Compliance Timeline: Falling Short of the Mark

July 2019 : Hazardous Drug Handling - Vol.16 No. 7 - Page #1

The goal of USP <800> is to promote safety by limiting occupational exposure to hazardous drugs (HDs). While hospital pharmacies are endeavoring to provide this safety to their staff, coworkers, and patients, it is important to recognize that this is not an easy journey. The requirements are challenging and progress toward compliance has been slow for most facilities across the country.

Survey Design

To monitor pharmacy’s progress in this effort, in the second quarter of 2019, Pharmacy Purchasing & Products polled a random, nationwide sample of health system pharmacy directors. We queried these pharmacy leaders as to their current compliance levels with USP <800> as well as their timelines for achieving full compliance. In addition, we asked about HD policies and procedures, staff training, wipe sampling practices, and more. Responses were solicited via email and a total of 202 pharmacy directors replied, yielding a confidence interval of 6.77 (95% +/-6.77).

We intentionally survey a random sample of pharmacy directors, not just readers of PP&P, to ensure the data reflects trends across the entirety of US hospital pharmacy practice. Given this approach, we are pleased that 93% of pharmacy directors rely on PP&P as a resource for HD handling information.

More than nine out of every 10 health systems rely on PP&P to serve as a resource for compounding compliance.

Efforts Underway

The struggle toward full compliance has been a universal experience; this is not a situation wherein those facilities with larger budgets are having more success. In fact, facilities of all sizes are leveraging this regulation for budgetary support and yet full compliance is barely in the double digits.

Nevertheless, efforts are underway with most facilities having created an HD list, which is updated annually, and assigned a staff member to serve in the Designated Person role. Of course the devil is in the details, and few have a written job description for the designated person role and some facilities have yet to classify their HD list by severity.

Standard operating procedure (SOP) development is one area where larger facilities have a distinct advantage and are more likely to have developed and instituted USP <800> compliant SOPs for HD handling, particularly in areas such as compounding, hand hygiene and PPE, spill control, and dispensing.

Because the USP standards are just that—minimum standards that must be met to ensure an equal baseline of safety for all staff—compliance efforts provide an opportunity to enhance QA efforts beyond what is required by USP <800>. Consider implementing best practices for wipe sampling, for example, that exceed the standards. Wipe sampling conducted on a monthly or quarterly basis will serve to quantify the effect of the improvements you are making and to identify any developing trends.


With hospital pharmacy making herculean efforts to improve their HD handling, we expect to see improved compliance rates in the coming months; nonetheless, many facilities will likely not be inspection ready by December 1st.

PP&P will continue to support your efforts through December and beyond by showcasing the successes of your peers. Take the opportunity when constructing new cleanrooms, designing new workflows, and writing new policies and procedures to exceed the standards and utilize best practices.

Deanne Halvorsen is the editorial director of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at


Like what you've read? Please log in or create a free account to enjoy more of what has to offer.

Current Issue

Enter our Sweepstakes now for your chance to win the following prizes:

Just answer the following quick question for your chance to win:

To continue, you must either login or register: