Based on popular demand, we now offer “USP 800 – Hazardous Drugs” policy through our compliance platform RxPolicy.
Starting this year, most PBMs require this policy for recredentialing. In addition, it is a required policy for compounding, retail, LTC, and clinical pharmacies, and any other entities that handle hazardous drugs. There is a mistaken assumption that if a pharmacy does not compound, it does not need to worry about complying with USP 800. Note that you must comply with USP 800 if you receive, store, compound, handle in any way, dispense, or administer hazardous drugs (“HDs”). HDs are defined in NIOSH List of Antineoplastic and Other Hazardous Drugs. HDs include any drugs with the following characteristics:
– carcinogenicity or other development toxicity
– organ toxicity at low doses
– reproductive toxicity.
Accordingly, HDs include drugs that are used for chemotherapy, antiviral drugs, hormones, and many others that are dispensed by a typical retail pharmacy. So the chance that you do not have to comply with USP 800 is very slim.
Your USP 800 must be customized to address:
– HDs that the pharmacy handles
– applicable facility and engineering controls
– safe segregation and disposal of HD
– exposures (such as spills)
– responsibilities of personnel handling HDs
– personnel training
– proper labeling
– cleaning steps.
You can download a template from RxPolicy or feel free to contact us if you have any questions regarding this policy.