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KMID : 1142220110060010099
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.99 ~ p.106
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A Study on the Management and the Prospect of Narcotic Reference Standards in Korea
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Kim In-Kyu
Choi Lan
Sohn Kyung-Hee
Kim Dong-Sub
Kim Seung-Hee
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Abstract
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The use of narcotics can cause psychological and physical dependence but some of them have been used legally under strict governmental control as they are essential medicines for some patients who are suffering from intense pain. For the quality control of narcotic medicines, the securement of a reference standards (RS) of narcotics is essential. The reference standards of narcotics are defined as highly purified substances of the listed narcotics whose content is accurately known. They are manufactured separately as per the purpose of the use or obtained from the raw materials through purification. Pharmaceutical companies have trouble in obtaining the reference standards due to complicated and strict purchase process and high cost of narcotics. The Korean Food and Drug Administration(KFDA) have produced and distributed the reference standards of narcotics since 2003, which has contributed to cost-reduction as well as time saving to pharmaceutical companies, research institutes and so on. The current management system of KFDA RS(or KP RS) is not complete and it is difficult to establish a longterm strategy because the reference standards of chemical drugs, biological drugs, herbal drugs are handled by several divisions in KFDA respectively. In future, the integrated management system of reference standards for drugs including narcotic medicines should be adopted for specialized and uniformity management.
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KEYWORD
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Narcotics, Psychotropic drugs, Reference Standard, Production, Distribution
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