法定药指收载于药典或其他规定药品标准规格的法律性文件中的药物。
要依据美国食榀、药榀、化让路法案501款以及美国药典和国家处方集的各论中的含量测定和质量标准来构建法定标准。
According to Section 501 of the Federal Food Drug and Cosmetic Act assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.
符合ANDA状态的制剂的原料药通常是法定的药品并应很好的分析其特点。
The drug substance for a pharmaceutical product eligible for ANDA status normally is an official article and should be well characterized analytically.
药局方>>（JP）是日本《药事法》中规定的日本药品的法定标准。
The Japanese Pharmacopoeia (JP) was designated as the official Japanese drug standard by The Pharmaceutical Administration Law of Japan.
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