FDA has published a number of “recipes” or monographs for drugs intended to cure conditions that are common and amenable to self-diagnosis. If a drug manufacturer creates a product for external pain relief that conforms to the monograph for external pain relievers, it can be sold directly to consumers (“over-the-counter”) without a prescription. A Prescription must be purchased from a licensed pharmacist, and it must have been prescribed by a doctor or other licensed medical practitioner.
