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;
“Section 404388. (A) The purpose of this section is to provide standards for the preparation, labeling, and distribution of sterile products by pharmacies, pursuant to or in anticipation of a prescription drug order for a patient in home health care. (B) The pharmacy shall have a separate area designated for placement of the Class 100 laminar airflow hood, which must: (1) be constructed so as to allow visual observation; (2) not be a thruway for traffic; (3) have walls, floor, ceiling, and work surfaces constructed of materials that are nonporous and do not produce particulate matter; (4) be ventilated in a manner that will not interfere with the outward flow of air from the hood; (5) not be used for unpacking bulk supplies; (6) not be used for storage of bulk supplies and materials; and (7) have an eye wash station and sink readily accessible to the area. (C)(1) All sterile pharmaceuticals must be prepared within the airflow hood work surface. (2) Work surfaces of the airflow hood must be cleaned with seventy percent isopropyl alcohol or an equivalent disinfectant every eighthour work shift and as needed for microbial, drug, and particulate matter removal. This cleaning must be documented by date, time, and initials. Documentation must be retained for two years. (3) The airflow hood must be certified by a qualified technician every twelve months and must be recertified each time the hood is moved for operational efficiency in accordance with federal standards. The certification must be attached to the front of the hood and shall state the date the certification was performed. Certification documents must be retained for two years. (4) The sterile product preparation area must be cleaned and disinfected weekly with appropriate agents according to written policy and procedures. This must be documented by date and initials and retained for two years. (5) Prefilters must be changed in accordance with manufacturer’s specifications. Changes must be documented by date and initials and documentation must be retained for two years. (6) Work surfaces inside the airflow hood must be clear of drugs, records, labels, and equipment unrelated to work in process.