FDA's determination of Delaying, Denying, Limiting, or Refusing a Drug Inspection Circumstances
ZANG Ke-cheng1,2, ZHANG Ling1, SHAO Rong1*
1. The Research Center of National Drug Policy and Ecosystem, China Pharmaceutical University, Nanjing 211198, China; 2. Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Abstract：OBJECTIVE In 2012, "Federal Food, Drug, and Cosmetic Act" added new provisions to include drugs that companies delay, deny, limit or refuse inspections into the category of adulterated drugs, and define this type of behavior in a legal sense. The article hopes to learn from the USA for this judgment and handling experience of similar behaviors provide references for China's drug inspection work. METHODS The article sorts out the specific circumstances that constitute delay, deny, limit or refuse to inspect in the FDA guidelines, as well as statistics through data query and summarizes the corresponding treatment measures. RESULTS It was found that the USA guidelines described the specific circumstances of such behaviors in a more detailed and rigorous manner, including descriptions of exclusions; treatment measures included punishments for prohibited behaviors, issuing warning letters, and listing import alerts. CONCLUSION China can learn from the USA experience and issue guidelines to guide the determination of delay, deny, limit or refuse to inspect specific behaviors, while considering the legitimacy and rationality of the inspection behavior itself, and give discretion to determine the situation.
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2022, Vol. 57 
