Nonprescription Drug Manufacturers Association

OTC Facts and Figures, Nonprescription Drug Manufacturers Association, Washington, D.C., 1995. 

Nonprescription Drug Manufacturers Association established voluntary limits for alcohol content of nonprescription products [72] ... 

Similar comments regarding this problem were also submitted by the Cosmetics, Toiletry and Fragrance Association and Nonprescription Drug Manufacturers Association, both of the United States, to the FDA, on December 6, 1996 to quote, "...formulations which do not achieve or provide the desired level of protection for any reason can be screened out. If the photochemistry or absorbance characteristics of the active ingredients are significantly altered rendering them incapable of providing UV protection or..., the formulation would fail to meet its expected SPF level."... 

There are severe acute and chronic concerns around pediatric medicines containing ethanol. Hepatic metabolism of ethanol involves a nonlinear saturable pathway. Young children have a limited ability to metabolize and thereby detoxify ethanol. Ethanol intoxication has been recorded in children with blood levels as low as 25 mg/dL. Alcohol has a volume of distribution of approximately 0.65 L/kg. Ingestion of 20 mL of a 10% alcohol solution will produce a blood level of 25 mg/dL in a 30-lb. child. The American Academy of Pediatrics (AAP) Committee on Drugs recommends that pharmaceutical formulations intended for use in children should not produce ethanol blood levels of >25 mg/dL after a single dose. In general, manufacturers have voluntarily complied with the recommendations. In 1992 the Nonprescription Drug Manufacturers Association established voluntary limits for alcohol content of nonprescription products (65). 

NDMAC Code of Preferred Packaging Practices Nonprescription Drug Manufacturer s Association of Canada Ottawa, Ontario http //www.ndmac.ca/about/C-Pakag. html (accessed July 2003). 

St. John s wort, an herbal nonprescription medication containing hyperi-cum, may be effective for mild to moderate depression, but it is associated with several drug-drug interactions. Its potency, purity, and manufacture are not regulated by the FDA. As depression is a potentially life-threatening disease, all antidepressant treatments should be overseen by a trained healthcare professional. 

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