What to Do When You Can’t Find the Compounded Medications You Are Looking For?

As often happens in life, just when you think you’ve got things figured out, something changes and throws you a curve ball. The latest updates to the United States Pharmacopeia (USP) compounding standards’ beyond use date (BUD) guidelines have done just that for many veterinary practices, making it more difficult to source the compounded medications they need for their patients in a timely manner through traditional 503A compounding pharmacies. Luckily, options to fill this gap do exist and are readily accessible.

Why It’s Become Harder to Source Compounded Medications

503A compounding pharmacies, which veterinary clinics and hospitals have traditionally relied upon to provide compounded medications to their individual patients, must comply with the standards set by the USP. On November 1, 2023, changes to USP Chapters <795> and <797> guidelines for compounding nonsterile and sterile pharmaceuticals, respectively, went into effect. These changes restrict the ability of 503A compounding pharmacies to extend the beyond-use dates (BUDs) assigned to their preparations.

As a result, the usability window for many 503A-prepared compounded medications has been drastically shortened, with the BUD of many high-demand compounded preparations being reduced from 180 days to as little as 1-4 days, making it difficult to get medications to patients within the usable timeframe.

The updates to the BUD limits take into consideration two critical factors pertaining to compounded medications, including the:

1. Chemical stability of the preparation.
2. Risk of microbial contamination through the compounding process.

For many compounded medications, 503A compounding pharmacies must now perform stability studies and/or sterility testing before they can extend the BUD. Because this type of testing was not previously required for 503A compounding pharmacies, many do not have testing processes and equipment in place to meet these new requirements. Some 503A compounding pharmacies have started using third-party companies to perform the stability and sterility testing required to assign extended BUDs, but backlogs at these external testing sites pose a challenge.

While these changes were put in place for a good reason—to protect patients from unsafe medication and ensure medication quality and efficacy—veterinarians and clients may face difficulties obtaining needed medications in time to use them within the usability window and maintaining an on-hand supply to support consistent adherence to treatment plans.

How These Changes Create Opportunities for Veterinary Practices

While the USP changes can be a challenge to get used to, there are several alternatives veterinary hospitals and clinics have to still support their patients with the best – maybe even better – care.

1) Stock Compounded Medications for Office Use

It’s not feasible or cost-effective for veterinary practices to keep 503A medications in stock due to short BUD timeframes and restrictions preventing 503A pharmacies from dispensing without a patient-specific prescription.

Veterinary hospitals and clinics do have another option, however. 503B outsourcing facilities prepare compounded veterinary medications just like 503A pharmacies, but these medications are manufactured in bulk to stock for office use and have longer usability timeframes due to the testing protocols they follow.

There are some key differences that make 503B outsourcing facilities a valuable addition to your supplier mix. 503B outsourcing facilities:

• Are regulated by the Food and Drug Administration (FDA) and must comply with the FDA’s more stringent current Good Manufacturing Practice (cGMP) standards in addition to USP standards.
• Produce large quantities of compounded medications that can be ordered for office administration and dispensing per federal law (FDA Federal SEC. 503B. [21 U.S.C. 353b]), enabling veterinary hospitals and clinics to stock high-demand medications and immediately provide patients with needed medication.
• Have in-house stability, sterility, and finished product testing capabilities and perform testing on every compounded drug batch before assigning an expiration date, ensuring medication safety and efficacy.
• Assign expiration dates to their compounded preparations instead of BUDs. Compounded drugs with expiration dates have a longer usability window than those with BUDs making it practical to stock preparations from a 503B outsourcing facility.

Overall, adding 503B outsourcing facilities to your supplier base can be a turning point in dealing with supply challenges.

2) Diversify Your Suppliers

Establishing relationships with multiple suppliers, including a mix of 503A compounding pharmacies and 503B outsourcing facilities, can provide your veterinary practice with more flexibility when facing a variety of supply chain challenges.

When assessing current and prospective suppliers, some important factors to consider include:

• Lead times: After you place an order, how long will it take to receive your order? Shorter lead times are typically preferable to minimize treatment delays, reduce inventory carrying costs, and increase responsiveness to demand variations.
• Testing capabilities: Does the supplier conduct its own stability, sterility, and release testing? Compounded medications from suppliers that do in-house testing will likely have longer usability windows and these suppliers may have faster lead times.
• Product range: Does the supplier specialize in a handful of compounded preparations or do they offer a wide range of medications? Having suppliers on hand that can fulfill an entire order can increase productivity and efficiency.

3) Create an Efficient Inventory Management Process

Once you have a strong supplier network in place and high-need compounded medications in stock, you can then focus on efficient management of your inventory. Having an efficient inventory management process in place can help you proactively anticipate your practice’s medication needs so out-of-stock issues can be minimized or even avoided altogether.

To improve the effectiveness of your inventory management process you can:

• Set reorder points for the medications you stock, which will help your practice balance the need to have in-demand medications on hand with the need to operate profitably by avoiding the costs associated with excess inventory and product waste. Analyzing prior sales and repurchase history is helpful in determining specific reorder points.
• Determine optimal reorder quantities. The reorder quantity is the amount of medication you need to order once you hit your reorder point.