586.110 - Copper: Label requirements

Current through June 11, 2024
If a pesticide contains a copper compound of uncertain
				composition, the ingredient statement may be given in terms of copper expressed
				as metallic if the type of compound is also shown. For example, the name of the
				active ingredient may be stated as "Copper expressed as metallic (derived from
				basic copper sulfate)."
Dep't of Agriculture,
				No. 86.10, eff. 7-1-56-NAC A 12-9-81
NRS
				  586.401