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The FDA ruled that all over the counter (OTC) products have some kind of statement about use on them. This statement must be for a self-diagnosable and self-treatable ailment. In FDA thinking, a bladder problem is self-diagnosable, but a kidney problem is not. Therefore getting OTC indications for Berberis is possible, but you may not mention kidneys.
There are two problems with the nosodes. First is that very few of them have monographs in the HPUS. Medorrhinum may not be monographed, but Psorinum might be. Without a monograph, a drug is not ‘official’ and therefore cannot be sold OTC. Next, if it is monographed, what are the OTC indications for Syphilinum or Medorrhinum? Without acceptable OTC labels, these must be by prescription only.
The HPCUS attempted to get the FDA to look at three categories:
The thinking was that category #2 would include all remedies except the stuff which is poison and needs a prescription such as Aconite tincture, Lachesis 5X, etc. This stuff would not have to have usage labels since it was sold on request and therefore it is assumed that the buyer was knowledgeable about its use. The FDA rejected this scheme since, they said, it would create a third category for drugs, and they want to have only two: OTC and prescription. Prescription does not mean that an MD must get it. Other professionals can get the stuff but it is not as readily available as it was.
