USP–NF General Chapter <800>

Hazardous Drugs—Handling in Healthcare Settings

Chapter USP <800> explicitly addresses the handling of compounded hazardous drugs (HDs) within healthcare settings. USP <800> is meant “to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations.” 

Understanding the definitions, best practices, and ideal consumables for certain applications is fundamental to meeting proposed guidelines. Contec is committed to providing quality, data, and research-driven consumables for sterile compounding areas, but more importantly, we are helping to protect employees and patients from unnecessary risks during HD Compounding. 

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USP <800> Guidelines

About USP <800>

USP <800> Hazardous Drugs —Handling in Healthcare Settings specifically addresses the handling of compounded Hazardous Drugs (HDs*) in healthcare settings. USP <800> is intended “to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations.”

*See current NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

Understanding the definitions, best practices, and recommended solutions are key to meeting the USP <800> standards. Contec is committed to providing quality, research and experience-driven consumables for critical compounding areas, but also to protect employees, patients, and the compounding environment from exposure to hazardous drugs.

USP <800> describes many aspects of decontamination during compounding of hazardous drugs.  Several issues are highlighted below that impact the selection of appropriate chemistries, applicators and processes.

USP <800> Guidelines - Section 15

Deactivating, Decontaminating, Cleaning and Disinfecting

  • All areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned.
  • Additionally, sterile compounding areas and devices must subsequently be disinfected.
  • The deactivating, decontaminating, cleaning, and disinfecting agents selected must be appropriate for the type of HD contaminant(s), location, and surface material.
  • The products used must be compatible with the surface material.
  • Agents for deactivation, decontamination, and cleaning should be applied through the use of wipes wetted with appropriate solution and not delivered by a spray bottle to avoid spreading HD residue.
USP <800> Guidelines - Section 15.1

Deactivation

  • Deactivation renders a compound inert or inactive.
  • The ultimate goal should be complete surface decontamination.
  • Products that have known deactivation properties (EPA-Registered oxidizing agents that are appropriate for the intended use) should be used when possible.
  • Care should be taken when selecting materials for deactivation due to potential adverse effects (hazardous byproducts, respiratory effects and caustic damage to surfaces).
  • Damage to surfaces is exhibited by corrosion to stainless steel surfaces caused by sodium hypochlorite if left untreated.
USP <800> Guidelines - Section 15.2

Decontamination

  • Decontamination occurs by inactivating, neutralizing, or physically removing HD residue from non-disposable surfaces and transferring it to absorbent materials (e.g., wipes, pads or towels) appropriate to the area being cleaned.
  • When choosing among various products available for decontaminating HDs, consideration should be given to surface compatibility and facility requirements.
USP <800> Guidelines - Section 15.3

Cleaning

  • Cleaning is a process that results in the removal of contaminants (e.g., soil, microbial contamination, HD residue) from objects and surfaces using water, detergents, surfactants, solvents and/or other chemicals.
  • Cleaning agents used on compounding equipment should not introduce microbial contamination.
USP <800> Guidelines - Section 15.4

Disinfection

  • Disinfection is a process of inhibiting or destroying microorganisms.
  • Before disinfection can be adequately performed, surfaces must be cleaned.
  • Disinfection must be done for areas intended to be sterile, including the sterile compounding areas.

 

 

USP <800> Guidelines for Deactivating, Decontaminating, Cleaning and Disinfecting

Cleaning Steps

Cleaning Steps
Cleaning Step and
C-D3 Protocol with PeridoxRTU
PurposeExample Agents

Deactivation

 
PeridoxRTU® is an EPA-registered oxidizer

Render compound inert or inactive

As listed in the HD labeling or other agents which may incorporate Environmental Protection Agency (EPA) registered oxidizers (e.g., peroxide formulations, sodium hypochlorite etc.)

Decontamination

 
The C-D3 Protocol has been proven effective by independent third-party lab testing and field trials*

Remove HD residue

Materials that have been validated to be effective for HD decontamination, or through the use of other materials proven to be effective through testing, which may include alcohol, water, peroxide, or sodium hypochlorite

Cleaning

 
PeridoxRTU meets the definition of a germicidal detergent

Remove organic and inorganic materials

Germicidal detergent

Disinfection

(for compounding sterile preparations)  

PeridoxRTU is an EPA-registered disinfectant

Destroy microorganisms

EPA-registered disinfectant and/or sterile alcohol as appropriate for use

If the actions described in Section 15 of USP <800> are considered as separate steps, the practical order for resolving hazardous drug residues in sterile compounding would be cleaning, decontamination, deactivation and disinfection. However, all four of these aspects can be accomplished with a single chemical formulation applied with an appropriate wiping protocol.

Contec has introduced the C-D3 Protocol to describe products and protocols that can accomplish Cleaning, Deactivation, Decontamination and Disinfection of hazardous drugs during sterile compounding. Currently, PeridoxRTU® Sporicidal Disinfectant and Cleaner used with appropriate textiles and wiping procedures qualifies as a C-D3 Protocol.  As shown below, PeridoxRTU satisfies all the requirements indicated in Table 5 of USP <800>.