Food and Drug Administration general

U.S. Food and Drug Administration. General Principles of Validation. Rockville, MD Center for Drug Evaluation and Research (CDER), (May 1987). 

CFC CIO CSDS DDT EPA FDA GM MCA MIT NCI PCB PCE PHS RCRA TCE Chlorofluorocarbon Congress of Industrial Organizations Chemical Safety Data Sheet Dichloro-diphenyl-trichloroethane Environmental Protection Agency Food and Drug Administration General Motors Manufacturing Chemists Association Massachusetts Institute of Technology National Cancer Institute Polychlorinated biphenyl Perchloroethylene Public Health Service Resource Conservation and Recovery Act Trichloroethylene... 

Food and Drug Administration "General Principles for Evaluating the Safety of Compounds Used in... 

Food and Drug Administration. General Wellness policy for low risk devices. Draft guidance for industry and food and drug Administration Staff. U.S. Department of Health tuid Human Services 2015. 

Methyl parathion is approved only for use on crops. The maximum amount of methyl parathion residue allowed by the Food and Drug Administration (FDA) and EPA on crops used as food is 0.1-1 ppm. The FDA has monitored the food supply for pesticides for a number of years. FDA purchases many kinds of foods through Market Basket Surveys and analyzes them for residue levels of pesticides. These FDA studies allow scientists to estimate the daily intake of pesticides. Generally, the FDA monitoring studies conclude that the U.S. food supply contains only very small amounts of pesticides that are not a concern. However, there have been some reports of the illegal use of methyl parathion inside homes. For more information, see Section 1.7 and Chapter 6. 

Guideline for Approval No. 3 General Principles for Evaluating the Safety of Compounds Used in Food-producing Animals. Revised July 1994. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Veterinary Medicine, RockvUle, MD(1994). 

Because these types of polymeric matrix systems are the simplest to design and the easiest to obtain approval by the Food and Drug Administration, they have been the most extensively studied in the past two decades. Numerous polymers have been evaluated for these types of drug delivery systems and although it would be impractical to present each of these polymers and its specific application to drug delivery, this chapter will review in general the types of polymers used as matrices for drug delivery (1-4). 

FDA. 1998. Direct food substances affirmed as generally recognized as safe. U.S. Food and Drug Administration. Code of Federal Regulations. 21 CFR 184. 

Past chlordane use, coupled with atmospheric transport as the major route of dissemination, produced global contamination of fish and wildlife resources and human populations. The chemical and its metabolites were frequently detected in all species examined, but usually at low concentrations. Residues in fish muscle sometimes exceeded the U.S. Food and Drug Administration action level of 0.3 mg/kg fresh weight recommended for human health protection. In general, chlordane in animals is highest near areas where the chemical has been applied to control termites concentrations are highest in fat and liver, especially in predatory species. 

It should be remembered that in 1970, when drug-release/dissolution tests first became official through the leadership of USP and NF, marketed tablets or capsules in general simply did not have a defined dissolution character. They were not formulated to achieve a particular dissolution performance, nor were they subjected to quality control by means of dissolution testing. Moreover, the U.S. Food and Drug Administration (FDA) was not prepared to enforce dissolution requirements or to even to judge their value. 

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