(A) The purpose of this section is to provide “Section 404388. 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 must be documented by manufacturer’s specifications. Changes 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.
“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.
3161_20130227.docx