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

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?
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?

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