80 FR 53802 - A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Request for Comment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 173 (September 8, 2015)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. The document and instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law.

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53802-53803]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2015-0075, Docket Number NIOSH-288]


A Vapor Containment Performance Protocol for Closed System 
Transfer Devices Used During Pharmacy Compounding and Administration of 
Hazardous Drugs; Request for Comment

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of draft document available for public comment.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability of the following draft document for public 
comment entitled A Vapor Containment Performance Protocol for Closed 
System Transfer Devices Used During Pharmacy Compounding and 
Administration of Hazardous Drugs. The document and instructions for 
submitting comments can be found at www.regulations.gov.
    This guidance document does not have the force and effect of law.

Table of Contents

     DATES:
     ADDRESSES:
     FOR FURTHER INFORMATION CONTACT:
     SUPPLEMENTARY INFORMATION:


DATES: Electronic or written comments must be received by November 9, 
2015.

ADDRESSES: You may submit comments, identified by CDC-2015-0075 and 
Docket Number NIOSH-288, by either of the two following methods:
     Federal eRulemaking Portal: www.regulations.gov Follow the 
instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
1090 Tusculum Avenue, MS-C34, Cincinnati, Ohio 45226.
    Instructions: All information received in response to this notice 
must include the agency name and the docket number (CDC-2015-0075; 
NIOSH-288). All relevant comments received will be posted without 
change to www.regulations.gov, including any personal information 
provided. All electronic comments should be formatted as Microsoft 
Word. Please make reference to CDC-2015-0075 and Docket Number NIOSH-
288. All information received in response to this notice will also be 
available for public examination and copying at the NIOSH Docket 
Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226-1998.

FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Division of 
Applied Research and Technology, Alice Hamilton Laboratories, 1090 
Tusculum Avenue, MS R-5, Cincinnati, Ohio 45226, (513) 841-4141 (not a 
toll free number), Email: [email protected].

SUPPLEMENTARY INFORMATION: The purpose of the protocol is to test a 
closed system transfer device's (CSTD) capability to perform as a 
closed system. During an evaluation of the protocol,

[[Page 53803]]

registered pharmacists, familiar with the use of CSTDs, tested the 
protocol's prescribed compounding and administration tasks using five 
commercially available CSTDs. They also performed the assigned tasks 
using a negative control condition without a CSTD. Prescribed tasks 
were performed in a NIOSH-developed environmental test chamber with 70% 
isopropyl alcohol (IPA) as the challenge agent. A highly specific gas 
analyzer, with measurement capabilities specific to IPA and with a low 
limit of detection (LOD), was used to detect vapor concentrations of 
escaped IPA during the tasks. The protocol is not intended for CSTDs 
designed to operate using air-cleaning technologies. This protocol has 
multiple applications and can be used by manufacturers to evaluate 
prototype CSTDs, by consumers to compare CSTD products, or by 
jurisdictions wishing to adopt the protocol for a CSTD performance 
certification procedure.
    A panel consisting of peer reviewers and stakeholders was asked to 
review and comment on the draft guidance document and protocol. NIOSH 
reviewed the recommendations of the peer reviewers and stakeholders 
then made the final determination regarding document content as well as 
the decision not to propose a specific pass/fail performance threshold. 
The protocol is being published for comment in CDC-2015-0075 and Docket 
Number NIOSH-288 and can be found at www.regulations.gov.

    Dated: September 1, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-22525 Filed 9-4-15; 8:45 am]
 BILLING CODE 4163-19-P