<USP 800> is a new safety standard with the intent to minimize the exposure to hazardous drugs from healthcare personnel, patients, and anyone else coming into contact with these drugs written by the United States Pharmacopeia (USP) and the Food and Drug Administration (FDA)
The standard regulates the practice and quality standards of handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling HDs includes but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non sterile products and preparations.
Since all pharmacy operations handle hazardous drugs, you must make sure your pharmacy complies with these guidelines by December 1, 2019 or risk your pharmacy license and your pharmacist-in-charge-license.
What Are the Steps to Comply With USP <800>?
With the December 1 deadline looming, we’ve broken down the steps needed right now for getting in compliance for USP <800>.
- Identify Hazardous Drugs (HDs) for their final dosage form
- Designate a hazardous drugs point person in your store
- Complete an Assessment of Risk annually
- Ensure hazardous drugs are dispensed or returned a minimum of nine months prior to expiration
- Training – Hazardous Communication, Spill control, competency
Let’s unpack the steps below so you can get a clear understanding of the actions you must take to ensure your pharmacy isn’t at risk.
1. Identify Hazardous Drugs for Final Dosage Form
Final dosage form is when a HD is packed by the manufacturer in a pill or capsule and the pharmacy only counts and repackages them. The existing practices you use to manage this workflow is most likely in compliance, however, there are steps you need to be aware of to comply with <USP> 800. You must segregate your HDs from your regular stock. The way you segregate these drugs, whether it’s on a shelf or a rack, is up to your discretion, as long as it is segregated and labeled as a “Hazardous Drugs Storage Area.” This applies to all pharmacy operations, whether you’re retail, long-term-care or compounding pharmacy.
How do you segregate?
- You can start by referencing the National Institute for Occupational Safety and Health (NIOSH) list to know which drugs to segregate.
- Ensure that your wholesaler is segregating your drugs when they come to you.
- Inventory all your drugs. Document the hazardous drug name, whether they are a tablet, capsule, liquid, and if there is dust in the container.
Some of the HD’s that require more manipulation (if you’re mixing, splitting/crushing or pouring) may require a containment primary engineering control (C-PEC), which is a ventilated device designed and operated to minimize worker and environmental exposures to HDs. We get into more details on this device and how to segregate in our on-demand webinar, USP <800> and Your Pharmacy – What You Need to Know.
2. Designate a USP <800> HD Designee in Your Pharmacy
Assigning a point person in your store is critical to ensure proper processes and procedures are in place. This person should be your pharmacist-in-charge, a pharmacist, or your compliance officer.
3. Perform an Assessment of Risk
This is the most important step you must take as a retail pharmacy operation. An assessment of risk must be performed annually for every hazardous drug dispensed from the pharmacy and must, at a minimum, consider the following:
- Drug Name
- Type of hazardous drug
- Contained in manufacturer’s packaging
- What form is the hazardous drug in?
- Is there any type of manipulation needed?
- Assessment completed annually
Whether you write your own assessment of risk or find other resources online, the bottom line is that this document is not intended to be complicated. As long as you conduct your assessment of risk annually and you include the above information, you’re on your way to compliance. This document must be created between now and December 1, 2019 and must be renewed annually. In our on-demand webinar, USP <800 and Your Pharmacy – What You Need to Know, we detail the second part of the assessment of risk involving an alternate containment strategy plus more options for your pharmacy. Watch it here.
4. Ensure Hazardous Drugs are Dispensed or Returned a Minimum of Nine Months Prior to Expiration
Trace hazardous drug waste includes empty vials with dust or other HD residue in the containers. This type of waste must be disposed of in a licensed hazardous waste landfill. Expired HDs are also considered hazardous waste. Expired HDs are a black hole for money. Even if only one tablet is leftover in a bottle, the cost you pay to dispose of them properly is significant.
How do you solve this? In order to comply with USP <800> standards, you should pull hazardous drugs a minimum of nine months prior to their expiration date unless you are guaranteed to dispense within 45 days. If you cannot guarantee dispensing, you must return back to your returns company. You’ll also want to keep a lookout for the drugs you receive from your wholesaler. If they send you products that will expire within one year and it is a large amount you know you will not use, do not accept it from your wholesaler, otherwise you will get stuck with the waste and have to take steps to dispose of them. Watch our on-demand webinar, USP <800 and Your Pharmacy – What You Need to Know, for more information on hazardous waste and proper disposal practices.
Insider Tip: EPA and State Environmental Agencies are checking pharmacies now for ‘warfarin’ to see whether you are in compliance with the expired drug and whether it is listed as a hazardous waste. They will then ask if you have a hazardous waste generator permit, which you don’t need unless you generate >220 lbs per month. If you’re not educated, they will hit you with a fine. Be warned!
5. Training for Hazardous Communication, Spill Control, and Competency
In order to avoid fines or risking your pharmacy license, you must know the intricacies of USP <800> and what it will impact. If you have a hazardous communication program and training (which is required by OSHA), it must be changed and updated to cover hazardous drugs and hazardous waste, per USP <800>.
Who Regulates What for USP <800>? A Quick Cheat Sheet
It’s easy to get lost with all this talk of hazardous drugs and related jargon. Here is a quick list of who regulates and enforces what.
- Hazardous Drugs are regulated by the U.S. Health and Human Services
- Hazardous Materials are regulated by the U.S. Department of Transportation
- Hazardous Waste is regulated by the Environmental Protection Agency
Start Your USP <800> Compliance Process Now
This is not a hard problem to resolve if you start now. You don’t want to be in a panic in October when you have the fear of the USP <800> deadline around the corner. Luckily, PDS has your back! Below, you’ll find resources on how to properly manage your hazardous drugs before December 1st.
Hazardous Drugs and USP <800> Resources
- Our on-demand webinar hosted by Jeffrey Hedges with R.J. Hedges & Associates, USP <800> and Your Pharmacy – What You Need to Know goes into more detail on the steps above and provides even more insight on what you need to do and why you need to pay attention. Watch it here.
- Don’t do it alone! If you would like more information on how you can get help preparing your pharmacy for USP <800>, contact R.J. Hedges & Associates at
- For more information on USP <800>, visit the United States Pharmacopeia website.
- Chat with your fellow pharmacy owners about how they’re making strides towards the deadline.
- PDS members, use your member portal, PDSadvantage. Click here to login.
- Not a PDS member? There’s an industry message board for you in PDSadvantage — and it’s free to join!
Click here to join and get that conversation started.
Get the Clarity You Need to Run a Better Pharmacy
Pharmacy owners are constantly hit with new rules, regulations and other seemingly endless circumstances that affect your business. Partner with a team who has your back and their ears to the ground! PDS can inform you when industry-related news, such as USP <800> will impact your business and show you your biggest growth opportunities.
Click below to take the first steps to a better pharmacy.