Open Forum

TJC will begin enforcing the new USP 797 guidelines for sterile compounding in 2024. We are reviewing our current practices around "immediate use" compounded medications to make sure we are in compliance with this standard and had the following questions we would like to learn from our national colleagues:

1. Are you performing immediate use compounding of injectables with the updated USP 797 guidelines, as defined below?
2. Do you have updated policies? Would you care to share?
3. Do you have updated competencies? Would you care to share?
4. Who can perform compounding in your clinics (MA's, LPN's, RN's, etc.)?

Immediate use is defined as compounded medication preparations of not more than 3 sterile products used within 4 hrs from the start of preparations.

Sterile compounding is defined as the process of combining, mixing, or altering two or more sterile products to create a medication tailored to the needs of an individual patient and creates a product that is typically not FDA approved. Sterile compounding can also be one medication drawn up into a syringe, but not immediately administered. Examples of sterile compounding for immediate use include but are not limited to: joint injection preparations, mixing injectable potassium into sterile saline, drawing up a single medication from a vial for injection, etc.

Thank you in advance for your responses!

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Jami Kyle BSN RN AMB-BC
UK Healthcare
Lexington, KY
(859)553-0899
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Hi AAACN Community!! I am reigniting this THREAD! I am working on configuring a playbook to marry with some work our outpatient educational team has developed around IMMEDIATE USE COMPOUNDING, specifically, preparing medications on behalf of a provider for intra-articular injections. We are attempting to establish best practices for level setting and spread them throughout our outpatient health care system. I have read more about 797 and immediate-use compounding requirements than I have in my entire career! I also have a copy of the current USP 797 compendium and have worked closely with pharmacy partners to understand how best to translate it to our clinical spaces, which have both non-clinical and clinical leadership oversight. State pharmacy law, evidence-based literature, etc., have all been considered. We have a policy draft in the queue to undergird our work. In all of this, we are taking a look at scope (MA's, LPNs, RNs, ATCs, etc.). We have robust Standard Work developed to "sense make" aseptic, no-touch technique, as we have many MAs in the current state performing immediate-use compounding. So, I want to run some questions by the community: 

1) What SOPs do you have in place to ensure immediate use compounding is done according to best practice? Are you willing to share? 

2) Has anyone implemented the use of PharmTechs in high-volume compounding practices (with pharmacist oversight)? IF so, can you describe that structure? 

3) Do you keep compounding logs for medications that are not "batched"? Are you even batching in the immediate use environment (medications cannot be kept longer than four hours from preparation). 

4) What roles are immediate use compounding in your areas? 

So many questions :) thank you in advance!

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Margaret Beckner, MSN, RN
Administrator, Nursing Projects
IU Health Medical Group, Indy Metro Region
Indianapolis, Indiana
317-709-1282 mbeckner@iuhealth.org
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