person shall be eligible to apply anew. A person whose license, permit, or other authorization has been permanently revoked by the board shall never again be eligible for a license or permit of any kind from the board. (86) engineering means a buffer area and an ‘Secondary control’ ante area that meet the designated ISO classification. (87) compounding area for compounding sterile ‘Segregated means a designated space: products’ (a) confined to a room or a demarcated area; (b) restricted to preparing lowrisk CSPs with a twelve hour or less beyonduse time; (c) containing a device that provides unidirectional air flow of ISO 5 air quality; (d) free of materials extraneous to sterile compounding; and (e) not used for other activities or purposes. (4988) adverse drug means a drugrelated ‘Significant reaction’ incident that may result in serious harm, injury, or death to the patient. (5089) means a dosage form devoid of ‘Sterile pharmaceutical’ viable microorganisms. (90) means a process designed to determine the ‘Sterility test’ presence of bacteria or fungi in or on a test device or solution. (5191) means a drug product with ‘Therapeutically equivalent’ the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 392440. (92) means the displacement air flow across the line ‘Velocity’ of demarcation between a buffer area into the ante area in a single room. (5293) means a person engaged in ‘Wholesale distributor’ wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; repackagers; ownlabel distributors; privatelabel distributors; jobbers; brokers; warehouses including and manufacturers’ distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions. "Wholesale distributor" does not include: (a) intracompany sales, being defined as a transaction or transfer between a division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity;
person shall be eligible to apply anew. A person whose license, permit, or other authorization has been permanently revoked by the board shall never again be eligible for a license or permit of any kind from the board. (86) ‘Secondary engineering control’ means a buffer area and an ante area that meet the designated ISO classification. (87) ‘Segregated compounding area for compounding sterile products’ means a designated space: (a) confined to a room or a demarcated area; (b) restricted to preparing lowrisk CSPs with a twelve hour or less beyonduse time; (c) containing a device that provides unidirectional air flow of ISO 5 air quality; (d) free of materials extraneous to sterile compounding; and (e) not used for other activities or purposes. (4988) ‘Significant adverse drug reaction’ means a drugrelated incident that may result in serious harm, injury, or death to the patient. (5089) ‘Sterile pharmaceutical’ means a dosage form devoid of viable microorganisms. (90) ‘Sterility test’ means a process designed to determine the presence of bacteria or fungi in or on a test device or solution. (5191) ‘Therapeutically equivalent’ means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 392440. (92) ‘Velocity’ means the displacement air flow across the line of demarcation between a buffer area into the ante area in a single room. (5293) ‘Wholesale distributor’ means a person engaged in wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; repackagers; ownlabel distributors; privatelabel distributors; jobbers; brokers; warehouses including manufacturers’ and distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions. "Wholesale distributor" does not include: (a) intracompany sales, being defined as a transaction or transfer between a division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity;
3161_20130227.docx