Over-the-counter Drug Review

Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labelling of drugs sold without prescription. 

Over-the-Counter Drug Review, 18 685 Over/under scales, 26 252 Overvoltage, 12 206-207, 214 mass transport (concentration),... 

Pinco R. Implications of FDA s proposal to include foreign marketing experience in the over-the-counter drug review process. Food Drug Law J 1998 53 105-122. 

J. E. Finchman, Over-the-counter drug use and misuse by the ambulatory elderly A review of the literature, J. Geriatr. Drug Ther., 1, 3 (1986). 

When reviewing medications of a new patient (including herbal remedies, over-the-counter drugs, anabolic steroids, contraceptives, and recreational drugs) or... 

Glick, R. Hoying, J. Cerullo, L. Perlman, S. Phenylpropa- 64. nolamine an over the counter drug causing central nervous system vasculitis and intra cerebral Hemorrhage. Case reports and review. Neurosurgery 1987, 20, 969-974. 

Controversy over alteration of the microbial flora of the skin flared in the FDA Over-the-Counter (OTC) Review of Antimicrobial Drugs, especially with reference to total body exposure to antimicrobial/deodorant soaps. The relationship of routine bathing (rinsing) with these soaps with infection was implied in several studies [43-45] and shown conclusively in the study by Taplin [46] in Costa Rica in a population with a high infection rate utilizing a 2% solution of chlorhexidine in water (therefore, 2% available chlorhexidine). 

Over-the-counter drug product review was implemented to improve safety and effectiveness. The review process included labeling of over-the-counter drugs products. 

Serious drug-induced skin disorders have been reviewed in relation to 2370 cases of Stevens-Johnson syndrome (2.2% of 110023 suspected adverse reactions), of which 146 cases were possibly associated with over-the-counter drugs [1 ]. The outcomes were as follows 1373 recovered or improved, 85 did not recover, 84 had sequelae, 239 died, and the outcome was unknown in 589. The authors warned that although Stevens-Johnson syndrome is rare, it can occur with any medication. They recommended that when a rash and accompanying hyperthermia develop after the administration of a medication, and Stevens-Johnson syndrome is suspected, the medicine should be withdrawn and the patient should be promptly referred to a dermatologist. 

Donn, Jeff. Zicam Not Alone in Side Effect Reports. ABCNews.com. Available online. URL http //abcnewscom/Health/wireStory id=7863 624. Posted June 17, 2009. Problems experienced by users of Zicam, an over-the-counter treatment for colds, reveal a gap in review and approval of drugs by the FDA, according to this Associated Press article. Since a 1938 law passed Congress, homeopathic remedies have not had to go through the approval process of prescription drugs. This article describes some examples of safety problems that have resulted. In the case of Zicam, the... 

If the product is the subject of an NDA or an ANDA, a supplemental NDA must be filed [21CFR314.70(b)(2)]. It must be shown that the change does not affect the bioavailability of the active ingredient(s). CMC information for drug substances used in over-the-counter (OTC) products covered by an OTC monograph (e.g., calcium carbonate) are not reviewed. Therefore, a DMF need not be filed. The fact that there are existing DMFs for calcium carbonate does not mean that they are reviewed. CMC information for OTC products not covered by an OTC monograph (e.g., famotidine) does need to be reviewed. A DMF is an appropriate mechanism to submit such information. 

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