Beyond-use dates: Ready or not, USP guidelines will impact your practice

Halfpoint / stock.adobe.com

New revisions to the United States Pharmacopeia (USP) Chapter <795>, for compounding of nonsterile pharmaceuticals, and Chapter <797>, for compounding sterile preparations, are in effect. The revised USP guidelines limit the ability of 503A compounding pharmacies to extend beyond-use dates (BUDs). This regulatory change is one of many by both the USP and the FDA to improve the testing and manufacturing standards for veterinary medicines. It can be challenging to keep up—what is the real impact on your veterinary practice?

Traditionally, veterinary hospitals and clinics utilized neighborhood or national 503A compounding pharmacies to fill prescriptions for compounded medications with a BUD label. The new regulations will further shrink the window for usability. Alternately, 503B veterinary medicines are manufactured according to carefully controlled manufacturing and testing standards, and typically offer a longer, proven expiration date, usually up to 365 days.

Many of the most-prescribed medications have been impacted. For 503A compounding pharmacies without testing in place to verify BUDs, these use-by dates may decrease from 180 days to 1 to 4 days, making them impractical to prescribe. Some of the common 503A prescriptions and their available 503B medication alternatives include¹:

• Flurbiprofen 0.03% ophthalmic ointment, 1-day, controlled room temperature under new USP guidelines. Alternate option: flurbiprofen 0.04% ophthalmic solution, 365 days from date manufactured.
• Cidofovir 1% ophthalmic solution, 4 days refrigerated under new USP guidelines. Alternate option: cidofovir 0.5% ophthalmic solution, 365 days from date manufactured.
• Tacrolimus AQ 0.05% ophthalmic suspension, 4 days refrigerated under new USP guidelines. Alternate option: tacrolimus AQ 0.03% or 0.1% ophthalmic suspension, 365 days from date manufactured.

Testing processes have traditionally varied widely in compounding pharmacies, and many pharmacies have expanded testing in anticipation of these regulations. These new pressures may cause backlogs at external testing facilities, presenting a logistics challenge in getting these to your patients within the usability window.

What you need to know to prescribe

The BUD is important to ensure the product’s safety, quality, and efficacy, and plays an important role in safeguarding patient well-being. Products that exceed their shelf life can cause a variety of problems that impact patient health, including degradation or increased concentration of the active ingredient, contamination during distribution or storage, changes in the drug’s bioavailability that alter the rate and amount absorbed by the patient, and the development of toxic by-products over time.

These changes can cause some disruption and confusion. Here’s what you need to know to safeguard both your patients and practice:

Familiarize yourself with standard formulations and dosages available. The higher testing standards of 503B medicines can mean that a standard strength is closer to your desired dosage than a custom compound.

Design for flexibility. Help pet owners get what their pets need by recommending acceptable alternatives if a medication or drug is unavailable or impractical.

Anticipate questions. This will impact your clients’ prescription refill schedules, and many will likely need to adjust from a quarterly refill to a monthly refill. Make sure your front office is prepared to answer questions and modify prescriptions to ensure clients have access to the medications their pets need.

Understand that pharmacies must follow the regulations but are ready to support you with guidance on available right-fit medications to fit your patients’ needs.

Takeaways for clients

Advise your clients to stay on top of refills and pay attention to the BUDs: Clients should stop using drugs past the BUD and plan for replenishment. Their pharmacy can help them figure it out.

Consider 503B manufactured medicines whenever appropriate, as they offer a far-longer shelf life, ranging from months to years. The expiration date is determined after robust stability testing required by the FDA’s current good manufacturing practice regulations. This longer shelf life and comprehensive stability testing offer your clients easy availability with more convenient refill schedules, and offer veterinary practices the following:

• Improved inventory management and reduced waste

• Stock available for office use, improving patient care

• Accurate dosing and reduced risk of contaminated drugs and toxic byproducts

Navigating regulatory changes

The latest USP changes may seem sudden to your clients but have been in the works for years. Pharmacies are prepared to help you and your clients understand the changes and recommend alternatives. It’s a challenging time, and as these regulations roll out state by state, your practice can improve patient safety by working with a reputable pharmacy partner to assess your inventory needs and make adjustments to ensure clients have access to right-fit medications held to a higher standard.

Reference

New United States Pharmacopeia (USP) Guidelines. Epicur Pharma. Accessed January 16, 2024. https://epicurpharma.com/ usp-guidelines

Melissa King, PharmD, is a pharmacist and director of manufacturing operations for Epicur Pharma. King is a pharmacist and operations leader for Epicur Pharma. She oversees manufacturing and distribution operations in accordance with current good manufacturing practices, which are integral to 503B drug manufacturing. She holds a doctor of pharmacy degree from the former University of the Sciences in Philadelphia, Pennsylvania.

Andrew Filewicz, PharmD, is director of pharmacy compounding for Stokes Pharmacy and a multistate licensed pharmacist with 14 years of experience in compounding. As director of pharmacy compounding, he is focused on continuous process improvement while streamlining the compounding process. Filewicz holds a doctor of pharmacy degree from Fairleigh Dickinson University School of Pharmacy and Health Sciences and previously served as Stokes Pharmacy’s production manager.