Easy breezy question about expiration date on T

[Brooksy Chuck]

I noticed the compounded test seems to have much soon expiration date than the big brand pharmacutial meds. i have 2 vials of compounded stuff that says discard after " 9.10.13" and one says 10. 22. 13"

curious why the expiration dates are so short and do i really discard this stuff? seems like such a waste..

thanks

 

[Gene Devine]

I noticed the compounded test seems to have much soon expiration date than the big brand pharmacutial meds. i have 2 vials of compounded stuff that says discard after " 9.10.13" and one says 10. 22. 13"

curious why the expiration dates are so short and do i really discard this stuff? seems like such a waste..

thanks

I personally wouldn't worry about it.

The FDA makes all drug manufactures have a expiration date for a drug...some are longer then others.

The reality is there has to be some "end date" in the FDA eyes so we have these "expiration dates".

I've used Test Cyp vials past expiration date with no problems whatsoever.

 

[Brooksy Chuck]

thanks Gene! i wont worry.. i take such a small dose this stuff seems to last me forever.. how will i know when it is time to toss? thanks!

 

[Gene Devine]

thanks Gene! i wont worry.. i take such a small dose this stuff seems to last me forever.. how will i know when it is time to toss? thanks!

I honestly don't know when to toss it past expiration date.

I can remember past discussions where men have used it a couple of years past expiration date and it was still effective.

There may some research on it somewhere if you dig for it.

Keith or Nelson can probably chime in here as well.

 

[Dave Barry]

I've wondered myself as well, when I see a compounded, oil-based product, with a 6-8 month expiration date on it as compared to a 2-3 year expiration date on a name-brand product. My first thought is to wonder if they are using a different oil/preservative? I vaguely remember seeing a study, in which they tested the potency of some water/oil-based products, one-year after the expiration date. The results indicated that water-based products degraded faster than oil-based products. Generally, the oil-based products still had full potency after one year, but these were name-brand products with longer expiration dates. Regardless, I'd have a tendency to agree with Gene (I'd feel comfortable using an oil-based product one year after the expiration date) and would ask the person from empower.com to clear-up any expiration date confusion.

 

[Nelson Vergel]

It is empowerrxpharmacy.com

 

[EmpowerPharmacy]

This is a great question as there is a lot on confusion on how Beyond Use Dates (BUD) are established with compounded products. All compounders are required to use the United States Pharmacopeia (USP) standards when compounding preparations. USP states that for Oil-Based Products a BUD of 6 months or less shall be used if a stability study isn't available for that specific compound. For Water Based Products a BUD of 14 days or less shall be used if a stability study isn't available for that specific compound.

The reason manufacturers can assign 2-3 year Expiration Dates is because they have performed stability studies that take $100,000+ and years to perform. Obviously, compounders cannot afford to do these studies, so when assigning a beyond-use date, compounders consult and apply drug-specific and general stability documentation and literature, and consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy to come to a conservative BUD.

There are many factors to consider in a compounded product including the preservative, base, concentration, excipient, source of active ingredient, vial, stopper, seal, sterilization method, etc. If any of these factors in a compounded product deviates greatly from a manufacturer's then we can't use the same stability results the manufacturer came up with. Since most compounds are made differently from manufactured products we assign very conservative BUDs.

Even though some compounders feel safe to assume stability information on certain compounds, like testosterone cypionate, and have years of data from patients receiving good results from the medication even after the 6 month BUD has past, technically we are still required to put a BUD of 6 months or less unless we have the proper stability study to reference and our product doesn't vary greatly from the manufacture's.

I've personally done 2 year long potency over time studies on our Testosterone Cypionate and it's shown a degradation of less than 7%, but this isn't considered a full blown stability study that the FDA considers valid. Other compounders put what they feel comfortable with at the risk of getting in trouble with the FDA, but that all depends on the compounder.

 

[Gene Devine]

^^^^Great response.

Stay active in the forum we can learn much from you...and I know I just did!

 

[EmpowerPharmacy]

To answer Dave's questions, which are also great, oil based products, in general, do last much longer than water-based ones due to the main degradation mechanism of hydrolysis being absent in oils. This is why water-based testosterone suspension injection and water-based testosterone cream have much lower beyond use dates than oil-based testosterone cypionate or testosterone enanthate.

Most compounders use different oils (cottonseed oil, sesame oil, grape seed oil) at the request of a prescriber. Prescribers usually request difference base oils or preservatives due to a patient allergy or if the prescriber believes that compound will benefit the patient's therapy.