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.