A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
September 2016
NIOSH Docket Number 288-A, CDC-2016-0090
NIOSH will hold a public meeting to discuss a universal closed system drug-transfer device (CSTD) testing (draft) protocol entitled, A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. The new universal performance test protocol is applicable to both barrier and air-cleaning types of CSTDs. The meeting will allow commenters the opportunity to address the new draft protocol, the proposed list of hazardous drug test surrogates, and to discuss NIOSH questions regarding the new protocol. The meeting is open to the public, limited only by the capacity (80 attendees) of the conference room. The public meeting will be held on November 7, 2016, 9:00 a.m. – 3:00 p.m. Eastern Time, or until after the last public commenter has spoken, whichever occurs first. It will be held at CDC/NIOSH Alice Hamilton Laboratories Conference Room C, 5555 Ridge Avenue, Cincinnati, OH 45213. Registration is required for both in-person and LiveMeeting participation. Information on how to register is in the Federal Register notice along with information for any non-U.S. citizen wishing to attend this meeting.
To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2016-0090 in the search field and click “Search.”
To view previous docket see CDC-2015-0075; NIOSH-288.
Reference Documents
- Federal Register Notice: Federal Register Notice 7-26-17 [PDF – 204 KB] – Comment period extended
- Federal Register Notice: Federal Register Notice 6-1-17 – Comment period extended
- Federal Register Notice: Federal Register Notice 12-8-16 [PDF – 187K] – Comment period extended
- Federal Register Notice: Federal Register Notice [PDF – 216K]
- Background Information: DRAFT A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs [PDF – 2M]
Public Comment Period
Comments will be accepted until 11:59 p.m. ET on February 28, 2018.
Written comments, identified by CDC-2016-0090 and docket number NIOSH-288-A, may be submitted by any of the following methods:
- Federal rulemaking portal: Follow the instructions for submitting comments.Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov
- Mail: National Institute for Occupational Safety and Health
NIOSH Docket Office
1090 Tusculum Avenue
MS C-34
Cincinnati, OH 45226-1998
Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov
- Page last reviewed: September 7, 2016
- Page last updated: July 26, 2017
- Content source:
- National Institute for Occupational Safety and Health Education and Information Division