Thursday, October 27, 2016

USP 800 - Frequently Asked Questions (FAQs) Updated in September 2016

The United States Pharmacopeia (USP) --- the scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide" such as USP 797 and USP 800, has recently their FAQs for <800>.


The updated list of USP 800 FAQ's is available at http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings.
The <800> FAQs were last updated on the USP website on September 15, 2016.
Below is the list of USP 800 questions that are answered in the above link:
What is a hazardous drug?
Additional Resources:
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What is the purpose of this chapter?
Who enforces the chapter?
Who does the chapter apply to?
What settings does the chapter apply to?
Does the chapter apply to administration of HDs?
What is the status of the General Chapter <800> and when will General Chapter <800> become official?
Will there be updates or changes to the chapter?
How can I obtain a copy of General Chapter <800>?
Have there been any documented/published studies involving harm related to handling of HDs?
Where does the designated person obtain training? How much training does the designated person need?
Are there requirement for posting signs that HDs are being handled in the facility?
Can sterile and nonsterile HDs be stored together?
Can refrigerated non-antineoplastic HDs be stored with antineoplastic HDs?
Where should the sink be located?
Can non-HDs and HDs be compounded in C-PECs located in the same C-SEC?
Can a Laminar Airflow Workbench (LAFW) or compounding aseptic isolator (CAI) be used for compounding a non-antineoplastic HD?
Can a BSC or CACI used for compounding HDs be used for compounding non-HDs?
Is there an evaluation tool one can use for evaluating the performance of the different closed-system drug-transfer devices (CSTDs) available?
How can a closed-system drug-transfer device (CSTD) be chemically incompatible with a HD?
What is meant by "fixed walls"?
Are pressure gauges required to monitor the pressure differential between the C-SEC and the adjacent areas?
Is environmental wipe sampling required?
Why is environmental wipe sampling recommended when there is currently no standard for acceptable limits on HD surface contamination?
What are the acceptable limits for HD surface contamination?
Are compounders required to remove all PPE when leaving the compounding area?
Can gowns be re-worn during the same day if a compounder leaves the HD compounding area?
What documentation is required to show that a gown will resist permeability by HDs?
Where should HD APIs be handled prior to sterilization when compounding sterile HDs?
Does the chapter apply if the HD is dissolved in a liquid dosage form and does not become an aerosol or 
If the HD is a liquid dosage form, may it be compounded in a positive pressure non-HD cleanroom?
Do personnel of reproductive capability include both male and females?
Does the HD return waiting area have to be separate from the regular HD storage area?
What container materials are considered impervious?
What is the tiered approach for receiving HDs?
What must be on the label for HDs?
What kind of packaging containers can be used for packaging HDs?
Can HDs be transported in pneumatic tubes, robots, or patient carts?
Are personnel involved in waste removal and cleaning required to don PPE?
What if the employee wants to keep their medical records private from the employer?
What "health variables" should be followed over time for individual workers?
In a medical surveillance program, how does an employer obtain data from the unexposed workers for comparison to the exposed workers?



USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia


USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800


USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

USP 800
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp800.guru 
W: www.usp800.guru 


USP 800 Hazardous Drugs - New List Published

USP 800 governs the handling of hazardous drugs. But what drugs does USP 800 define as hazardous?

The list of hazardous drugs referred to in USP 800 is the list published by the National Institute for Occupational Safety and Health (NIOSH). The list is entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings".

This list of hazardous drugs was first published in September 2004. It was updated in 2010 and 2012. The latest version of this list was published in September 2016.

To download a copy of the latest list of hazardous drugs, as of the date of this article, published by NIOSH, which are the hazardous drugs referred to in USP 800, go to:
http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

Additional Resources:

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USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow USP797.org:

USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow PharmacyDesign.org:

PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP800.guru:

USP800.guru
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp800.guru 
W: www.usp800.guru 

USP 800 Architectural Design Article to be Published

Bernstein & Associates, Architects is pleased to announce that an article written by the firm's principle, William N. Bernstein, AIA, on the architectural and engineering design of USP 800 compliant spaces, is scheduled for publication in November 2016. 

Further details on the article will be provided when the article is published. 

Bernstein & Associates, Architects has been on the vanguard of understanding and implementing the USP 797 guidelines since 2005, and the draft USP 800 guidelines since 2014. The firm has designed over (25) USP 797 compliant pharmacies and currently has (5) USP 800 compliant compounding suites that are in the design phase.  

For further information on USP 800 architectural design, please see http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/

For further information on USP 800 architectural design, please see http://bernarch.com/healthcare-design-usp-797-compliant-pharmacy-design-and-consulting/

For further information on pharmacy design, please see http://bernarch.com/healthcare-design-pharmacy/

Additional Resources:

Follow Bernstein & Associates, Architects:

Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Follow USP800.guru:

USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook:  https://www.facebook.com/USP800

Follow USP797.org:

USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797

Follow PharmacyDesign.org:

PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP800.guru:

USP800.guru
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp800.guru 
W: www.usp800.guru