Prescription drugs status change

Abuse of antihistamines in Scandinavia has been found in schoolchildren, and particularly involved diphenhydramine (alone or in combination with caffeine). As a consequence such formulations were changed from over-the-counter to prescription-only status (7,8). Abuse of diphenhydramine with drug-seeking behavior and anticholinergic adverse effects have been reported in five children and adolescents with chronic hematological or oncological diseases (5). 

Brass EP Changing the status of drugs from prescription to over-the-counter availability. N Engl 3 Med 2001 345 810. 

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. 

Hexachlorophene was a widely used antibacterial in over-the-counter skin cleansers in the United States. Reports of neurotoxicity resulted in a change of status to prescription-only by the Food and Drug Administration. 

---