Nevada Administrative Code

NAC 585.160 “Procaine hydrochloride with preservatives and stabilizers” defined. (NRS 585.210) “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-…

NAC 585.170 “Quality control unit” defined. (NRS 585.210) “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, Amygda…

NAC 585.180 “Strength” defined. (NRS 585.210) “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…

NAC 585.200 Amygdalin: Ingredients. (NRS 439.200) 1. The State Board of Health licenses amygdalin (laetrile) in the form of D-mandelonitrile-B-D-glucosido-6-B-D-glucoside: 2. No other active ingredient is permitted. [Bd. of Health, Licensing Reg. §§ 1.1 & 1.1.1, eff. 5-26-78]

NAC 585.210 Procaine hydrochloride: Ingredients. (NRS 439.200) 1. The State Board of Health licenses procaine hydrochloride with preservatives and stabilizers in the form of procaine hydrochloride: with preservatives and stabilizers. 2. Active ingredients other than procaine hydr…

NAC 585.220 License required to manufacture, prepare or compound drug; qualifications for license. (NRS 585.210, 585.245) 1. No natural person, partnership, association, corporation or other business organization may manufacture, prepare or compound amygdalin (laetrile) or procai…

NAC 585.225 License to manufacture drug other than amygdalin or procaine hydrochloride: Prerequisites to issuance. (NRS 585.210, 585.245) 1. An applicant for a license to manufacture a drug other than amygdalin or procaine hydrochloride must submit to the Commissioner for his or …

NAC 585.230 Application for license to operate drug manufacturing plant. (NRS 585.210, 585.245) 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 infor…

NAC 585.240 Application for license to manufacture amygdalin or procaine hydrochloride: Action by Commissioner and applicant. (NRS 585.210, 585.245, 585.495) 1. The Commissioner will give a notice of hearing by letter to each applicant desiring to manufacture amygdalin (laetrile)…

NAC 585.245 Application for license to manufacture, prepare or compound amygdalin or procaine hydrochloride: Action by Board. (NRS 439.200) 1. The Board will consider an application for a license required pursuant to NAC 585.220 to manufacture, prepare or compound amygdalin (laet…

NAC 585.250 Denial, suspension or revocation of license. (NRS 585.210, 585.245) 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. Noti…

NAC 585.260 Fees. (NRS 585.210, 585.245) 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 …

NAC 585.270 Qualifications of personnel. (NRS 585.210, 585.245, 585.495) 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…

NAC 585.280 Exclusion of certain employees from direct contact with drugs. (NRS 585.210, 585.245, 585.495) 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 hav…

NAC 585.290 Buildings used in manufacturing drugs. (NRS 585.210, 585.245, 585.495) 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 adequat…

NAC 585.300 Requirements for manufacturing facilities. (NRS 585.210, 585.245, 585.495) 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 contr…

NAC 585.310 Approval of plans for construction, remodeling of plants. (NRS 585.210, 585.245, 585.495) 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 p…

NAC 585.320 Use of equipment in production and control. (NRS 585.210, 585.245, 585.495) 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. …

NAC 585.330 Maintenance, construction of equipment. (NRS 585.210, 585.245, 585.495) 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 b…

NAC 585.340 Identification of containers, lines and other equipment used during production. (NRS 585.210, 585.245, 585.495) 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 accur…

NAC 585.350 Containers. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.360 Filters. (NRS 585.210, 585.245, 585.495) 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 us…

NAC 585.370 Cleaning and storing of equipment. (NRS 585.210, 585.245, 585.495) 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 ba…

NAC 585.380 Components: Storage; handling. (NRS 585.210, 585.245, 585.495) 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 materia…

NAC 585.390 Components: Examination; testing. (NRS 585.210, 585.245, 585.495) 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…

NAC 585.400 Components: Identification; use. (NRS 585.210, 585.245, 585.495) 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 th…

NAC 585.410 Components: Records. (NRS 585.210, 585.245, 585.495) 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 examin…

NAC 585.420 Components: Retention of sample. (NRS 585.210, 585.245, 585.495) 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 d…

NAC 585.430 Laboratory controls. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.440 Security. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.450 Provisions for control of quality. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.460 Checks and tests of significant steps in process. (NRS 585.210, 585.245, 585.495) 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, t…

NAC 585.470 Tests and checks upon drugs. (NRS 585.210, 585.245, 585.495) 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 adequac…

NAC 585.480 Precautions generally. (NRS 585.210, 585.245, 585.495) 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 represent…

NAC 585.490 Precautions against contamination. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.500 Precautions respecting penicillin. (NRS 585.210, 585.245, 585.495) 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 reason…

NAC 585.510 Review of records before release of batch. (NRS 585.210, 585.245, 585.495) 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 distributi…

NAC 585.520 Investigation of unexplained discrepancies in batches. (NRS 585.210, 585.245, 585.495) 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 a…

NAC 585.530 Stability of finished drugs. (NRS 585.210, 585.245, 585.495) 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 closu…

NAC 585.540 Date of expiration of drugs. (NRS 585.210, 585.245, 585.495) 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…

NAC 585.550 Control of packaging, labeling operations. (NRS 585.210, 585.245, 585.495) 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 producti…

NAC 585.560 Labeling: Controls; disclosure. (NRS 585.210, 585.245, 585.495) 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 previou…

NAC 585.570 Returned drugs. (NRS 585.210, 585.245, 585.495) 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 …

NAC 585.580 Master record of drugs. (NRS 585.210, 585.245, 585.495) 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 check…

NAC 585.590 Records of batches. (NRS 585.210, 585.245, 585.495) 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 a…

NAC 585.600 Records of distribution. (NRS 585.210, 585.245, 585.495) 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 necess…

NAC 585.610 Complaints. (NRS 585.210, 585.245, 585.495) 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 comp…