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21 U.S. Code § 384. Importation of prescription drugs
(a) DefinitionsIn this section:
(1) Importer
The term “importer” means a pharmacist or wholesaler.
(2) Pharmacist
The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.
(3) Prescription drugThe term “prescription drug” means a drug subject to section 353(b) of this title, other than—
(A)
a controlled substance (as defined in section 802 of this title);
(B)
a biological product (as defined in section 262 of title 42);
(C)
an infused drug (including a peritoneal dialysis solution);
(D)
an intravenously injected drug;
(E)
a drug that is inhaled during surgery; or
(F)
a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply.
(4) Qualifying laboratory
The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section.
(5) Wholesaler
(A) In general
The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title.
(B) Exclusion
The term “wholesaler” does not include a person authorized to import drugs under section 381(d)(1) of this title.