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Expert: Annie Lambert, PharmD, BCSCP  |  Interested in submitting a different question? Ask your question here!

Compounding Scope

  • (USP 797) For immediate use, does that refer to procedural areas like OR? How do you suggest we handle compounding in these settings?

    Develop an immediate-use compounding program the same way you would for a full sterile compounding program.

    • Start with a policy to define immediate-use compounding requirements.
    • Assess who, what, and where in your organization this is happening.
    • Work with stakeholders to review requirements.
    • Consider students, residents, or light-duty nurses to be designated as "assigned trainers" to complete training and competency assessment.
    • Implement the plan.
  • (USP 795) Are compounding kits considered in scope of 795?

    • Compounding kits are supplied with premeasured API components and mixing these components is compounding subject to USP <795>. Some compounding kits or convenience kits are supplied without FDA approval.
    • In contrast, reconstituting an FDA-approved commercially available suspension according to the package insert or manufacturer instruction is not compounding. The major difference is if the medication has FDA approval. Compounding kits or convenience kits are supplied without FDA approval.


  • (USP 797) Does the disinfecting agent for inside the ISO class 5 have to be sterile? All sterile cleaning solutions once opened in the hood, need to remain in the hood, correct?
    • All cleaning and disinfecting agents used within the PEC must be sterile. This is a new requirement in 797. The reason behind this is we want to keep the ISO 5 area where compounding occurs – and therefore the greatest risk to the final CSP – as clean as possible. This is why we use sterile gloves, disinfect regularly with sterile IPA, and use sterile cleaning agents.
    • All sterile cleaning agents need to be dated with an expiration date once opened per manufacturer specifications. Once opened, the agents should remain in the ISO-classified location where they were opened. However, if you open sterile cleaning agents inside your PEC and do not want to store them inside the PEC when you are compounding CSPs, remove the dated agent and store them in the ISO 7 buffer room. Wipe the exterior of the agent per protocol prior to moving it back inside the PEC.
  • (USP 795) When is cleaning required if you don’t compound every day?
    • Cleaning and sanitizing the nonsterile compounding area is required only on days when compounding occurs. This includes cleaning work surfaces at the beginning and end of each shift and between compounding of different CNSPs. Floors must be cleaned daily on days when compounding occurs.
    • For example, if you only compound on Mondays, Wednesdays, and Fridays, but do it on both day and evening shift, the work surfaces would need to be cleaned at least 3 times (opening shift, between shifts, end of shift) and the floors cleaned once on those days of operation.

Training and Competency

  • (USP 797) For a pharmacist that is just checking CSPs remotely via an IV workflow system, what training and competency is required, and how often?
    • The simple answer is to review training and competency as it’s defined by your SOPs, as long as these staff do not have direct oversight of or perform compounding.
    • The more complex answer is that training and competency programs must equip staff with the knowledge and skills they need specific to their job duties. So how do pharmacists performing in-process checks or final verification know what is expected of them? How do you know they are completing the tasks consistently?
    • Also, consider your staffing model. Will that pharmacist ever be required to compound on a weekend or holiday? Or enter the IV room to have more direct oversight of compounders? Do they perform immediate-use compounding in the ED or on a code? If the answer to any of these is yes, then they need additional training and competency as required by 797 or your SOPs.
  • (USP 795) What are your thoughts on pharmacists needing to demonstrate competency annually, beyond annual training?
    • One important difference between 795 and 797 is the frequency of training and competency. USP 795 requires annual training at a minimum for compounders and those with direct oversight of compounding. The content of the training and competency program must include the 7 core skills identified in the chapter in addition to understanding 795, SDS and COAs, and facility SOPs.
    • These personnel, including pharmacists, must have the knowledge of principles and demonstrate competency of skills in these procedures as applicable to their assigned tasks.
    • That includes some type of competency assessment related to the work that they do.

Facilities and Environmental Monitoring

  • (USP 795) What are examples of a designated area for nonsterile compounding? Does it have to be used exclusively for compounding?
    • USP 795 requires an area dedicated for compounding with enough space to organize components and equipment, easy to keep clean and maintained in good repair. The area should be designed to minimize cross-contamination from non-compounding areas.
    • This can be as simple as a countertop with a line demarcating the compounding space to a separate room dedicated to nonsterile compounding.
    • The space can be used for other activities, but when compounding takes place, no other activities should be happening in that space. Keep in mind the cleaning requirements, space needed for equipment, and storage of components as well. A sink for hand hygiene and cleaning of equipment must also be easily accessible.
  • (USP 797) Where does surface sampling have to be done monthly?
    • With the 2023 updated chapter, surface sampling is required monthly in all classified areas including PECs, clean room suites and pass-throughs. If you have a segregated compounding area, surface sampling is only required inside the PEC.
    • The impact of this change is a 6x increase in media needs, as well as incubator space and support for interpreting the results. Many pharmacies have decided to in-source the collection of monthly surface samples. Ensure these staff have received training and demonstrated competency in this important role.

Documentation (SOPs, MFR, CR)

  • (USP 797) When is an MFR and CR required?
    • For sterile compounding, an MFR is required for all CSPs prepared from nonsterile ingredients or CSPs prepared for more than one patient.
    • A compounding record is required for all Category 1, 2, and 3 CSPs and for immediate-use CSPs prepared for more than one patient. Note that a prescription or medication order or label may serve as the CR. Or this data may be stored within an IVWS. As long as the required information is included and is readily retrievable.
  • (USP 795) Do we need to make separate MFR for different size preparations of the same medication? Can we just make one MFR and put amounts on the compounding record?
    This was just clarified by the USP CEC in their updated FAQs! It is acceptable to have an MFR for the same preparation and specify the quantity compounded in the compounding record.
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