Safety First Blog

Requirements for Drug Assessments

Posted by Laura Paxton on May 11, 2023 8:50:30 AM
Laura Paxton
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A Recap of the  April 27th USP <800> Preparedness Lunch + Learn

When thinking about hazardous drug characteristics, the things that you have to consider are the following:  

  • Carcinogenicity 
  • Teratogenicity or other developmental toxicity 
  • Reproductive toxicity 
  • Organ toxicity at low doses 
  • Genotoxicity 
  • Structures and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the previously mentioned criteria


In a perfect healthcare world, drugs reviewed by P&T have already been assessed for hazardous characteristics, but what about those that have yet to make it to P&T?

How long after a new hazardous drug comes through your facility's doors does the staff have the information needed for managing the risk? 


  • 66% said a month or longer.
  • 33% said one to five days.

Restating some commonly known aspects of the NIOSH 2016 and 2020 lists is worthwhile. 

NIOSH 2016 consists of three groups: 

  • Group one: Antineoplastics
  • Group two: Non-antineoplastics that meet one or more criteria and of the NIOSH criteria for a hazardous drug 
  • Group three: Drugs primarily pose a reproductive risk to men and women 

Interestingly, in our first client installation, he asked us to create groups four and five for his organization because he wanted a group for flammable products and one for monoclonal antibodies. Some toxic drugs may be on your state's EPA list that might not be on either NIOSH list. If you're handling flammable products in your compounding area, which are often caustic, hazardous chemicals, consider adding a group for those drugs.  

Many clients include all the NIOSH 2016 drugs on their hazardous drugs list to mitigate risk, but then they categorize them based on the NIOSH 2020 list using the Table One and Table Two criteria. 

A gap we often see is hazardous drugs missing from an organization’s list because many drugs are approved or fast-tracked through the FDA but not on the NIOSH list. This requires that your organization determine whether the drug is deemed hazardous. Assessing drugs can be challenging because information regarding toxicities for new, fast-tracked or investigational drugs can be scarce. 

How to complete an assessment: 

  1. Refer to a subscription drug information source such as Lexicomp or Clinical Pharmacology. 
  2. Considering the formulation and risk of exposure
  3. Reviewing the six HD characteristics using:
    1. Drug package insert or safety data sheet to identify any previously mentioned HD characteristics.
      1. Box warnings
      2. Warnings and precautions
      3. Adverse reactions
      4. Use in specific populations
      5. Nonclinical Toxicology
      6. Storage and handling
    2. International Agency for Research on Cancer (IARC) to identify carcinogenicity.
    3. Published studies in humans or animals. 
      1. PubMed by the National Institutes of Health is a valuable source for published studies in humans or animals.

At Rpharmy, we search for any available hazardous drug information when a new antineoplastic is brought to the market or a drug with similar characteristics to one on the NIOSH 2016 or NIOSH 2020 lists. When one of our clients adds one of the new FDA-approved drugs to their hazardous drug list, we share that with you on Twitter at @Rpharmy. 

Be aware that NIOSH removed any standard monoclonal antibodies from the list of the hazardous drugs. One reason is that the molecular size of these medications is too large to have any appreciable penetration through the skin. However, some are conjugated with other properties and would need to be handled accordingly. 

The NIOSH 2016 list is updated periodically with interim changes noted on their website, and an organization’s Designated Person should be monitoring the NIOSH website for updates. 

A rule of thumb is: If available sources do not provide enough evidence to ensure the drug is nonhazardous, it should be considered hazardous until NIOSH reviews it or additional literature is available.


Knowing the below information, would you be inclined to put capsaicin 8% on your HD list?

Unintended exposure to capsaicin can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others.

Ensure that the recommended procedures and protective measures are used when administering. For healthcare professionals:

    • Wear nitrile gloves when administering and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.
    • Use of a face mask and protective glasses is advisable.


  • 66% said yes, you would put capsaicin 8% on your hazardous drug list. 
  • 33% said no, you would not. 


There is no right or wrong. The objective is to protect everyone from known risks. 

Remember that your hazardous drug list may be NIOSH-based, but it is also your decision to determine what additions are made to your organization's list. An inspector is not going to cite you for being overprotective.

Check out the Rpharmy Resource Page with quick links to NIOSH 2016, NIOSH 2020, DrugBank, DailyMed, and much more. 

Also, learn more about the USP <800> Preparedness Lunch + Learn, watch videos from previous sessions, and register for the next live event.  

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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