US and EU Regulations Update

United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs:

  1. Nasal moisturizer drug products
  2. Urinary analgesic/antiseptic drug products
  3. Urinary acidifiers and alkalinizers
  4. Aloe vera and urea
  5. Wrinkle remover products
  6. Lubricants and vaginal moisturizers


More in Regional