Road To USP 800 Compliance

Section 12  Dispensing Final Dosage Forms

Sections 1 through 11 of USP Chapter 800: Hazardous Drugs—Handling in Healthcare Settings provides the blueprint for safely getting a hazardous drug into our facilities and on to shelves on our road to compliance. Section 12 provides us with a brief guidance on handling hazardous drug in their final dosage forms. The primary goal of this section is to provide guidance on clarifying products in their most ready to use form for patient administration. This section is primarily devoted to solid oral dosage formulations.

When hazardous drugs do not require any compounding or ‘manipulation’ of the manufacturers commercial products (intact tablets, capsules) outside of repackaging into unit of use forms, the products may be prepared for dispensing without any further requirements for containment. Package inserts of defined hazardous drugs should be reviewed with focus on the manufacturer handling requirements.

Sites should try to purchase defined hazardous drugs in unit of use packaging from the manufacturer to minimize the need to repackage on-site. The process of counting and repackaging of hazardous drug must be done carefully. For products that are not available from manufacturers in unit of use packaging, sites should examine each bulk product and look for tablets and/or capsules that may have powder residue. This is commonly seen with punch tablets without a protective coating. Noting the bulk packages with particulate-potential should prompt sites to have those products handled and repackaged in a containment primary engineering control or a containment ventilated enclosure with a full or partial enclosure that uses ventilation to capture, contain, and remove airborne particulates using HEPA filtration. Staff should be educated on the products that have the potential to illicit particulates. As sites change manufacturers of on-formulary products and add new drugs to the formulary, products should be examined for particulate-generation potential.

Outlined in both USP <800> and in USP <795>, clean equipment should be dedicated for use with hazardous drugs and should be decontaminated after every use.  Decontamination as defined by USP <800> denotes the “Inactivation, neutralization, or removal of hazardous drug contaminants on surfaces, usually by chemical means.”  Isopropyl alcohol is commonly used for this step, however, isopropyl alcohol is a disinfectant and is not able to inactivate and neutralize any hazardous drug residues.  Sites must use the same products used in the compounding of sterile hazardous drugs when preparing the primary engineering controls, e.g., sodium hypoclorite solution followed by sterile isopropyl alcohol. Equipment dedicated to hazardous drugs may include counting trays, counting spatulas, scales, and manual unit dose equipment.

Solid dosage formulations of antineoplastic agents must not be placed in automated unit dose packaging devices. These devices can inadvertently stress drugs or crush them resulting in the generation of hazardous drug particulate matter leading to a dry hazardous drug spill. This should not be confused with the ability to store these medications in automated dispensing cabinets and drug storage carousels.

As the NEW official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.


[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings accessed 2018 September 15.


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