Following are the questions posed and answers given by Rpharmy's Customer Experience Specialist Sherlene Christen on the April 13th USP <800> Lunch + Learn.
Q: What PPE is required for compounding hazardous drugs?
A: For sterile and non-sterile compounding, USP states that a chemotherapy gown, head, hair and shoe covers, and two pairs of chemotherapy gloves are required. However, for sterile compounding, that outer glove needs to be sterile.
Also, USP states that when you go into the C-SEC clean room, two pairs of shoe covers are required. When entering the C-SEC, the outer pair needs to be removed and placed in the trace waste bin when exiting the C-SEC.
Q: Can gowns be re-worn on the same day if a compounder leaves the compounding area?
A: No, in general, disposable PPE must not be reused. You need to consider all PPE contaminated if worn when handling HDs.
However, if compounding Category 1 or 2 compounded sterile preparations, a gown may be reused within the same shift by the same person if the gown is maintained in a classified area or adjacent to, or within, the SCA in a manner that prevents contamination.
Of note, there is a new, first-to-market chemotherapy-rated gown available. The ASTM number for that gown is ASTMF 3267-22. It may be a good option for your organization.
Q: With your interpretation of USP <797>, do you read that a base layer gown needs to be worn under a “chemo” rated gown?
A: In the last USP <800> webinar, it was mentioned that a chemo-rated gown that was impermeable should go over a bunny suit before entering the C-SEC. The chemo gown must be removed - just like that secondary shoe cover -before exiting the C-SEC. Based on this, if you are wearing a base layer gown under that chemo-rated gown, that would fall into the same category.
Q: Does the Designated Person have to be a pharmacist?
A: No, the Designated Person does not have to be a pharmacist. USP simply states that the designated person must have a thorough understanding of the USP <800> chapters - meaning they've studied that chapter and can develop and implement the procedures that are called out in that chapter. They also oversee the compliance for the facility and ensure that they're following all the laws, regulations and standards. The Designated Person also must have full competency for the personnel and ensure environmental control of not only the storage but the compounding area.