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Potential Impact to Inventory Management 

USP <795>, <797>, & <800> standards updated

November 1, 2023

 

Last Updated: May 17, 2024

As your trusted partner in veterinary compounding, we want to ensure that you're well-informed about the revisions to United States Pharmacopeia (USP) standards and the impact they may have on you, your practice, and your patients.
 
Rest assured, we're here to help minimize the potential impact. See What's Next.

We've got you covered.

Recent changes to United States Pharmacopeia (USP) guidelines have impacted Beyond-Use Dates (BUD) for preparations compounded at state-licensed (503A) pharmacies throughout the nation. Read More Here.

Without stability testing, many commonly prescribed compounds have a BUD of only 14 days. Wedgewood has you covered - we've invested in the testing necessary to provide you with industry-leading Beyond-Use Dates!

BUD Chart (2)

Beyond-Use Dates for medications prepared at our FDA-registered outsourcing facility, Wedgewood Connect, ship fast, with much longer, cGMP-based dating. Additionally, these items can all be ordered for office stock or prescribed for home delivery.**

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**Subject to state restrictions in HI.

What do the new USP standards mean for veterinarians?

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Shortened Beyond-Use Dates (BUDs) for office stock and prescriptions.

•  Practices and pet owners may need to order more frequently.

•  Our technology can help by making the ordering process easier and more efficient for your staff.

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More products will come from our 503B outsourcing facility.

•  Practices may need to familiarize their staff with new preparations and labels as medication appearances and forms may change.

•  Currently, 82 medications are being compounded at Wedgewood Connect, our FDA-registered 503B outsourcing facility, which adheres to cGMP practices.

•  21 additional medications will be transitioning to Wedgewood Connect.

•  You can view and order seamlessly from our entire combined Wedgewood Pharmacy and Wedgewood Connect formularies at WedgewoodPharmacy.com.

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Changes and their impact

The revised USP chapters introduce changes to compounded medication BUDs. This may necessitate more frequent ordering for uninterrupted treatment.

<795> - Nonsterile Preparations: Changes include shortened BUDs.

<797> - Sterile Preparations: Changes include mandated stability testing to determine BUDs.

Non Sterile medication BUD changes: USP <795>

795 Chart (6)

 

Sterile medication BUD changes: USP <797>

797 Chart (11 x 8.5 in) (1)

 

Examples of affected medications
Examples of affected medications USP Chart (1)

 

 

What's next?

Rest assured that we are here to help you navigate these changes. We have always followed USP standards, and we are well-equipped to comply.

•  We are investing significant resources into conducting the stability testing required by the revised USP standards so that we can continue to offer you the longest BUDs possible in the industry.

•  Our ordering platform will show the BUDs for all medications. (If a medication is affected, you will see an alert!)

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FAQ's:
What is USP and why does it exist?
USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. USP exists to ensure that compounded medications produced at pharmacies meet the highest quality practice standards. USP standards on their own are not regulations, but nearly every state has incorporated the standards into their state pharmacy regulations.
What are Beyond-Use Dates (BUDs)?

State-regulated compounding pharmacies must adhere to Beyond-Use Dates (BUDs). Beyond-Use Dates are assigned to compounded medications to indicate the date after which the medication should not be used, as determined by the pharmacy's stability testing or other considerations.

What is the difference between expiration dates and BUDs?
Both types of dates serve to inform healthcare providers and patients about the duration of a medication's usability and play essential roles in ensuring medication quality. BUDs are the date or time after which a compounded preparation may not be stored or transported and is calculated from the date or time of compounding. Expiration date is a manufacturer-defined term based on very specific testing used for commercially available products. 
Why is USP changing the BUDs of medications I have been using without incident for years?
USP chapters <795> and <797> were revised to update the standards for compounding non-sterile and sterile medicines based on the latest scientific evidence and stakeholder input. The goal is to protect patients and personnel, ensure high-quality compounding preparations, and promote patient safety. For more information, visit US Pharmacopeia (USP).
What is USP <800> and how will it impact veterinary medicine?
USP <800> addresses the handling of hazardous drugs to safeguard both healthcare workers and animal patients. It requires specialized facilities and equipment for compounding and dispensing hazardous medications.
What BUDs can be expected after November 1?

USP Dosage Form BUD Chart

 

Get In Touch

We'd love to hear your questions and feedback. Please reach out to us at hello@wedgewoodpharmacy.com.