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.
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.
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.
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.