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How To Meet USP <800> Labeling Requirements

It’s a common occurrence in health systems every day. Workers handle hazardous drugs (HD). In fact, more than 12 million doses of an HD are administered each year by nearly 8 million healthcare workers. What’s more, if the drugs are handled improperly, the workers put themselves and others at risk. That’s why it’s vital to design a process to avoid these dangers which is the purpose behind USP <800>. The United States Pharmacopeial Convention (USP) developed requirements for hazardous drugs with intent to limit exposure to healthcare workers, patients, staff, family or visitors. And it goes into effect December 1, 2019.

Who Does USP 800 Apply To?

Many organizations including pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices use HDs. And the steps recommended in USP 800 promote patient safety, worker safety, and environmental protection when handling hazardous drugs. USP 800 is enforced by the FDA and other oversight agencies such as The Joint Commission. 

So use these strategies to comply with the standard and protect those who administer and come into contact with hazardous drugs.

How To Comply With USP 800

In fact, it’s the drug that determines the proper strategy. For example, if the drug is a hazard or not determines which regulations to follow. Further, if the drug requires compounding, you may need to implement additional controls. So first, identify the HDs you handle to ensure proper management. 

Identify Hazardous Drugs (HDs)

Start by closely reading the National Institute for Occupational Safety and Health’s (NIOSH) 2016 list of HD to see which are classified as hazardous. They offer a list of Hazardous Drugs in Healthcare Settings 2019.

NIOSH defines HDs as the following:

  • Carcinogenicity
  • Teratogenicity or other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profiles that mimic existing drugs determined hazardous by the above criteria

Inventory Hazardous Drugs (HDs)

Once you’ve identified the HDs, segregate the inventory. Typically, the hazardous drug name, its form and whether it is a tablet, capsule or liquid, should be noted. Shelf labels help communicate that vital information to your staff. In addition, precaution labels applied to the container alert workers to the hazardous drug and its potential harm.  

Use Appropriate Personal Protective Equipment

Use Appropriate Personal Protective Equipment (PPE)

An essential USP <800> safety element is the use of appropriate PPE. In fact, it must be worn when handling HDs during receipt, storage, transport, compounding, administration, deactivation/decontamination, cleaning and disinfecting, spill control, and waste disposal. Moreover, use auxiliary labels to help guide staff on the proper administration and disposal of the PPE. 

HD Transportation

Handling and Transporting Hazardous Drugs (HDs)

When shipping HDs to locations outside your operation, consult the transport information on the safety data sheet (SDS). You must ensure that labels and accessory labeling for the HDs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier's policies. GHS labels are a common method used to communicate this information. 

Medication Compounding Labeling

Also, some HDs are formed by medication compounding. When compounding HDs, in addition to the recommended PPE and safe handling requirements, proper labeling is also a must. In fact, personnel must ensure that the labeling processes for compounded preparations do not introduce contamination into the non-HD handling areas.

>Further, labeling should be done according to state and federal regulations and include the:

  • Generic or chemical names of the active ingredients
  • Strength or quantity
  • Pharmacy lot number
  • Beyond-use date
  • Any special storage requirements

Typically, organizations use pharmacy and prescription medication labels for compounding applications. 

USP 800 Processes Protect Your Staff

HD Transportation

Without proper safeguards, HDs can severely impact your staff. And, even though clinicians understand that drugs can be harmful, what they fail to realize is that they are potentially exposed when performing routine handling activities. Exposure can cause numerous issues ranging from hair loss to kidney damage and even cancer. Implementing the safeguards detailed in USP 800 will reduce those risks. 

United Ad Label USP 800 Services

United Ad Label provides stock and custom USP <800> labels that help healthcare organizations protect their workers, patients, staff, family and visitors. Contact us to learn more.

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