Understanding Drug Expiration Dates: Why They Benefit Veterinary Medicine

The Main Takeaways:

  • Expiration dates, which are used by 503B manufacturers offer benefits to veterinary patient care that beyond-use dates do not.
  • Using medications that have expiration dates can maximize veterinary practice profits by reducing expenses.
  • Medications from 503A pharmacies with BUDs have small usage windows – as little as 12 hours for sterile products!
  • 503B manufactured products have a shelf-life range of months to years, without compromising quality.

In veterinary medicine, dates matter—specifically drug expiration dates. The testing that goes into determining accurate expiration dates enables veterinarians to be assured they are providing safe and effective medication to their patients. Plus, when compounded drugs, specially formulated to meet the unique needs of veterinary patients, go through the testing required to be labeled with an expiration date, it allows veterinary hospitals and clinics to keep these drugs in stock for office use— improving patient care, while minimizing costs. The ability to have standing orders also optimizes inventory management and budgets by reducing unit prices.

What is a drug expiration date?

An expiration date indicates how long a drug is expected to maintain its stability, meaning its strength, purity, and quality when the drug is stored in accordance with the conditions specified on its label. Expiration dates are determined based on the results of rigorous stability testing that meets Food and Drug Administration (FDA) standards.

Most commonly, expiration dates are found on commercial pharmaceutical products. However, 503B outsourcing facilities, which manufacture large batches of drug products for office use, are held to the same FDA manufacturing standards as large pharmaceutical companies. This means 503B’s are required to label their products with expiration dates, giving veterinary professionals an advantage in patient care.

Are expiration dates and beyond-use dates (BUDs) the same thing?

Expiration dates and BUDs are similar in that they both are indicators of a drug’s shelf-life, but they are not exactly the same. Expiration dates can only be assigned to a drug after extensive testing is completed.

In contrast, BUDs are assigned to medications that have been prepared by traditional 503A compounding pharmacies for individual patient use. By United States Pharmacopeia (USP) definition, BUDs are “the date or time after which a compounded sterile preparation shall not be administered, stored, or transported” (USP <797>) and for nonsterile compounded drugs as “the date after which a compounded preparation should not be used; determined from the date the preparation is compounded” (USP <795>).  The key difference that impacts veterinary patients – 503As aren’t required to put their medications through stability testing.

Click here to learn more about the differences and the benefits of stocking manufactured products with an expiration date rather than a compounded preparation with a beyond-use date…

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