While researching for a post I’d wanted to make to one of the threads about Canadian OTC codeine, I was already aware that, by U.S. Federal laws and regulations, Schedule V drugs could be sold without prescriptions. Usually, state and local laws are stricter, and do require prescriptions for these drugs, but possibly there still are some places in the U.S. where that isn’t true.
Anyhow, I came across Title 21 § 1306.26 of Federal Code Of Regulations, which addresses the dispensing of non-prescription drugs listed in Schedules III - V of the Controlled Substances Act. These drugs are to be dispensed in much the same way as pseudoephedrine–only to adults, and without exceeding certain quantities per single transaction, or over specified time spans, and the transactions have to logged. But Schedule III, for example, contains some major heavy-duty drugs, such as single ingredient dihydrocodeine and ketamine. So my question becomes this: What kind of a drug could possibly be in Schedule III or IV and not require a prescription?
Remember, we want to disregard stricter local regulations here.
It seems evident to me that the point of classifying any drug under Schedule III, is in most part because of it’s abuse potential. And opiates have some of the strongest potential for abuse, but hear me out…
I’ve been in periods of short lived pain that the usual OTC just won’t cut through. It’d be great if I could approach a pharmacist and ask for a small quantity of pills, say, 8 - 12, lower-level opiate like codeine or Vicodin for these situations.
Depressants, amphetamines and the like seem used medicinally for more chronic situations, but pain can come fast and hard, and in so many varieties, where it’s just an acute and short-lived situation (e.g. Threw your back out, Body aches from a fever, twisted your ankle…), in which going to the doctor, convincing him you need something stronger than ibuprofen, paying the whatever dollar copay, then having it filled is a huge PITA, especially when you’re hurtin’.
Hallucinogens and hormones, I can’t think of a reason where this would apply to acute situations.
The way this wording sounds to me is that there may be a subset of “Schedule III” substances that are not approved to be used as drugs, just like there are chemicals that are used to make meth that don’t require a prescription, but are still controlled.
A quick dig through the official lists pulls up a lot of drugs I recognize, and then a lot I don’t, whether they are just not in use anymore or for some other reason.
Is it possible that there are substances that may have a medical use, that the FDA has assigned a schedule to, but are not approved drugs, therefore can not have a prescription written?
I’d be curious to see if that wording just means something else that I don’t get, but
sounds to me like they are not talking about Valium or Vicodin or any number of other familiar dosage forms.
Hopefully someone with more knowledge will come by and set me straight, because I genuinely don’t know if the FDA would schedule something before it’s approved as a drug, or if old-timey things like opium would be available for sale through a pharmacy.
There is actually two government agencies involved here, the DEA and FDA. The FDA only specifies a drug as legend (requires a prescription ) or OTC, while the DEA is who schedules something as controlled and picks the schedule.
I’m not aware of anything in schedules II - IV that isn’t a legend drug, while there are some CV’s that are OTC. I’m assuming the wording Is because they didn’t want to step on any toes when writing the rules.
Oh, and opium is a CII, and a legend drug. I have seen it on the shelf.
Oh, ok, thanks. I’ve only ever seen the opium/belladonna suppositories and paregoric before, and didn’t know that plain opium was still available.
I really wish my answer were correct for some sort of hilarious OTC CII backdoor shenanigans, though. I haven’t ever even had the thrill of buying Robitussin AC over the counter.
With regard to OTC scheduled drugs, I think we have two meanings of “control” here. Mostly, it seems to be about controlling how these drugs should be used in treating patients, and about who should get them. That fits pretty closely the everyday usage of the word control. But another meaning of control is “to track and manage”.
Evidently federal regulators haven’t gone to the extent of controlling who gets pseudoephedrine; you can still just walk in and buy it. But they are definitely interested in tracking its movements so as to catch any unusual spikes in the traffic.
And paregoric is not only still available, it’s in fact OTC in some countries; I saw a bottle of it in with the cough syrup last time I was in Belize.
In the drug world, “controlled substance” has a very specific meaning. All prescription drugs are controlled in the generic use of the word, but “controlled substances” means specifically drugs that are governed by the Controlled Substances Act. These are drugs that have been placed on one of five schedules by the DEA, and pseudoephedrine isn’t one of them.
Pseudoephedrine is neither a controlled substance nor a legend drug – in most jurisdictions. There are some in which a prescription is required for it., but in no US jurisdiction is is a controlled substance.
Moreover, some of the drugs the DEA has placed in schedule V are OTC in some places and Rx-only in others. For instance, in Hirka’s practice, he can dispense a limited amount of cough syrup with codeine at his pharmacy without a prescription, whereas a pharmacist in my state could not. There are various state laws that control these drugs tighter than the DEA does at a national level.
Not for long here, or maybe it’s gone already (my last job had a bottle on the shelf but we don’t have any at the hospital) - it’s one of the latest victims of “it’s been on the market for decades but doesn’t meet our testing standards” action. How does the saying go? If you outlaw opium, only outlaws will have opium?
