Drug Legislation

A synopsis of the history of U.S. drug legislation is presented in Table 2.1. Here we will review the history of the three major legislative acts covering pharmaceuticals. 

The interface between chemistry and society refuses to be drawn in such neat lines as good and bad, however. The search for chemical warfare agents popularized the method of project research that would be used so fruitfully in peacetime investigations. The ravages of Elixir Sulfanilamide provoked the present stricter food and drug legislation. These case studies suggest some of the complexity, as well as the diversity, of chemistry s influence on modern civilization. 

Jackson, Charles 0. "Food and Drug Legislation in the New Deal" Princeton University Press Princeton, 1970, Chapter 7. 

Where the medicinal product in question is a controlled drug within the Misuse of Drugs legislation, additional controls will apply. Drugs are classified in various schedules according to their perceived risk of harm. In the case of most of the products covered by the legislation, it will be necessary to obtain a licence from the home office in order to import the product from another country. 

Details about orphan drug legislation, its application and associated procedures and guidance notes are available at the EMEA website (see end of chapter). 

Although many of the problems related to drug misuse are personal and social as well as medical and legal, current treatment responses have been strongly influenced by the historical emphasis on opioids in drug legislation to the detriment of a naturally evolving and wider multidisciplinary treatment and rehabilitation service. 

While the impact of vastly improved chemical analysis has been felt by essentially all phases of science, dramatically more precise data have been of notable significance in the area of pollutants and pharmaceuticals. The effects of minute impurities, beyond detection just a few years ago, now can be determined and become the basis for pollution and drug legislation, litigation, etc. In some cases, unfortunately, the long-term effects of impurities in substances and in the environment remains a... 

Moreover, it s now clear that many of the substances outlawed by drug legislation are actually important neurotransmitters. Shulgin, in a 1977 talk in San Francisco, commented on the federal prohibitions against peyote which proscribe "every compound of this plant ... 

A small amount of ibogaine has been synthesized for the psychedelic subculture, but this is rare. It is proscribed in Schedule I of the 1970 drug legislation. Its illegal status and the difficult manufacturing process have led most psychedelic chemists to conclude, as Michael Valentine Smith suggests in Psychedelic Chemistry, that it isn t worth the trouble. 

History of Generic Drug Legislation in United States... 

Food and drug legislation—the story behind the law. In history of FDA and legislation The GMP Institute Tampa, FL http //www.gmplst.com/histlaw.htm (accessed July 2003). 

Abuse of buprenorphine has been reported in many countries and it is now widely dealt with under psychotropic drug legislation. 

These changes will influence greater harmonisation of drug legislation in the Slovak Republic with that of the EU. 

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