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Nevada Administrative Code (Last Updated: January 6, 2015) |
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Chapter585 Drugs and Cosmetics |
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MANUFACTURE OF DRUGS |
| General Provisions |
| NAC 585.010. Scope. |
| NAC 585.020. Definitions. |
| NAC 585.030. “Active ingredient” defined. |
| NAC 585.040. “Amygdalin,” “laetrile” defined. |
| NAC 585.050. “Batch” defined. |
| NAC 585.060. “Board” defined. |
| NAC 585.070. “Commissioner” defined. |
| NAC 585.080. “Component” defined. |
| NAC 585.090. “Drug” defined. |
| NAC 585.100. “Inactive ingredient” defined. |
| NAC 585.110. “In process” defined. |
| NAC 585.120. “Licensee” defined. |
| NAC 585.130. “Lot” defined. |
| NAC 585.140. “Lot number” defined. |
| NAC 585.150. “Mixup” defined. |
| NAC 585.160. “Procaine hydrochloride with preservatives and stabilizers” defined. |
| NAC 585.170. “Quality control unit” defined. |
| NAC 585.180. “Strength” defined. |
| Licensing |
| NAC 585.200. Amygdalin: Ingredients. |
| NAC 585.210. Procaine hydrochloride: Ingredients. |
| NAC 585.220. License required to manufacture, prepare or compound drug; qualifications for license. |
| NAC 585.225. License to manufacture drug other than amygdalin or procaine hydrochloride: Prerequisites to issuance. |
| NAC 585.230. Application for license to operate drug manufacturing plant. |
| NAC 585.240. Application for license to manufacture amygdalin or procaine hydrochloride: Action by Commissioner and applicant. |
| NAC 585.245. Application for license to manufacture, prepare or compound amygdalin or procaine hydrochloride: Action by Board. |
| NAC 585.250. Denial, suspension or revocation of license. |
| NAC 585.260. Fees. |
| Personnel, Facilities, Equipment and Components |
| NAC 585.270. Qualifications of personnel. |
| NAC 585.280. Exclusion of certain employees from direct contact with drugs. |
| NAC 585.290. Buildings used in manufacturing drugs. |
| NAC 585.300. Requirements for manufacturing facilities. |
| NAC 585.310. Approval of plans for construction, remodeling of plants. |
| NAC 585.320. Use of equipment in production and control. |
| NAC 585.330. Maintenance, construction of equipment. |
| NAC 585.340. Identification of containers, lines and other equipment used during production. |
| NAC 585.350. Containers. |
| NAC 585.360. Filters. |
| NAC 585.370. Cleaning and storing of equipment. |
| NAC 585.380. Components: Storage; handling. |
| NAC 585.390. Components: Examination; testing. |
| NAC 585.400. Components: Identification; use. |
| NAC 585.410. Components: Records. |
| NAC 585.420. Components: Retention of sample. |
| Controls on Production |
| NAC 585.430. Laboratory controls. |
| NAC 585.440. Security. |
| NAC 585.450. Provisions for control of quality. |
| NAC 585.460. Checks and tests of significant steps in process. |
| NAC 585.470. Tests and checks upon drugs. |
| NAC 585.480. Precautions generally. |
| NAC 585.490. Precautions against contamination. |
| NAC 585.500. Precautions respecting penicillin. |
| NAC 585.510. Review of records before release of batch. |
| NAC 585.520. Investigation of unexplained discrepancies in batches. |
| NAC 585.530. Stability of finished drugs. |
| NAC 585.540. Date of expiration of drugs. |
| NAC 585.550. Control of packaging, labeling operations. |
| NAC 585.560. Labeling: Controls; disclosure. |
| NAC 585.570. Returned drugs. |
| Records |
| NAC 585.580. Master record of drugs. |
| NAC 585.590. Records of batches. |
| NAC 585.600. Records of distribution. |
| NAC 585.610. Complaints. |
| NAC 585.620. Confidentiality of records. |
| Enforcement |
| NAC 585.630. Inspections. |
| NAC 585.640. Amygdalin, procaine hydrochloride: Verification of substances; appeal. |