US Codex
Bill
Notes

Title II — Development of FDA-approved drugs using cannabidiol and marihuana

S. 2032 · 116th Congress · Dec 15, 2020 · Lineage

II Development of FDA-approved drugs using cannabidiol and marihuana

Sec. 201 Medical research on cannabidiol

Notwithstanding any provision of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or any other Federal law, an appropriately registered covered institution of higher education, a practitioner, or a manufacturer may manufacture, distribute, dispense, or possess marihuana or cannabidiol if the marihuana or cannabidiol is manufactured, distributed, dispensed, or possessed, respectively, for purposes of medical research for drug development or subsequent commercial production in accordance with section 202.

Sec. 202 Registration for the commercial production and distribution of Food and Drug Administration approved drugs

The Attorney General shall register an applicant to manufacture or distribute cannabidiol or marihuana for the purpose of commercial production of a drug containing or derived from marihuana that is approved by the Secretary of Health and Human Services under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in accordance with the applicable requirements under subsection (a) or (b) of section 303 of the Controlled Substances Act (21 U.S.C. 823).

Sec. 203 Importation of cannabidiol for research purposes

The Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.) is amended—
(1)
in section 1002(a) (21 U.S.C. 952(a))—
(A)
in paragraph (1), by striking “and” at the end;
(B)
in paragraph (2)(C), by inserting “and” after “uses,”; and
(C)
inserting before the undesignated matter following paragraph (2)(C) the following:

“(3) such amounts of marihuana or cannabidiol (as defined in section 2 of the Cannabidiol and Marihuana Research Expansion Act) as are—

“(A) approved for medical research for drug development (as such terms are defined in section 2 of the Cannabidiol and Marihuana Research Expansion Act), or

“(B) necessary for registered manufacturers to manufacture drugs containing marihuana or cannabidiol that have been approved for use by the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),”

(2)
in section 1007 (21 U.S.C. 957), by amending subsection (a) to read as follows:

“(a)

“(1) Except as provided in paragraph (2), no person may—

“(A) import into the customs territory of the United States from any place outside thereof (but within the United States), or import into the United States from any place outside thereof, any controlled substance or list I chemical, or

“(B) export from the United States any controlled substance or list I chemical,

“(2) Paragraph (1) shall not apply to the import or export of marihuana or cannabidiol (as defined in section 2 of the Cannabidiol and Marihuana Research Expansion Act) that has been approved for—

“(A) medical research for drug development authorized under section 201 of the Cannabidiol and Marihuana Research Expansion Act; or

“(B) use by registered manufacturers to manufacture drugs containing marihuana or cannabidiol that have been approved for use by the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”