reglab/statecodes huggingface dataset:
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9101 - Complaint

Current through June 11, 2024
1. A complaint which alleges a violation of this chapter or chapter 584 of NRS may be made by a member or employee of the Commission or any aggrieved person.
2. The complaint must be made in writing and filed with the Executive Director.
Added to NAC by Dairy Comm'n, eff. 8-26-96; A by R151-01, 12-17-2001, eff. 1-1-2002
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9112 - Answer

Current through June 11, 2024
If the Commission determines that a complaint warrants administrative action, the Commission shall forward a copy to the party or parties against whom the complaint is made. A party may respond to the complaint by filing an answer within 20 days after receipt of the complaint. If a party fails to answer within the time prescribed, the party shall be deemed to have denied generally the allegations of the complaint.
Dairy Comm'n, Practice Rules § 5.8, eff. 12-1-77-Substituted in revision for NAC 584.9191
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9121 - Representation of parties

Current through June 11, 2024
A party to a hearing conducted by the Commission may be represented by an attorney if the attorney is an attorney at law, admitted to practice and in good standing before the highest court of any state. If the attorney is not admitted and entitled to practice before the Supreme Court of Nevada, he or she must associate with an attorney who is admitted and entitled to practice before the Supreme Court of Nevada.
Dairy Comm'n, Practice Rules § 4.3, eff. 12-1-77-NAC A 8-26-96
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9131 - Service upon attorney

Current through June 11, 2024
After an attorney appears as counsel for a party, all notices, pleadings and orders to be served upon the party must be served upon the attorney, and service upon the attorney shall be deemed service upon the party he or she represents.
Dairy Comm'n, Practice Rules § 4.4, eff. 12-1-77-NAC A 8-26-96
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9142 - Subpoenas

Current through June 11, 2024
1. Before a hearing before the Commission, and during a hearing upon reasonable cause shown, the Commission will issue subpoenas and subpoenas duces tecum at the request of a party. A party must prepare and present its subpoenas to the Secretary of the Commission for issue, serve them and bear all costs in connection with them.
2. A witness appearing pursuant to a subpoena, other than a party, officer or employee of the State of Nevada or any political subdivision thereof, is entitled to fees and mileage in the same amounts and under the same circumstances as provided by law for witnesses in civil actions in the district courts, upon making a request in writing to the Commission within 7 days after entering an appearance.
3. A witness who is entitled to fees or mileage and attends hearings at points so far from the witness's residence as to preclude his or her return from day to day is entitled, in addition to witnesses' fees and in lieu of mileage, to the subsistence allowances and travel expenses authorized by NRS 281.160 for each day of actual attendance and for each day necessarily occupied in traveling to and from the hearings.
4. Fees, subsistence and transportation expenses must be paid by the party at whose request the witness is subpoenaed.
Dairy Comm'n, Practice Rules § 8.15, eff. 12-1-77-Substituted in revision for NAC 584.9421
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9312 - Show cause orders

Current through June 11, 2024
An order issued pursuant to NRS 584.643 to show cause why a distributor's license should not be suspended or revoked will contain:
1. The specific violation for which the Commission proposes to suspend or revoke the distributor's license; and
2. Any other information the Commission determines is necessary to enable the distributor to prepare for the hearing to determine whether his or her license should be suspended or revoked.
Added to NAC by Dairy Comm'n, eff. 8-26-96
NRS 233B.050, 584.067, 584.643
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9322 - Stipulations

Current through June 11, 2024
Upon the approval of the presiding member of the Commission, the parties may stipulate to any fact at issue by a written stipulation introduced in evidence as an exhibit or by an oral statement shown upon the record. A stipulation is binding upon all parties to the stipulation, and it may be treated as evidence at the hearing. The presiding member of the Commission may require proof of the facts stipulated, notwithstanding the stipulation.
Dairy Comm'n, Practice Rules § 8.8, eff. 12-1-77-NAC A 8-26-96-Substituted in revision for NAC 584.9381
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9331 - Failure to appear

Current through June 11, 2024
1. If a party fails to appear at a hearing scheduled by the Commission for which the Commission has not granted a continuance, the Commission may hear the testimony of witnesses who have appeared and proceed to consider the matter and dispose of it based on the evidence before it.
2. If, because of accident, sickness or other reasonable cause, a person fails to request a continuance of a hearing, the person may, within 15 days after the hearing is conducted, apply to the Secretary of the Commission to reopen the proceedings.
3. Upon finding the applicant's reason for not requesting a continuance to be sufficient and reasonable, the Commission will immediately fix a time and place for hearing and give the applicant notice thereof. Witnesses who have previously testified may not be required to appear at the second hearing unless directed to appear by the Commission.
Dairy Comm'n, Practice Rules § 8.2, eff. 12-1-77-NAC A 8-26-96
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9371 - Consolidation

Current through June 11, 2024
The member of the Commission who will preside at a hearing conducted by the Commission may consolidate two or more proceedings for hearing whenever it appears that the issues are substantially the same and the interests of the parties will not be prejudiced by a consolidation.
Dairy Comm'n, Practice Rules § 8.7, eff. 12-1-77-NAC A 8-26-96
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 584 - Dairy Products and Substitutes › PRACTICE BEFORE THE STATE DAIRY COMMISSION › Section 584.9391 - Briefs

Current through June 11, 2024
The Commission may order briefs to be filed at any time. A brief filed with the Commission must be accompanied by proof that the brief was served upon the opposing party.
Dairy Comm'n, Practice Rules § 8.12, eff. 12-1-77-NAC A 8-26-96
NRS 233B.050, 584.067
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.010 - Scope

Current through June 11, 2024
The criteria prescribed in NAC 585.010 to 585.640, inclusive, apply in determining whether the methods used in, or the facilities or controls used for, the manufacture, processing, packing or holding of a drug conform to, or are operated or administered in conformity with, current good manufacturing practice to ensure that the drug:
1. Meets the requirements of NRS 585.370 to 585.495, inclusive, as to safety; and
2. Has the identity, strength, quality and purity which it is purported or represented to possess.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 2.1, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.020 - Definitions

Current through June 11, 2024
As used in NAC 585.010 to 585.640, inclusive, unless the context otherwise requires, the words and terms defined in NAC 585.030 to 585.180, inclusive, have the meanings ascribed to them in those sections.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.1, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.030 - "Active ingredient" defined

Current through June 11, 2024
1. "Active ingredient" means any component which is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of a human being or other animals.
2. The term includes components which may undergo chemical change in the manufacture of the drug and be present in the finished drug product in a modified form intended to furnish the specified activity or effect.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.2, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.040 - "Amygdalin," "laetrile" defined

Current through June 11, 2024
"Amygdalin" or "laetrile" is defined by the formula contained in NAC 585.200.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.3, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.050 - "Batch" defined

Current through June 11, 2024
"Batch" means a specific quantity of a drug which has uniform character and quality within specified limits and is produced according to a single manufacturing order during the same cycle of manufacture.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.4, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.060 - "Board" defined

Current through June 11, 2024
"Board" means the State Board of Health.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.5, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.070 - "Commissioner" defined

Current through June 11, 2024
"Commissioner" means the Commissioner of Food and Drugs.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.6, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.080 - "Component" defined

Current through June 11, 2024
"Component" means any ingredient used in the manufacture of drugs in dosage form, whether or not the ingredient appears in the finished product.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.7, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.090 - "Drug" defined

Current through June 11, 2024
1. "Drug" has the meaning ascribed to it in NRS 585.080.
2. The term includes amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers.
[Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.8, eff. 5-15-78]-(NAC A 9-17-82)
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.100 - "Inactive ingredient" defined

Current through June 11, 2024
"Inactive ingredient" means any component other than an active ingredient present in a drug.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.9, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.110 - "In process" defined

Current through June 11, 2024
"In process" means in the course of manufacture. Goods in process are distinguished from raw materials or finished products.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.10, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.120 - "Licensee" defined

Current through June 11, 2024
"Licensee" means a natural person, partnership, association, corporation or other form of business organization which is licensed pursuant to NRS 585.245 or 585.495 to manufacture, compound, process or package any drug.
[Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.11, eff. 5-15-78]-(NAC A 9-17-82)
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.130 - "Lot" defined

Current through June 11, 2024
"Lot" means a batch or any portion of a batch of a drug or, if the drug is produced in a continuous process, any amount of the drug produced in a unit of time or quantity in a manner that ensures its uniformity. A lot is identified by a distinctive number and has uniform character and quality within specified limits.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.12, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.140 - "Lot number" defined

Current through June 11, 2024
"Lot number" means 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.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.13, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.150 - "Mixup" defined

Current through June 11, 2024
"Mixup" means a miscalculation or misuse of any component in any step of the manufacture, control, packaging, labeling or distribution of a drug.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.14, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.160 - "Procaine hydrochloride with preservatives and stabilizers" defined

Current through June 11, 2024
"Procaine hydrochloride with preservatives and stabilizers" is defined by the formula contained in NAC 585.210.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.15, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.170 - "Quality control unit" defined

Current through June 11, 2024
"Quality control unit" means any organizational element having the authority and responsibility to approve or reject components, materials in process, packaging materials and final products.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.16, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › General Provisions › Section 585.180 - "Strength" defined

Current through June 11, 2024
"Strength" means:
1. The concentration of each active ingredient of the drug; or
2. The potency of each active ingredient of the drug, which is the therapeutic activity of the ingredient as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 1.17, eff. 5-15-78
NRS 585.210
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.200 - Amygdalin: Ingredients

Current through June 11, 2024
1. The State Board of Health licenses amygdalin (laetrile) in the form of D-mandelonitrile-B-D-glucosido-6-B-D-glucoside:
Click here to view image.
2. No other active ingredient is permitted.
Bd. of Health, Licensing Reg. §§ 1.1 & 1.1.1, eff. 5-26-78
NRS 439.200
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.210 - Procaine hydrochloride: Ingredients

Current through June 11, 2024
1. The State Board of Health licenses procaine hydrochloride with preservatives and stabilizers in the form of procaine hydrochloride:
Click here to view image.
with preservatives and stabilizers.
2. Active ingredients other than procaine hydrochloride are not permitted.
Bd. of Health, Licensing Reg. §§ 1.2 & 1.2.1, eff. 5-26-78
NRS 439.200
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.220 - License required to manufacture, prepare or compound drug; qualifications for license

Current through June 11, 2024
1. No natural person, partnership, association, corporation or other business organization may manufacture, prepare or compound amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers without a license from the State Board of Health.
2. The State Board of Health will not grant a license to manufacture amygdalin or procaine hydrochloride unless the applicant has satisfied the Commissioner that the applicant:
(a) Is a person of good character, honesty and integrity;
(b) Is a person whose background, reputation and associations will not result in adverse publicity for the State of Nevada and its drug manufacturing industry; and
(c) Has adequate business competence and experience for the role or position for which application is made.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.225 - License to manufacture drug other than amygdalin or procaine hydrochloride: Prerequisites to issuance

Current through June 11, 2024
1. An applicant for a license to manufacture a drug other than amygdalin or procaine hydrochloride must submit to the Commissioner for his or her examination and approval:
(a) The formula for the drug, including all its components; and
(b) The procedures to be used in processing the drug.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.230 - Application for license to operate drug manufacturing plant

Current through June 11, 2024
1. An application for a license to operate a drug manufacturing plant must be completed and sent to the Commissioner.
2. The applicant must provide the Commissioner with complete information regarding ownership and must report promptly all significant changes in ownership. If the applicant is a publicly held corporation, only the information regarding the person holding a majority interest need be so provided.
3. A corporate applicant must provide the Commissioner with the name and address of each of its officers, directors and managers. An applicant who is not a corporation must provide the Commissioner with the name and address of each of his or her managerial employees. An applicant shall notify the Commissioner of any change in this information.
4. An applicant must state the proposed hours of operation of the plant. The applicant shall notify the Commissioner of any change in the hours of operation.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.3-7.3.4, eff. 5-15-78
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.240 - Application for license to manufacture amygdalin or procaine hydrochloride: Action by Commissioner and applicant

Current through June 11, 2024
1. The Commissioner will give a notice of hearing by letter to each applicant desiring to manufacture amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers, stating the time and place for consideration of the application. The applicant must appear at the hearing. The Commissioner will notify the applicant in writing of the disposition of his or her application.
2. An applicant must submit the formula, including all components, for review and approval to ensure compliance with the formula contained in the license issued by the Board. An applicant must also submit the procedures to be used in processing the drug for review and approval to ensure that the formula contained in the license issued by the Board is not altered thereby.
3. An applicant shall cooperate fully in any background, financial or other investigation made to ensure the accuracy and truthfulness of the information supplied to the Commissioner. The investigation will be conducted before the issuance of any license.
4. An applicant is required to satisfy the Commissioner of its ability to meet the requirements of NAC 585.010 to 585.640, inclusive, before the issuance of any license.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.3.5-7.3.8, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.245 - Application for license to manufacture, prepare or compound amygdalin or procaine hydrochloride: Action by Board

Current through June 11, 2024
1. The Board will consider an application for a license required pursuant to NAC 585.220 to manufacture, prepare or compound amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers, and the written recommendation of the Commissioner regarding the application, at a public hearing held:
(a) At the time and place of the next regularly scheduled meeting of the Board;
(b) At the next meeting of the Board that is scheduled in Reno or Las Vegas, whichever city is requested by the applicant; or
(c) As soon as the schedule of the Board permits.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.250 - Denial, suspension or revocation of license

Current through June 11, 2024
1. A failure or refusal of an applicant or a licensee to comply with any provision of NAC 585.010 to 585.640, inclusive, is a ground for denial, suspension or revocation of his or her license.
2. Notice of any denial, suspension or revocation of a license will contain the legal authority and reasons for the action and will be sent to the applicant or licensee by certified mail within 10 days after the action.
3. Within 30 calendar days after receipt of a notice of denial, suspension or revocation, the applicant or licensee may file a notice of appeal with the State Health Officer.
4. Within 30 calendar days after receiving a notice of appeal, the State Health Officer will hold a hearing on the appeal.
5. The State Health Officer will give the applicant or licensee notice of a hearing on appeal at least 15 working days before the date set for the hearing.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.4-7.4.4, eff. 5-15-78
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Licensing › Section 585.260 - Fees

Current through June 11, 2024
1. An applicant for a license to manufacture amygdalin or procaine hydrochloride must pay an initial licensing fee of $30,000 for the first year to the Commissioner before a license will be issued. To provide for receipt of licensing fees on the basis of fiscal years beginning July 1 and ending June 30, the Commissioner will prorate an initial licensing fee for the period from the date of issuance until the end of the current fiscal year.
2. A license to manufacture amygdalin or procaine hydrochloride is effective until June 30 of the fiscal year in which it is issued, but it is renewable on July 1 of each year. The fee for renewal is $30,000. The Commissioner will prorate a fee for a renewal if it is for part of a fiscal year. An application for a renewal of a license must be received by the Commissioner 30 days before the expiration of the license.
3. An applicant for a license to manufacture a drug other than amygdalin or procaine hydrochloride must pay an initial licensing fee of $2,000 for the first year to the Commissioner before a license will be issued. To provide for receipt of licensing fees on the basis of fiscal years beginning July 1 and ending June 30, the Commissioner will prorate an initial licensing fee for the period from the date of issuance until the end of the current fiscal year.
4. A license to manufacture a drug other than amygdalin or procaine hydrochloride is effective until June 30 of the fiscal year in which it is issued, but it is renewable on July 1 of each year. The fee for renewal is $2,000. The Commissioner will prorate the fee for a renewal if it is for part of a fiscal year. An application for a renewal of a license must be received by the Commissioner 30 days before the expiration of the license.
5. An amount paid as a licensing fee, whether an initial fee or a fee for renewal, is not refundable.
[Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.5-7.5.2, eff. 5-15-78; A 12-20-79]-(NAC A 9-17-82)
NRS 585.210, 585.245
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.270 - Qualifications of personnel

Current through June 11, 2024
1. The personnel who are responsible for directing the manufacture and control of a drug must be adequate in number and have sufficient education, training and experience, or a combination thereof, to ensure that the drug will have the safety, identity, strength, quality and purity that it is purported or represented to possess.
2. All personnel must have:
(a) Capabilities commensurate with their assigned functions;
(b) A thorough understanding of the manufacturing or control operations which they perform;
(c) The necessary training or experience; and
(d) Adequate information concerning the reasons for the application of the pertinent provisions of this chapter to their respective functions.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.280 - Exclusion of certain employees from direct contact with drugs

Current through June 11, 2024
1. A licensee shall exclude from direct contact with drugs or their components 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 drugs until the condition is corrected.
2. A licensee shall instruct all his or her employees to report to supervisory personnel any conditions that may have an adverse effect on drugs or their components.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 2.4 & 2.4.1, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.290 - Buildings used in manufacturing drugs

Current through June 11, 2024
1. A licensee shall maintain in a clean and orderly condition the buildings used in the manufacture of drugs. 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 holding of a drug. Separate rooms may be required to prevent cross-contamination of products.
2. A licensee shall provide buildings with adequate space for:
(a) The orderly placement of equipment and materials to minimize the risk of mixups between different drugs, components of drugs, materials in process, packaging materials, or labeling and to minimize the possibility of contamination;
(b) The receipt, storage and withholding from use of components, pending their sampling, identification and testing before release for manufacturing or packaging;
(c) The holding of rejected components before disposition to preclude the possibility of their use in any manufacturing or packaging procedure for which they are unsuitable;
(d) The storage of components, containers, packaging materials and labeling;
(e) Any manufacturing and processing operations;
(f) Any packaging or labeling operations;
(g) The storage of finished products; and
(h) The control of production and laboratory operations.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.300 - Requirements for manufacturing facilities

Current through June 11, 2024
A licensee shall provide:
1. Adequate lighting (at least 50 foot-candles), ventilation and screening and, if necessary for intended production or control purposes, facilities for adequate control of air pressure, microbiological contamination, dust, humidity and temperature in order to:
(a) Minimize contamination of products by extraneous adulterants, including cross-contamination of one product by dust or particles of ingredients arising from the manufacture, storage or handling of another product;
(b) Minimize dissemination of microorganisms from one area to another; and
(c) Maintain suitable conditions for storage of drug components, materials in process and finished drugs in conformance with information on stability derived pursuant to NAC 585.530.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.310 - Approval of plans for construction, remodeling of plants

Current through June 11, 2024
1. Before a licensee constructs or extensively remodels a plant for manufacturing drugs, or converts an existing structure for use as such a plant, the licensee must submit the plans to the Commissioner for his or her approval. 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 fixed equipment and facilities.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.320 - Use of equipment in production and control

Current through June 11, 2024
The use of precision, automatic or electronic equipment in the production and control of a drug is permissible if procedures for inspection and checking are used to ensure proper performance.
[Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 2.2, 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 › Personnel, Facilities, Equipment and Components › Section 585.330 - Maintenance, construction of equipment

Current through June 11, 2024
A licensee shall maintain in a clean and orderly condition all equipment used for the manufacturing, processing, packaging, labeling, holding, testing or controlling of drugs. The equipment must be of suitable design, size, construction and location to facilitate cleaning, maintenance and operation for its intended purpose. The equipment must:
1. Be so constructed that all surfaces which come into contact with a drug or any of its components are not reactive, additive or absorptive in a way which alters the safety, identity, strength, quality or purity of the drug or any of its components.
2. Be so constructed that any substances required for operation of the equipment, such as lubricants or coolants, do not come into contact with any drug in a way which alters the safety, identity, strength, quality or purity of the drug or any of its components.
3. Be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance to ensure reliability of control procedures, uniformity of production and exclusion from the drugs of contaminants from previous and current operations that might affect the safety, identity, strength, quality or purity of the drug or any of its components.
4. Be of suitable type, size and accuracy for any testing, measuring, mixing, weighing or other processing or storage operation.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 3.2-3.2.4, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.340 - Identification of containers, lines and other equipment used during production

Current through June 11, 2024
Each container, line and other piece of equipment used during the production of a batch of a drug must be properly identified at all times to indicate accurately and completely its content and, when necessary, the stage of processing of the batch.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 4.1.2, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.350 - Containers

Current through June 11, 2024
1. A licensee shall use suitable specifications, test methods and cleaning procedures and, when necessary, sterilization procedures to ensure that containers, closures and other component parts of drug packages are suitable for their intended use.
2. A licensee shall clean containers for parenteral drugs or products or components of drugs with water which has been filtered in accordance with NAC 585.360.
3. Containers of products and their components must not be reactive, additive or absorptive, so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or established limitations.
4. Containers of products and their components must provide adequate protection against external factors that can cause deterioration or contamination of the drug.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.4-4.4.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.360 - Filters

Current through June 11, 2024
1. Filters used in manufacturing, processing or packaging the components of any drug for parenteral injection in humans must not release fibers into the drug. No filter containing asbestos or releasing any other fiber may be used in manufacturing, processing or packaging such a drug unless the drug or its component cannot be manufactured without the use of such a filter.
2. Filtration must be accomplished by a filter which does not release fiber, except as provided in subsections 3 and 4.
3. If use of a filter which releases fiber is required, an additional filter which does not release fiber and has a maximum pore size of 0.22 microns (0.45 microns if the manufacturing conditions so dictate) must subsequently be used to reduce the content of any asbestos-form particles in the drug or component.
4. Use of a filter containing asbestos followed by use of a filter which does not release fiber is permissible only if the licensee submits proof to the Commissioner that use of only the latter filter will or is likely to compromise the safety or effectiveness of the drug.
5. For the purposes of this section:
(a) A "filter which does not release fiber" is a filter, other than an asbestos filter, which, after any appropriate pretreatment, such as washing or flushing, will not continue to release fibers into the drug or component being filtered.
(b) A "fiber" is any particle whose length is at least three times greater than its width.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.370 - Cleaning and storing of equipment

Current through June 11, 2024
To minimize contamination and prevent mixups, all equipment, utensils and containers must be thoroughly and appropriately cleaned and properly stored and have previous identification removed between batches or at suitable intervals during continuous production.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 4.1.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.380 - Components: Storage; handling

Current through June 11, 2024
1. A licensee shall, upon receipt, store and handle in a safe, sanitary and orderly condition all components and other materials used in the manufacturing, processing and packaging of drugs and all materials necessary for maintenance of buildings and equipment.
2. A licensee shall take adequate measures to prevent any cross-contamination of drugs and products of drugs.
3. A licensee shall withhold components from use until they have been identified, sampled and tested for conformance with specifications and are approved for release by the quality control unit.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.2-4.2.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.390 - Components: Examination; testing

Current through June 11, 2024
1. A licensee shall visually examine each container of components before it is used to detect any damage, contamination or indication of breakage of the seal.
2. A licensee shall take an adequate number of samples from a representative number of component containers from each lot and shall subject the samples to a sufficient number of tests to establish their specific identity.
3. A licensee shall appropriately examine representative samples of components liable to contamination with filth, insect infestation or other extraneous contaminants.
4. A licensee shall test representative samples of all components intended for use as active ingredients to determine whether the strength of the ingredients conforms to the appropriate specifications.
5. The licensee shall subject representative samples of components liable to microbiological contamination to microbiological tests before they are used. The components must not contain microorganisms that are objectionable in view of the intended use of the components.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.3-4.3.5.1, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.400 - Components: Identification; use

Current through June 11, 2024
1. A licensee shall, as often as necessary, appropriately identify and retest approved components to ensure that they conform to appropriate specifications of identity, strength, quality and purity at the time of use.
2. A licensee shall rotate approved components in such a manner that the oldest stock is used first.
3. A licensee shall identify and hold rejected components to preclude their use in procedures of manufacturing or processing for which they are unsuitable.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.3.6-4.3.6.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.410 - Components: Records

Current through June 11, 2024
A licensee shall maintain appropriate records, including:
1. A record of the identity and quantity of the component, the name of the supplier, the supplier's lot number and the date of receipt.
2. A record of examinations and tests performed and rejected components and their disposition.
3. An individual inventory and record for each component used in each batch of a drug manufactured or processed.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.3.7-4.3.7.3, eff. 5-15-78
NRS 585.210, 585.245, 585.495
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Personnel, Facilities, Equipment and Components › Section 585.420 - Components: Retention of sample

Current through June 11, 2024
A licensee shall retain an appropriately identified, reserve sample of each active ingredient, consisting of at least twice the quantity necessary for all required tests, except those for sterility and determination of the presence of pyrogens, for at least 2 years after distribution of the last drug lot incorporating the component has been completed, or 1 year after the expiration date of the last drug lot, whichever period is longer. The samples must be representative and adequately identified.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.3.8, 4.5.2.1 & 4.5.3, 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 585.430 - Laboratory controls

Current through June 11, 2024
1. The laboratory controls of a licensee must include the establishment of scientifically sound and appropriate specifications, standards and test procedures to ensure that components, drugs in process and finished products conform to appropriate standards of identity, strength, quality and purity.
2. The laboratory controls must also include the establishment of master records containing appropriate specifications for the acceptance of each lot of drug components, product containers and their components used in the production and packaging of drugs and a description of the sampling and testing procedures used.
3. The records must also provide for appropriate retesting of drug components, product containers and their components subject to deterioration.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.5-4.5.2 & 4.5.2.2, 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 585.440 - Security

Current through June 11, 2024
1. Every licensee shall provide effective procedures to prevent theft, diversion or adulteration of processed drugs or their components. The procedures must be registered with and approved by the Commissioner.
2. Every person responsible for security must be registered with the Commissioner and is subject to investigation by the Commissioner to determine his or her suitability for the role.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 9.1 & 9.2, 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 585.450 - Provisions for control of quality

Current through June 11, 2024
The licensee shall provide for:
1. The establishment of master records, when needed, containing specifications and a description of sampling and testing procedures for in-process drug preparation. The samples must be adequately representative and properly identified.
2. The establishment of master records containing a description of sampling procedures and appropriate specifications for finished drugs. The samples must be adequately representative and properly identified.
3. Adequate provisions for checking the identity and strength of drugs for all active ingredients and for ensuring:
(a) Sterility of drugs purported to be sterile and freedom from objectionable microorganisms for those drugs which should be so because of their intended use;
(b) The absence of pyrogens for those drugs purported to be free of pyrogens;
(c) Not more than minimal contamination of ophthalmic ointments by foreign particles and harsh or abrasive substances; and
(d) The pattern of drug release in products designed for a sustained release is tested by laboratory methods to ensure conformance to specifications for the release.
Nevada Administrative Code › Chapter 585 - Drugs and Cosmetics › MANUFACTURE OF DRUGS › Controls on Production › Section 585.460 - Checks and tests of significant steps in process

Current through June 11, 2024
1. Except as provided in subsection 2, each significant step in the process, such as the selection, weighing or measuring of components, the addition of ingredients during the process, the weighing and measuring during various stages of the process and the determination of the finished yield, must be performed by a competent and responsible person and checked by a second competent and responsible person.
2. If the significant steps are controlled by precision, automatic, mechanical or electronic equipment, the proper performance of the equipment must be adequately checked by one or more competent and responsible persons.
3. A written record of the tests and checks at the significant steps in the process must be made by the person performing these tests and by the person charged with checking these steps. An identification of each step must be recorded immediately following its completion.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.1 & 4.1.1.1, 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 585.470 - Tests and checks upon drugs

Current through June 11, 2024
1. To ensure the uniformity and integrity of his or her products, a licensee must provide adequate controls during production, such as checks upon the weights and disintegration times of tablets, the adequacy of mixing, the homogeneity of suspensions and the clarity of solutions.
2. Sampling of drugs in process must be done at appropriate intervals and with suitable equipment.
3. A licensee shall test representative samples of all drugs in dosage form before their distribution to determine whether they conform to the applicable specifications.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.6-4.1.7, 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 585.480 - Precautions generally

Current through June 11, 2024
The procedure for production and control must include all reasonable precautions to ensure that the drugs produced will have the safety, identity, strength, quality and purity which they are purported or represented to possess.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. § 4.1, 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 585.490 - Precautions against contamination

Current through June 11, 2024
1. A licensee shall take appropriate precautions to minimize microbiological and other contamination in the production of drugs purporting to be sterile or which, because of their intended use, should be free from objectionable microorganisms.
2. A licensee shall establish appropriate procedures to minimize cross-contamination of drugs while they are being manufactured or stored.
Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.4 & 4.1.5, 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 585.500 - Precautions respecting penicillin

Current through June 11, 2024
1. If penicillin is being manufactured on the same premises or with the same equipment as is being used to manufacture products subject to NAC 585.010 to 585.640, inclusive, and the products may reasonably be regarded as susceptible to contamination by penicillin, the licensee shall provide for testing the products to determine whether any of them have become contaminated by the penicillin.
2. A licensee shall not market such products if they are intended for use in humans and they are contaminated with an amount of penicillin:
(a) Equivalent to 0.05 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for parenteral administration; or
(b) Equivalent to 0.5 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for oral use.