Defy Medical HCG Shortage?

[Johnny Test]

This whole situation is completely fucked.

 

[tareload]

This whole situation is completely fucked.

Look on the bright side...you get a preview of what it will be like once compounders can't do other hormones like Testosterone. Women who use these products will really be in a bind.

 

[JYD21]

This sounds crazy. I'm not on TRT, but looking at it for a while. What does this really mean? Why is the FDA doing this?

 

[stayingbalanced]

I had a pretty shady experience with Empower just recently. I really expected Defy to have my back on it, but they just rolled over on me. Been debating about whether to post the event(s) here to see if anything similar has happened to anybody else.

Please do always post info about this. We need to share when that happens

 

[Jon H]

Ref: Empower....I've never had a bad experience with Empower that was anything other than a miscommunication. When it comes to compounding pharmacies I don't think there's a single one that has welcomed more oversight and has more verifiable certifications. I feel the same way about Defy. If someone feels the need to comment otherwise, I hope they put it in a separate thread, so this one doesn't get off-topic.

 

[Jon H]

There are many drugs sold by Empower that aren't compounded (e.g., Cabergoline, Avodart/Dutasteride, Exemestane, Synthroid). They even sell branded testosterone cypionate. I'm hoping that when they are no longer allowed to compound HCG, they will be able to do the same thing with branded HCG, and people that are Defy Medical patients will be able to continue using the "normal" process (but I'm sure at a higher price point).

 

[Phil Goodman]

Contemplated making a new thread for this question but decided to ask in here first:


Is there a consensus on the best way to store HCG that hasn’t been reconstituted? Since most of us will end up with extra vials that we’d like to stretch for as long as possible it would be nice to know the best way to store for maximum potency.

 

[Dicky]

Contemplated making a new thread for this question but decided to ask in here first:


Is there a consensus on the best way to store HCG that hasn’t been reconstituted? Since most of us will end up with extra vials that we’d like to stretch for as long as possible it would be nice to know the best way to store for maximum potency.

I'm freezing mine

 

[tareload]

Contemplated making a new thread for this question but decided to ask in here first:


Is there a consensus on the best way to store HCG that hasn’t been reconstituted? Since most of us will end up with extra vials that we’d like to stretch for as long as possible it would be nice to know the best way to store for maximum potency.

Under research conditions you'd store lyophilized powder with dessicant at -20 or -80 deg C (potency would keep for a few years).

At home keep the lyophilized powder on your fridge or freezer which should last you a while. Freezer better for multi year storage.

https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/research-and-disease-areas/cell-and-developmental-biology-research/handling-and-storage

 

[madman]

Contemplated making a new thread for this question but decided to ask in here first:


Is there a consensus on the best way to store HCG that hasn’t been reconstituted? Since most of us will end up with extra vials that we’d like to stretch for as long as possible it would be nice to know the best way to store for maximum potency.

2. How are expiration dates established?

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug. This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.





*Can be stored at room temperature (15°C–30°C or 59°F–86°F) prior to reconstitution

Think of how long the expiration date is on the vial.

Should be no issue with the potency when storing it at room temperature long-term.

If you are worried then storing it in a cool/dark place would be more than enough.

 

[tareload]

2. How are expiration dates established?

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug. This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.





*Can be stored at room temperature (15°C–30°C or 59°F–86°F) prior to reconstitution

Think of how long the expiration date is on the vial.

Should be no issue with the potency when storing it at room temperature long-term.

If you are worried then storing it in a cool/dark place would be more than enough.

Pregnyl or Fresenius vials I have usually 12 to 18 months on the expiration from the specialty pharmacy. If you are looking to store for years, fridge or freezer better than room temp. Oxidation and decomposition typically modeled with 50 to 100 kJ/mol Ea and so dropping storage temp on the lyophilized powder will add significant shelf life if you want to maximize potency long term.

Is it overkill if you will use the vials in a couple of years...sure . That's why the glycoprotein is lyophilized to begin with. Stable at RT for a while.

 

[madman]

Pregnyl or Fresenius vials I have usually 12 to 18 months on the expiration from the specialty pharmacy. If you are looking to store for years, fridge or freezer better than room temp. Oxidation and decomposition typically modeled with 50 kJ/Mol Ea and so dropping storage temp on the lyophilized powder will add significant shelf life if you want to maximize potency long term.

I use Pregnyl and the expiration date is 2 years.

Would not even waste my time storing in the freezer unless you plan on stockpiling.

 

[tareload]

I use Pregnyl and the expiration date is 2 years.

Would not even waste my time storing in the freezer unless you plan on stockpiling.

Interesting point. You made me go look at my vials in the fridge. Fresenius is 12 to 18 months based on my recollection of receipt and I have a Pregnyl vial that's marked 12/24. So either my specialty pharmacy doesn't turn over the stock too fast or some of these manufacturers are more conservative than others. I'd have to get C of A or manufacture date to chase this down.

So just to make sure I convey the message I'm not arguing, guys are fine to store to expiration date in the dark closet. I just keep all my stock in the fridge. Those guys who want to invest in the -80 C freezer, enjoy!!

 

[schismz]

This sounds crazy. I'm not on TRT, but looking at it for a while. What does this really mean? Why is the FDA doing this?

The same reason they do almost everything? Because money? See also: vaping (bad for cigarette bonds).

The FDA is a gargantuan organization with myriad departments, with regulatory power over roughly .25-.30 cents of every dollar spent in the US. It's impossible to make a blanket statement such as, "the FDA is good" or the "FDA is bad." The pilot drugs evaluation unit went from essentially rubber-stamping whatever the DEA told them to, to being completely rebooted in the early 1990s, which is why we have clinical trials with psychedelic drugs now. But significant portions of the FDA are completely political and corrupt, which could be said of all government in general, but I will cut short my rant.

The answer is: money, and the desire to control people. The FDA deeply cares about big Pharma's profit margins. The same reason hGH is price-fixed in the US and lumped into the AAS/schedule III category.

Go to another jurisdiction the same products are OTC. It's a strange world where the laws vary tremendously. At the end of the day you can either 1. buy your way into any situation you desire, or 2. lacking infinite funds spend time doing research on how to acquire same using some more complex methodology.

It is what it is, see also: consensual reality and the world around us circa 2021.

 

[StepbyStep]

On the topic of "stockpiling" HCG...at one point I had more unconstituted HCG than I knew what to do with. I kept the boxes in gallon zip lock bags and stored them in the fridge. Used them for a couple of years, by the time I was getting to the end of my stash I was using vials that were over a year "expired". Still worked great.

 

[HealthMan]

They called in for you in NY? Weird. In NY HCG is a controlled substance same as in CT. They are unable to call in for me that lives in CT

 

[lunchbeast]

They called in for you in NY? Weird. In NY HCG is a controlled substance same as in CT. They are unable to call in for me that lives in CT

Testosterone is a controlled substance as well, but I finally got them (Defy) to call it in for me at my local pharmacy. Took a lot of complaining - Defy is extremely reluctant to use anything but Empower or Hallandale and even tried to tell me it was illegal to call in across state lines (I checked and knew otherwise) - but the end result was that my Test cost me $25 locally for a 10ml vial with a GoodRx coupon vs $100+ from either of the two Defy options. They did charge me an extra $30 for the 'effort', but I still saved a bundle.

 

[HealthMan]

Testosterone is a controlled substance as well, but I finally got them (Defy) to call it in for me at my local pharmacy. Took a lot of complaining - Defy is extremely reluctant to use anything but Empower or Hallandale and even tried to tell me it was illegal to call in across state lines (I checked and knew otherwise) - but the end result was that my Test cost me $25 locally for a 10ml vial with a GoodRx coupon vs $100+ from either of the two Defy options. They did charge me an extra $30 for the 'effort', but I still saved a bundle.

I guess as long as the prescribing doctor is licensed in that state it is ok to call in controlled substances

 

[bennettjc]

Testosterone is a controlled substance as well, but I finally got them (Defy) to call it in for me at my local pharmacy. Took a lot of complaining - Defy is extremely reluctant to use anything but Empower or Hallandale and even tried to tell me it was illegal to call in across state lines (I checked and knew otherwise) - but the end result was that my Test cost me $25 locally for a 10ml vial with a GoodRx coupon vs $100+ from either of the two Defy options. They did charge me an extra $30 for the 'effort', but I still saved a bundle.

Lunchbeast,

You are working with a company that is lying to you and nickle and diming you. Fortunately you were assertive and saw through it. But would you consider looking elsewhere? Also... it is not impossible to get decent TRT, particularly if you are already dialed in, from a local urologist or primary care (if you have insurance).

 

[Vince]

Got my 6 + months supply of HCG last night.