3I. BackgroundThe Food, Drug, and Cosmetic Act (FDCA), makes itunlawful to introduce into interstate commerce a misbrandeddrug, 21 U.S.C. § 331(a), or an unapproved new drug, §355(a).
A drug is misbranded if, among other things, it was
“manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered” with the
FDA. § 352(o). An unapproved new drug is one that isneither
ally recognized, among experts ... as safe and
effective” for its labeled use,
§ 321(p)(1), nor approved by theFDA as safe and effective for its proposed use, § 355(d).The FDCA also regulates the importation of drugs. 21U.S.C. § 381(a) provides:The Secretary of the Treasury shall deliver to theSecretary of Health and Human Services [HHS], upon hisrequest, samples of ... drugs ... being imported or offeredfor import into the United States .... The Secretary of [HHS] shall furnish to the Secretary of the Treasury a listof establishments registered [with the FDA] ... and shallrequest that if any drugs ... manufactured, prepared, propagated, compounded, or processed in anestablishment not so registered are imported or offeredfor import into the United States, samples of such drugs... be delivered to the Secretary of [HHS] .... If it appearsfrom the examination of such samples or otherwise that... such article is adulterated, misbranded, or [anunapproved new drug] ..., then such article shall berefused admission.
The FDCA is codified at 21 U.S.C. § 301
. For convenience, we refer to sections of 21 U.S.C. as though they weresections of the Act.
USCA Case #12-5176 Document #1448004 Filed: 07/23/2013 Page 3 of 21