The sweeping changes to USP compounding guidelines

Rick Meyer, Senior USP Consultant, sheds light on the differences between the USP <800> and the revised USP <797>, and what they mean to compounding facilities

The clock is ticking. The chapter <800> of the United States Pharmacopeia (USP) “Hazardous Drugs — Handling in Healthcare Settings” goes into effect on 1 December 2019 featuring a range of changes to the existing chapter for pharmaceutical compounding for sterile preparations, USP <797>, but what are the main differences?

The USP <800> has been expressly developed to provide three specific aspects of safety: protect the staff from exposure to hazardous drugs (HDs), prevent cross-contamination inside storage areas, and prevent transference of HDs from the preparation area to the patient space.

Protecting the employee from HD includes measures to prevent inhalation, exposure to skin absorption and HD transfer out of HD areas to other non-HD areas.

Cross-contamination inside the storage areas is prevented using isolation and negative pressure to contain the HDs and separation from non-HD drugs. The transference of HDs from the preparation area to the patient space is prevented by containing the hazardous materials until processed and leaving for the pharmacy.

To protect employees, the standard states gowns, gloves and other PPE should be used so no-HDs can penetrate them. The use of respirators to prevent inhalation of these drugs is required, so understanding the HD's possible routes of entry into the human body is paramount.

The removal of PPE is also a concern, as garments may have contacted the hazardous element and could release it during the degowning process, possibly contaminating the room and people if SOPs are not updated and followed.

Personnel protection can also come by utilising a hood to receive and wipe down the HDs in, thus protecting cross-contamination from cleaning in an open atmosphere and does not require a respirator for the operator.

If using a hood, work surface and base cabinet, the work surface needs a pass-through hole in it to allow contaminated wipes, gloves and waste to be dropped into a waste container in the cabinet below.

This approach has several advantages: it will eliminate product cross-contamination and protect the employee; lessen the cost of PPE as no respirator is needed; provide a vented hazardous waste storage area. If placed in the HD storage room, the hood ventilation system can be used to achieve the 12 ACPH required for the storage room.

What's new?

On the other hand, the USP <797> was implemented to tighten sterility and lessen contamination due to environmental concerns and personnel cross-contamination.

Everything from the type of materials used for construction, the sterilants used, all the way to the microbial (sampling required), are under constant change.

USP <797> now recognises that ante-rooms do harbour contamination and we expect to find microbial growth there.

The sampling methods change from 500 l/m to 1000 l/m minimum to meet ISO Classes 7 and 8 to match the ISO 5 Class from past changes. The increment in the sample volume leads to finding more contaminates and, in the long run, being able to determine where they are coming from.

There is much more to look at in regards to the changes and differences between these two standards. The best advice is to go get the latest documents and if need be, reach out to your local consultant to bounce issues or concerns off of them.

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