美国联邦法规定，所有生产预期用于疾病的诊断，治疗，症状缓解，处理或疾病的预防中有活性药物成分或其它直接作用，或能影响机体的功能和结构的药品工厂（包括药品生产商，原料药生产商，代理工厂和再包装企业）需要向FDA进行注册并申报其所有成分。非处方药OTC（例如：免洗洗手液，带有防晒功能的化妆品，含氟牙膏等）美国FDA要求其生产商、包装商和经销商进行FDA注册。

Both the domestic and foreign manufacturers and certain distributors that manufacture, prepare, propagate, compound or process drugs and intend to market in US are required to register the establishment by using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. FDA also requires the establishments renew the registration annually between October 1 and December 31 of each year.