Calculate Beyond-Use Date

How to Calculate Beyond-Use Date (BUD)

Understanding the Basics

To accurately calculate the Beyond-Use Date for compounded medications, it is essential to follow strict guidelines set forth by USP and FDA. This date reflects when a compound’s potency and safety are no longer assured.

Essential Components for Calculation

The BUD should be the earliest date among all individual components' expiration or retest-by dates, ensuring maximum drug stability. It must also adhere to specific storage conditions, aligning with those recommended for any FDA-approved drugs included in the compound.

Conducting Stability Studies

For extending a BUD up to a maximum of 180 days, stability studies should be conducted using a validated, stability-indicating method. The studies must cover the exact formulation in its final container-closure system, confirming the compound's stability throughout the projected beyond-use period.

Regulatory Adherence

Every BUD assignment must obey applicable regulatory guidelines, including those from the USP and FDA draft guidance. This ensures the safety, efficacy, and quality of the compounded medication.

Compounder’s Responsibility

The compounder must ensure the assigned BUD is accurately calculated based on all pertinent data. This includes stability of the drug under appropriate conditions and within specified timeframes.

How to Calculate Beyond-Use Date for Compounded Medications

To accurately calculate the Beyond-Use Date (BUD) for compounded medications, follow a series of critical steps to ensure patient safety and drug efficacy. Understanding BUD is essential for maintaining the integrity of compounded preparations.

Step 1: Determine Compounding Date

Identify the date or the date and time of medication compounding. The BUD is calculated from this point, as it marks the beginning of the medication’s shelf life.

Step 2: Understand Stability Studies

To extend the BUD up to 180 days, perform stability studies using a validated, stability-indicating method. Studies must be specific to the compound’s exact formulation and conducted in the final container-closure system.

Step 3: Follow Regulatory Guidelines

Refer to FDA and USP guidelines to further refine the BUD. Ensure your BUD does not exceed the established storage conditions and timeframe of any incorporated FDA-approved drug, or the expiration dates of any component used in the compound.

Step 4: Implement Conservative Approaches

Choose the most conservative BUD from among all the ingredients to enhance patient safety. The compounder’s responsibility is to ensure the appropriateness of the BUD by maintaining physicochemical stability.

Step 5: Additional Testing

For preserved, aqueous dosage forms, proceed with USP 51> Antimicrobial Effectiveness Testing (AET). This test ensures that the medication’s preservative is effective at inhibiting microbial growth.

In conclusion, calculating an appropriate BUD for compounded medications involves a thorough understanding of compounding dates, stability studies, regulatory guidelines, and conservative safety measures. By adhering to these practices, pharmacists enhance medication safety and effectiveness.

Calculating Beyond-Use Dates for Medications

Understanding how to calculate beyond-use dates (BUDs) is crucial for ensuring the safety and efficacy of medications. Here are practical examples of how to determine BUDs under different scenarios.

Example 1: Non-Aqueous Liquids and Solid Formulations

For non-aqueous liquids and solid dosage forms like tablets and capsules, the BUD is generally not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier. Calculate it with BUD = min(Time until API expiration, 6 months).

Example 2: Water-Containing Oral Formulations

When calculating BUDs for oral formulations that contain water, the date is limited to 14 days when stored at controlled cold temperatures. A typical calculation would profile storage conditions and adjust accordingly: BUD = 14 days from preparation date, to be stored refrigerated.

Example 3: Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations

For these formulations, the beyond-use date should not exceed 30 days. This can be calculated as BUD = 30 days from preparation date.

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