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USP 800…be ready !

UPS 800 (organization depending from US Pharmacopeia) has developed very clear standards to protect healthcare personal handling cytotoxic drugs. These rules will be enforceable by federal law as per December 1st, 2019 in the US.
Please find below answers to key questions you might have.


“Get prepared to safe handling of Hazardous Drugs
with 6 key questions & answers extracted from USP 800 Standards”
(Enforceable by December 2019 in the U.S)

1. What is a CSTD?

A CSTD (Closed System Drug Transfer Device) mechanically prohibits the transfer of environmental contaminants into the system and the escape of Hazardous Drugs (HD’s) or vapor concentrations outside the system.

2. Does USP 800 require the use of CSTD’s for compounding HD’s?

USP recommends the use of CSTD’s for compounding, but it is not a requirement.

3. Does USP 800 require the use of CSTD’s for administering HD’s?

Antineoplastics must be administered with a CSTD when the dosage form allow.

4. Why do nurses need to use a CSTD when administering chemo?

Without CSTD, nurses have no protection other than PPE (Protective Personal Equipment). The CSTD provides protection to personnel and the environment while they are administering antineoplastic agents.

5. What precautions must be in place for the nursing staff who administer HD’s to patient in an outpatient infusion setting?

All personnel who come in contact with HD’s must wear appropriate PPE, use of CSTD’s, and other requirements of USP 800.

6. How does USP 800 apply to patient’s home?

It doesn’t because the home is not a healthcare setting. However, it may apply to home healthcare workers who should be included in the entity’s policies and procedures.