HealthJune 13, 2023

USP 800 compliance improves, but there's more to be done

Pharmacies have continued to make progress toward full USP <800> compliance. That’s impressive, but now is the time to push through with USP Chapter 800 becoming official with U.S. Pharmacopeia Chapter's 795 and 797 enforcement later this year.

USP Chapter 800 reference standards progress

According to Pharmacy Purchasing & Product's report, 73% of compounding facilities report meeting most or all of the USP <800> requirements. While facilities below 100 beds have lower compliance rates, the number of hospitals reporting full compliance doubled to 24%. Meanwhile, the number of facilities that have yet to address the requirements at all fell by half; fewer than 10% remain that are still in the planning stages of addressing the requirements.

Other specific indicators of USP 800 standards progress include:

  • Facilities have increased external venting of Containment Primary Engineering Controls
  • Installation of pressure indicators now exceeds 90%
  • More than 80% of facilities have committed to segregating the storage of hazardous drugs
  • Less than 20% of facilities still unpack hazardous drugs in either positive or unmeasured pressure areas
  • More than 80% of facilities have invested in the installation of dedicated refrigerators for antineoplastic hazardous drugs in a negative pressure area

Maintaining USP 800 progress and complying with NIOSH hazardous drug standards

Between the current need to prioritize COVID-19 vaccine storage and compliance with interim compounding guidance, pharmacies may feel overwhelmed as they strive to maintain their progress.

Our advice, therefore, is to keep it simple by paying attention to USP <800> standards that are not changing.

  1. Conduct Hazardous Drug rounds assessing for compliance with policies and procedures. Whether safe-handling practices have been in place for a few months or a few years, it is important to look for compliance with personal protective equipment (PPE), use of engineering controls, and to solicit feedback from stakeholders. This may inform your annual review of policies or confirm your risk assessment, containment strategies, and work practices.
  2. Conduct an annual review of your facility's NIOSH hazardous drug list and prepare to adapt based on the proposed NIOSH two-table structure. This review should also include an assessment of drugs approved since 2015 for inclusion on your facility list. Regulatory bodies will be looking for criteria that extend beyond the NIOSH list. 
  3. Ensure hazardous drug training and competencies are up to date. Inspectors will be looking for documentation of training and acknowledgment of hazardous drug risk that is consistent with USP <800> and your policies, especially for staff involved in receiving the preparation of hazardous drugs.

Designated Persons and hazardous drug handling

Finally, according to the Pharmacy, Purchasing & Products report mentioned above, more than 81% of facilities have assigned a designated person to manage hazardous drug handling. Too often, however, facilities fail to fully define the role beyond responsibility for annually reviewing and updating SOPs. Just over a quarter of facilities also list key responsibilities, required skills, attributes, experience, and reporting relationships for the designated person (DP).

Yet if the DP is accountable and responsible for the operation and performance of the compounding facility and personnel, he or she must have clear authority to oversee quality assurance and control programs that establish a system of adherence to procedures, address quality problems, evaluate complaints and adverse events, and implement appropriate investigations and corrective actions. Moreover, with those responsibilities, the DP must be fully qualified to play such a role. Senior leadership backing is also critical for the DP to be able to drive the implementation of all compounding requirements and hold teams accountable.

In short, establishing a clearly defined DP role, with the clear support of senior leadership, sends an essential message about your organization’s commitment to a culture of quality and patient safety. The benefits are many and include saved lives, reduced morbidity, prevention of adverse events, financial savings, and strong regulatory compliance.

On the last point, it’s worth noting that as of this writing about 2/3 of states have adopted the USP compounding standards wholesale, with other states adopting pieces. Moreover, The Joint Commission is cross-walking the USP standards to The Joint Commission accreditation standards, meaning it will check each organization’s decision to follow USP General Chapter <800> and its policies for such items as staff training, garbing and use of PPE, facility and engineering controls (including microbial sampling) and beyond-use dating.

Because progress in the past year across all of these areas is so encouraging, now is an opportune time to finish the process. It’s the right thing to do for patient and employee safety – and your entire facility will reap the benefits.

Simplifi 797®
Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.
Annie Lambert
Clinical Program Manager for Compliance Solutions
Compliance Solution Clinical Program Manager Annie Lambert, PharmD, BCSCP is committed to providing up-to-date USP content and expert compliance guidance, and to work with you to optimize the use of our Simplifi+ pharmacy compliance solutions.
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.
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