Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

United States drug laws

Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of October 16,1973 amended in 2009)], as well as their continued use by the U.S. Environmental Protection Agency (EPA) [Kavlock R, Dix D. J Toxicol Environ Health B Crit Rev 13(2-4) 197-217, 2010] and U.S. Food and Drug Administration (FDA) [U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) TSCA (1976) Toxic Substances Control Act. United States Publ. Law 94-469, 90 Stat 2003, USA],... [Pg.74]

U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) TSCA (1976) Toxic Substances Control Act. United States Publ. Law 94-469, 90 Stat 2003, USA... [Pg.88]

HO-DMT is a minor metabolite of DMT in man, and it was studied for the same reasons. Could this compound play a role in explaining the activity of the parent dialkylamine It was explored in a series of subjects who had responded spectacularly to DMT. The five volunteers in this study were former opium addicts who were serving sentences for violation of United States narcotics laws. They were administered 6-HO-DMT at either 0.75 mg/Kg (one subject) or 1.0 mg/Kg (four subjects) and reported no differences from the inactive placebo control. The objective measures (blood pressure, respiration and heart rate, pupillary dilation) confirmed this absence of activity at this level. The active control drug was DMT itself, and it showed the expected responses in all regards. [Pg.43]

Ephedra is subject to the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994. The act essentially protects dietary supplements like ephedra. That is, while U.S. federal agencies can regulate prescription drug and food additives, DSHEA exempts herbal products and supplements from federal regulation. The law states that the United States Food and Drug Administration (FDA) cannot regulate dietary supplements unless, or until, they are proven to be unsafe and pose a risk to users. The United States Drug Enforcement Administration (DEA) monitors ephedrine because it can be used to make methamphetamine. [Pg.189]

United States food law is codified in the Eederal Eood Drug Cosmetic Act (EEDCA) with amendments and further clarification in the Code of Eederal Regulations, (CER), Title 21. This deals with food and food additives. [Pg.1163]

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 (United States Public Law 103-417) amended the Federal Food, Drug and Cosmetic Act by defining as a dietary supplement any product (other than tobacco) that contains a vitamin, mineral, herb or other botanical, or amino acid and is intended as a supplement to the diet. Food is considered safe by definition, but new foods or food additives must be demonstrated to be generally recognized as... [Pg.367]

Canada. Sorbic acid and potassium sorbate are cleared in Canada as Class II and Class III preservatives (Table XI, Parts II and III, Food and Drug Regulations) (162). They are cleared for use in the same food types. As in the United States, their lawful use is predicated upon conformity with published food standards. Otherwise they may be used in bread and unstandardized foods, except meat (Divisions 14 and 21 of the regulations), fish, and poultry, at levels up to 1000 ppm, in cider and wine at 500 ppm, and in cheeses at 3000 ppm in accordance with the food standards for cheese (Section B of the regulations). [Pg.287]

U.S. Laws and Regulations Related to Drug Product Development and Manufacture. Until early in the twentieth century, dmg products were made and sold in the United States having virtually no imposed control. QuaUty was generally poor. Many products were patent medicines of dubious value. Some were harmful and addicting. [Pg.225]

Many laws have been enacted over the last century that affect drug distribution and administration. Those included here are the Pure Food and Drug Act Harrison Narcotic Act Pure Food, Drug, and Cosmetic Act and the Comprehensive Drug Abuse Prevention and Control Act. These laws control the use of the three categories of drugs in the United States (prescription, nonprescription, and controlled substances). [Pg.5]

Caution New Drug-Limited by Federal (or United States) law to investigational use . [Pg.95]

USPC, The United States Pharmacopeia is a compendium of information on drug products. The standards set forth in the USP are recognized in both federal and state law. [Pg.156]

Drugs Under Patent. This book [77] is a cross-referenced listing of over 2500 drugs covered in the United States under patent law and marketing exclusivity provisions of the Waxman-Hatch Act. Eight indexes provide market and patent status information by company, trade name, generic name, expiration date, dosage form, exclusivity code, patent number, and NDA number. Updated annually, this book is available commercially. [Pg.775]

While the tripartite countries of the more developed regions of the world have their own patent laws, and while they honor each other s property protection rights, some countries do not. Patent pirates in these countries freely copy (pirate) innovator drugs and drug products that are under patent protection in the United States and elsewhere without compensating patent holders. India is perhaps the worst pirate offender,... [Pg.816]

Bums, J. (1982). Overview of safety regulations governing food, drug and cosmetics. In The United States in Safety and Evaluation and Regulation of Chemicals 3 Interface between Law and Science (Homberger F., Ed.) Karger, New York. [Pg.96]

In the United States antioxidant use is subject to regulation under the Federal Food, Drug, and Cosmetic Act.8 Antioxidants for food products are also regulated under the Meat Inspection Act, the Poultry Inspection Act, and various state laws. Antioxidants permitted for use in foods are divided into two groups ... [Pg.291]

Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). The U.S. Food and Drug Administration (FDA) regulates all gene therapy products in the United States and oversees research in this area. Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. [Pg.45]


See other pages where United States drug laws is mentioned: [Pg.54]    [Pg.54]    [Pg.627]    [Pg.97]    [Pg.22]    [Pg.198]    [Pg.111]    [Pg.345]    [Pg.45]    [Pg.20]    [Pg.113]    [Pg.914]    [Pg.448]    [Pg.136]    [Pg.914]    [Pg.1944]    [Pg.13]    [Pg.215]    [Pg.545]    [Pg.223]    [Pg.629]    [Pg.631]    [Pg.816]    [Pg.47]    [Pg.329]    [Pg.117]    [Pg.242]    [Pg.37]    [Pg.73]    [Pg.11]    [Pg.493]    [Pg.495]    [Pg.528]    [Pg.537]    [Pg.22]   
See also in sourсe #XX -- [ Pg.97 , Pg.98 , Pg.99 , Pg.100 , Pg.101 , Pg.102 ]




SEARCH



Drug laws

© 2024 chempedia.info