USP <800> Will Become Enforceable for Facilities Once Revisions of <795>, <797> Approved

Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable.

In a presentation at the American Association of Pharmacy Technicians 2022 Annual Pharmacy Technician Convention, Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, discussed what pharmacists should know about USP <800>.

“The purpose of USP <800> is to protect the pharmacy department, nursing department, anyone that works in the hospital, and any patients at the hospital from being unnecessarily exposed to hazardous drugs,” Straughn said in his presentation.

“It kind of gets a bad rap because there is a lot of implementations required, but it is for us. It's not like USP <797>, which is to protect the patients from infection. This is for us, so we really should be invested in this and do the best that we can to make sure that everybody is safe.”

Straughn said that the revisions of USP <795> are not yet enforceable, but once the revisions do become enforceable, USP <800> will also become enforceable for facilities that compound nonsterile products, including any community pharmacies that do compounding.

He said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable.

His presentation highlighted a list of the type of hazardous drugs, specifically from the National Institute of Occupational Safety and Health (NIOSH), which is what USP <800> refers to.

“The USP 800 also says you can't just take the NIOSH list and say, ‘oh, this is our hazardous drug list. We might have some medications on here.’ They say you need to take the medications off the NIOSH list your institution has and listed separately so that your staff knows what to watch out for,” Straughn said in the presentation.

The hazardous drugs NIOSH refers to include carcinogenicities, developmental toxicities, reproductive toxicities, organ toxicities at low doses, and genotoxicities.

There are 3 categories on the NIOSH list. Category 1 includes antineoplastic drugs, which is chemotherapy; category 2 includes non-antineoplastic drugs deemed hazardous by other NIOSH criteria; and category 3 includes drugs that have a reproductive risk and are only hazardous to women of childbearing age, women who are pregnant, or women trying to become pregnant.

Straughn also mentioned that in 2022-2023, NIOSH will be removing any medication antibodies from their list, which will include cancer medications, which are still hazardous.

“My recommendation is your institutions are going to be going through all this work to implement USP <800>. You all should include these other medications that might not be on that NIOSH list yet are still hazardous,” Straughn said in the presentation.

A pharmacy’s list of hazardous drugs should be reviewed ever 12 months with a document review, when a new agent or dosage form is added, or if storage, preparation, or administration of the hazardous drug will not meet USP <800> standards and an assessment of risk must be done.

The elements of USP <800> include receipt, storage, compounding, dispensing, administration, disposal, and cleaning.

When receiving hazardous drugs, they must be unpacked in a neutral or negative pressure room and cannot be unpacked in sterile compounding areas.

“The shipping containers should come to you intact, ready for you to unpackage. It should say hazardous on it, and you should know,” Straughn said in the presentation. “If it comes to you damage and you're worried that vial is in there, its leaked…you should contact the manufacturer and see if they can be returned.”

When storing hazardous drugs, they must be stored to prevent spillage or breakage, ideally in an externally ventilated, negative pressure room. For compounding, C-PEC is used as the primary engineering controlled ventilated device and C-SEC is the secondary engineering control in the room where C-PEC resides.

There are also closed-system transfer devices to help prevent chemotherapy spills, offer more protection, and must be used when administering the drug.

It offers more protection because an individual is never exposed to the liquid, and though there is no universal performance standard, it is recommended to be used when compounding.

For chemotherapy drugs, USP <800> also says that a second pair of gloves for chemotherapy, a second gown, and a second pair of shoe covers must be used. Eye and face protection should also be used when there is a risk of spills and splashes.

Hazardous personal protective equipment (PPE) should be disposed as chemotherapy waste and an individual should de-garb the secondary layer in the same room as the chemotherapy was.

When dispensing hazardous drugs, they must be labeled as hazardous and packaged to protect from damaging and leaking. They should also be transported in acceptable containers to minimize the risk of breakage and leakage.

When administering hazardous drugs, PPE must be used. The individual must prime the intravenous tubing in the C-PEC and the closed system drug-transfer device should be used when the dosage form allows.

It is also suggested to avoid manipulating hazardous drugs when possible, such as crushing tablets and opening capsules.

Hazardous drugs should be disposed in the designated yellow waste bins. Cleaning is also in compliance with <795> and <797>, including deactivation, decontamination, cleaning, and disinfecting. Additional requirements include spill kits where hazardous drugs are administered, prepared, or received.

Documentation and standards of practices should be maintained for all stages of handling hazardous drugs. Additionally, medical surveillance as an assessment and documentation of evidence suggesting potentially harmful hazardous drugs should be used.

Community pharmacies that do not perform compounding activities are not required to follow USP <800>. However, if they do compounding, they will need to follow USP <800> and need an assessment of risk that includes type of hazardous drug, the dosage, risk of exposure, packaging, and manipulation.

Editor's Note: Changes were made on July 27, 2022 to reflect that community pharmacy that do not perform compounding are not rquired to follow USP <800> or have an assessment of risk.

References

Straughn K. USP <800>: protecting you and your co-workers from hazardous drugs. Raleigh-Durham, NC: AAPT 2022 Annual Pharmacy Technician Convention; July 23, 2022.