New USP guidelines are limiting beyond-use dates (BUDs) on drugs compounded at all 503A compounding pharmacies.
We’re here to help you understand the new USP guidelines and ensure you get the right medications for your patients—at the highest quality. Here’s a quick overview of the USP guidelines and changes to your practice:
USP 795 refers to compounding standards for non-sterile compounding while USP 797 refers to compounding standards for sterile compounding. The change that will have the biggest impact on your practice is some preparations from 503A compounding pharmacies will have a shorter beyond use date (BUD).
Under the new USP guidelines, 503A compounding pharmacies are limited in extending BUDs. New default BUDs for compounded products are specified in these USP updates. 503A compounding pharmacies can only extend the BUD of a preparation if a stability study is completed. Even with a stability study, there is a maximum BUD that a compounded preparation will be given as per USP standards. Stokes Pharmacy, our 503A sister pharmacy, has invested in stability testing to extend the BUD of frequently prescribed preparations. The goal of stability testing at Stokes Pharmacy is to provide clients the longest BUD that meets USP standards.
Because Epicur Pharma is a 503B outsourcing facility regulated by the FDA, our 503B manufactured medications are NOT required to follow the requirements of USP 795 or 797. Epicur must follow the rigorous testing requirements under current good manufacturing practice (cGMP) regulations that allow 503B manufactured medications to have expiration dates of up to 365 days, which are longer than beyond use dates of 503A compounded medications.
Epicur Pharma is here to help! Epicur is a trusted 503B pharmacy partner that can assist you in finding high quality manufactured products that fits the needs of your patients and practice!
dvm360 magazine, February 2024 issue
Epicur’s Pharmacist and Director of Manufacturing, Melissa King, PharmD, and Stokes Pharmacy’s Director of Pharmacy, Andrew Filewicz, PharmD, explain the real impact on your veterinary practice and beyond-use dates (BUDs) under the revised USP guidelines.
Download, print, and share our free PDF with veterinary professionals at your veterinary office or hospital.
For the drugs compounded at Stokes Pharmacy where the dating is significantly reduced, we can help! Both our direct to office team and our iFill online ordering platform will:
Epicur’s Melissa King, PharmD, shares her insights and explains why expiration dates are an advantage for you and your patients.
When it’s time to place an order for your hospital, you can trust Stokes Pharmacy and Epicur will help you find the best alternative choices. Below are some examples of how we plan to handle medications affected by short dating (starting early 2024 but some as early as 11/1/23):
|
Stokes Drug Impacted
|
New Dating Per USP
|
Recommendation
|
Facility*
|
Dating on Recommended Drug
|
|---|---|---|---|---|
|
Acetylcysteine 2.5% Ophthalmic Solution
|
4 days refrigerated
|
Acetylcysteine 5% Ophthalmic Solution (Refrigerated)
|
Stokes
|
BUD of 90 days minus testing1
|
|
Cidofovir 1% Ophthalmic Solution
|
4 days refrigerated
|
Cidofovir 0.5% Ophthalmic Solution
|
Epicur
|
365 days from date manufactured
|
|
Flurbiprofen 0.03% Ophthalmic Ointment
|
1 day controlled room temperature
|
Flurbiprofen 0.04% Ophthalmic Solution
|
Epicur
|
365 days from date manufactured
|
|
Tacrolimus AQ 0.05% Ophthalmic Suspension
|
4 days refrigerated
|
Tacrolimus AQ 0.03% or 0.1% Ophthalmic Suspension
|
Epicur
|
365 days from date manufactured
|
|
Tacrolimus MCT 0.2% Ophthalmic Solution
|
4 days refrigerated
|
Tacrolimus MCT 0.3% Ophthalmic Solution or AQ 0.1% Ophthalmic Suspension
|
Epicur
|
365 days from date manufactured
|
|
Voriconazole 1% Ophthalmic Ointment
|
1 day controlled room temperature
|
Voriconazole 1% Ophthalmic
Solution (Refrigerated)
|
Stokes
|
BUD of 90 days minus testing1
|
|
EDTA 2% Ophthalmic Ointment
|
1 day controlled room temperature
|
EDTA 2% Ophthalmic Solution or Gel (coming in 2024)
|
Epicur
|
365 days from date manufactured
|
|
EDTA 3% Ophthalmic Solution
|
4 days refrigerated (ships when made) or 45 days minus testing1
|
EDTA 2% Ophthalmic Solution
|
Epicur
|
365 days from date manufactured
|
|
Nalbuphine 1.2% Ophthalmic Solution
|
4 days refrigerated or 45 days minus testing1
|
No alternative
|
N/A
|
N/A
|
*Epicur Pharma drugs are manufactured in an FDA Registered 503B Facility. Stokes Pharmacy drugs are compounded in a 503A pharmacy
1-Sterility testing takes a minimum of 14 days.
If you receive any medications from Stokes Pharmacy, or any other pharmacy which you may be concerned about, please feel free to call with any questions at 888-508-5032.
Don’t let the new USP guidelines slow your practice down from giving the best care possible. When you’re looking for a compounded medication, consider Epicur Pharma’s manufactured medications. Both you and the pet owner will benefit from longer expiration dates and the order will ship the same business day.
Explore our complete product portfolio of 100% manufactured 503B drugs:
New partners: Start your account online or call us at 888-508-5032.
Existing iFill accounts:
Patient refills: