I have two different scripts for my T: the original 10 ml bottle that is not covered by my insurance, and 2 smaller bottles that are covered. I prefer the larger because it lasts like 5 months. I was just told by the pharmacy that FDA regulations say to throw away an open bottle 28 days later. So the 10 ml would have to be discarded well before it's empty. I'm back to refilling it every 3-4 weeks now unfortunately. Just a heads up.

This isn't a new regulation. I was told the same thing by the pharmacist when I filled my original prescription back in July. Doctors don't follow it, so I figure it's one of those FDA regulations that there's not a legitimate reason for because let's face it nobody is going to use a 10ml bottle of testosterone in 30 days.

New as in within the last 8 months I believe. Because I don't refill the 10er often I'm just hearing about it.

I've never heard of that before. It's really interesting because I filled my script for a 10ml vial and I can't refill it for 70 something days.

I really wouldn't be surprised if it's inaccurate and designed to control prescriptions.

The limit of 28 days after first puncturing the vial is a requirement not only by FDA, but also all other health regulating agencies ( state medical boards and JCAHO) in the US.

The medication may have bacteria introduced during the first injection and if allowed to grow, you may end up with a contaminated vial. I work in hospitals and some vials are limited to 24 hours and even less. Being outside of a hospital, the possibility of contaminating with environmental bacteria is much less than inside a hospital. Often times, vials are kept in the refrigerator, just to prevent bacteria growth. In the case of Testosterone in an oil base, this is not a good idea. The oil thickens to be totally unusable. Additionally, some vials have added ingredients that are bactericidal and others do not.

If you use excellent technique in a home environment when drawing out your Testosterone dose, you should have little chance of contaminating your vial in the first place.

I'm wondering if this restriction is due to the fact that Testosterone is regulated as a controlled substance. (Estrogen is not.) I didn't learn this until it came up in a Callen-Lorde Patient Advisory Board than I'm a member of.

I would just ignore that. I clean off the top of the bottle and the needle every time I use the bottle so gunk shouldn't be getting in it in the first place.

Quote from: Sydney_NYC on March 22, 2017, 06:50:47 PM
I'm wondering if this restriction is due to the fact that Testosterone is regulated as a controlled substance. (Estrogen is not.) I didn't learn this until it came up in a Callen-Lorde Patient Advisory Board than I'm a member of.

The 28 day limit applies to all injectable drugs, such as insulin and estradiol injectables.

My current doctor didn't mention anything about discarding the vial just to clean off the top with an alcohol pad every time and follow the other steps to make sure everything is as sterile as you can keep it. I have to switch doctors because the one I was with went private and I'm establishing care with another in two weeks. I'll bring this up with them and see what they have to say about it and let you guys know. 

I went with the 10 ml again. I didn't have an issue before and it ends up being cheaper in the long run even without insurance because my pharmacy always gives me a coupon.

My understanding with the 28 day limit (at least with estradiol), was if the rubber stopper was removed.  If you draw through the rubber stopper, the limit does not apply, and does not count as "opened".

I just got a 10ml from the doctor. We both recognized that its a 5 months worth of doses. She had no problems writing a script for me and didn't say anything about keeping it clean or proper injection methods. Was also 1/3 cheaper without insurance than my regular 2ml with insurance. SCORE

I got a refill (10ml vial) maybe two months ago? It wasn't covered by my insurance, so that was out of pocket. Chase-Brexton offered my two 5ml for even more money, come to think of it (I buy at the grocery store, it's cheaper for me). Well, a few weeks ago I get a letter in the mail that my insurance company has reconsidered my case, and will now start covering my Testosterone Cypionate. They didn't mention anything specific about the vial, though, so now I'm curious as to how this will go once I need a refill.

Quote from: Muscle Matt on March 28, 2017, 02:44:47 PM
Well, a few weeks ago I get a letter in the mail that my insurance company has reconsidered my case, and will now start covering my Testosterone Cypionate. They didn't mention anything specific about the vial, though, so now I'm curious as to how this will go once I need a refill.

Some insurance doesn't cover the 10ml and some states don't sell the 10ml. In MA they don't fill that much so I mail ordered from Portland Oregon and got to me by Friday morning and I ordered it Wednesday afternoon. They also gave me 20 free needles/syringes. I was very pleased and will be ordering from them again.

Yes, I ran into this just last month. They will NOT prescribe 10mL vials anymore. Now I have to try and make every single drop of a 1mL equal four doses, as presently written - and I literally can't do it, even trying to use the rather unsafe "bubble" method (in attempt to push every last drop out; it is physically IMPOSSIBLE).

It is the CDC that is the problem - this 28-day after first puncture malarkey is their new rule, not the FDA. And the insurance is now enforcing not only that, but the 30-day supply rule -  so there is now ZERO grace period between how long that is calculated EXACTLY, DOWN TO THE LAST DROP to last you, and when you're to get your new prescription. If your doctor is overbooked (county ALWAYS is - there are no, scheduled precisely to the day, bookings), you will now be going without a couple to a few doses in-between appointments and your last dose. I was also curtly informed that they also will not allow "phone-in" refills on this (over-)controlled substance, either... the county pharmacy, to clarify. And even if they did, it wouldn't happen because none of them EVER answer their damn phone/fax anyway.

And, so, I am now going to have to try and reason with my endo (no mean feat) at next appoint, for him to increase the written dosage to at least make up for the waste left in the vial neck as well as in the syringes that LITERALLY cannot be gotten out/used. As it is now, I am not getting a whole dose out of these baby vials that, as written, I should be (only way I could, would be reducing my already low dose by close to a third and I am NOT willing to do it because it would then be only JUST clinically effective at that point... not effective enough). It all hinges on my Endo now, whether or not I actually get every, full, dose into my body that I am supposed to be (I have estimated that it would require 5, not 4, 1mL vials x four months). Not holding my breath just yet. It's like pulling teeth to try and get a point across with him. Always a problem with the script. It's ridiculous.


Also, I'm wondering now how these outfits are justifying sweeping under the rug the manufacturer's disclaimer, effective that single-dose vials are NOT to be used for multi-dose................................ and they really aren't. They're difficult enough to draw for one dose, never mind four. Takes absolutely forever, and I always wind up with a frothy mess in the syringe for it too. One reason I started getting the 10mL vial in the first place, frankly.

Quote from: Magnus on April 03, 2017, 06:22:33 AM
Yes, I ran into this just last month. They will NOT prescribe 10mL vials anymore. Now I have to try and make every single drop of a 1mL equal four doses, as presently written - and I literally can't do it, even trying to use the rather unsafe "bubble" method (in attempt to push every last drop out; it is physically IMPOSSIBLE).

It is the CDC that is the problem - this 28-day after first puncture malarkey is their new rule, not the FDA. And the insurance is now enforcing not only that, but the 30-day supply rule -  so there is now ZERO grace period between how long that is calculated EXACTLY, DOWN TO THE LAST DROP to last you, and when you're to get your new prescription. If your doctor is overbooked (county ALWAYS is - there are no, scheduled precisely to the day, bookings), you will now be going without a couple to a few doses in-between appointments and your last dose. I was also curtly informed that they also will not allow "phone-in" refills on this (over-)controlled substance, either... the county pharmacy, to clarify. And even if they did, it wouldn't happen because none of them EVER answer their damn phone/fax anyway.

And, so, I am now going to have to try and reason with my endo (no mean feat) at next appoint, for him to increase the written dosage to at least make up for the waste left in the vial neck as well as in the syringes that LITERALLY cannot be gotten out/used. As it is now, I am not getting a whole dose out of these baby vials that, as written, I should be (only way I could, would be reducing my already low dose by close to a third and I am NOT willing to do it because it would then be only JUST clinically effective at that point... not effective enough). It all hinges on my Endo now, whether or not I actually get every, full, dose into my body that I am supposed to be (I have estimated that it would require 5, not 4, 1mL vials x four months). Not holding my breath just yet. It's like pulling teeth to try and get a point across with him. Always a problem with the script. It's ridiculous.


Also, I'm wondering now how these outfits are justifying sweeping under the rug the manufacturer's disclaimer, effective that single-dose vials are NOT to be used for multi-dose................................ and they really aren't. They're difficult enough to draw for one dose, never mind four. Takes absolutely forever, and I always wind up with a frothy mess in the syringe for it too. One reason I started getting the 10mL vial in the first place, frankly.

So you can't get a 10 ml vial even without going through insurance?

Quote from: CMD042414 on April 03, 2017, 08:59:24 PM
So you can't get a 10 ml vial even without going through insurance?

I just picked up a 10ml Vial last week from a mail-in pharmacy in Oregon. My doctor said absolutely zero about this new FDA rule when writing the script and the pharmacy called me and said zero about not carrying 10ml anymore. So I think this is probably a case by case bases. Unless your Doc says no, I wouldn't be too worried about not getting them.

I did a little searching and I found the government page from 2010 that discusses this. It appears that it can be used beyond 28 days if the manufacture certifies it will remain sterile beyond 28 days .
https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html

Quote from: CMD042414 on April 03, 2017, 08:59:24 PM
So you can't get a 10 ml vial even without going through insurance?

Not even that way, not anymore. I even had my Endo write down the NDC with the "10mL vial" bit, and the pharmacy shot it down (writing it specifically for a "10mL vial"/NDC is supposed to have bypassed the "30 day supply" rule also... apparently doesn't anymore, either). They made me stand there an hour while they called this person and that, even the regional director. Overkill, and no, "can't do it". Totally unreasonable, now a major inconvenience (it's literally an all-day affair to drop off and pick up), and as it stands right now a compromise of my care to cap it off. I shouldn't have to go without doses or be otherwise short-changed, and I really am. It's entirely wrong.

The icing will be if he refuses to up the dose "on paper" to make up for that shortage. Final straw, really.