If you didn’t get a chance to attend, the webinar is available on-demand here. A special thanks to all who asked such good questions, both before and during the webinar. We received more questions than we could answer in a one-hour webinar, so here for the benefit of all are our responses to your questions.
USP <800> is meant to work in conjunction with <797>, so a lot of the regulations are harmonious. There are a few exceptions, and expect <797> to be updated with these new changes shortly. USP <800> states that the negative pressure room has to be between 0.01 and 0.03 inches of water column more negative than the surrounding areas. <797> didn’t have an upper limit. C-PECs now have to be located within a negative pressure room for all hazardous drug work. This does not have to be a CACI. The last difference is that all hazardous drug work needs to be done in a C-PEC.
Yes, you have to wear appropriate PPE at all times when you are at risk of being exposed to a hazardous drug. There are some exceptions. Some drugs when in their final dosing forms may fall outside of <800> restrictions and may not require full PPE. A risk assessment needs to be done on each hazardous drug to determine if this is appropriate or not.
If you are doing sterile hazardous drug compounding, then yes, both pairs of gloves need to be sterile. For non-sterile hazardous drug compounding, the gloves do not need to be sterile. All gloves need to follow USP <800> guidelines for testing and composition: powder-free chemotherapy gloves that meet American Society for Testing and Materials (ASTM) standard D6978 (or its successor) and are inspected for defects prior to use.
USP <800> does not have any restrictions or guidelines on the use of sharps with hazardous drugs. Caution should be exercised and precautions used to prevent exposure. A risk assessment of the technique used should be done to make sure the risk of exposure (e.g. puncture, cuts, etc.) is minimized or eliminated. Sharp containers should be easily accessible within the C-PEC during a procedure requiring the use of sharps. Note: sharp waste that has been exposed to hazardous drugs needs to be disposed of properly, and not mixed with non-hazardous drug sharp waste.
Hazardous drugs have to be prepared in their own designated biosafety cabinet (BSC) that is enclosed in a specially regulated room (at a minimum: 12 air changes per hour, exhausted outdoors through HEPA filtration, physically separated from other areas, 0.01-0.03 inches of water column negative pressure relative to surrounding rooms). You cannot use a standard biological preparation BSC for occasional hazardous drug preparation. Some non-hazardous drugs may be prepped in a hazardous drug BSC, only if the non-hazardous preparation is wrapped prior to being removed from the BSC, and all hazardous drug-appropriate PPE is worn at all times when the non-hazardous drug preparation is being handled. This is not an ideal situation.
No. The C-SEC, or room in which the BSC is located for hazardous drug preparation, must be between 0.01 and 0.03 inches of water column more negative than the surrounding areas.
All the personnel who may possibly come in contact with hazardous drugs are responsible for being compliant with the new USP <800> regulations. This includes all aspects of handling the drugs, from receiving to storage, compounding, administering and disposal. These regulations will be enforced by the FDA.
All personnel who come in contact with hazardous drugs need to be fully trained. They also need to be wearing the appropriate PPE. A risk assessment should be done to determine whether a CSTD would be beneficial during the transport and administration of any hazardous drugs in this setting.
It may. Some hazardous drugs in specific forms, and many final dosing forms, may fall outside of USP <800> regulations. As always, a risk assessment needs to be performed prior to making this decision.
Yes, this configuration is outlined in USP <800>, Appendix 2, and denoted to be typically used in oncology clinic settings. Both rooms need to be ISO Class 7 and have 30 ACPH (air changes per hour). This configuration has a restriction on the BUD (beyond-use date) which is outlined in Chapter <797>. As a reminder, the non-hazardous drug room is under positive pressure, and the hazardous drug room needs to be 0.01-0.03 inches of water column more negative than the non-hazardous drug room.
No, C-SECs (rooms) for sterile and non-sterile compounding do not require HEPA filtered external exhaust. The C-SEC must...
No. Non-sterile hazardous drug C-SECs do not require an ante-room. They only require being physically separated from other areas, negative pressure of 0.01-0.03 inches of water column relative to surrounding areas, and 12 ACPH.
Refrigerated antineoplastic hazardous drugs must be stored in their own designated refrigerator. No sharing with non-hazardous drugs is allowed. Some hazardous drugs, particularly those in their final dosing forms, may be allowed to be stored with non-hazardous drug materials, after a risk assessment has been performed.
The hazardous drug refrigerator must be in a negative pressure room with at least 12 ACPH. Examples include a storage room, buffer room, or C-SCA. You should consider an exhaust located adjacent to the refrigerator’s compressor and space behind the refrigerator in this negative pressure room.
Check out our pharmacy compounding resources page, where you can find links to even more information about USP <800>, <797>, and <795>.