USP 800 Checklist: Priority Areas to Address


To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.


Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting.

This could include:

  • Outsourcing high-volume CSPs to 503B facilities
  • Utilizing workflow management systems
  • Utilizing automation/robotics

Performing a USP <797> GAP analysis can help pharmacies determine compliance gaps. Additionally, pharmacists should look out for “invisible errors” that could occur, including errors made in dosage, volume, preparation technique, and form of delivery. Potential strategies to mitigate these errors include barcoding, gravimetric verification, volumetric photo verification, training and continual evaluation, and labeling.

Maintain Cleanroom Environment
The importance of maintaining a clean room environment with strategies that involve personnel practices and design standards. Personnel should wear the proper garments and utilize the proper cleansing process to prevent contamination in the cleanroom.

Personnel should also ban unsanitary items from the cleanroom, including cellphones, cosmetics, visible jewelry, artificial nails or nail polish, natural nails longer than ¼ inch, and cardboard/particleboard.

Personnel should also work to eliminate touch-contamination points to prevent contamination in cleanrooms and CSPs. Reinforce proper cleansing/garbing practices with personnel by using ‘glove-boxes’ and implementing hand-free options in cleanroom spaces. For this purpose, we have developed a complete XLTC product line.

Pharmacists are urged to read their cleanroom validation report in detail and make sure that they understand the requirements needed. We strongly recommend double checking the most common sources of contamination and unsanitary conditions:

  • Unsealed, loose ceiling tiles
  • Vermin in production areas
  • Visible contamination
  • Non-microbial contamination
  • Improper gowning
  • Failure to disinfect gloves
  • Exposed wrists during aseptic manipulations

If construction or renovation is needed to improve compliance, Infection Control Risk Assessments should be utilized and cleanroom spaces should be designed to promote a clean environment while considering workflow. If you are constantly pushing off on the renovation process because you might have ceased all pharmacy operations for some time, look no further as our Mobile Compounding Cleanroom is a plug and playfully furnished USP 797-800 compliant cleanroom delivered on-site.

Give us a call at 800.418.9289 and we can discuss your USP compliance questions.

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