Do compounded medications expire more quickly? WARNING TO PATIENTS

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Arcane

Member
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?
 
Defy Medical TRT clinic doctor

Nelson Vergel

Founder, ExcelMale.com
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

Founder, ExcelMale.com
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

Member
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

Founder, ExcelMale.com
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".

 

Charliebizz

Well-Known Member
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?
 
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