USP <800> Regulations

Effective 12/1/2019, the following procedures for handling Hazardous Drugs must be complied with:

Here is the latest list (May 2019) of Hazardous Drugs from NIOSH – Lists drugs such as Dilantin, Klonopin, Coumadin, & Depakote so please review carefully.

These drugs must be kept in a segregated and marked area within the pharmacy away from regular pharmacy stock  (Sign just states “Hazardous Drug Storage Area”)

– Hazardous Drugs CANNOT be used in Robot.
– Hazardous Drugs CANNOT be used with a mechanical pill counter.
– Counting of Hazardous Drugs must be used with dedicated trays, spatulas, etc., and decontaminated after every use.

FOR ACTIVITIES PERFORMED WITHIN THE PHARMACY OF HAZARDOUS DRUGS (HD)

– Receiving, unpacking, and placing into storage, single gloves must be used – (I presume wholesalers and distributors will package HD separately by December 1st, 2019)
– Cutting, crushing, or otherwise manipulating tabs or capsules – must use Phenol or double nitrile gloves, wear a Hazardous (chemo) gown and perform in a Biological Safety Cabinet.
– Sterile and non-sterile compounding – – must use Phenol or double nitrile gloves, wear a Hazardous (chemo) gown and perform in a Biological Safety Cabinet.
– Counting or repackaging/pouring from one container to another – must use single gloves.
– Spills and leaks – must use double gloves, gown, eye protection & N-95 Respirator mask.

Also attached is an example of “Assessment of Risk” form.

At least every 12 months,  pharmacies that handle HD must complete an Assessment of Risk for the drugs and dosage forms on the NIOSH List of Antineoplastic and Other HD.

The CE below include practical tips to use during the process.
PPA has a pre-recorded CE on this subject that offers 1 ½ hours of CE.
Go to PPA Website – click on CE tab – find under miscellaneous or click on the link above.

The State Board Inspectors are already asking stores about their preparation for USP <800> regulations.

If you have friends that are not Keystone/PARD members, ask them to review.
By PARD Board rules, PARD can answer questions only to PARD/KEYSTONE members.

Thank You – GET IT STARTED AS SOON AS POSSIBLE!