Abstract: Objective: Through a comparative study of the proprietary chinese medicine instructions with American drug instructions to find out the problems of proprietary chinese medicine instructions and gives suggestions for improvement. Method: Literature analysis: choose the CNKI library as the data source, “proprietary chinese medicine instructions” as the Keywordto search papers, learn from the methods of analysis of the retrieved 189 articles from 2008 to 2013 and form the research ideas of this paper. 2. Statistical sampling investigation method: random select 30 proprietary chinese medicine instructions and 30 American drug instructions as a sample, follow the relevant regulations, using statistics method and analysis the contents of each project. Result and conclusion: compared with the American drug instructions, proprietary chinese medicine instructions have a serious lack of pharmacology and toxicology, pharmacokinetics, drug interactions, clinical research and storage project; precautions, contradictions, adverse reactions and special populations and other projects are not perfect and the express of proprietary chinese medicine instructions are lack of theoretical research. When compared with the American drug regulations, proprietary chinese medicine regulations are not perfect.