OBJECTIVE： To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called “Chinese patent medicine （CPM） containing toxicity” for short] in clinic. METHODS： The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia （part Ⅰ） were summarized and analyzed to put forward the suggestion  on improving safe use of them in clinic. RESULTS & CONCLUSIONS： A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia （part Ⅰ）， accounting for 31.75％ of set prescription preparations. There are 435 oral preparations （12 preparations both for oral and external use）， 38 preparations for external use， one intramuscular injection，accounting for 91.77％，8.02％， 0.21％ of CPM containing toxicity， respectively. There are 318， 93， 32， 31 set prescription preparations containing 1， 2， 3 or more ingredients toxic decoction pieces， accounting for 67.09％， 19.62％， 6.75％， 6.54％， respectively. At present， basic research on CPM containing toxicity is weak； the information of the instructions is not perfect； guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity， develop drug use study among special population， improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.