federal_register: 2016-00827
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
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| 2016-00827 | Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs | Notice | The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices (CSTDs) that adopt air-cleaning technologies. CSTDs are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. A draft protocol titled, "A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs," was developed by NIOSH to evaluate how protective the physical barrier-type CSTD devices were as an indicator of how effective they would be at preventing hazardous drug escape from the closed system. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic. | 2016-01-19 | 2016 | 1 | https://www.federalregister.gov/documents/2016/01/19/2016-00827/request-for-information-on-development-of-a-performance-test-protocol-for-closed-system-transfer | https://www.govinfo.gov/content/pkg/FR-2016-01-19/pdf/2016-00827.pdf | Health and Human Services Department; Centers for Disease Control and Prevention | 221,44 | The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices... |