Tools to Simplify the Process of USP 797 Compliance for Your Business

Staying in compliance is one of the challenges that face many businesses. Compliance can be difficult because it is not the focus of your business, however, if you do not maintain compliance you can be fined, shut down, or have other damages assessed. Using a web-based management system to help keep compliance can streamline the process and ensure nothing falls through the cracks.

Compliance Standards and the Importance of Meeting Them

For individuals involved in the preparation and compounding of pharmaceutical products, USP 797 is a compliance standard that must be maintained. This refers to a chapter in the USP National Formulary that discusses sterile compounding standards that must be met. The standards are enforceable, which means not doing so can leave you out of compliance.

The standards discussed in USP 797 compliance apply to persons and places involved in the compounding of sterile products. This includes pharmacies and physicians’ practices as well as hospitals and healthcare institutions. The requirements must be met by everyone involved in compounding, including nurses, physicians, pharmacy technicians, and pharmacists.

Meeting these standards requires an important level of attention to the environment where you are working. You must do an honest assessment of the environment where you are working and take active measures to ensure compliance. This can involve everything from instituting a specific handwashing protocol to testing the air quality in the facility. If you oversee keeping compliance and accreditation for your facility, using a web-based tool to help develop and implement a plan can be a great tool.

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