If you are grappling with the United States Pharmacopeia (USP) chapter on the Safe Handling of Hazardous Drugs (USP 800), you are not alone. While USP 800 is noted for being the first enforceable federal set of standards for protecting human and veterinary healthcare personnel from the risks involved with handling hazardous drugs, understanding and complying with these requirements is a challenging task for many veterinary hospitals and clinics.
Below we break down the basics, answer key questions, and share five tips for navigating these compliance standards.
What Is USP 800? How Does it Impact the Veterinary Industry?
The USP is a nonprofit organization that sets standards for the safe preparation and handling of medicines. The USP is not a regulatory agency and does not have control over whether its standards are implemented. However, oftentimes its standards are adopted and enforced by a variety of regulatory agencies. USP 800 works hand in hand with the USP chapters on Pharmaceutical Compounding—Nonsterile Preparations (USP 795) and Pharmaceutical Compounding—Sterile Compounding (USP 797), but whereas those standards focus primarily on best practices for compounding medications to protect patient health, USP 800’s scope is much broader.
While USP 800 aims to protect patients, it also protects workers in healthcare settings, including veterinary hospitals and clinics, who encounter hazardous drugs or hazardous drug waste products by minimizing exposure to those substances. The standard applies to all phases of the lifecycle of a hazardous drug, from arrival at a facility to storage, preparation, and administration, through to the management and disposal of all hazardous waste produced during these phases.
USP 800 uses the criteria set forth by the National Institute for Occupational Safety (NIOSH) to determine which drugs are hazardous. The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 is the most recently published criteria; a draft produced in 2020, the NIOSH List of Hazardous Drugs in Healthcare Settings is under review, but the final publication date has not been announced. Overall, the drugs on the list include those that pose the risk of carcinogenicity, reproductive toxicity, genotoxicity, organ toxicity at low dosage levels, and new drugs similar in structure or toxicity to known hazardous drugs.
Do I Need to Be USP 800 Compliant?
The USP 800 standard has been official since December 1, 2019. However, because it is referenced in USP 795 and USP 797, which are currently being reviewed, USP 800 is considered “informational only” at the federal level right now and is not yet a requirement. Federal agencies such as the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) could enforce USP 800 but are not doing so at this time. Some state pharmacy and veterinary boards have already implemented portions or the entirety of USP 800 though, while others have implemented their own regulations pertaining to hazardous drugs similar to those found in USP 800.
Simply put, compliance is often still necessary. Even if not yet required, taking steps toward adherence results in increased safety for staff, patients, and pet owners and makes the transition much smoother once the standard becomes a requirement.
Improved safety is a driving factor in Epicur’s recent switch to blister packaging for all chemotherapy tablets produced in our 503B facility. The benefits of unit-dose blister packs simplify your practice’s alignment with USP 800 requirements and keep your veterinary practice ahead of compliance challenges.
Navigating Compliance Hurdles
As veterinary clinics and hospitals navigate meeting the requirements of USP 800, some considerations to keep in mind include:
Update the list of hazardous drugs used in your practice at least every 12 months. Regardless of when the 2020 NIOSH list is officially published, the NIOSH list updates from 2016 to 2020 need to be reflected in your organization’s list. Veterinary-specific hazardous drugs (e.g., toceranib phosphate or Palladia®) may not be on the NIOSH list, but do need to be included on your list if they are used. So, referring to the NIOSH list as a starting point and adding the veterinary-specific medications that have similar toxicological profiles is a good approach. Check the NIOSH website or HazRx app regularly for updates to the list.
Once your hazardous drug list is updated, complete an Assessment of Risk (AoR) for each drug and dosage form on your list. If a veterinary hospital or clinic does not complete an AoR annually for each hazardous drug on their list, all of the drugs must be handled according to USP 800’s strictest requirements, which impairs efficiency and increases costs. The AoR is not meant to be a complex process, but must take into consideration:
- The type of hazardous drug—antineoplastic, non-antineoplastic, or reproductive-risk only
- The dosage form—capsule, tablet, or liquid
- Risk of exposure
- Manipulation required
- The alternate containment strategies and/or work practices that will be used
Consider outsourcing the compounding of the hazardous drugs on your list. The facilities and engineering controls needed to meet USP 800 requirements for safe compounding can be cost-prohibitive or simply not the best use of resources for some practices. Strategic use of 503B outsourcing facilities which are required to adhere to USP standards and the FDA’s Current Good Manufacturing Practice (cGMP) regulations can be a good option for managing requirements that are unfeasible for your practice.
Assess whether some of the hazardous drugs in your practice can be purchased in final dosage form from a 503B outsourcing facility. This option provides the following advantages:
- It allows for an AoR to be conducted to decrease the amount of personal protective equipment required for your personnel—instead of needing two sets of chemotherapy gloves, a protective gown, protection for the eyes and face, and respiratory protection, drugs like chemotherapy tablets that are in tablet-unit dose blister packaging can be dispensed and administered with only a single pair of gloves.
- The need for ventilated engineering controls is eliminated.
- Antineoplastic hazardous drugs in final dosage forms may be stored with your other inventory, eliminating the requirement for a segregated storage area.
If you use a 503B outsourcing facility, make sure they are shipping your hazardous drugs in the safest way possible. At Epicur Pharma, for example, final decontamination wipes of hazardous drugs are done after they are packaged to remove drug residue from the containers. Also, impervious chemotherapy drug transport bags are used to separate these hazardous drugs from others in your shipments. Finally, clearly marked shipping containers are used to transport chemotherapy drugs to minimize exposure risk for employees unpacking and storing inventory.