Sec. 505. Transition periods
475 words·~2 min read·
/bill/117/s/4591/is/section-505A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
With respect to a cannabis product that was marketed in the United States within 30 days of the date of enactment of this Act pursuant to a State law permitting the marketing of such product, such product shall not be considered to be in violation of chapter XI of the Federal Food, Drug, and Cosmetic Act (as added by section 501) or section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by this title, as applicable, during the 18-month period following the date of enactment of this Act.
With respect to a drug containing cannabis that was being marketed in the United States within 30 days after the date of enactment of this Act pursuant to a State law permitting cannabis for medical use, such drug shall not be considered to be in violation of chapter V or section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ; 351 et seq.) during the 3-year period following the date of enactment of this Act. As a condition for continuing to market a drug described in paragraph
(1)during the 3-year period specified in such paragraph, during the 18-month period beginning on the effective date of this Act, the manufacturer shall submit a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 355(b)) for such drug. Except as provided in subparagraph (C), with respect to a drug containing cannabis for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such drug in the State described in paragraph
(1)during the 3-year period beginning on the effective date of this Act. If the Secretary of Health and Human Services issues an order refusing to approve an application under section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) for a drug that contains cannabis, such drug shall not be eligible for continued marketing under subparagraph (B). Beginning on the date that is 3 years after the date of enactment of this Act the Secretary may take enforcement action, as appropriate, for a drug described in paragraph
(1)(including such a drug that is the subject of a pending application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 )) found to be in violation of chapter V or section 301 of the Federal Food, Drug, and Cosmetic Act. Nothing in this subsection shall be construed to prohibit the marketing of a cannabis product otherwise in compliance with relevant provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). For purposes of this section, the term drug containing cannabis means any drug that contains any article made or derived from cannabis.
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