November 1, 2023, marked the effective date of the revised United States Pharmacopeia (USP) chapters <795> and <797>. Under these revised guidelines, 503A compounding pharmacies are required to comply with the new beyond-use date (BUD) regulations on their preparations, which are much shorter than what was previously allowed.
Under the new guidelines, 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 can be given that meets USP guidelines.
As a care provider, you may be wondering, ‘What are my options for my patients and/or veterinary practice when I have trouble getting some compounded medications or I’m impacted by shorter dating?’
With the changes to BUDs, you may have to shift to alternative medications or make the switch to a 503B pharmacy partner for the best dating.
503B outsourcing facilities, like Epicur, are regulated by the FDA and are NOT impacted by the USP BUD changes! Epicur operates under the requirements of current good manufacturing practices (cGMP), which means our manufactured products have longer, proven dating and will continue to have an expiration of up to 365 days!
Need help finding an alternative medication?
Epicur can help you find the medications your practice and patients need!
Reminders for BUDs and Expirations Dates
Before we dive into the details of the USP changes, let’s refresh ourselves on the differences between beyond-use dates and expiration dates.
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Beyond-Use Dates
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Expiration Dates
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503A pharmacies, or traditional compounding pharmacies, make compounded drugs on a prescription-basis to meet a specific patient’s needs.
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503B outsourcing facilities manufacture large batches of compounded medications for office use.
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BUDs are assigned to these compounded preparations based on the standards established in USP General Chapters (non-sterile) and (sterile).
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These facilities must comply with the FDA’s stringent cGMP regulations, which ensure a drug has the ingredients and strength stated and is safe for use up to the studied expiration date.
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The BUD is the time or date beyond which the compound can no longer be administered, stored, or transported.
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A drug’s expiration date indicates when the manufacturer can no longer guarantee the strength and/or safety of a medication.
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The date of compounding is used in calculating the BUD, which usually ranges from a few days to several months.
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Expiration dates are assigned only after rigorous testing is done to assess the stability of the active pharmaceutical ingredient (API) and are often longer than BUDs.
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While both BUDs and expiration dates serve a similar purpose of decreasing patient risks associated with any changes a medication may undergo during storage, expiration dates have key advantages:
- Expiration dates have a high degree of accuracy—they are determined using stability testing methods validated by cGMP regulations enforced by the FDA.
- Expiration dates can range up to 365 days, significantly longer than the allowable timeframe for BUDs.
Take a deeper dive into the differences between expirations dates and beyond-use dates with our resources:
- BUD vs. Expiration 1-pager
- Breaking the Myth of Exact Strength – a blog & guide from Dr. Renee Alsarraf.
A Closer Look at the Revised USP Guidelines
Below is a summary of the BUD changes for USP <795> and <797>.
USP <795> (non-sterile)
Oral Solutions and Suspensions
- Preparations that are in a non-water containing base (anhydrous) are given a longer beyond-use date (BUD) than a water-containing base (aqueous).
- The effect of the November 1st change on the BUD of oral solutions and suspensions is as follows:
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Type of Oral Preparation
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USP Prior to Nov. 2023
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USP as of Nov. 2023 (Current Official USP)
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Non-aqueous base (examples include COSG and MCT oil base)
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Up to 180-day BUD
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Up to 90-day BUD*+
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Aqueous base with a preservative
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Up to 14 days unless potency over time data establishes a longer BUD
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Up to 35-day BUD *+
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* The BUD of the compounded non-sterile preparation must not exceed the shortest remaining expiration date of any of the starting components.
+ The BUD may be extended past the dates listed above (up to a max of 180 days) if stability studies are performed and meet passing criteria
Other Dosage Forms
The BUD of the dosage forms below are not impacted by the November 2023 USP changes:
- Capsules
- Tablets
- Medi-turns in anhydrous lipoderm for transdermal application
- Chews
- A-PLO for transdermal application
- Suppositories
USP <797> (Sterile)
- USP <797> will no longer base the BUD of a sterile preparation on a risk category (low, medium, or high) but rather on how the preparation was sterilized, the storage condition, and the testing requirements of the preparation.
- The categories listed in the revised USP <797> are 1 through 3, with category 3 preparations requiring the most robust stability testing data to support the BUD stated in USP <797>.
- After stability data testing requirements have been established for a category 3 preparation, release testing must be performed each time a category 3 preparation is compounded.
- Category 2 Preparations’ BUD
- The BUD of category 2 preparations can range from 1 to 90 days based upon how it was sterilized, storage conditions, and if a sterility test was performed and passed.
- Category 3 Preparations’ BUD
- The BUD of category 3 preparations can range from 60 days to 180 days based upon how it was sterilized, storage conditions, and if stability testing criteria were performed and passed.
- The BUDs that 503A pharmacies have previously established will no longer be applicable.
- Certain formulations are undergoing stability data testing requirements to meet the criteria of a category 3 preparation.
- The majority of sterile preparations that are compounded at Stokes Pharmacy are categorized as category 2 or category 3 preparations.
Example Use Case:
Based on USP <797> prior to November 2023, cyclosporin/tacrolimus MCT ophthalmic solution 2/1% had a BUD of 180 days.
Under the current USP <797>, as a Category 3 sterile preparation, a max BUD of 60 days may be assigned based on sterilization method, storage, and category 3 testing requirements being fulfilled.
It’s important to note that although BUDs are established in USP standards, the time it takes for release testing of sterile preparations is not built into the stated BUD. Rather, testing will affect the time the preparation is available on the shelf for sale and ultimately the time the patient has to use it.
Navigating USP Changes with Stokes and Epicur
Veterinary medicine regulations are getting stricter, which is a good thing for the standard of patient care. However, we know these changes can put a strain on veterinary practices. That’s why our brands are dedicated to being a partner who simplifies and streamlines the switch for you.
Stokes Pharmacy and Epicur Pharma are dedicated to improving the standard of care in veterinary medicine by providing practices and the patients they serve with the highest quality sterile and non-sterile preparations. Even through USP or other guideline changes, such as GFI #256, we continue to keep this goal our top priority.
Stokes Pharmacy, a 503A pharmacy, is investing in stability testing for high-demand preparations and recommends the use of Epicur Pharma-manufactured products when they can be appropriately used. Epicur, a registered 503B facility, can help you find an alternative to a compounded preparation with faster availability and longer expiration dates! Check out our examples of medications affected by shorter dating and the alternatives we can provide.
Get a copy of our USP guide that details alternative medications when shorter dating occurs and which facility to request each medication from.
If you’re ready to place an order or need help finding the right medication for your practice or patients, give us a call at 888-508-5032 or send us a message! Our team is ready to help.
