Maintaining USP BUD Settings?

Overview

The USP BUD Settings section allows you to configure standard Beyond-Use Date (BUD) rules for CSP products (Compounded Sterile Preparations) within SiCompounding.

These settings ensure that BUDs applied to formulas are calculated consistently and remain compliant with USP (United States Pharmacopeia) regulations.

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Purpose of USP BUD Settings

The USP BUD list is designed specifically for sterile products. Each entry documents how a product was prepared and stored so that the correct BUD can be applied automatically when formula criteria are matched.

Information Captured in Each USP BUD Row

Each BUD setting defines:

• How the product was prepared:
  • Aseptically
  • Terminally sterilized
• Whether the product was prepared using only sterile ingredients
• The sterile product category:
  • Category 1
  • Category 2
  • Category 3
• Whether sterility testing was performed and passed
• Required storage conditions:
  • Controlled
  • Refrigerated
  • Frozen
• The resulting final BUD, based on the documented criteria

All BUD outcomes must be compliant with applicable USP regulations.

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Accessing USP BUD Settings

Follow the steps below to navigate to the USP BUD Settings screen.

Step-by-Step Navigation

1. Click the FileMaker Pro icon to open FileMaker.
2. When FileMaker opens, locate the large menu bar on the left side of the window.
3. Click SiCompounding (near the top).
4. In the next window, several icons appear across the middle of the screen.
5. Click Pharmacy to open the Dashboard.
6. From the blue sidebar menu, scroll to the bottom and select Settings.
7. Under General Settings, select USP BUD Settings
   (USP – United States Pharmacopeia, BUD – Beyond-Use Date)

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Viewing USP BUD Settings

The USP BUD Settings window displays all configured BUD rules.

• Each row represents a USP BUD rule.
• BUDs are automatically applied to formulas when the documented criteria are matched.

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Creating a New USP BUD Setting

1. At the top of the USP BUD Settings window, click + BUD.
2. The USP BUD Settings window opens.
3. Enter all required preparation, testing, storage, and BUD information.
4. Verify that all data entered complies with USP requirements.
5. Click Save to create the new USP BUD setting.

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Editing an Existing USP BUD Setting

1. Locate the USP BUD row you want to update.
2. In the Actions column, click the gear (settings) button.
3. A popup menu appears.
4. Select Edit.
5. You will be taken back to the USP BUD Settings window.
6. Make the necessary changes.
7. Click Save to apply the updates.

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Deleting a USP BUD Setting

1. In the Actions column, click the gear (settings) button for the desired USP BUD row.
2. Select Delete.
3. A Deletion Confirmation dialog box appears with two options:
   • DELETE – Permanently deletes the USP BUD setting
   • CANCEL – Closes the dialog box without deleting the record

Note: Deleting a USP BUD setting permanently removes it from the system.

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Pharmacy Settings Overview

The Pharmacy Settings section contains the templates and default configurations for your pharmacy and must be completed before using any other area of SiCompounding.

Areas Managed in Pharmacy Settings

• Product settings
• Facility Areas
• Equipment
• Workflows
• Costs and Fees
• Lab Work
• COM Templates
• Notifications
• Integrations
• Access logs (available through the Automations tab)

:::callout type="warning" It is important to enter all available and required data for each section and subsection in Pharmacy Settings to ensure compliance, accuracy, and proper system functionality. :::

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Summary

Maintaining accurate USP BUD Settings ensures:

• USP-compliant Beyond-Use Dates
• Correct BUD assignment to formulas
• Consistent, auditable sterile compounding processes

USP BUD Settings should be reviewed regularly to reflect regulatory updates and pharmacy practices.