Labeling USP 795

Non-Sterile Compounding <795>

Non-Sterile Compounding <795>

Purpose/ Applicability:  To provide guidelines for labeling non-sterile compounded preparations properly to ensure quality control and error prevention.


Scope: Applies to non-sterile compounded preparations compounded in the VTH Dispensary.

Definition(s): N/A



  • N/A



  1. The compounder is responsible for ensuring the preparation container is labeled according to all applicable state and federal laws. The labeling shall include the BUD, any warning statements, and storage and handling information. Auxiliary labels specific to each formulation will be listed on the master formulation document.

  2. Labeling operations must be controlled to prevent labeling errors and compounded preparation mix-ups. Personnel can refer to the auxiliary poster and/or the formulation recipe sheet for clarification on what labels are required for that specific compound.  A final check must be conducted to verify that the correct label has been affixed to the finished preparation.

  3. When the compounder reconstitutes a preparation according to the manufacturer’s labeling instructions, then further documentation is not required (e.g. reconstituting an Amoxicillin powder per the label instructions), but should attach any appropriate auxiliary stickers.

  4. Every compounded non-sterile preparation must be labeled with adequate, legible identifying information to prevent errors during storage, dispensing and use. In addition to the prescription label, labels must contain BUD (Beyond Use Date), storage information (if other than room temperature), special handling information, and any warning statements that are applicable.



Keywordslabel, preparation, identification   Doc ID130888
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:39:45Updated2023-09-07 15:33:19
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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