As featured in dvm360 Magazine, February 2024 Issue
By Melissa King, PharmD, Director of Manufacturing Operations, Epicur Pharma and Andrew Filewicz, PharmD, Director of Pharmacy Compounding, Stokes Pharmacy
February, 29 2024— New revisions to the United States Pharmacopeia (USP) Chapter 795, for compounding of non-sterile pharmaceuticals, and Chapter 797, for compounding sterile preparations, are in effect. These standards of practice can now be enforced by the FDA, local state boards of pharmacy, and accreditation organizations. The new 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 FDA to improve the testing and manufacturing standards for veterinary medicines. It can be challenging to keep up—what is the real impact to your veterinary practice?
Traditionally, veterinary hospitals and clinics utilized neighborhood or national 503A compounding pharmacies to fill prescriptions for compounded medications. These medications are labeled with a “Beyond-Use Date” or BUD. These regulations will further shrink the window for usability. 503B veterinary medicines are manufactured according to carefully controlled manufacturing and testing standards, and typically offer a longer, proven expiration date, typically up to 365 days.
Many of your most prescribed medications have been impacted. For 503A compounding pharmacies without testing in place to verify BUD, these use-by dates may change from 180 days to 1-4 days, making them impractical to prescribe. Some of the common 503A prescriptions, and their available 503B medication alternatives include:
- 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. Alternate option: Cidofovir 0.5% Ophthalmic Solution, 365 days from date manufactured.
- Tacrolimus AQ 0.05% Ophthalmic Suspension, 4 days refrigerated. 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 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
It might be easy to suggest clients disregard these dates, but the BUD date 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, altering the rate and amount absorbed by the patient, and the development of toxic byproducts over time.
This is a paid sponsored content article from Epicur.
