Drugs Bureau

Guidelines for reproduction and teratology of drugs." Bureau of Drugs. Food and Drug Administration, 1966. 

Approved Prescription Drug Products, with Therapeutic Equivalence Evaluations, Bureau of Dmgs, Pood and Dmg Administration, U.S. Dept, of Health and Human Services, Bethesda, Md., 1980. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Compiled from the following reports of the U.S. Department of Interior, Bureau of Mines Rl 5753, The Explosibility of Agricultural Dusts Rl 6516, Explosibility of Metal Powders Rl 5971, Explosibility of Dusts Used in the Plastics Industry Rl 6597, Explosibility of Carbonaceous Dusts Rl 7132, Dust Explosibility of Chemicals, Drugs. Dyes and Pesticides and Rl 7208, Explosibility of Miscellaneous Dusts.)... 

J. H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States Business Office, Bureau of Food and Drugs, Austin, Texas, Chap. Dermal Toxicity, Texas State Dept, of Health, 1959, pp. 46-48. 

The Bureau of Chemistry is re-organised with regulatory functions now residing in the Food, Drug and Insecticide Administration. 

Epstein, M. S. Velapoldl, R. A. Blackburn, D. Evaluation of Luminescent Glass Spheres as Calibration Standards for Micro-spectrofluorimetry National Bureau of Standards Gaithersburg, MD Annual Task Report to Food and Drug Administration, 1984, 1985, 1986 also, paper to be submitted. 

Tennessee s Department of Agriculture prohibits the use of DDT because its Food and Drug Law considers a food adulterated if it may have become contaminated. This is possible, it is alleged, when DDT is used. Knoxville s Health Bureau, on the other hand, permits the use of residual sprays, provided the food is protected from contamination, and the food must be pure and wholesome. ... 

These observations have motivated the U. S. Department of Agriculture and Bureau of Food and Drugs recently to take steps banning the use of DDT in spraying of dairy barns and of dairy and meat cattle. 

During the media blitz that followed, Patterson urged the public to buy Chicken of the Sea tuna because the Van Camp Sea Food Company s molded steel cans were lead-free. With characteristic bluntness, Patterson lambasted a host of government laboratories from the Environmental Protection Agency and its Bureau of Foods to the National Marine Fisheries Service and the Food and Drug Administration (FDA). Asked if any other laboratories agreed with his findings, Patterson declared loftily that scientific questions are not determined by majority vote. 

Reed, D. 1982. Atrazine. (Unpubl. mimeo.) Available from U.S. Food and Drug Administration, Bureau of Foods, Washington, D.C. 6 pp. 

The U. S. Antibiotics Standards Research Group (USASRG) is an ad hoc collaboration of antibiotics researchers at the U S. Food and Drug Administration. Contributors to this monograph from the Bureau of Drugs include T. Alexander, R. Barron, V. Folen, K. Furnkranz, G. Mack (Baltimore District), M. Maienthal, G Mazzola (Bureau of Foods), G. Schwartzman, G Selzer, E. She min, J. Taylor. L. Wayland. and J. Weber. 

Currently, drug trafficking is a 400-billion-per-year industry in our country and represents 8% of the world s trade. According to the White House Office of National Drug Control Policy, Americans currently spend 46— 79 billion annually on just two (of many possible) psychoactive drugs cocaine and heroin (Kari Associates, 2004). The Bureau of Justice Statistics (1999) indicates that between 60% and 83 % of the nation s correctional population have used drugs at some point in their lives, roughly twice as many as others in the U.S. population. 

A chemist from the Federal Bureau of Narcotics and Dangerous Drugs, who was in Bolivia to observe clandestine cocaine operations, related the following step-by-step procedure for manufacturing cocaine. The method can be conveniently divided into three major steps (1) extraction of cocaine from the leaf and chemical conversion to the sulfate (2) treatment of cocaine sulfate with potassium permanganate and conversion to the free base (aka paste) and (3) conversion of the paste or free base to cocaine hydrochloride. In general, steps (1) and (2) are carried out in sulfate labs while step (3) is performed in crystal labs. 

Bureau of Alcohol, Tobacco, and Firearms (BATF), 10 553 12 34 Bureau of Narcotics and Dangerous Drugs (BNDD), 18 685... 

FD C Yellow No. 5 Aluminum Lake, in nail-care products, 7 853 FDA Bureau of Drug Abuse Control,... 

Bureau of Chemistry renamed the Food, Drug and Insecticide Administration. 

JMHW (1984). Guidelines for Testing of Drugs for Toxicity. Pharmaceutical Affairs Bureau, Notice No. 118. Ministry of Health and Welfare, Japan. 

Food and Drug Administration (1966). Guidelines for Reproduction Studies for Safely Evaluation of Drugs for Human Use. Drug Review Branch, Division of Toxicological Evaluation, Bureau of Science, Food and Drug Administration, Washington, D.C. 

Regulatory functions of the Bureau of Chemistry become the Food, Drug, and Insecticide... 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

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