Public Law 117–215: To expand research on cannabidiol and marijuana, and for other purposes. Public Law215 Public Law 117–215136 Stat. 2257 2022-12-02 2022-12-02 United States Government Publishing OfficeNational Archives and Records AdministrationOffice of the Federal Registertext/xmlENPursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. GPO Locator to USLM Converter 4.15.31;Stage2.202507022026-01-02 117public PUBLIC LAW 117–215—DEC. 2, 2022 136 STAT. 2257 Public Law117–215 117th Congress
An Act To expand research on cannabidiol and marijuana, and for other purposes.

Dec. 2, 2022

[H.R. 8454]

   Be it enacted by the Senate and House of Representa­tives of the United States of America in Congress assembled,

Medical Marijuana and Cannabidiol Research Expansion Act.
SECTION 1.

21 USC 801 note.

SHORT TITLE; TABLE OF CONTENTS.(a) Short Title.—This Act may be cited as the “Medical Marijuana and Cannabidiol Research Expansion Act”. (b) Table of Contents.—The table of contents for this Act is as follows: Sec. 1.  Sec. 2.  Sec. 3.  TITLE I— Sec. 101.  Sec. 102.  Sec. 103.  Sec. 104.  Sec. 105.  Sec. 106.  TITLE II— Sec. 201.  Sec. 202.  TITLE III— Sec. 301.  TITLE IV— Sec. 401. 
SEC. 2. DEFINITIONS.(a)

21 USC 801 note.

In General.—In this Act—(1) the term “appropriately registered” means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marijuana, as applicable; (2) the term “cannabidiol” means—(A) the substance, cannabidiol, as derived from marijuana that has a delta-9-tetrahydrocannabinol level that is greater than 0.3 percent; and (B) the synthetic equivalent of the substance described in subparagraph (A);136 STAT. 2258 (3) the terms “controlled substance”, “dispense”, “distribute”, “manufacture”, “marijuana”, and “practitioner” have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act; (4) the term “covered institution of higher education” means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—(A)(i) has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or (ii) is an accredited medical school or an accredited school of osteopathic medicine; and (B) is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); (5) the term “drug” has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)); (6) the term “medical research for drug development” means medical research that is—(A) a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marijuana or cannabidiol as a drug; and (B) conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and (7) the term “State” means any State of the United States, the District of Columbia, and any territory of the United States. (b) Updating Term.—Section 102(16) of the Controlled Substances Act (21 U.S.C. 802(16)) is amended—(1) in subparagraph (A), by striking “the term ‘marihuana’ means” and inserting “the terms ‘marihuana’ and ‘marijuana’ mean”; and (2) in subparagraph (B), by striking “The term ‘marihuana’ does not” and inserting “The terms ‘marihuana’ and ‘marijuana’ do not”.
SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.  The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.
<num value="I">TITLE I—</num><heading>REGISTRATIONS FOR MARIJUANA RESEARCH</heading> <section id="d118080e384" identifier="/us/pl/117/215/tI/s101" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="101">SEC. 101. </num><heading>MARIJUANA RESEARCH APPLICATIONS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x81a47319-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120">  Section 303(f) of the Controlled Substances Act (<ref href="/us/usc/t21/s823/f">21 U.S.C. 823(f)</ref>) <amendingAction type="amend">is amended</amendingAction>—<page identifier="/us/stat/136/2259">136 STAT. 2259</page></chapeau><paragraph class="fontsize10" id="y81a4731a-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s101/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (1) through (5) as subparagraphs (A) through (E), respectively;</content></paragraph> <paragraph class="fontsize10" id="y81a4731b-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s101/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>(f) The Attorney General</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(f)(1) The Attorney General</quotedText>”;</content></paragraph> <paragraph class="fontsize10" id="y81a4731c-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s101/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Registration applications</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentDown1 firstIndent0 fontsize10" id="y81a4731d-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2)</num><subparagraph class="inline" id="y81a4731e-e819-11f0-bc57-ad3ac4b1618c"><num value="A">(A) </num><content>Registration applications”</content></subparagraph> </paragraph> </quotedContent>;</content></paragraph> <paragraph class="fontsize10" id="y81a4731f-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s101/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Article 7</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentDown1 firstIndent0 fontsize10" id="y81a49a30-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>Article 7”</content></paragraph> </quotedContent>; and</content></paragraph> <paragraph class="fontsize10" id="y81a49a31-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s101/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (2)(A), as so designated, the following:<quotedContent><subparagraph class="indentDown1 firstIndent0 fontsize10" id="y81a4e852-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B)</num><clause class="inline" id="y81a4e853-e819-11f0-bc57-ad3ac4b1618c"><num value="i">(i) </num><chapeau>The Attorney General shall register a practitioner to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if—</chapeau><subclause class="fontsize10" id="y81a4e854-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><chapeau>the applicant’s research protocol has been reviewed and allowed—</chapeau><item class="fontsize10" id="y81a4e855-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>by the Secretary of Health and Human Services under section 505(i) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/i">21 U.S.C. 355(i)</ref>);</content></item> <item class="fontsize10" id="y81a4e856-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>by the National Institutes of Health or another Federal agency that funds scientific research; or</content></item> <item class="fontsize10" id="y81a4e857-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="cc">“(cc) </num><content>pursuant to sections 1301.18 and 1301.32 of <ref href="/us/cfr/t21">title 21, Code of Federal Regulations</ref>, or any successors thereto; and</content></item> </subclause> <subclause class="fontsize10" id="y81a4e858-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>the applicant has demonstrated to the Attorney General that there are effective procedures in place to adequately safeguard against diversion of the controlled substance for legitimate medical or scientific use pursuant to section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, including demonstrating that the security measures are adequate for storing the quantity of marijuana the applicant would be authorized to possess.</content></subclause> </clause> <clause class="indentUp0 firstIndent0 fontsize10" id="y81a4e859-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a4e85a-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Determination.</p></sidenote><chapeau>The Attorney General may deny an application for registration under this subparagraph only if the Attorney General determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the Attorney General shall consider the factors listed in—</chapeau><subclause class="fontsize10" id="y81a4e85b-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>subparagraphs (B) through (E) of paragraph (1); and</content></subclause> <subclause class="fontsize10" id="y81a4e85c-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>subparagraph (A) of paragraph (1), if the applicable State requires practitioners conducting research to register with a board or authority described in such subparagraph (A).</content></subclause> </clause> <clause class="indentUp0 firstIndent0 fontsize10" id="y81a4e85d-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii)</num><subclause class="inline" id="y81a4e85e-e819-11f0-bc57-ad3ac4b1618c"><num value="I">(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a4e85f-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadline.</p></sidenote><chapeau>Not later than 60 days after the date on which the Attorney General receives a complete application for registration under this subparagraph, the Attorney General shall—</chapeau><item class="fontsize10" id="y81a4e860-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>approve the application; or</content></item> <item class="fontsize10" id="y81a4e861-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>request supplemental information.</content></item> </subclause> <subclause class="indentUp0 firstIndent0 fontsize10" id="y81a4e862-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>For purposes of subclause (I), an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under clause (i) are satisfied.</content></subclause> </clause> <clause class="indentUp0 firstIndent0 fontsize10" id="y81a4e863-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a4e864-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>Not later than 30 days after the date on which the Attorney General receives supplemental information as described in clause (iii)(I)(bb) in connection with an application described in this subparagraph, the Attorney General shall approve or deny the application.</content></clause> <clause class="indentUp0 firstIndent0 fontsize10" id="y81a4e865-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">“(v) </num><content>If an application described in this subparagraph is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.”</content></clause> </subparagraph> </quotedContent>.<page identifier="/us/stat/136/2260">136 STAT. 2260</page></content></paragraph> </section> <section id="d118080e576" identifier="/us/pl/117/215/tI/s102" style="-uslm-lc:I658143"><num class="fontsize12" value="102">SEC. 102. </num><heading>RESEARCH PROTOCOLS.</heading><subsection class="firstIndent0 fontsize10" id="y81a53686-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s102/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Paragraph (2)(B) of section 303(f) of the Controlled Substances Act (<ref href="/us/usc/t21/s823/f">21 U.S.C. 823(f)</ref>), as added by section 101 of this Act, is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp0 firstIndent0 fontsize10" id="y81a5d2c7-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="vi">“(vi)</num><subclause class="inline" id="y81a5f9d8-e819-11f0-bc57-ad3ac4b1618c"><num value="I">(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9d9-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Notifications.</p><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9da-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadlines.</p></sidenote><chapeau>If the Attorney General grants an application for registration under clause (i), the registrant may amend or supplement the research protocol without notification to, or review by, the Drug Enforcement Administration if the registrant does not change—</chapeau><item class="fontsize10" id="y81a5f9db-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>the quantity or type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof);</content></item> <item class="fontsize10" id="y81a5f9dc-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>the source of such marijuana or cannabidiol; or</content></item> <item class="fontsize10" id="y81a5f9dd-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="cc">“(cc) </num><content>the conditions under which such marijuana or cannabidiol is stored, tracked, or administered.</content></item> </subclause> <subclause class="indentUp0 firstIndent0 fontsize10" id="y81a5f9de-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II)</num><item class="inline" id="y81a5f9df-e819-11f0-bc57-ad3ac4b1618c"><num value="aa">(aa) </num><content>If a registrant under clause (i) seeks to change the type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof), the source of such marijuana or cannabidiol, or the conditions under which such marijuana or cannabidiol is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.</content></item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e0-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9e1-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Effective date.</p></sidenote><content>A registrant may proceed with an amended or supplemental research protocol described in item (aa) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (aa).</content></item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e2-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="cc">“(cc) </num><content>The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security measures are needed to safeguard against diversion or abuse.</content></item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e3-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="dd">“(dd) </num><content>If a registrant under clause (i) seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol.</content></item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e4-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="ee">“(ee) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9e5-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Effective date.</p></sidenote><content>A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (dd).</content></item> </subclause> <subclause class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e6-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III)</num><item class="inline" id="y81a5f9e7-e819-11f0-bc57-ad3ac4b1618c"><num value="aa">(aa) </num><content>If a registrant under clause (i) seeks to change the quantity of marijuana needed for research and the change in quantity does not impact the factors described in item (bb) or (cc) of subclause (I) of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General.</content></item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9e8-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><chapeau>A notification under item (aa) shall include—</chapeau><subitem class="fontsize10" id="y81a5f9e9-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="AA">“(AA) </num><content>the Drug Enforcement Administration registration number of the registrant;</content></subitem> <subitem class="fontsize10" id="y81a5f9ea-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>the quantity of marijuana or cannabidiol already obtained;</content></subitem> <subitem class="fontsize10" id="y81a5f9eb-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="CC">“(CC) </num><content>the quantity of additional marijuana or cannabidiol needed to complete the research; and<page identifier="/us/stat/136/2261">136 STAT. 2261</page></content></subitem> <subitem class="fontsize10" id="y81a5f9ec-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="DD">“(DD) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9ed-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Attestation.</p></sidenote><content>an attestation that the change in quantity does not impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered.</content></subitem> </item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9ee-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="cc">“(cc) </num><chapeau>The Attorney General shall ensure that—</chapeau><subitem class="fontsize10" id="y81a5f9ef-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="AA">“(AA) </num><content>any registered mail return receipt with respect to a notification under item (aa) is submitted for delivery to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General; and</content></subitem> <subitem class="fontsize10" id="y81a5f9f0-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General.</content></subitem> </item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9f1-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="dd">“(dd)</num><subitem class="inline" id="y81a5f9f2-e819-11f0-bc57-ad3ac4b1618c"><num value="AA">(AA) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9f3-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Effective date.</p></sidenote><content>On and after the date described in subitem (BB), a registrant that submits a notification in accordance with item (aa) may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in item (ee).</content></subitem> <subitem class="indentUp0 firstIndent0 fontsize10" id="y81a5f9f4-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>The date described in this subitem is the date on which a registrant submitting a notification under item (aa) receives the registered mail return receipt with respect to the notification or the date on which the registrant receives notice that the notification using an electronic means permitted under item (aa) was received by the Attorney General, as the case may be.</content></subitem> </item> <item class="indentUp0 firstIndent0 fontsize10" id="y81a5f9f5-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="ee">“(ee) </num><chapeau>A notification submitted under item (aa) shall be deemed to be approved unless the Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity—</chapeau><subitem class="fontsize10" id="y81a5f9f6-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="AA">“(AA) </num><content>does impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered; or</content></subitem> <subitem class="fontsize10" id="y81a5f9f7-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>necessitates that the registrant implement additional security measures to safeguard against diversion or abuse.</content></subitem> </item> </subclause> <subclause class="indentUp0 firstIndent0 fontsize10" id="y81a5f9f8-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="IV">“(IV) </num><chapeau>Nothing in this clause shall limit the authority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in—</chapeau><item class="fontsize10" id="y81a5f9f9-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>the method of administration of marijuana or cannabidiol;</content></item> <item class="fontsize10" id="y81a5f9fa-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>the dosing of marijuana or cannabidiol; and</content></item> <item class="fontsize10" id="y81a5f9fb-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="cc">“(cc) </num><content>the number of individuals or patients involved in research.”</content></item> </subclause> </clause> </quotedContent>.</content></subsection> <subsection class="firstIndent0 fontsize10" id="y81a5f9fc-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s102/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a5f9fd-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s823">21 USC 823 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Regulations</inline>.—</heading><content>Not later than 1 year after the date of enactment of this Act, the Attorney General shall promulgate regulations to carry out the amendment made by this section.</content></subsection> </section> <section id="d118080e784" identifier="/us/pl/117/215/tI/s103" style="-uslm-lc:I658143"><num class="fontsize12" value="103">SEC. 103. </num><heading>APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH.</heading><subsection class="firstIndent0 fontsize10" id="y81a7327e-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Section 303 of the Controlled Substances Act (<ref href="/us/usc/t21/s823">21 U.S.C. 823</ref>), as amended by sections 101 and 102 of this Act, is further amended—</chapeau><paragraph class="fontsize10" id="y81a7327f-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (c) through (k) as subsections (d) through (l), respectively;</content></paragraph> <paragraph class="fontsize10" id="y81a73280-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (b) the following:<quotedContent><subsection class="indentDown1 firstIndent0 fontsize10" id="y81a7a7b1-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c)</num><paragraph class="inline" id="y81a7a7b2-e819-11f0-bc57-ad3ac4b1618c"><num value="1">(1)</num><subparagraph class="inline" id="y81a7a7b3-e819-11f0-bc57-ad3ac4b1618c"><num value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7b4-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Notice.</p><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7b5-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Federal Register,</p><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7b6-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7b7-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadline.</p></sidenote><chapeau>As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this Act to manufacture marijuana to supply appropriately <page identifier="/us/stat/136/2262">136 STAT. 2262</page> registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application—</chapeau><clause class="fontsize10" id="y81a7a7b8-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>approve the application; or</content></clause> <clause class="fontsize10" id="y81a7a7b9-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>request supplemental information.</content></clause> </subparagraph> <subparagraph class="indentUp0 firstIndent0 fontsize10" id="y81a7a7ba-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><chapeau>For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following:</chapeau><clause class="fontsize10" id="y81a7a7bb-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>The requirements designated in the notice in the Federal Register are satisfied.</content></clause> <clause class="fontsize10" id="y81a7a7bc-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>The requirements under this Act are satisfied.</content></clause> <clause class="fontsize10" id="y81a7a7bd-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><chapeau>The applicant will limit the transfer and sale of any marijuana manufactured under this subsection—</chapeau><subclause class="fontsize10" id="y81a7a7be-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>to researchers who are registered under this Act to conduct research with controlled substances in schedule I; and</content></subclause> <subclause class="fontsize10" id="y81a7a7bf-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/i">21 U.S.C. 355(i)</ref>).</content></subclause> </clause> <clause class="fontsize10" id="y81a7a7c0-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General.</content></clause> <clause class="fontsize10" id="y81a7a7c1-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">“(v) </num><content>The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I.</content></clause> <clause class="fontsize10" id="y81a7a7c2-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="vi">“(vi) </num><content>The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act.</content></clause> <clause class="fontsize10" id="y81a7a7c3-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="vii">“(vii) </num><content>The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marijuana, if that State requires such a license.</content></clause> </subparagraph> <subparagraph class="indentUp0 firstIndent0 fontsize10" id="y81a7a7c4-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7c5-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application.</content></subparagraph> </paragraph> <paragraph class="indentUp0 firstIndent0 fontsize10" id="y81a7a7c6-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><content>If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.”</content></paragraph> </subsection> </quotedContent>;</content></paragraph> <paragraph class="fontsize10" id="y81a7a7c7-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a/3" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subsection (h)(2), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (g)</quotedText>”;</content></paragraph> <paragraph class="fontsize10" id="y81a7a7c8-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a/4" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in subsection (j)(1), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (d)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (e)</quotedText>”; and</content></paragraph> <paragraph class="fontsize10" id="y81a7a7c9-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/a/5" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>in subsection (k), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (g)</quotedText>”.</content></paragraph> </subsection> <subsection class="firstIndent0 fontsize10" id="y81a7a7ca-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Technical and Conforming Amendments</inline>.—</heading><paragraph class="fontsize10" id="y81a7a7cb-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>The Controlled Substances Act (<ref href="/us/usc/t21/s801/etseq">21 U.S.C. 801 et seq.</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y81a7a7cc-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in section 102 (<ref href="/us/usc/t21/s802">21 U.S.C. 802</ref>)—</chapeau><clause class="fontsize10" id="y81a7a7cd-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><chapeau>in paragraph (52)(B)—</chapeau><subclause class="fontsize10" id="y81a7a7ce-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/A/i/I" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”; and<page identifier="/us/stat/136/2263">136 STAT. 2263</page></content></subclause> <subclause class="fontsize10" id="y81a7a7cf-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/A/i/II" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">(II) </num><content>in clause (i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(d), or (e)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(e), or (f)</quotedText>”; and</content></subclause> </clause> <clause class="fontsize10" id="y81a7a7d0-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in paragraph (54), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”;</content></clause> </subparagraph> <subparagraph class="fontsize10" id="y81a7a7d1-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in section 302(g)(5)(A)(iii)(I)(bb) (<ref href="/us/usc/t21/s822/g/5/A/iii/I">21 U.S.C. 822(g)(5)(A)(iii)(I)</ref>(bb)), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d2-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in section 304 (<ref href="/us/usc/t21/s824">21 U.S.C. 824</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)(1)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)(1)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d3-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>in section 307(d)(2) (<ref href="/us/usc/t21/s827/d/2">21 U.S.C. 827(d)(2)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d4-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>in section 309A(a)(2) (<ref href="/us/usc/t21/s829a/a/2">21 U.S.C. 829a(a)(2)</ref>), in the matter preceding subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)(2)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)(2)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d5-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>in section 311(h) (<ref href="/us/usc/t21/s831/h">21 U.S.C. 831(h)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d6-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/G" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">(G) </num><content>in section 401(h)(2) (<ref href="/us/usc/t21/s841/h/2">21 U.S.C. 841(h)(2)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d7-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/H" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">(H) </num><content>in section 403(c)(2)(B) (<ref href="/us/usc/t21/s843/c/2/B">21 U.S.C. 843(c)(2)(B)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7d8-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/1/I" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>in section 512(c)(1) (<ref href="/us/usc/t21/s882/c/1">21 U.S.C. 882(c)(1)</ref>) by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(f)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(g)</quotedText>”.</content></subparagraph> </paragraph> <paragraph class="fontsize10" id="y81a7a7d9-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>Section 1008(c) of the Controlled Substances Import and Export Act (<ref href="/us/usc/t21/s958/c">21 U.S.C. 958(c)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y81a7a7da-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(d)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(e)</quotedText>”; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7db-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in paragraph (2)(B), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(h)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(i)</quotedText>”.</content></subparagraph> </paragraph> <paragraph class="fontsize10" id="y81a7a7dc-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/3" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>Title V of the Public Health Service Act (<ref href="/us/usc/t42/s290aa/etseq">42 U.S.C. 290aa et seq.</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y81a7a7dd-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in section 520E–4(c) (<ref href="/us/usc/t42/s290bb–36d/c">42 U.S.C. 290bb–36d(c)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)(2)(B)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)(2)(B)</quotedText>”; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7de-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in section 544(a)(3) (<ref href="/us/usc/t42/s290dd–3/a/3">42 U.S.C. 290dd–3(a)(3)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)</quotedText>”.</content></subparagraph> </paragraph> <paragraph class="fontsize10" id="y81a7a7df-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/4" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><chapeau>Title XVIII of the Social Security Act (<ref href="/us/usc/t42/s1395/etseq">42 U.S.C. 1395 et seq.</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y81a7a7e0-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/4/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in section 1833(bb)(3)(B) (<ref href="/us/usc/t42/s1395l/bb/3/B">42 U.S.C. 1395l(bb)(3)(B)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)</quotedText>”;</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7e1-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/4/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in section 1834(o)(3)(C)(ii) (<ref href="/us/usc/t42/s1395m/o/3/C/ii">42 U.S.C. 1395m(o)(3)(C)(ii)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)</quotedText>”; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a7a7e2-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/4/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in section 1866F(c)(3)(C) (<ref href="/us/usc/t42/s1395cc–6/c/3/C">42 U.S.C. 1395cc–6(c)(3)(C)</ref>), by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)</quotedText>”.</content></subparagraph> </paragraph> <paragraph class="fontsize10" id="y81a7a7e3-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s103/b/5" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>Section 1903(aa)(2)(C)(ii) of the Social Security Act (<ref href="/us/usc/t42/s1396b/aa/2/C/ii">42 U.S.C. 1396b(aa)(2)(C)(ii)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>303(g)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>303(h)</quotedText>”.</content></paragraph> </subsection> </section> <section id="d118080e1309" identifier="/us/pl/117/215/tI/s104" style="-uslm-lc:I658143"><num class="fontsize12" value="104">SEC. 104. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7a7e4-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s823">21 USC 823 note</ref>.</p></sidenote><heading>ADEQUATE AND UNINTERRUPTED SUPPLY.</heading><subsection class="firstIndent0 fontsize10" id="y81a7f605-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s104/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7f606-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x81a7f607-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Assessment.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>On an annual basis, the Attorney General, in consultation with the Secretary of Health and Human Services, shall assess whether there is an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.</content></subsection> <subsection class="firstIndent0 fontsize10" id="y81a7f608-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s104/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7f609-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Determination.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Report to Congress</inline>.—</heading><chapeau>If the Attorney General, in consultation with the Secretary of Health and Human Services, determines there is an inadequate or interrupted supply of marijuana, including of specific strains for research purposes, the Attorney General shall <page identifier="/us/stat/136/2264">136 STAT. 2264</page> report to Congress within 60 days of the determination on at least—</chapeau><paragraph class="fontsize10" id="y81a7f60a-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s104/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>the factors contributing to the inadequate or interrupted supply of marijuana;</content></paragraph> <paragraph class="fontsize10" id="y81a7f60b-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s104/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>expected impacts of the inadequate or interrupted supply on ongoing research protocols; and</content></paragraph> <paragraph class="fontsize10" id="y81a7f60c-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s104/b/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.</content></paragraph> </subsection> </section> <section id="d118080e1365" identifier="/us/pl/117/215/tI/s105" style="-uslm-lc:I658143"><num class="fontsize12" value="105">SEC. 105. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7f60d-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s823">21 USC 823 note</ref>.</p></sidenote><heading>SECURITY REQUIREMENTS.</heading><subsection class="firstIndent0 fontsize10" id="y81a7f60e-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s105/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>An individual or entity engaged in researching marijuana or its components shall store it in a securely locked, substantially constructed cabinet.</content></subsection> <subsection class="firstIndent0 fontsize10" id="y81a7f60f-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s105/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Requirements for Other Measures</inline>.—</heading><content>Any other security measures required by the Attorney General to safeguard against diversion shall be consistent with those required for practitioners conducting research on other controlled substances in schedules I and II in section 202(c) of the Controlled Substances Act (<ref href="/us/usc/t21/s812/c">21 U.S.C. 812(c)</ref>) that have a similar risk of diversion and abuse.</content></subsection> </section> <section id="d118080e1397" identifier="/us/pl/117/215/tI/s106" style="-uslm-lc:I658143"><num class="fontsize12" value="106">SEC. 106. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a7f610-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t42/s241">42 USC 241 note</ref>.</p></sidenote><heading>PROHIBITION AGAINST REINSTATING INTERDISCIPLINARY REVIEW PROCESS FOR NON-NIH-FUNDED RESEARCHERS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x81a81d21-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120">  The Secretary of Health and Human Services may not—</chapeau><paragraph class="fontsize10" id="y81a81d22-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s106/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>reinstate the Public Health Service interdisciplinary review process described in the guidance entitled “Guidance on Procedures for the Provision of Marijuana for Medical Research” (issued on May 21, 1999); or</content></paragraph> <paragraph class="fontsize10" id="y81a81d23-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tI/s106/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>require another review of scientific protocols that is applicable only to research on marijuana or its components.</content></paragraph> </section> <num value="II">TITLE II—</num><heading>DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND MARIJUANA</heading> <section id="d118080e1425" identifier="/us/pl/117/215/tII/s201" style="-uslm-lc:I658143"><num class="fontsize12" value="201">SEC. 201. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a81d24-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s823">21 USC 823 note</ref>.</p></sidenote><heading>MEDICAL RESEARCH ON CANNABIDIOL.</heading><content style="-uslm-lc:I658120">  Notwithstanding any provision of the Controlled Substances Act (<ref href="/us/usc/t21/s801/etseq">21 U.S.C. 801 et seq.</ref>), the Safe and Drug-Free Schools and Communities Act (<ref href="/us/usc/t20/s7101/etseq">20 U.S.C. 7101 et seq.</ref>), <ref href="/us/usc/t41/ch81">chapter 81 of title 41, United States Code</ref>, or any other Federal law, an appropriately registered covered institution of higher education, practitioner, or manufacturer may manufacture, distribute, dispense, or possess marijuana or cannabidiol if the marijuana 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.</content></section> <section id="d118080e1446" identifier="/us/pl/117/215/tII/s202" style="-uslm-lc:I658143"><num class="fontsize12" value="202">SEC. 202. </num><heading>REGISTRATION FOR THE COMMERCIAL PRODUCTION AND DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-APPROVED DRUGS.</heading><content style="-uslm-lc:I658120">  The Attorney General shall register an applicant to manufacture or distribute cannabidiol or marijuana for the purpose of commercial production of a drug containing or derived from marijuana that is approved by the Secretary of Health and Human Services under section 505 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355">21 U.S.C. 355</ref>), in accordance with the applicable requirements <page identifier="/us/stat/136/2265">136 STAT. 2265</page> under subsection (a) or (b) of section 303 of the Controlled Substances Act (<ref href="/us/usc/t21/s823">21 U.S.C. 823</ref>).</content></section> <num value="III">TITLE III—</num><heading>DOCTOR-PATIENT RELATIONSHIP</heading> <section id="d118080e1468" identifier="/us/pl/117/215/tIII/s301" style="-uslm-lc:I658143"><num class="fontsize12" value="301">SEC. 301. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a84435-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s801">21 USC 801 note</ref>.</p></sidenote><heading>DOCTOR-PATIENT RELATIONSHIP.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x81a86b46-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658120">  It shall not be a violation of the Controlled Substances Act (<ref href="/us/usc/t21/s801/etseq">21 U.S.C. 801 et seq.</ref>) for a State-licensed physician to discuss—</chapeau><paragraph class="fontsize10" id="y81a86b47-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIII/s301/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>the currently known potential harms and benefits of marijuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or</content></paragraph> <paragraph class="fontsize10" id="y81a86b48-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIII/s301/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>the currently known potential harms and benefits of marijuana and marijuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of the patient of the physician if the patient is a legal adult.</content></paragraph> </section> <num value="IV">TITLE IV—</num><heading>FEDERAL RESEARCH</heading> <section id="d118080e1499" identifier="/us/pl/117/215/tIV/s401" style="-uslm-lc:I658143"><num class="fontsize12" value="401">SEC. 401. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a86b49-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180"><ref href="/us/usc/t42/s284">42 USC 284 note</ref>.</p></sidenote><heading>FEDERAL RESEARCH.</heading><subsection class="firstIndent0 fontsize10" id="y81a8b96a-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a8b96b-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Reports.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in coordination with the Director of the National Institutes of Health and the heads of other relevant Federal agencies, shall submit to the Caucus on International Narcotics Control, the Committee on the Judiciary, and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce and the Committee on the Judiciary of the House of Representatives a report on—</chapeau><paragraph class="fontsize10" id="y81a8b96c-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>the potential therapeutic effects of cannabidiol or marijuana on serious medical conditions, including intractable epilepsy;</content></paragraph> <paragraph class="fontsize10" id="y81a8b96d-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>the potential effects of marijuana, including—</chapeau><subparagraph class="fontsize10" id="y81a8b96e-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>the effect of increasing delta-9-tetrahydrocannabinol levels on the human body and developing adolescent brains; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a8b96f-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>the effect of various delta-9-tetrahydrocannabinol levels on cognitive abilities, such as those that are required to operate motor vehicles or other heavy equipment; and</content></subparagraph> </paragraph> <paragraph class="fontsize10" id="y81a8b970-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x81a8b971-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x81a8b972-e819-11f0-bc57-ad3ac4b1618c" style="-uslm-lc:I658180">tions.</p></sidenote><chapeau>the barriers associated with researching marijuana or cannabidiol in States that have legalized the use of such substances, which shall include—</chapeau><subparagraph class="fontsize10" id="y81a8b973-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>recommendations as to how such barriers might be overcome, including whether public-private partnerships or Federal-State research partnerships may or should be implemented to provide researchers with access to additional strains of marijuana and cannabidiol; and</content></subparagraph> <subparagraph class="fontsize10" id="y81a8e084-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>recommendations as to what safeguards must be in place to verify—</chapeau><clause class="fontsize10" id="y81a8e085-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/3/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>the levels of tetrahydrocannabinol, cannabidiol, or other cannabinoids contained in products obtained from such States is accurate; and</content></clause> <clause class="fontsize10" id="y81a8e086-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/a/3/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>that such products do not contain harmful or toxic components.<page identifier="/us/stat/136/2266">136 STAT. 2266</page></content></clause> </subparagraph> </paragraph> </subsection> <subsection class="firstIndent0 fontsize10" id="y81a8e087-e819-11f0-bc57-ad3ac4b1618c" identifier="/us/pl/117/215/tIV/s401/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Activities</inline>.—</heading><content>To the extent practicable, the Secretary of Health and Human Services, either directly or through awarding grants, contacts, or cooperative agreements, shall expand and coordinate the activities of the National Institutes of Health and other relevant Federal agencies to better determine the effects of cannabidiol and marijuana, as outlined in the report submitted under paragraphs (1) and (2) of subsection (a).</content></subsection> </section> Approved December 2, 2022.
LEGISLATIVE HISTORY—H.R. 8454: CONGRESSIONAL RECORD, Vol. 168 (2022):

July 26, considered and passed House.

Nov. 16, considered and passed Senate.

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