Changes to USP 797 regarding compounding took effect on November 1, 2023. Anyone who performs IV hydration needs to understand these changes and comply with them. USP 797 requires everyone who performs IV hydration to have written protocols and documented training. If a provider is mixing more than a certain number of ingredients, specialized equipment is also needed. 

Lengea Law is available to amend your current policies and procedures to be compliant and to create standard operating procedures if your practice does not have them.

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What is USP 797? 

USP 797 is a set of guidelines created by the United States Pharmacopeia (USP). These guidelines ensure the quality, safety, and sterility of compounded drugs. Although USP is not a government agency, many states use these guidelines as baseline laws for drug compounding. Some states now have more stringent requirements than USP 797.

USP 797 covers a range of topics related to compounding, including:

  1. Personnel training and evaluation;
  2. Facilities and engineering controls (like laminar airflow workbenches and cleanrooms);
  3. Aseptic technique and handling;
  4. Storage and beyond-use dating of compounded sterile preparations;
  5. Quality assurance and quality control procedures; and
  6. Standard operating procedures.

Pharmacies, hospitals, and any other providers, including solo entrepreneurs, that compound sterile preparations are expected to adhere to these standards to ensure patient safety. Non-compliance can have both clinical and regulatory consequences.


What Should Be in Standard Operating Procedures (SOPs)? 

SOPs should detail how compounding personnel sterilize the environment, prepare medications, label them, and more in compliance with the USP 797 immediate use guidelines.


When does USP 797 apply?

USP 797 applies to everyone involved in IV hydration. Even if you are not mixing ingredients, you need written protocols and training in place if you are doing IV hydration.

At least 32 states in the US require full compliance with USP Chapter 797, including ten states with reporting standards equivalent to or stricter than USP Chapter 797. Lengea Law can help assist you with guidance on the requirements in your state. Please consult with us before purchasing any equipment. Many IV clinics (especially Mobile IV companies) may need to consider changing their formulas and revising their SOPs to comply with the new requirements of USP 797.