USP 800 Labeling Requirements
Although sterile compounding standards have been in place for two decades, a recent ISPM study found gaps in how organizations handled and processed those drugs. With errors ranging from an incorrect dose or concentration to incorrectly labeling the CSP, only 56% of those surveyed reported that they defined and always followed SOPs.
In fact, Patricia C. Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, found this result “pretty alarming.”
Difficulty in complying with USP standards was cited as a common problem. Handling hazardous drugs remains a challenge for many healthcare organizations. Recently USP proposed revisions to their November 20119 release. This article details those changes and the compliance steps necessary to meet USP 800 labeling requirements and ensure the safety of your staff and patients.
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.
NIOSH defines HDs as the following:
- Teratogenicity or other developmental toxicity
- Reproductive toxicity
- Organ toxicity at low doses
- 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 (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.
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. And it's the compounding area, and specifically Beyond Use Dates (BUDs) that the new USP revisions impact the most.
First, 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.
New Beyond Use Date Requirements
In fact, it was the 2019 proposed BUD revisions that prompted appeals and led to this latest revision. The new BUDs allow longer storage times if sterility testing is performed. Now the BUD can be assigned based on professional experience and careful interpretation and application of stability and sterility considerations. You can read the specific details here.
USP 800 Processes Protect Your Staff
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.
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This post was originally published in December 2019 and has been updated with the recently released proposed revisions.