FDA Releases Small Entity Compliance Guide on Drug Importation From Canada
FDA on May 25 released a new small entity compliance guide on its final rule allowing imports of drugs from Canada. The guidance “is intended to help small entities better understand the final rule,” which was published in October 2020…
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(see 2009290018). It includes information on who and what is eligible for importing under the Section 804 Importation Programs (SIPs) provided for under the final rule, as well as on entry, labeling and testing requirements. Comments on the guide may be submitted at any time, FDA said.