45 Day Limit on Serum Tears

[pythonidler]

I got a blood draw for a new supply of serum tears on Wednesday. Last Friday, though, the compounding pharmacy that makes the serum tears for me said they would no longer be able to give me a 90-day supply of serum tears. They said there were new FDA regulations about sterile compounds, and that the most they could give me was a 45-day supply. So when I had my blood drawn on Wednesday, they drew half the blood that they normally would have.

Now, I know for a fact that serum tears is supposed to last 3 months in the freezer, so this new limit seems somewhat arbitrary. I was wondering how many other people have had this happen to them, or if it's just my pharmacy that's doing this.

[linguininess]

Had no idea this was a new FDA regulation. I went to the compounding pharmacy here in LA, and they told me these only last for 45 days frozen or unfrozen.

[pythonidler]

I've heard a number of things regarding the shelf life of serum tears. For acceptable freezer time, I've heard anywhere from 8 months to 6 months to 3 months (my current doctor says 3 months, and I believe him because he's done research on serum tears). For refrigerator time (not frozen), I've heard anywhere from 1 week to 1 month.

If this is truly a new FDA regulation, it seems like a reaction to something bad that happened with a different sterile compound.

[Hokucat]

Hello Pythonidler. I don't use serum tears anymore, but my friend just started so I asked her. Apparently this is happening everywhere. But they still gave her a 90 day supply, and told her it was good only for 30 days, but told her to check with her doctor if it was good for 45 or 90 days. Her doctor said good for 90.

[ltree]

Hello pythonidler.. I am in Canada and I have not heard about this when I had my last batch made 3 months ago. That new restriction is making it more troublesome for us, to have to go through the process twice for the same 3-month supply.

Also, I realize that my prescription was written when I needed several doses a day. Now I am using the serum only morning and evening, because I am wearing sclerals, so my supply lasts a lot longer. Wondering if your eye doctor is willing to prescribe a higher dosage rate so your "45-day supply" will actually last you longer, to save you the trouble of refilling often.

My impression of the shelf life is also 3 months. Does anyone know if afterewards, the serum simply becomes less effective, or if it is harmful to use? Because of my lower dose, I have an excess supply that is going to go past the 3-month date.

[pythonidler]

ltree - fortunately for me, the pharmacy that makes my serum tears fills them in 3 ml bottles. When I pick them up this week, I'll get 40 of them, and they will say to use one a day and discard the rest. Of course, it's like using Restasis - there's no point in throwing away a good supply. So in reality, if I use about 12 drops a day, it'll last me about 80 days. I'll be in trouble if the pharmacy decides to only fill up 1 ml or so of each bottle. But if they do, I can always try to do as you suggest - have my doctor prescribe twice as many drops per day as is actually needed.

[pythonidler]

My impression of the shelf life is also 3 months. Does anyone know if afterewards, the serum simply becomes less effective, or if it is harmful to use? Because of my lower dose, I have an excess supply that is going to go past the 3-month date.

I've used serum tears for 6 months before, and it's seemed fine to be honest. I imagine some components start breaking down at the 3-month mark, and others break down later.

[MGD30]

I have both serum and PRP drop. The serum can stay 30 days in the freezer and 10 days in the fridge. The PRP 30 days in the freezer and only 4 days in the fridge.

The pharmacist told me that different places coumpound it differently. My serum has some kind of soudium solution but the PRP uses artificial tears which might explain the different expiration dates.

[Gerri55455]

Neal Matthews, who makes his own serum (100% - no saline: you can look him up on youtube) recently told me he freezes his for up to 12 months. I have a bunch compounded in December 2016 (50% serum - 50% saline) but had to travel before I could use it all. Left it in the freezer and then hesitated tossing it away. So after the discussion with Neal I'm back to using it this week. It feels just fine. I'll have frozen it for 9 months by the time I finish it next month. Thereafter, I'll be making my own ....

[farmgirl]

My batches regularly last 6 months frozen, no problem and at least 30 days in the fridge....F/G