(TL;DR at the bottom.)

Due to new regulations going into effect November 1, 2023, you will see significant changes in the Beyond Use Dating (BUD) of your prescriptions, both sterile and non-sterile.

Expiration dates are legally confined to commercial drug products. Beyond Use Dates are for compounded drugs. They do not mean the same thing.

Anything compounded that contains water, like creams, oral suspensions, eye drops, or injections, will have their BUD cut to new standards based on how it was prepared, processed, and whether it contains preservatives.

The old ways of determining a compounded medication’s beyond use dating are no longer permissible according to these new rules.

A pharmacist has always been able to rely on published data, historical evidence, and outside lab testing to set BUDs. The new rules state that extending dates beyond the new maximums, can only be applied to the actual medication being tested, not a medication compounded using the same method and ingredients.

We are an “extemporaneous compounding pharmacy”, and testing every compound and waiting 14 days for test results before dispensing would be incredibly expensive and essentially halt our ability to deliver our services.

So while nothing has changed in how we operate, our methods, practices, ingredients, and procedures remain consistent with best practices across the industry. Whenever there is a new rule, we do our very best to follow it.

We must comply with the new dating requirements, and vow that there will be no reductions in our quality or service.

The NEW BUDs do not mean that items will “go bad” immediately after the beyond use date printed on the label. IT ONLY means we didn’t prove it by testing THE specific prescription you receive. We can no longer legally rely on our 40 years of experience, previous testing results, and applicable historical data.

The rule is relatively simple, we either prove our dating is accurate, every single time, or we lower the BUD on the prescription label to those mandated by law.

Eye drops and injections:
-Most of our preparations had dating between 30 and 90 days when stored in the refrigerator. All will now be 4 days in the refrigerator or 45 days frozen.
PLEASE NOTE: We do not recommend the repeated freezing and thawing of sterile products.
Topical creams using cream bases that include water:
-Most had dating between 30 and 90 days. All of them will now be 14 days when no preservative is used, or 35 days if a preservative is used.

Oral liquids using suspending vehicles that include water:
Our dating has been 14 days for most oral liquids, but all will now be 14 days.

As always, we are always happy to discuss all alternatives with you at any time.
– joel

TL;DR (Too Long; Didn’t Read):

We want to inform you of incoming regulatory changes that impact nearly all of the medicines we make.

Due to newly adopted updates to USP <795>, <797>, and <800>, we are required to report beyond use dates (BUDs) that are no more than 4 to 30 days out from the time your prescription is compounded, depending on water content and dosage form.

Absolutely no change in your prescription, nor the ingredients or methods by which it is made, has occurred.

This change is due to a new regulation that every batch must be tested for BUDs, and this cannot be done for all of the custom medicines we make here. We are confident that our methods are accurate, and stand by any date printed on our labels, but we must comply in order to continue operation.