The United States Pharmacopeial Convention (USP) estimates that more than 8 million US healthcare workers are exposed to hazardous drugs (HDs) in the workplace each year. Hazardous drugs (HDs) are a class of pharmaceuticals that pose serious health risks to individuals who handle them, including organ toxicity, reproductive and developmental defects, genetic toxicity, cancer and even death. With an ever increasing number of HDs being used in the healthcare industry, the risks to healthcare workers are on the rise.
Like other hazardous chemicals, HDs are regulated under OSHA’s Hazard Communication (HazCom) standard unless they are specifically exempted from the standard according to the provisions listed in 1910.1200(b)(6)(vii). However, the frequency and variety of ways which healthcare workers receive, prepare, administer, transport, or otherwise handle HDs not only tend to fall under applicability of HazCom, but also can create unanticipated modes of potential exposure. Recognizing this, USP developed USP <800> standards in an effort to further minimize the risks of handling hazardous drugs in healthcare settings, and help promote greater patient safety, worker safety, and environmental protection.
What is USP <800>?
USP has issued other standards related to protection of workers, including USP <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations. USP <800> expands these protections by providing a formal set of standards and guidelines for the safe handling and use of HDs in healthcare settings. USP <800> establishes a broad set of requirements for:
- Maintaining an inventory of hazardous drugs
- Responsibilities of personnel who handle hazardous drugs
- Facilities and engineering controls
- Environmental quality and controls
- Personal protective equipment
- Hazard communication
- Personnel training
- Receiving
- Labeling, storage, packaging, transport, and disposal
- Dispensing final dosage forms
- Compounding
- Administering
- Deactivating, decontaminating, cleaning, and disinfecting
- Spill control
- Documentation and standard operating procedures
- Medical surveillance for workers who handle HDs
For a detailed description of these requirements, click here to download USP General Chapter Hazardous Drugs – Handling in Healthcare Settings.
What agency enforces USP <800>?
USP <800> standards were originally developed by USP in conjunction with the U.S. FDA, but it is ultimately up to the states to determine how the standards will be incorporated into their respective laws, and how those laws will be enforced. While many states have chosen to directly adopt USP <800> standards into their regulations for handling HDs, the specific requirements and how they are enforced will vary from state-to-state.
In many states that have adopted USP <800> standards, the state board of pharmacy (SBOP) is responsible for inspecting workplaces and issuing citations for non-compliance. In others, the state’s public health department is responsible for enforcement. It is important to note that, despite its primary mission of enforcing workplace health and safety laws, U.S. federal OSHA has no role in enforcement of USP <800> standards. However, leading industry publication Pharmacy Times notes that because employee safety is a primary objective of USP <800>, it is reasonable that where OSHA-approved state plans apply, the state office of Occupational Safety and Health Administration may be the enforcing agency.
If you have questions about your state’s USP <800> implementation and HD handling requirements, you can find contact information for your state board of pharmacy at the National Association of Boards of Pharmacy. If you operate in a state with an OSHA approved state plan, you can find contact information at the OSHA State Plan Directory.
Who does USP <800> apply to?
USP <800> applies to all healthcare personnel who handle HD preparations including pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. USP <800> also applies to all facilities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices).
When does USP <800> go into effect?
The “official date” for USP <800> compliance was December 1, 2019. After this date, all covered facilities in states that have adopted USP <800> standards were expected to be in compliance with the applicable requirements. Some states including California and Minnesota had adopted some or all of these requirements prior to the December 1, 2019, while others like Michigan and Washington have had their own separate, yet similar HD regulations in place prior to the publication of USP <800>.
There has been some confusion among stakeholders regarding the effective date for USP <800>. On June 1, 2019, USP published revisions to USP chapters <795> and <797>, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. After publication of the revised and new compounding standards, USP received appeals from stakeholders concerning specific provisions contained in <795>, <797>, and <825>. USP’s bylaws state that the official effective date of a standard under appeal must be postponed while an appeal is pending. Therefore, USP has postponed the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice.
Because several of the requirements contained in USP <800> are directly related to provisions in USP <795> and <797>, there had been some speculation that the postponement and ongoing appeals to USP <795> and <797> would delay the December 1, 2019 deadline for USP <800> compliance. To address the concern over these delays, USP issued a news release on September 23, 2019 stating:
“General Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health.”
Let’s take a look at a few USP <800> requirements and discuss some best practices and technology tools that employers in the healthcare industry can use to better ensure the safety of their employees, and maintain compliance with USP <800>.
USP <800> Requirements for Maintaining an Inventory of Hazardous Drugs
USP <800> defines HDs according to the criteria established in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. USP <800> requires covered workplaces to maintain an internal list of HDs used in their facilities, and review that list at least every 12 months. Whenever a new HD or dosage form is introduced in the workplace, it should be reviewed against your internal list using the NIOSH list criteria. If the information available on a drug is not sufficient to make a determination as to whether it is considered an HD, (e.g. the SDS and/or label does not contain detailed information on the drug’s health effects) consider the drug hazardous until more information becomes available and add it to your internal list.
Compliance with this particular aspect of USP <800> relies almost entirely on maintaining a full and accurate inventory of the HDs used in your facility, and being able to update that inventory quickly as new HDs or dosage forms enter your workplace. The chemical management software from VelocityEHS makes it easy to edit and update your physical inventory as HDs enter your workplace, map their locations and quantities on a virtual floor plan of your facility, and distribute inventory information in real-time to help healthcare workers better identify their risk of exposure to HDs in the workplace.
USP <800> Requirements for Hazard Communication
Maintaining a strong workplace hazard communication program is key to compliance with USP <800>. As with OSHA’s HazCom standard, USP <800> requirements for your workplace hazard communication program include:
- A written plan that describes, in specific detail, how your HazCom program will be implemented at your facility [workplace specific]
- All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings
- Employers must have an SDS for each hazardous chemical they use and ensure that the SDSs for each hazardous chemical used are readily accessible to personnel in work areas during each work shift
- Personnel who may be exposed to HDs must be provided information and training before the initial assignment to work with HDs, and also whenever new HDs are introduced or hazard information changes
- Personnel must confirm in writing that they understand the reproductive risks of handling HDs
OSHA HazCom compliance is already significant challenge for employers, especially those in the healthcare industry who regularly handle large numbers of HDs and other chemicals. In fact, HazCom violations have ranked second on OSHA Top 10 List of Most Frequently Cited Standards for the past six years running, and changes to OSHA’s HazCom Standard that are slated to begin as early as 2020 are sure to add to the confusion. Considering all of the other USP <800> requirements you have to meet, it’s easy to understand how things can start to feel a little overwhelming.
Simplify USP <800> Hazard Communication Requirements with VelocityEHS!
Whether you’re looking to update your workplace hazard communication program or you’re just getting started on the path to compliance, check out our OSHA Written HazCom Plan Template. It’s a free, customizable template that includes the basic elements of an OSHA-compliant plan which you can easily edit to provide information that’s specific to your work environment.
Chemical management solutions from VelocityEHS make it fast, easy and cost-effective to manage all elements of OSHA HazCom compliance, offering cloud-based storage and management of SDSs, immediate mobile access to your SDS library, intuitive container labeling and printing capabilities and, as we mentioned earlier, detailed real-time chemical inventory information. In addition, our On-Demand Training and Training Management solutions let you quickly deploy expert-designed, customizable web-based training content to your workers, while giving you the ability to track and document training progress and completion, all from a single easy-to-use system. It’s a centralized, all-in-one solution to help you ensure OSHA HazCom compliance and workplace chemical safety.
And that’s just the start! VelocityEHS offers a comprehensive suite of EHS management software solutions to help you with a variety of USP <800> compliance challenges, including:
- Risk analysis, assurance & governance
- Medical surveillance and IH program management
- Spill control and Emergency Response Services (ERS)
- Facility inspections & audits
- And more!
USP <800> requirements are now in effect and if you’re not already in compliance, it’s time to act! Request a Demo today to learn how VelocityEHS solutions including our chemical management software can help you.