Testosterone No Good After 28 Days???

[52hoosier]

My CNP wrote me a new script for 10ML of 200MG/ML. When I went to Sam's to pick it up, they had a 1 ML vial. When I told them I wanted a 5ML or 10ML vial, the Pharmacist told me that they only do 1 ML vials because Testosterone goes bad after 28 days....AND once you pierce the rubber cap with a syringe needle, you are introducing all kinds of bacteria into the vial which makes it unsafe. I could see that IF you used the same needle and did not wipe the cap with an alcohol swab.

If true, I should be dead by now as I have been injecting from 5ML vials for years.

I politely disagreed with Pharmacist in spite of her rant. Is there any definitive information/study on spoilage after 28 days or bacteria being introduced into the vial when precautions are taken.

Thanks.

 

[Cataceous]

We talked about where that figure of 28 days comes from in this thread:

True /false -Multi-dose 10ml vial expires after 28 days of puncturing??

Hey hey guys, out of curiosity I was googling questions about Pfizer brand testosterone multi-dose 10ml vial because I just started getting them. I used to just get the single-use vials because my insurance stopped covering the single dose vials except Perrigo which I don't use I had an...

www.excelmale.com

It's at least theoretically possible to inject bacteria-laden dust particles into your vial along with the air you're putting in to equalize pressure. However, bacteriostatic preservatives such as benzyl alcohol are supposed to prevent the bacteria from multiplying; usually it takes higher numbers of them to cause serious problems.

 

[52hoosier]

We talked about where that figure of 28 days comes from in this thread:

True /false -Multi-dose 10ml vial expires after 28 days of puncturing??

Hey hey guys, out of curiosity I was googling questions about Pfizer brand testosterone multi-dose 10ml vial because I just started getting them. I used to just get the single-use vials because my insurance stopped covering the single dose vials except Perrigo which I don't use I had an...

www.excelmale.com

It's at least theoretically possible to inject bacteria-laden dust particles into your vial along with the air you're putting in to equalize pressure. However, bacteriostatic preservatives such as benzyl alcohol are supposed to prevent the bacteria from multiplying; usually it takes higher numbers of them to cause serious problems.

Thank you. I did a search for "spoilage" but did not find the above thread.

 

[52hoosier]

So far, Sams, Smith's (Kroger) and Walgreens only carry the 1ML vials of TC. CVS does have the 10ML vial. Will check Costco on Monday

We may not believe the 28 day expiration, but seems like most retail Pharmacies do.

 

[Bulldog]

The issue is that the big pharma companies only test for safety for up to 28 days. Because of this pharmacists usually will not distribute a 5 or 10 ML vial if it is intended to be used for longer than that because its use would be outside the known safety window.

 

[tareload]

Make sure she gives you some 18 g needles to go with that 1 mL vial .

Must be very region specific as I've gotten 10 mL vials from Walgreens for years at my location and of course cash pay compounding pharmacies will sell you standard 10 mL vials no problem. I typically use a 10 mL vial over 6 or 7 months at roughly 75 mg/week. If I switch to 100 mg/week then it's a tad under 5 months. Happy hunting.

 

[Gladiator]

Just use it all in a month. Problem solved

 

[Gladiator]

I always fill my syringe with air with the cap on. Hope this stops the bacteria getting in. Alcohol swab the top before and after so it’s clean.

 

[Jason Sypolt]

The 28-day lifespan of a multi-use vial is based on guidelines from the CDC regarding contamination and sterility. The retail pharmacies are corporate entities and are going to create corporate policy around those requirements in an effort to do anything to reduce their liability and exposure, so they are going to follow those guidelines.

Technically yes, you introduce contaminants into the vial with every puncture, but that is what the preservative is for. The vial, even a 1mL does not immediately “spoil” at 28 days.

The guidelines are actually intended for a hospital setting.

Questions about Multi-dose vials | Injection Safety | CDC

Can multi-dose vials be used for more than one patient? And other questions about the use of multi-dose medication vials.

www.cdc.gov

Read carefully and you will notice phrases such as “whenever possible” and “should”, not “must”. Even these guidelines are not absolute as a corporate pharmacist would have you believe. And note #5. It’s a suggested (“should”) 28 days UNLESS a date is otherwise specified by manufacturer on the vial, which they all have.

 

[Cataceous]

Because nobody wants to follow the link I'll duplicate the information here. The figure of 28 days comes from the United States Pharmacopeia (USP) standard:

Multiple-Dose Container: (see 659) A multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. The beyond-use date (BUD) for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days (see Antimicrobial Effectiveness Testing 51), unless otherwise specified by the manufacturer.​

https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf

The USP standard is federal law. Therefore healthcare professionals might reasonably be unwilling to contradict the directive. There are no qualifiers like "should" in the standard. "The beyond-use date ... is 28 days..."

Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist.​

United States Pharmacopeia - Wikipedia

en.wikipedia.org

This article is quite cautionary and explains the challenge tests required of manufacturers.

Without getting into the incredibly detailed science describing these tests, it has been accepted that multi-use vials can only be used safely for 28 days after the first puncture.​

More details on Antimicrobial Effectiveness Testing here:

https://latam-edu.usp.org/wp-content/uploads/2021/01/USP-NF-51.pdf

 

[tareload]

Because nobody wants to follow the link I'll duplicate the information here. The figure of 28 days comes from the United States Pharmacopeia (USP) standard:

Multiple-Dose Container: (see 659) A multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. The beyond-use date (BUD) for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days (see Antimicrobial Effectiveness Testing 51), unless otherwise specified by the manufacturer.​

https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf

The USP standard is federal law. Therefore healthcare professionals might reasonably be unwilling to contradict the directive. There are no qualifiers like "should" in the standard. "The beyond-use date ... is 28 days..."

Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist.​

United States Pharmacopeia - Wikipedia

en.wikipedia.org

This article is quite cautionary and explains the challenge tests required of manufacturers.

Without getting into the incredibly detailed science describing these tests, it has been accepted that multi-use vials can only be used safely for 28 days after the first puncture.​

More details on Antimicrobial Effectiveness Testing here:

https://latam-edu.usp.org/wp-content/uploads/2021/01/USP-NF-51.pdf

I followed the link! Thank you.

Interesting to ponder the origin of the 10 mL (200 mg/mL) esterified testosterone vial and then the USP standard. For personal prescription use, you either have to run 500 mg/week or throw out a bunch of test if you are a rule follower .

Self consistent isn't how I would describe a 2000 mg vial that would be used to dispense the typical 200 mg every other week (typical dosing from the old days) at home in light of USP standard.

Of course in a doctor's office with the physician/nurse doing the dispensing then all these constraints and inputs can fit together perfectly.

 

[Cataceous]

...
Of course in a doctor's office with the physician/nurse doing the dispensing then all these constraints and inputs can fit together perfectly.

Exactly. This old school approach is how Botox/Dysport injections work these days. The vials are supposed to be used within hours of puncturing even though some contain enough for multiple patients. Larger volume clinics have no problems with this, while others have discovered that they can push the hours to a week or more. Of course they're substituting bacteriostatic saline for the regular saline called for in the prescribing information.

 

[Jason Sypolt]

Parts of USP standards, and in particular the NF standards are enforced by the FDA under federal law, yes. USP is itself independent and a non-profit organization. The standards have nothing to do with dispensing medications; they have everything to do with defining standards to stability, purity, and quality of each ingredient in a medication or dietary supplements in some cases.

The FDA will not and cannot go after Walgreens or Walmart for dispensing a 5mL vial instead of #5 1mL vials. If they could, you would never see these pharmacies taking that risk and all of the dispensing inconsistencies across the country. Dispensing and manufacture are entirely different. It’s corporate policy.

As to the original question, no, there is not a study showing that testosterone will go bad after 28 days. 28 days is the standard USP 51 that the product must be tested to. It is the minimum. In other words it must be guaranteed to remain within defined safety parameters for 28 days after first puncture. It may be safe after that, but it is not tested.

You will often see the same thing for BUD (discard date). It is often 1 year from date of manufacture. That is what it is and must be tested to. A lyophilized product would last nearly indefinitely as long as the vial remained intact. But it is only tested out to 1 year.

 

[Lookingforward]

We all would be better off without the CDC. The Governement in the US is just screwing everything up here in a once great country.

 

[NoVa Biker]

I have been using 10 ml vials for 10 years now with no ill effects, prescribed as 0.3 ml every 4 days with a refill every 3 months. My insurance company objected and wanted to give me six 1 ml vials, saying that was all I would need for 3 months.

That wasn't enough for me because I use a little more than prescribed. So I asked the pharmacy for a 10 ml vial that I would pay for myself without using insurance. They gave me the 10 ml vial. It's not that much more expensive to just pay for it myself without insurance.

 

[Cataceous]

... The standards have nothing to do with dispensing medications; they have everything to do with defining standards to stability, purity, and quality of each ingredient in a medication or dietary supplements in some cases.

The FDA will not and cannot go after Walgreens or Walmart for dispensing a 5mL vial instead of #5 1mL vials. If they could, you would never see these pharmacies taking that risk and all of the dispensing inconsistencies across the country. Dispensing and manufacture are entirely different. It’s corporate policy.
...

Where these entities would get into trouble is if they specified a beyond use date greater than the default USP standard of 28 days without evidence of safety. The teeth for enforcement are in FDCA 502(g), which can actually include jail time. In reality Walgreens, etc. would never set such a policy. If you tried to pin them down then they would either cite the USP standard or more likely defer to their pharmacists. If pharmacists or prescribers invented a longer beyond use date without evidence then they could easily end up in trouble, though presumably at the state level. Tell me, what would Defy Medical say in writing about the beyond use dates for the vials they prescribe? Would they contradict the standard and say that a longer period is fine? I assume ambiguity is better. There's at least a smidgeon of deniability in not specifying a BUD but still prescribing in ways that ignore the default BUD. Or would they pass the buck to the compounding pharmacies?

None of this is to argue that the standard is not overly cautious, or that enforcement is likely. But it's not great to have the hammer of selective enforcement sitting out there waiting to be used by someone who has it in for you.

 

[Jason Sypolt]

Well, the question of what would an entity such as Defy do is something that should be directed to a pharmacy or compounding pharmacy. Defy is the doctor providing the script such as dispense “#1 5mL of Testosterone Enanthate…”

A pharmacist can choose to do that, or they could choose to dispense #5 1mL vials as equivalent. Or they always have the option of refusing to fill it.

From a liability perspective ambiguity has its place for sure, but that can also get you into trouble. Ambiguity can also be used against you. But, we are getting off track.

One thing that you guys who are having a script written for you can try is to ask the provider to include “dispense as written” on your testosterone prescription. Those words compel the pharmacist to dispense exactly what the provider specifies with no substitutions. They can’t substitute #10 1mL vials for a single 10mL. Keep in mind that they also can refuse to fill it, but if you are going to a chain pharmacy then refusals are likely tracked as a part of performance since they are for profit businesses and a pharmacist probably is not going to refuse a C3 simply because they don’t like the vial size on a valid prescription.

 

[Jason Sypolt]

But it's not great to have the hammer of selective enforcement sitting out there waiting to be used by someone who has it in for you.

Not great at all and that is exactly how some enforcement works unfortunately for various reasons. There are pharmacies and “clinics” who know that they won’t be noticed or caught doing something incorrectly or outright against the law for a long time - long enough to make it worth the effort for the money anyway.

The rules can also change with the wind at the federal and state levels, and the states are different. It isn’t fair, it keeps some of us awake at night, and it costs a lot of time and money to do things the right ways and for the right reasons. But there is also satisfaction in knowing that.

 

[Lookingforward]

Yeah but all this stuff is the fault of the Lawyers and an overreaching government that no longer serves the public.

 

[52hoosier]

My CNP called in a script to CVS for 10ml of 200mg TC this week. They told her that they would not fill it as 10ml was "too much" of a controlled substance to dispense. Oddly, they carry 10ml vials. Why carry it if you won't dispense it???

They also told her that the FDA is cracking down based on the 28 day rule. This is why they are only dispensing 1ml vials. Same for Walgreens, Costco and Sams. I think the real issue may be that a 1ml vial is about $20 but with GoodRX you can get a 10ml vial at CVS for $40 IF they would dispense it.

I think I solved the problem by having my CNP send the script to Talon Pharmacy. IF the pricing they told me is correct, they are much cheaper than Empower.