Do compounded medications expire more quickly? WARNING TO PATIENTS

[Arcane]

So I noticed that my medication, whether it be testosterone, clomiphene, or anastrozole Always has a discard date of around four months from the time I received it in the mail. I found this strange because typical pharmacy medication is usually good for two or three years. So I gave My HRT clinic a call and asked why this was the case. The representative told me that compounded medicine degrades much more quickly.

Can anyone confirm if this is true? And if so why is that the case?

 

[Nelson Vergel]

Unfortunately, the FDA has limited compounding pharmacies to shorter BUDs, even when they are able to do the same time-point stability studies that commercial pharmaceutical companies utilize. The maximum BUD under USP conditions is 1 year, however due to the high cost of doing stability studies most compounders strive for 3-6 months. In addition, many products that compounding pharmacies produce for HRT/Integrative health contain ingredients that do not remain stable for a long time. This includes many of the injectable nutrients, peptide hormones, etc. When a compounding pharmacy produces a batch that has been established with a 6 month BUD that doesn't mean there will be 6 months left of usage by the time the patient receives it, most compounders try to dispense everything with a min of 3 month remaining which usually accommodates most uses.

This might also be a good place to plug the current “BUD issue” where the FDA wants to limit compounders to 90 days BUD max. This will essentially put compounders out of business. Since there is zero scientific basis for this proposal everyone suspects it’s a “hail mary” to hinder compounding. There is a great white paper submitted by APC proving the FDA has no scientific reason for this. I believe there is a commenting period for providers/patients.

 

[Nelson Vergel]

USP’s proposed changes to sterile compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add “likely cost-prohibitive” to that list: Stability studies have a price tag of around $30,000, Davis said.

The proposals would also limit batch sizes across the board to 250 units – a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times.

USP’s proposals would also impose arbitrary upper BUD limits as low as 60 days — even if existing, rigorous stability data justify a longer BUD.

“At the end of the day, these proposals won’t do anything for patients except require them to refill more frequently and increase the costs of those refills,” said Grzib.

For more detail, on the USP proposals, you can read the slides presented at the town hall here (PDF)

 

[Arcane]

USP’s proposed changes to sterile compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add “likely cost-prohibitive” to that list: Stability studies have a price tag of around $30,000, Davis said.

The proposals would also limit batch sizes across the board to 250 units – a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times.

USP’s proposals would also impose arbitrary upper BUD limits as low as 60 days — even if existing, rigorous stability data justify a longer BUD.

“At the end of the day, these proposals won’t do anything for patients except require them to refill more frequently and increase the costs of those refills,” said Grzib.

For more detail, on the USP proposals, you can read the slides presented at the town hall here (PDF)

Do you have faith in the future of HRT?

 

[Nelson Vergel]

Do you have faith in the future of HRT?

Only if we organize and fight back.

That is why I created:

Take Action

Tell the FDA and Congress to Protect Your Access to Affordable Compounded Hormones

hormoneaccesscoalition.org

 

[Nelson Vergel]

Please watch this video to understand everything that is at risk:

 

[Arcane]

Please watch this video to understand everything that is at risk:

Wouldnt we still be able to get prescribed retail pharmacy medication? I get pregnyl hcg now rather than compounded (empower) and TBH I like it better

 

[Nelson Vergel]

Wouldnt we still be able to get prescribed retail pharmacy medication?

Yes, you will. But when the FDA eliminates cheaper alternatives, prices increase and inventories decrease. hCG (10,000 IU) at regular pharmacies (10,000IU) went from $118/vial 6 months ago to around $300 now. Don't be fooled by thinking "I am safe since I buy my TRT or hCG from regular pharmacies".

https://www.goodrx.com/hcg

 

[Charliebizz]

Would a unopened non-punctured vial of testosterone enanthate from empower compound it in grapeseed oil still be good now when the bud date was 2/22?

 

[Dicky]

Would a unopened non-punctured vial of testosterone enanthate from empower compound it in grapeseed oil still be good now when the bud date was 2/22?

I have used compounded cypionate (Empower brand) with a BUD date that was greater than 1 year past. I didn't notice any product degradation.

 

[Nelson Vergel]

Update: The newly revised USP General Chapter <797>, which became official on Nov. 1, 2023.

 

[granger]

talk to your pharmacist about it certian drugs your taking and ask if its an issue when expired(very few actually do).

also depending on what the compounding is ie if just capsules. as long as kept dry and stable compound normal BUD could be applied, and infact MANY drugs last double or triple the expiry date.. some dont though.

so we could say this for normal pharma aswell. BILLIONs of perfectly usuable meds get destroyed every year outside of compounding, and of course that saving is passed on to you aswell.

just ask yourself
-does this medication keep me alive? if yes, take less risks
-does this medication degrade into dangerous compounds? yes, def follow BBD
- have a kept the medication dry and cool out of sunlight?

as for price increases, i think the BETTER idea for you folks in USA is to use what the rest of the free world does. ie have gov regulate the pricing and essentially do "group discount", this is why canada and mex get cheaper meds. yes it adds regulations but if means people can afford medication i think it probably is worth it esp having ability to really hold big pharmas feet for better deals. Canada is now providing diabetes medications for free. i really hope USA and canada can work together with perhaps mexico and really start maufacturing drugs in north america.. sucks but without gov help its unlikely to happen as SOO much cheaper and easier to operate in the third world.. I tihnk id be ok paying more tax if meant medical security for america. also important drug companies IP is protected and they are able to make tonnes of money, so it makes sense for them to develop new drugs.

I mean if want compounded HCG why not just order straight from china?