Nonprescription Drug Manufacturers

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."... 

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). 

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). 

In 1990 there were over 650 companies in the United States that manufactured drugs, but the top 10 U.S. companies accounted for 86.5 percent of domestic drug sales. Generic prescription drugs are estimated to be about 20 percent of the total market. Their use is emphasized in hospitals, which account for 20 percent, and health maintenance organizations (HMOs), which are responsible for 15 percent of prescription purchases. Mail order pharmacies dispense an estimated 5 percent of all outpatient prescriptions. In addition, shipments of nonprescription drugs reached an estimated 10.4 billion in 1990. Research expenditures accounted for 16.85 percent of pharmaceutical sales. 

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. 

Caffeine is derived by extraction of coffee beans, tea leaves, and kola nuts. It is also prepared synthetically. Much of the caffeine of commerce is a by-product of decaffeinized coffee manufacture. The compound is purified by a series of recrystallizations. Caffeine finds use in medicine and in soft drinks. Caffeine is also available as the hydrobromide and as sodium benzoate, winch is a mixture of caffeine and sodium benzoate, containing 47-50% anhydrous caffeine and 50-53% sodium benzoate. This mixture is more soluble in water than pure caffeine. A number of nonprescription (pain relief) drugs contain caffeine as one of several ingiedients. Caffeine is a known cardiac stimulant and in some persons who consume significant amounts, caffeine can produce ventricular premature beats. 

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