Is it legal to manufacture your own OTC drugs?

No specific jurisdiction is indicated. I’m curious about the legal situation in general.

Most jurisdictions have a set of “over the counter” drugs that can legally be sold to anyone, without the approval of any healthcare professional. Common examples include aspirin, acetaminophen, dextromethorphan, and other commonly available stuff like that. There are typically labeling requirements for manufacturers and possibly retailers. Most OTC drugs are not subject to current patents, but a few are. Let’s exclude patented drugs from this question because it is already clear that violating a patent is legally problematic.

My question is, is it legal to make your own OTC drugs for your own personal use (or perhaps for noncommercial use by your family or friends) assuming the drugs are not subject to patent? E.g. if I go get some willow bark and whip up my own batch of homemade aspirin, take two, and stick the rest in my cabinet, have I broken any laws? I would suspect that the only major possibility would be a breach of labeling requirements - but does the law really require me to properly label stuff I’m not going to sell?

Whether or not making your own OTC pharmaceuticals is a good idea (e.g. from a financial, health, or environmental perspective) is outside of the scope of this question.

I haven’t found anything that says you can synthesize your own OTC drugs. Many people use home remedies or herbs to treat themselves and I don’t see anybody trying to stop them.

I (along with the rest of the class) synthesized aspirin in my first-year chemistry lab. I think there were 2300 people in that class, so it seems like a huge liability if it were illegal.

I assume the various issues here are -

If it’s an illegal controlled substance then I assume it’s illegal to make or possess it as well as to traffic in it (sell or give for free).

What’s the category for medical pharmaceuticals that are not really narcotics etc. but are restricted to being prescribed by a doctor and dispensed by a licensed pharmacist? Presumably you certainly can’t sell or distribute these. I assume you can make them, but administering them to someone else could get you in trouble.

I doubt that patent laws apply if you are making, say, your own Viagra. as long as it is no being sold, or helping in your business process, then you are not violating the patent: IIRC the patents are only to restrict commercial uses.

Also if you make something novel and sell it, or administer it to someone else, then the usual health and safety laws kick in.

Aspirin, OTOH, is not controlled or patented.

Broadly speaking, the patent laws consider the manufacture of a patented invention to be infringement, whether it is done for commercial purposes or not:

(emphasis mine).

You can patent the drug, but not the chemical compound. For example, the drug, Arimidex, is, in fact, the chemical compound, anastrozole. The name “Arimidex” is trademarked, and if you want to sell anastrozole as a drug, then you have to go through the whole FDA approval process, but if you want to buy the chemical compound, it’s readily available through chemical supply houses. So you can’t manufacture the drug, Arimidex, but you can manufacture the chemical compound, anastrozole.

There is, in fact, a huge market in “drug” chemicals.

Of course, you generally don’t want to try and just take the API straight up for a number of reasons.

Oops, correct - but then again, who would know, unless you put it on youtube?

Plus the infringement would be a civil case (at least so far, I think) not an illegality - unless the laws have changed recently. Plus, the suing party would have to show damages?

That should have been can’t, not can… sigh

Indeed – as a practical matter, unless you publicize your manufacture, and the patent owner cares enough, there’s likely little that will happen to someone who makes a patented product without the blessing of the patent holder.

But if the patent owner cares enough to bring an infringement suit, he/she need not show damages, as the patent statute also allows for injunctive relief.