Why does insulin require a prescription in the US?

Regardless how your insulin is paid for, you still have a prescription, don’t you, and you still get a pharmacy prescription receipt?

I paid out of pocket for everything for years, and always submitted my prescription receipts at tax time. It could reduce taxable income by a not insignificant amount.

Terry - good catch. Its a typo - sorry. It should have been REMs https://www.fda.gov/drugs/drugsafety/rems/default.htm

They had a requirement for lung safety which was deemed completed as their clinical results have been so good. I would say better than anyone expected.

Chris - there was an announcement from the FDA yesterday to move insulin from a “drug” to biologic. I am not sure this will affect the prescription requirement and unless you have the prescription I am not sure you would get insurance coverage.

“Transitioning biological products currently regulated as drugs to being regulated as biologics will enable – for the first time – products that are biosimilar to, or interchangeable with, these products to come to market.”


I’m going to read the link now. I’m betting this change is more related to getting cheaper generics to market.

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Chris - I think you are correct. There is a huge misunderstanding on the part of Congress when it comes to “Insulin”.

What they do not understand is the “Analogs” are not human or animal insulin. They are analogs and a great deal of time and money went into engineering these molecules and they are all patent protected until the patent is up. Each one is also “special” in the way it works in the body.

I some cases like afrezza the manufacturing process is so unique that while “human insulin” is not patent protected they have a zillion patents on the manufacturing process.

Generally the animal insulins and non-analog insulins are OTC, and if you buy it with a prescription it has been covered for the past 40 years.

Now, in the 1970’s, a bottle of insulin was only $4 so the question was, why bother doing the insurance paperwork when your deductible is $5 or maybe $10? It’s very different today now that most analog insulins are $400.

As far as safety goes as the reason, I don’t buy that completely. There are many dangerous things that one can buy and use inappropriately. The people that regulations supposedly protect are apt to kill themselves with a million different things in the first place. For most people a warning of “this will kill you easy if used improperly” is enough to make them think twice before using it without thoroughly understanding it. Also many times regulations are not truly designed for safety as much as they are designed to protect a market or company/companies profits. Perhaps a good in between to make people feel better would be some sort of certificate from a doctor that specifies that you need it. Then you just buy however much you need when you need it.

As far as insurance coverage goes, test strips don’t require a prescription, but you can get a prescription so it is covered by insurance. Also, the insurance system of payment is a horrible system in the first place, and contributes to many of the issues we have, but of course that is a much broader issue.

As far as the rapid acting insulins, I know Humalog’s patent has already expired, and I think Novolog’s has as well. I am not sure on Apidra. I know some of the long acting ones have expired too. As to the money that went into development, they almost certainly received a grant from the government, as well as likely from other sources to help offset the costs. Obviously not completely, but they have almost certainly made that money back a long time ago and the ever increasing prices definitely have little to do with R and D or production costs.




People stopped caring about Liberty and let the control freaks run amok !

NPH and R are over the counter at Walmart. Thats probably the best you can do right now.

Insulin didn’t always require an Rx.

This would be a great bill to introduce to your state government.

I know you’re not implying this but the NPH/R insulin options I consider to be substandard care.

I’m concerned drug makers and politicians may point to them as a cheap/available option when they really should be considered obsolete and unhealthy options.

“There are already cheap options on the market”. It takes more expert understanding to know why that isn’t a real option and shouldn’t be considered a real option.


Chris, I took both regular and NPH insulin for decades. They both worked well for me and I would use them again if needed. Sure they aren’t as convenient, but for most people they work well.

I was dx in 1959. I have no neuropathies.

No Doc is going to recommend R/NPH, but these are the cheapest and simplest to obtain. When it comes to insulin, something is always better than nothing. There is very little that can stand in your way in obtaining them.

I dont believe anybody talks about R/NPH. I dont think they even want people to know that option exists. They dont make much $ off it.

Probably most of us have used R/NPH. If you need insulin, its there in an emergency. This is helpful when a prescription prevents you from obtaining insulin. R/NPH to the rescue. Before this was an option, we had nothing.

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The idea of something that is necessary for life requiring someone else’s constant approval for you to be able to have the opportunity to get (affordability being another question) just seems ridiculous to me.


I haven’t used them but the impression I get is using the older insulin makes it more difficult to maintain a target A1C. This is due to the curve of effect and more strict life style required for it work optimally.

I’ve had family members on the old insulin for ~30 years prior to the pump and they now have permeant damage from the poor control they could maintain on the old style insulin.

It does seem like some people (genetics?) are less sensitive/likely to develop long term problems even with more fluctuation in A1C. This is just based on reading many stories on this form.

I think you summed up my feeling very succinctly.

@displayname, I agree
Honestly, it’s a drug that can’t be any clearer that type 1’s have to have it to survive. Life or death. And while I’ve had no problem getting the insulin I want, I feel I shouldn’t be beholden to a doctor to get it. I realize you can get NPH, but why not any kind?

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I am not sure it would really matter if it was covered or not depending on other drugs you take or if you are on Medicare or private insurance. Remember the insurance is really a middleman and therefore if you are covered by insurance you are still paying (on average) for your medication + their markup (admin fees + profit). I am insured part D for my insulin but buy it directly in Canada and full pay as it costs 90% less there and is far less than even my copay by thousands of $ per year. If you select a plan that does not cover your insulin, you will probably find that your overall cost for a low-cost drug plan + out of pocket insulin cost will be a lot less than your current all or mostly inclusive plan. That is of course if insulin goes down in price similar to what it costs in other countries.

If “dangerous” insulins can be obtained without an Rx, why can’t “safe” ones?

The other important question, I think, is: How did Walmart negotiate that deal? With whom?

Its so counter to typical procedures, I have always wondered how they worked that out. That is the only instance that I know of that doesn’t require Rx. That makes it an interesting starting point.

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When using those insulins I kept my A1c around 6.6. I don’t remember having a higher A1c in almost 40 yrs. In the past 18 yrs my A1c’s have ranged from 4.7 to 5.6. I cleaned up my act when my first A1c was 10, and my eyes showed some retinopathy. I like to think that tight control has saved me, but it might be good genetics too.

I don’t use a pump or a CGM. I am going to try a CGM though in the near future.

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