Prescription status

Drugs are classified from a regulatory perspective, as either over-the-counter (OTC) or prescription-only medicines (POM, or Rx in America). Human medicines are subject to medical prescription where they 

Human prescription drugs may be further categorised into  

New drugs will only be authorised as prescription medicines in the first instance, as it requires considerable experience in the market to convince the regulators that it is safe to reclassify a drug as an OTC product. The term new drug may mean a new pharmaceutical substance, or a new therapeutic application of an existing one. 

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Although the pharmacist may only infrequently have contact with this particular dosage form, there has been a movement to give some feed additive drugs veterinary prescription status, which has been done in several European countries. This may have future implications to those pharmacists practicing in rural areas. 

FDA moves Romilar tablets from prescription status to OTC10S... 

To provide a context for our discussion of Rx-to-OTC switches, we will describe briefly the classifications of drugs that must be limited to prescription use. Specifically, the following types of drugs must be sold for prescription use only (1) drugs not safe for use except under the supervision of a licensed practitioner because of toxicity or other potential for harmful effect, method of use, or the collateral measures necessary for use and (2) drugs limited to prescription under an approved NDA [87]. FDA may remove by regulation a drug subject to the premarket approval requirements from prescription status when such requirements are not necessary for the public health [88]. 

There are three ways in which such a change can be made outside the drug review process. The manufacturer may file an NDA if the clinical research data, which proves that the drug can be approved for an OTC indication or OTC dosage levels, is available. The FDA itself can file for reclassification if it is determined that prescription status is not necessary for the safe and effective use of the drug. 

Ketoprofen was originally approved for over-the-counter sales in the USA by the FDA, but in the same year, in Italy, the Ministry of Health transferred two ketoprofen-containing products from non-prescription to prescription status (SEDA-20, 93). The reasons for this difference are not clear. 

The pricing and reimbursement of medicines cire still special issues in Hungary. Until 1997, legal (prescription) and reimbursement status were not fully separated and both were specified by the Ministry of Health. Application of a more restricted prescription status for expensive medicines was not uncommon. Since 1997, the legal status is specified, applying professional criteria exclusively, by the regulatory authority when the MA is issued. 

In Switzerland health controls are largely a cantonal responsibility including healthcare systems, hospitals, professional education and the registration of medicines. In exceptional cases differences can exist, for instance, in the prescription status of individual pharmaceutical products from canton to canton (these are more the exception than the rule, however). To avoid duplication of effort and conflicting advice, the responsibility for pharmaceutical registration lies with the national regulatory authority, the Intercantonal Office for the Control of Medicaments (Interkantonale Kontrollstelle fiir Heilmittel or IKS). 

Peter Barton Hutt, A Legal Framework for Future Decisions on Transferring Drugs from Prescription to Non-prescription Status, 37 Food Drug Cosmetic Law Journal 427 (October 1982). 

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