What You Need to Know About USP <800> Labeling Requirements

7/29/2024

Medication compounding — the process of mixing, combining, or altering ingredients to create a customized drug — is an effective tool that providers use to help meet patients’ unique needs. It serves to provide medications to patients who cannot be treated with an FDA-approved medication because of dosing requirements, allergies, rare diseases, etc. But medication compounding, especially sterile compounding, must incorporate specific standards to ensure patient safety. 

That’s the purpose behind USP <800>, the guidelines created by the United States Pharmacopeia Convention (USP). These guidelines, which are enforced by the U.S. Food and Drug Administration and other oversight agencies, help to avoid sub-potent, super-potent, or contaminated medications and prevent exposing patients to the risk of adverse events. After numerous USP guideline revisions, a final chapter was released and became enforceable as of November 1, 2023.  

The following information details the updates to USP <800> and the compliance steps that are necessary to meet USP labeling requirements and ensure the safety of staff and patients.

Identifying and inventorying hazardous drugs

Many organizations use hazardous drugs (HDs), including pharmacies, hospitals, and other healthcare institutions, patient treatment clinics, physicians' practice facilities, and veterinarians' offices. The steps recommended in USP <800> are designed to promote patient safety, worker safety, and environmental protection. Using these strategies protects those who administer and come into contact with HDs — and helps them stay in compliance.

Complying with USP <800> starts with identifying the type of drug you’re using. For example, if the drug is a hazard or not will determine which regulations to follow. Further, if the drug requires compounding, you may need to implement additional controls. 

Begin by reading the National Institute for Occupational Safety and Health’s (NIOSH) 2020 List of Hazardous Drugs in Healthcare Settings to see which drugs are classified as hazardous. Although the official list hasn’t been updated since 2016, NIOSH did propose updates in 2020, which serves as a useful guide.

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

Another valuable resource is this article from Pharmacy Practice News, which offers further insights about identifying and handling hazardous drugs.

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

PPE, handling, and transporting

Personal protective equipment (PPE) must be worn when handling HDs during compounding as well as during receipt, storage, transport, administration, deactivation/decontamination, cleaning/disinfecting, spill control, and waste disposal. Auxiliary labels are an effective way to guide staff on the proper administration and disposal of the PPE. 

Proper garbing and hand sanitation prior to donning gloves or other proper garbing are critical. In addition, staff cannot have the following on their person when entering a sterile compounding area:

• Gum or mints
• Jewelry and cosmetics 
• Fingernail polish or extenders 
• Eyeglasses

Further, soap containers located within the compounding area must be replaced, not simply refilled. 

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’s consistent with the carrier's policies. GHS labels are a common method used to communicate this information. 

Medication compounding labeling, BUD requirements

When compounding HDs, proper labeling is a must. In fact, personnel must ensure that the labeling processes for compounded preparations do not introduce contamination into the non-HD handling areas.

Labeling must be done according to state and federal regulations, and labels should include the following:

• 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. 

The new USP guidelines have also fine-tuned beyond use dates (BUDs). A BUD alerts healthcare workers to the time/day after which a compounded sterile preparation (CSP) or compounded non-sterile preparation (CNSP) must not be used.

Two primary changes were made affecting BUDs:

• The categorization of CSPs from microbial contamination risk levels (i.e., low-, medium-, and high-risk level) to Category 1 and Category 2 CSPs changed. Category 1 and Category 2 are distinguished primarily based on the conditions under which they are made, the probability for microbial growth, and the time period within which they must be used.
• Category 3 CSPs were added to describe the requirements a compounding facility must meet at all times for assigning BUDs. Category 3 CSPs may be assigned longer BUDs than the limits set for Category 2 CSPs up to a maximum of 180 days when compounded in accordance with all Category 3 CSP requirements.
• The revised chapter also addresses CNSPs requiring shorter BUDs and BUDs for CNSPs that may be extended. You can learn more about these changes here.

Reducing risks, protecting your staff

Without proper safeguards, HDs can severely impact your staff. Even though clinicians understand that drugs can be harmful, they often fail to realize that they are potentially exposed when performing even 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 and others. 

The information presented in this blog was originally published by RRD’s United Ad Label, a label manufacturing company that provides stock and custom USP <800> labels to help healthcare organizations protect their workers, patients, staff, family, and visitors.