§ 823. Registration requirements

Footnotes

1. 1 So in original. Probably should be preceded by “section”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1970

   Controlled Substances Act

   Pub. L. 91–513 title II § 303 · 84 Stat. 1236

   Enacted · 21 U.S.C. § 823

   Pub. L. 91–513, title II, § 303, Oct. 27, 1970, 84 Stat. 1253

   Source evidence

   Code source credit
   Pub. L. 91–513, title II, § 303, Oct. 27, 1970, 84 Stat. 1253

   Enacted provision · exact public law section
   Sec. 303. registration requirements (a) The Attorney General shall register an applicant to Factors consistent with public interest. manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on the effective date of this part. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular Controls, importation and bulk manufacture, limitation. controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately com-petitive conditions for legitimate medical, scientific, research, and industrial purposes; (2) compliance with applicable State and local law; (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety. (b) The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) compliance with applicable State and local law; (3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) past experience in the distribution of controlled substances; and (5) such other factors as may be relevant to and consistent with the public health and safety. (c) Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled Post, p. 1257. substances in excess of the quota assigned pursuant to section 306. (d) The Attorney General shall register an applicant to manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels; (2) compliance with applicable State and local law; (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety. (e) The Attorney General shall register an applicant to distribute controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) compliance with applicable State and local law; (3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) past experience in the distribution of controlled substances; and (5) such other factors as may be relevant to and consistent with the public health and safety. (f) Practitioners shall be registered to dispense or conduct research Research. with controlled substances in schedule II, III, IV, or V if they are authorized to dispense or conduct research under the law of the State in which they practice. Separate registration under this part for practitioners engaging in research with nonnarcotic controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required. Pharmacies (as distinguished Pharmacies. from pharmacists) when engaged in commercial activities, shall lie registered to dispense controlled substances in schedule II, III, IV, or V if they are authorized to dispense under the law of the State in which they regularly conduct business. Registration applications Research applications. by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Registration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section 304(a).

2. 1974

   Pub. L. 93–281 § 3 · 88 Stat. 124

   Added · 21 U.S.C. § 823(g)

   Pub. L. 93–281 added subsec. (g)

   Source evidence

   Code amendment note
   Subsec. (g). Pub. L. 93–281 added subsec. (g).

   Enacted provision · exact public law section
   Sec. 3. Section 303 of the Controlled Substances Act (21 U.S.C. 823) Practitioners, narcotic drug dispensation, annual registration. is amended by adding the following after subsection (f): “(g) Practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The Attorney General Qualifications. shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)— “(1) if the applicant is a practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought; “(2) if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting (A) security of stocks of narcotic drugs for such treatment, and (B) the maintenance of records (in accordance with section 307) on such drugs; and 21 USC 827. “(3) if the Secretary determines that the applicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.”.

3. 1978

   Psychotropic Substances Act of 1978

   Pub. L. 95–633 title I § 109 · 92 Stat. 3768

   Inserted · 21 U.S.C. § 823(f)

   Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances

   Source evidence

   Code amendment note
   Subsec. (f). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.

   Enacted provision · exact public law section
   Sec. 109. Subsection (f) of section 303 of the Controlled Substances Act (21 U.S.C. 823(f)) is amended by adding at the end the following sentence: “Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the Convention which is conducted in conformity with this subsection and other applicable provisions of this title.”.

4. 1984

   Pub. L. 98–473 title II § 511 · 98 Stat. 1837

   1. Amended · 21 U.S.C. § 823(f)

      Pub. L. 98–473 amended subsec. (f) generally

   2. Substituted · 21 U.S.C. § 823(f)

      Pub. L. 98–473 substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting registration, for provisions relating to general registration requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances

   Source evidence

   Code amendment note
   Subsec. (f). Pub. L. 98–473 amended subsec. (f) generally, substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting registration, for provisions relating to general registration requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances.

   Enacted provision · exact public law section
   Sec. 511. Funds appropriated by this Act may not be obligated or expended to provide assistance to any country for the purpose of aiding the efforts of the government of such country to repress the legitimate rights of the population of such country contrary to the Universal Declaration of Human Rights.

5. 1993

   Pub. L. 103–200 § 3(c) · 107 Stat. 2333

   Added · 21 U.S.C. § 823(h)

   Pub. L. 103–200 added subsec. (h)

   Source evidence

   Code amendment note
   Subsec. (h). Pub. L. 103–200 added subsec. (h).

   Enacted provision · exact public law section
   (c) Registration Requirements Under Section 303.— Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following new subsection: “(h) The Attorney General shall register an applicant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the distribution of a drug product that is exempted under section 102(39)(A)(iv). In determining the public interest for the purposes of this subsection, the Attorney General shall consider— “(1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels; “(2) compliance by the applicant with applicable Federal, State, and local law; “(3) any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law; “(4) any past experience of the applicant in the manufacture and distribution of cnemicals; and “(5) such other factors as are relevant to and consistent with the public health and safety.”.

6. 2000

   Drug Addiction Treatment Act of 2000

   Pub. L. 106–310 div. B title XXXV § 3502(a) · 114 Stat. 1101

   1. Amended · 21 U.S.C. § 823(g)

      Pub. L. 106–310 designated existing provisions as par. (1)

   2. Substituted · 21 U.S.C. § 823(g)

      Pub. L. 106–310 substituted “Except as provided in paragraph (2), practitioners who dispense” for “Practitioners who dispense”

   3. Redesignated · 21 U.S.C. § 823(g)

      Pub. L. 106–310 redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1)

   4. Redesignated · 21 U.S.C. § 823(g)

      Pub. L. 106–310 redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1)

   5. Added · 21 U.S.C. § 823(g)

      Pub. L. 106–310 added par. (2)

   Source evidence

   Code amendment note
   Subsec. (g). Pub. L. 106–310 designated existing provisions as par. (1), substituted “Except as provided in paragraph (2), practitioners who dispense” for “Practitioners who dispense”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1) and redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1), and added par. (2).

   Enacted provision · exact public law section
   (a) In General.— Section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) is amended— (1) in paragraph (2), by striking “(A) security” and inserting “(i) security”, and by striking “(B) the maintenance” and inserting “(ii) the maintenance”; (2) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively; (3) by inserting “(1)” after “(g)”; (4) by striking “Practitioners who dispense” and inserting “Except as provided in paragraph (2), practitioners who dispense”; and (5) by adding at the end the following paragraph: “(2) (A) Subject to subparagraphs (D) and (J), the requirements of paragraph (1) are waived in the case of the dispensing (including the prescribing), by a practitioner, of narcotic drugs in schedule III, IV, or V or combinations of such drugs if the practitioner meets the conditions specified in subparagraph (B) and the narcotic drugs or combinations of such drugs meet the conditions specified in subparagraph (C). “(B) For purposes of subparagraph (A), the conditions specified in this subparagraph with respect to a practitioner are that, before the initial dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment, the practitioner submit to the Secretary a notification of the intent of the practitioner to begin dispensing the drugs or combinations for such purpose, and that the notification contain the following certifications by the practitioner: “(i) The practitioner is a qualifying physician (as defined in subparagraph (G)). “(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services. “(iii) In any case in which the practitioner is not in a group practice, the total number of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number. “(iv) In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have. “(C) For purposes of subparagraph (A), the conditions specified in this subparagraph with respect to narcotic drugs in schedule III, IV, or V or combinations of such drugs are as follows: “(i) The drugs or combinations of drugs have, under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, been approved for use in maintenance or detoxification treatment. “(ii) The drugs or combinations of drugs have not been the subject of an adverse determination. For purposes of this Federal Register, publication. clause, an adverse determination is a determination published in the Federal Register and made by the Secretary, after consultation with the Attorney General, that the use of the drugs or combinations of drugs for maintenance or detoxification treatment requires additional standards respecting the qualifications of practitioners to provide such treatment, or requires standards respecting the quantities of the drugs that may be provided for unsupervised use. “(D) (i) A waiver under subparagraph (A) with respect to a practitioner is not in effect unless (in addition to conditions under subparagraphs (B) and (C)) the following conditions are met: “(I) The notification under subparagraph (B) is in writing and states the name of the practitioner. “(II) The notification identifies the registration issued for the practitioner pursuant to subsection (f). “(III) If the practitioner is a member of a group practice, the notification states the names of the other practitioners in the practice and identifies the registrations issued for the other practitioners pursuant to subsection (f). “(ii) Upon receiving a notification under subparagraph (B), the Attorney General shall assign the practitioner involved an identification number under this paragraph for inclusion with the registration issued for the practitioner pursuant to subsection (f). The identification number so assigned shall be appropriate to preserve the confidentiality of patients for whom the practitioner has dispensed narcotic drugs under a waiver under subparagraph (A). “(iii) Not later than 45 days after the date on which the Secretary receives a notification under subparagraph (B), the Secretary shall make a determination of whether the practitioner involved meets all requirements for a waiver under subparagraph (B). If the Secretary fails to make such determination by the end of the such 45-day period, the Attorney General shall assign the physician an identification number described in clause (ii) at the end of such period. “(E) (i) If a practitioner is not registered under paragraph (1) and, in violation of the conditions specified in subparagraphs (B) through (D), dispenses narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, the Attorney General may, for purposes of section 304(a)(4), consider the practitioner to have committed an act that renders the registration of the practitioner pursuant to subsection (f) to be inconsistent with the public interest. “(ii) (I) Upon the expiration of 45 days from the date on which the Secretary receives a notification under subparagraph (B), a practitioner who in good faith submits a notification under subparagraph (B) and reasonably believes that the conditions specified in subparagraphs (B) through (D) have been met shall, in dispensing narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, be considered to have a waiver under subparagraph (A) until notified otherwise by the Secretary, except that such a practitioner may commence to prescribe or dispense such narcotic drugs for such purposes prior to the expiration of such 45-day period if it facilitates the treatment of an individual patient and both the Secretary and the Attorney General are notified by the practitioner of the intent to commence prescribing or dispensing such narcotic drugs. “(II) For purposes of subclause (I), the publication in the Federal Register of an adverse determination by the Secretary pursuant to subparagraph (C)(ii) shall (with respect to the narcotic drug or combination involved) be considered to be a notification provided by the Secretary to practitioners, effective upon the expiration of the 30-day period beginning on the date on which the adverse determination is so published. “(F) (i) With respect to the dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment, a practitioner may, in his or her discretion, dispense such drugs or combinations for such treatment under a registration under paragraph (1) or a waiver under subparagraph (A) (subject to meeting the applicable conditions). “(ii) This paragraph may not be construed as having any legal effect on the conditions for obtaining a registration under paragraph (1), including with respect to the number of patients who may be served under such a registration. “(G) For purposes of this paragraph: “(i) The term ‘group practice’ has the meaning given such term in section 1877(h)(4) of the Social Security Act. “(ii) The term ‘qualifying physician’ means a physician who is licensed under State law and who meets one or more of the following conditions: “(I) The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. “(II) The physician holds an addiction certification from the American Society of Addiction Medicine. “(III) The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association. “(IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause. “(V) The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug. “(VI) The physician has such other training or experience as the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients. “(VII) The physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients. Any criteria of the Secretary under this subclause shall be established by regulation. Any such criteria are effective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional discrete 3-year periods as the Secretary considers Federal Register, publication. appropriate for purposes of this subclause. Such an extension of criteria may only be effectuated through a statement published in the Federal Register by the Secretary during the 30-day period preceding the end of the 3-year period involved. “(H) (i) In consultation with the Administrator of the Drug Enforcement Administration, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary shall issue regulations (through notice and comment rulemaking) or issue practice guidelines to address the following: “(I) Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies. “(II) Additional exemptions from the requirements of this paragraph and any regulations under this paragraph. Nothing in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are provided. “(ii) Not later than 120 days after the date of the enactment of the Drug Addiction Treatment Act of 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall be guided by science. “(I) During the 3-year period beginning on the date of the enactment of the Drug Addiction Treatment Act of 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs, to patients for maintenance or detoxification treatment in accordance with this paragraph unless, before the expiration of that 3-year period, the State enacts a law prohibiting a practitioner from dispensing such drugs or combinations of drug. “(J) (i) This paragraph takes effect on the date of the enactment of the Drug Addiction Treatment Act of 2000, and remains in effect thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect). “(ii) For purposes relating to clause (iii), the Secretary and the Attorney General may, during the 3-year period beginning on the date of the enactment of the Drug Addiction Treatment Act of 2000, make determinations in accordance with the following: “(I) The Secretary may make a determination of whether treatments provided under waivers under subparagraph (A) have been effective forms of maintenance treatment and detoxification treatment in clinical settings; may make a determination of whether such waivers have significantly increased (relative to the beginning of such period) the availability of maintenance treatment and detoxification treatment; and may make a determination of whether such waivers have adverse con-sequences for the public health. “(II) The Attorney General may make a determination of the extent to which there have been violations of the numerical limitations established under subparagraph (B) for the number of individuals to whom a practitioner may provide treatment; may make a determination of whether waivers under subparagraph (A) have increased (relative to the beginning of such period) the extent to which narcotic drugs in schedule III,IV, or V or combinations of such drugs are being dispensed or possessed in violation of this Act; and may make a determination of whether such waivers have adverse consequences for the public health. “(iii) If, before the expiration of the period specified in clause(ii), the Secretary or the Attorney General publishes in the Federal Register a decision, made on the basis of determinations under such clause, that this paragraph should not remain in effect, this paragraph ceases to be in effect 60 days after the date on which the decision is so published. The Secretary shall in making any such decision consult with the Attorney General, and shall in publishing the decision in the Federal Register include any comments received from the Attorney General for inclusion in the publication. The Attorney General shall in making any such decision consult with the Secretary, and shall in publishing the decision in the Federal Register include any comments received from the Secretary for inclusion in the publication.”.

7. 2002

   Drug Abuse Education, Prevention, and Treatment Act of 2002

   Pub. L. 107–273 § 2501(1) · 116 Stat. 1758

   Substituted · 21 U.S.C. § 823(g)(2)(I)

   Pub. L. 107–273, § 2501(1), which directed the substitution of “on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs,” for “on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,”, was executed by making the substitution for the phrase which in the original began with “on the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “on October 17, 2000,” to reflect the probable intent of Congress

   Source evidence

   Code amendment note
   Subsec. (g)(2)(I). Pub. L. 107–273, § 2501(1), which directed the substitution of “on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs,” for “on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,”, was executed by making the substitution for the phrase which in the original began with “on the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “on October 17, 2000,” to reflect the probable intent of Congress.

   Enacted provision · exact public law section
   (1) in subparagraph (I), by striking “on October 17, 2000,” and all that follows through “such drugs,” and inserting “on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs,”; and

8. 2002

   Drug Abuse Education, Prevention, and Treatment Act of 2002

   Pub. L. 107–273 § 2501(2) · 116 Stat. 1758

   Substituted · 21 U.S.C. § 823(g)(2)(J)(i)

   Pub. L. 107–273, § 2501(2), which directed the substitution of “the date referred to in subparagraph (I),” for “October 17, 2000,” was executed by making the substitution for text which in the original read “the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “October 17, 2000,” to reflect the probable intent of Congress

   Source evidence

   Code amendment note
   Subsec. (g)(2)(J)(i). Pub. L. 107–273, § 2501(2), which directed the substitution of “the date referred to in subparagraph (I),” for “October 17, 2000,” was executed by making the substitution for text which in the original read “the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “October 17, 2000,” to reflect the probable intent of Congress.

   Enacted provision · exact public law section
   (2) in subparagraph (J)(i), by striking “October 17, 2000,” and inserting “the date referred to in subparagraph (I),”.

9. 2005

   Pub. L. 109–56 § 1(b) · 119 Stat. 591

   Substituted · 21 U.S.C. § 823(g)(2)(B)(iii)

   Pub. L. 109–56, § 1(b), substituted “The total” for “In any case in which the practitioner is not in a group practice, the total”

   Source evidence

   Code amendment note
   Subsec. (g)(2)(B)(iii). Pub. L. 109–56, § 1(b), substituted “The total” for “In any case in which the practitioner is not in a group practice, the total”.

   Enacted provision · exact public law section
   (b) Conforming Amendment.— Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)) is amended in clause (iii) by striking “In any case” and all that follows through “the total” and inserting “The total”.

10. 2005

    Pub. L. 109–56 § 1(a) · 119 Stat. 591

    Struck · 21 U.S.C. § 823(g)(2)(B)(iv)

    Pub. L. 109–56, § 1(a), struck out cl. (iv) which read as follows: “In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B)(iv). Pub. L. 109–56, § 1(a), struck out cl. (iv) which read as follows: “In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have.”

    Enacted provision · exact public law section
    (a) In General.— Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)) is amended by striking clause (iv).

11. 2006

    Combat Methamphetamine Epidemic Act of 2005

    Pub. L. 109–177 title VII § 712(a)(3) · 120 Stat. 192

    Substituted · 21 U.S.C. § 823(h)

    Pub. L. 109–177 substituted “clause (iv) or (v) of section 802(39)(A) of this title” for “section 802(39)(A)(iv) of this title” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 109–177 substituted “clause (iv) or (v) of section 802(39)(A) of this title” for “section 802(39)(A)(iv) of this title” in introductory provisions.

    Enacted provision · exact public law section
    (3) in section 303(h), 21 USC 823. in the second sentence, by striking “section 102(39)(A)(iv)” and inserting “clause (iv) or (v) of section 102(39)(A)”.

12. 2006

    Office of National Drug Control Policy Reauthorization Act of 2006

    Pub. L. 109–469 § 1102(1) · 120 Stat. 3502

    Substituted · 21 U.S.C. § 823(g)(2)(B)(iii)

    Pub. L. 109–469, § 1102(1), substituted “unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The” for “except that the”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B)(iii). Pub. L. 109–469, § 1102(1), substituted “unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The” for “except that the”.

    Enacted provision · exact public law section
    (1) Deadline. Notification. in subparagraph (B)(iii), by striking “except that the” and inserting the following: “unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The”; and

13. 2006

    Office of National Drug Control Policy Reauthorization Act of 2006

    Pub. L. 109–469 § 1102(2)(A) · 120 Stat. 3502

    Substituted · 21 U.S.C. § 823(g)(2)(J)(i)

    Pub. L. 109–469, § 1102(2)(A), substituted “thereafter.” for “thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect).”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(J)(i). Pub. L. 109–469, § 1102(2)(A), substituted “thereafter.” for “thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect).”

    Enacted provision · exact public law section
    (A) in clause (i), by striking “thereafter” and all that follows through the period and inserting “thereafter.”;

14. 2006

    Office of National Drug Control Policy Reauthorization Act of 2006

    Pub. L. 109–469 § 1102(2)(B) · 120 Stat. 3502

    Substituted · 21 U.S.C. § 823(g)(2)(J)(ii)

    Pub. L. 109–469, § 1102(2)(B), substituted “December 29, 2006” for “October 17, 2000” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (g)(2)(J)(ii). Pub. L. 109–469, § 1102(2)(B), substituted “December 29, 2006” for “October 17, 2000” in introductory provisions.

    Enacted provision · exact public law section
    (B) in clause (ii), by striking “Drug Addiction Treatment Act of 2000” and inserting “Office of National Drug Control Policy Reauthorization Act of 2006”; and

15. 2006

    Office of National Drug Control Policy Reauthorization Act of 2006

    Pub. L. 109–469 § 1102(2)(C) · 120 Stat. 3502

    Substituted · 21 U.S.C. § 823(g)(2)(J)(iii)

    Pub. L. 109–469, § 1102(2)(C), substituted “subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective” for “this paragraph should not remain in effect, this paragraph ceases to be in effect”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(J)(iii). Pub. L. 109–469, § 1102(2)(C), substituted “subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective” for “this paragraph should not remain in effect, this paragraph ceases to be in effect”.

    Enacted provision · exact public law section
    (C) in clause (iii), by striking “this paragraph should not remain in effect, this paragraph ceases to be in effect” and inserting “subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective”.

16. 2008

    Ryan Haight Online Pharmacy Consumer Protection Act of 2008

    Pub. L. 110–425 § 3(b) · 122 Stat. 4820

    1. Inserted · 21 U.S.C. § 823(f)

       Pub. L. 110–425, in introductory provisions, inserted “and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet” after “schedule II, III, IV, or V”

    2. Substituted · 21 U.S.C. § 823(f)

       Pub. L. 110–425, in introductory provisions, substituted “or such modification of registration if the Attorney General determines that the issuance of such registration or modification” for “if he determines that the issuance of such registration”

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 110–425, in introductory provisions, inserted “and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet” after “schedule II, III, IV, or V” and substituted “or such modification of registration if the Attorney General determines that the issuance of such registration or modification” for “if he determines that the issuance of such registration”.

    Enacted provision · exact public law section
    (b) Registration Requirements.— Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended in the matter preceding paragraph (1)— (1) in the first sentence, by adding after “schedule II, III, IV, or V” the following: “and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet”; and (2) in the second sentence, by striking “if he determines that the issuance of such registration” and inserting “or such modification of registration if the Attorney General determines that the issuance of such registration or modification”.

17. 2015

    Improving Regulatory Transparency for New Medical Therapies Act

    Pub. L. 114–89 § 3 · 129 Stat. 698

    Added · 21 U.S.C. § 823(i)

    Pub. L. 114–89 added subsec. (i)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 114–89 added subsec. (i).

    Enacted provision · exact public law section
    SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.   Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: “(i) (1) For purposes of registration to manufacture a controlled substance under subsection (d) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c), not later than 180 days after the date on which the application is accepted for filing. “(2) For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c), unless the Attorney General has granted a hearing on the application under section 1008(i) of the Controlled Substances Import and Export Act.” .

18. 2016

    Ensuring Patient Access and Effective Drug Enforcement Act of 2016

    Pub. L. 114–145 § 2(a)(1) · 130 Stat. 354

    Added · 21 U.S.C. § 823(j)

    Pub. L. 114–145 added subsec. (j)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 114–145 added subsec. (j).

    Enacted provision · exact public law section
    (1) Factors as may be relevant to and consistent with the public health and safety.— Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: “(j) In this section, the phrase ‘factors as may be relevant to and consistent with the public health and safety’ means factors that are relevant to and consistent with the findings contained in section 101.” .

19. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(A) · 130 Stat. 695

    1. Added · 21 U.S.C. § 823(g)(2)(B)

       Pub. L. 114–198, § 303(a)(1)(A), added cls. (i) to (iii)

    2. Struck · 21 U.S.C. § 823(g)(2)(B)

       Pub. L. 114–198, § 303(a)(1)(A), struck out former cls. (i) to (iii) which read as follows:

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B). Pub. L. 114–198, § 303(a)(1)(A), added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:

    “(i) The practitioner is a qualifying physician (as defined in subparagraph (G)). “(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services. “(iii) The total number of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number.”

    Enacted provision · exact public law section
    (A) in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following: “(i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). “(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— “(I) all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and “(II) appropriate counseling and other appropriate ancillary services. “(iii) (I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. “(II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. “(III) The Secretary may by regulation change such applicable number. “(IV) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting.” ;

20. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(B)(i) · 130 Stat. 695

    Substituted · 21 U.S.C. § 823(g)(2)(D)(ii)

    Pub. L. 114–198, § 303(a)(1)(B)(i), substituted “Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)” for “Upon receiving a notification under subparagraph (B)”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(D)(ii). Pub. L. 114–198, § 303(a)(1)(B)(i), substituted “Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)” for “Upon receiving a notification under subparagraph (B)”.

    Enacted provision · exact public law section
    (i) in clause (ii), by striking “Upon receiving a notification under subparagraph (B)” and inserting “Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)”; and

21. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(B)(ii) · 130 Stat. 695

    1. Inserted · 21 U.S.C. § 823(g)(2)(D)(iii)

       Pub. L. 114–198, § 303(a)(1)(B)(ii), inserted “and shall forward such determination to the Attorney General” after “a waiver under subparagraph (B)”

    2. Substituted · 21 U.S.C. § 823(g)(2)(D)(iii)

       Pub. L. 114–198, § 303(a)(1)(B)(ii), substituted “assign the practitioner” for “assign the physician”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(D)(iii). Pub. L. 114–198, § 303(a)(1)(B)(ii), inserted “and shall forward such determination to the Attorney General” after “a waiver under subparagraph (B)” and substituted “assign the practitioner” for “assign the physician”.

    Enacted provision · exact public law section
    (ii) in clause (iii)— (I) by inserting “and shall forward such determination to the Attorney General” before the period at the end of the first sentence; and (II) by striking “physician” and inserting “practitioner”;

22. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(C)(i) · 130 Stat. 695

    Amended · 21 U.S.C. § 823(g)(2)(G)(ii)(I)

    Pub. L. 114–198, § 303(a)(1)(C)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(ii)(I). Pub. L. 114–198, § 303(a)(1)(C)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties.”

    Enacted provision · exact public law section
    (i) by amending clause (ii)(I) to read as follows: “(I) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.” ;

23. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(C)(ii) · 130 Stat. 695

    Amended · 21 U.S.C. § 823(g)(2)(G)(ii)(II)

    Pub. L. 114–198, § 303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The physician holds an addiction certification from the American Society of Addiction Medicine.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(ii)(II). Pub. L. 114–198, § 303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The physician holds an addiction certification from the American Society of Addiction Medicine.”

    Enacted provision · exact public law section
    (ii) by amending clause (ii)(II) to read as follows: “(II) The physician holds an addiction certification or board certification from the American Society of Addiction Medicine or the American Board of Addiction Medicine.” ;

24. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(C)(iii) · 130 Stat. 695

    Struck · 21 U.S.C. § 823(g)(2)(G)(ii)(III)

    Pub. L. 114–198, § 303(a)(1)(C)(iii), struck out “subspecialty” before “board certification”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(ii)(III). Pub. L. 114–198, § 303(a)(1)(C)(iii), struck out “subspecialty” before “board certification”.

    Enacted provision · exact public law section
    (iii) in clause (ii)(III), by striking “subspecialty”;

25. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(C)(iv) · 130 Stat. 695

    Amended · 21 U.S.C. § 823(g)(2)(G)(ii)(IV)

    Pub. L. 114–198, § 303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to amendment, subcl. (IV) read as follows: “The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(ii)(IV). Pub. L. 114–198, § 303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to amendment, subcl. (IV) read as follows: “The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.”

    Enacted provision · exact public law section
    (iv) by amending clause (ii)(IV) to read as follows: “(IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause. Such training shall include— “(aa) opioid maintenance and detoxification; “(bb) appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; “(cc) initial and periodic patient assessments (including substance use monitoring); “(dd) individualized treatment planning, overdose reversal, and relapse prevention; “(ee) counseling and recovery support services; “(ff) staffing roles and considerations; “(gg) diversion control; and “(hh) other best practices, as identified by the Secretary.” ; and

26. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(C)(v) · 130 Stat. 695

    Added · 21 U.S.C. § 823(g)(2)(G)(iii); 21 U.S.C. § 823(g)(2)(G)(iv)

    Pub. L. 114–198, § 303(a)(1)(C)(v), added cls. (iii) and (iv)

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(iii), (iv). Pub. L. 114–198, § 303(a)(1)(C)(v), added cls. (iii) and (iv).

    Enacted provision · exact public law section
    (v) by adding at the end the following: “(iii) The term ‘qualifying practitioner’ means— “(I) a qualifying physician, as defined in clause (ii); or “(II) during the period beginning on the date of enactment of the Comprehensive Addiction and Recovery Act of 2016 and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv). “(iv) The term ‘qualifying other practitioner’ means a nurse practitioner or physician assistant who satisfies each of the following: “(I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain. “(II) The nurse practitioner or physician assistant has— “(aa) completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines is appropriate for purposes of this subclause; or “(bb) has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner or physician assistant to treat and manage opiate-dependent patients. “(III) The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician. The Secretary may, by regulation, revise the requirements for being a qualifying other practitioner under this clause.” ; and

27. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(D)(i) · 130 Stat. 695

    Added · 21 U.S.C. § 823(g)(2)(H)(i)(III)

    Pub. L. 114–198, § 303(a)(1)(D)(i), added subcl. (III)

    Source evidence

    Code amendment note
    Subsec. (g)(2)(H)(i)(III). Pub. L. 114–198, § 303(a)(1)(D)(i), added subcl. (III).

    Enacted provision · exact public law section
    (i) in clause (i), by inserting after subclause (II) the following: “(III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.” ; and

28. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(a)(1)(D)(ii) · 130 Stat. 695

    Amended · 21 U.S.C. § 823(g)(2)(H)(ii)

    Pub. L. 114–198, § 303(a)(1)(D)(ii), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “Not later than 120 days after October 17, 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall be guided by science.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(H)(ii). Pub. L. 114–198, § 303(a)(1)(D)(ii), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “Not later than 120 days after October 17, 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall be guided by science.”

    Enacted provision · exact public law section
    (ii) by amending clause (ii) to read as follows: “(ii) Not later than 18 months after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act, the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. Consultation. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment.” .

29. 2016

    Comprehensive Addiction and Recovery Act of 2016

    Pub. L. 114–198 § 303(b) · 130 Stat. 695

    1. Added · 21 U.S.C. § 823(g)(2)(I); 21 U.S.C. § 823(g)(2)(J)

       Pub. L. 114–198, § 303(b), added subpar. (I)

    2. Struck · 21 U.S.C. § 823(g)(2)(I); 21 U.S.C. § 823(g)(2)(J)

       Pub. L. 114–198, § 303(b), struck out former subpars. (I) and (J) which limited a State’s ability to preclude a practitioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations

    Source evidence

    Code amendment note
    Subsec. (g)(2)(I), (J). Pub. L. 114–198, § 303(b), added subpar. (I) and struck out former subpars. (I) and (J) which limited a State’s ability to preclude a practitioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations.

    Enacted provision · exact public law section
    (b) State Flexibility.— Section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) is amended by striking subparagraphs (I) and (J), and inserting the following: “(I) Notwithstanding section 708, nothing in this paragraph shall be construed to preempt any State law that— “(i) permits a qualifying practitioner to dispense narcotic drugs in schedule III, IV, or V, or combinations of such drugs, for maintenance or detoxification treatment in accordance with this paragraph to a total number of patients that is more than 30 or less than the total number applicable to the qualifying practitioner under subparagraph (B)(iii)(II) if a State enacts a law modifying such total number and the Attorney General is notified by the State of such modification; or “(ii) requires a qualifying practitioner to comply with additional requirements relating to the dispensing of narcotic drugs in schedule III, IV, or V, or combinations of such drugs, including requirements relating to the practice setting in which the qualifying practitioner practices and education, training, and reporting requirements.” .

30. 2017

    Protecting Patient Access to Emergency Medications Act of 2017

    Pub. L. 115–83 § 2 · 131 Stat. 1267

    1. Added · 21 U.S.C. § 823(j); 21 U.S.C. § 823(k)

       Pub. L. 115–83 added subsec. (j)

    2. Redesignated · 21 U.S.C. § 823(j); 21 U.S.C. § 823(k)

       Pub. L. 115–83 redesignated former subsec. (j) as (k)

    Source evidence

    Code amendment note
    Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k).

    Enacted provision · exact public law section
    SEC. 2. EMERGENCY MEDICAL SERVICES.   Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended— (1) by redesignating subsection (j) as subsection (k); and (2) by inserting after subsection (i) the following: “(j) Emergency Medical Services That Administer Controlled Substances.— “(1) Registration.— For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General— “(A) shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and “(B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (f). “(2) Option for single registration.— In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency. “(3) Hospital-based agency.— If a hospital-based emergency medical services agency is registered under subsection (f), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection. “(4) Administration outside physical presence of medical director or authorizing medical professional.— Emergency medical services professionals of a registered emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is— “(A) authorized by the law of the State in which it occurs; and “(B) pursuant to— “(i) a standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or “(ii) a verbal order that is— “(I) issued in accordance with a policy of the agency; and “(II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient— “(aa) in the case of a mass casualty incident; or “(bb) to ensure the proper care and treatment of a specific patient. “(5) Delivery.— A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency— “(A) designates the unregistered location for such delivery; and “(B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location. “(6) Storage.— A registered emergency medical services agency may store controlled substances— “(A) at a registered location of the agency; “(B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or “(C) in an emergency medical services vehicle used by the agency that is— “(i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or “(ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General. “(7) No treatment as distribution.— The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of section 308. “(8) Restocking of emergency medical services vehicles at a hospital.— Notwithstanding paragraph (13)(J), a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of section 308, provided all of the following conditions are satisfied: “(A) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9). “(B) The hospital maintains a record of such delivery to the agency in accordance with section 307. “(C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances. “(9) Maintenance of records.— “(A) In general.— A registered emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of section 307 of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency’s registration, without regard to subsection 307(c)(1)(B). “(B) Requirements.— Such records— “(i) shall include records of deliveries of controlled substances between all locations of the agency; and “(ii) shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of. “(10) Other requirements.— A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that— “(A) all emergency medical services professionals who administer controlled substances using the agency’s registration act in accordance with the requirements of this subsection; “(B) the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency; “(C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph (6); and “(D) the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9). “(11) Regulations.— The Attorney General may issue regulations— “(A) specifying, with regard to delivery of controlled substances under paragraph (5)— “(i) the types of locations that may be designated under such paragraph; and “(ii) the manner in which a notification under paragraph (5)(B) must be made; “(B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and “(C) addressing the ability of hospitals, emergency medical services agencies, registered locations, and designated locations to deliver controlled substances to each other in the event of— “(i) shortages of such substances; “(ii) a public health emergency; or “(iii) a mass casualty event. “(12) Rule of construction.— Nothing in this subsection shall be construed— “(A) to limit the authority vested in the Attorney General by other provisions of this title to take measures to prevent diversion of controlled substances; or “(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection. “(13) Definitions.— In this section: “(A) The term ‘authorizing medical professional’ means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)— “(i) who is registered under this Act; “(ii) who is acting within the scope of the registration; and “(iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders. “(B) The term ‘designated location’ means a location designated by an emergency medical services agency under paragraph (5). “(C) The term ‘emergency medical services’ means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. “(D) The term ‘emergency medical services agency’ means an organization providing emergency medical services, including such an organization that— “(i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based; “(ii) provides emergency medical services by ground, air, or otherwise; and “(iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis. “(E) The term ‘emergency medical services professional’ means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification. “(F) The term ‘emergency medical services vehicle’ means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations. “(G) The term ‘hospital-based’ means, with respect to an agency, owned or operated by a hospital. “(H) The term ‘medical director’ means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. “(I) The term ‘medical oversight’ means supervision of the provision of medical care by an emergency medical services agency. “(J) The term ‘registered emergency medical services agency’ means— “(i) an emergency medical services agency that is registered pursuant to this subsection; or “(ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (f). “(K) The term ‘registered location’ means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (f), which shall be where the agency receives controlled substances from distributors. “(L) The term ‘specific State authority’ means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors. “(M) The term ‘standing order’ means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services. “(N) The term ‘verbal order’ means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.” .

31. 2018

    Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pub. L. 115–271 § 3201(a) · 132 Stat. 3894

    Amended · 21 U.S.C. § 823(g)(2)(B)(iii)(II)

    Pub. L. 115–271, § 3201(a), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B)(iii)(II). Pub. L. 115–271, § 3201(a), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.”

    Enacted provision · exact public law section
    (a) Conforming Applicable Number.— Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows: “(II) The applicable number is— “(aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; “(bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); “(cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)); or “(dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations).” .

32. 2018

    Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pub. L. 115–271 § 3202(a) · 132 Stat. 3894

    Added · 21 U.S.C. § 823(g)(2)(G)(ii)(VIII)

    Pub. L. 115–271, § 3202(a), added subcl. (VIII)

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(ii)(VIII). Pub. L. 115–271, § 3202(a), added subcl. (VIII).

    Enacted provision · exact public law section
    (a) Waivers for Maintenance Treatment or Detoxification.— Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following: “(VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that— “(aa) included not less than 8 hours of training on treating and managing opioid-dependent patients; and “(bb) included, at a minimum— “(AA) the training described in items (aa) through (gg) of subclause (IV); and “(BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.” .

33. 2018

    Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pub. L. 115–271 § 3201(b) · 132 Stat. 3894

    Amended · 21 U.S.C. § 823(g)(2)(G)(iii)(II)

    Pub. L. 115–271, § 3201(b), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “during the period beginning on July 22, 2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(iii)(II). Pub. L. 115–271, § 3201(b), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “during the period beginning on July 22, 2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).”

    Enacted provision · exact public law section
    (b) Eliminating Any Time Limitation for Nurse Practitioners and Physician Assistants To Become Qualifying Practitioners.— Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)) is amended— (1) in subclause (I), by striking “or” at the end; and (2) by amending subclause (II) to read as follows: “(II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or” .

34. 2018

    Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pub. L. 115–271 § 3201(b)(1) · 132 Stat. 3894

    Added · 21 U.S.C. § 823(g)(2)(G)(iii)(III)

    Pub. L. 115–271, § 3201(b)(1), (c), added subcl. (III)

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(iii)(III). Pub. L. 115–271, § 3201(b)(1), (c), added subcl. (III).

    Enacted provision · exact public law section
    (1) in subclause (I), by striking “or” at the end; and

35. 2018

    Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pub. L. 115–271 § 3201(d) · 132 Stat. 3894

    Substituted · 21 U.S.C. § 823(g)(2)(G)(iv)

    Pub. L. 115–271, § 3201(d), substituted “nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant” for “nurse practitioner or physician assistant” wherever appearing

    Source evidence

    Code amendment note
    Subsec. (g)(2)(G)(iv). Pub. L. 115–271, § 3201(d), substituted “nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant” for “nurse practitioner or physician assistant” wherever appearing.

    Enacted provision · exact public law section
    (d) Definition of Qualifying Other Practitioner.— Section 303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iv)) is amended by striking “nurse practitioner or physician assistant” each place it appears and inserting “nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant”.

36. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    1. Added · 21 U.S.C. § 823(c)(e)

       Pub. L. 117–215, § 103(a)(1), (2), added subsec. (c)

    2. Redesignated · 21 U.S.C. § 823(c)(e)

       Pub. L. 117–215, § 103(a)(1), (2), redesignated former subsecs. (c) and (d) as (d) and (e), respectively. Former subsec. (e) redesignated (f)

    Source evidence

    Code amendment note
    Subsecs. (c) to (e). Pub. L. 117–215, § 103(a)(1), (2), added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively. Former subsec. (e) redesignated (f).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

37. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(f)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

38. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 101 · 136 Stat. 2257

    1. Amended · 21 U.S.C. § 823(f)

       Pub. L. 117–215, § 101, designated introductory provisions through first sentence of concluding provisions as par. (1)

    2. Redesignated · 21 U.S.C. § 823(f)

       Pub. L. 117–215, § 101, redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1)

    3. Amended · 21 U.S.C. § 823(f)

       Pub. L. 117–215, § 101, designated second to fourth sentences of concluding provisions as subpar. (A) of par. (2)

    4. Added · 21 U.S.C. § 823(f)

       Pub. L. 117–215, § 101, added subpar. (B) of par. (2)

    5. Amended · 21 U.S.C. § 823(f)

       Pub. L. 117–215, § 101, designated last sentence of concluding provisions as par. (3)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–215, § 101, designated introductory provisions through first sentence of concluding provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), designated second to fourth sentences of concluding provisions as subpar. (A) of par. (2), added subpar. (B) of par. (2), and designated last sentence of concluding provisions as par. (3).

    Enacted provision · exact public law section
    SEC. 101. MARIJUANA RESEARCH APPLICATIONS.   Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended— (1) by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively; (2) by striking “(f) The Attorney General” and inserting “(f)(1) The Attorney General”; (3) by striking “Registration applications” and inserting the following: “(2) (A) Registration applications” ; (4) by striking “Article 7” and inserting the following: “(3) Article 7” ; and (5) by inserting after paragraph (2)(A), as so designated, the following: “(B) (i) The Attorney General shall register a practitioner to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if— “(I) the applicant’s research protocol has been reviewed and allowed— “(aa) by the Secretary of Health and Human Services under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); “(bb) by the National Institutes of Health or another Federal agency that funds scientific research; or “(cc) pursuant to sections 1301.18 and 1301.32 of title 21, Code of Federal Regulations, or any successors thereto; and “(II) 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. “(ii) 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— “(I) subparagraphs (B) through (E) of paragraph (1); and “(II) 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). “(iii) (I) 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— “(aa) approve the application; or “(bb) request supplemental information. “(II) 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. “(iv) 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. “(v) 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.” .

39. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 102(a) · 136 Stat. 2257

    Added · 21 U.S.C. § 823(f)(2)(B)(vi)

    Pub. L. 117–215, § 102(a), added cl. (vi)

    Source evidence

    Code amendment note
    Subsec. (f)(2)(B)(vi). Pub. L. 117–215, § 102(a), added cl. (vi).

    Enacted provision · exact public law section
    (a) In General.— Paragraph (2)(B) of section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), as added by section 101 of this Act, is further amended by adding at the end the following: “(vi) (I) 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— “(aa) the quantity or type of marijuana or cannabidiol (including any derivative, extract, preparation, and compound thereof); “(bb) the source of such marijuana or cannabidiol; or “(cc) the conditions under which such marijuana or cannabidiol is stored, tracked, or administered. “(II) (aa) 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. “(bb) 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). “(cc) 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. “(dd) 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. “(ee) 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). “(III) (aa) 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. “(bb) A notification under item (aa) shall include— “(AA) the Drug Enforcement Administration registration number of the registrant; “(BB) the quantity of marijuana or cannabidiol already obtained; “(CC) the quantity of additional marijuana or cannabidiol needed to complete the research; and “(DD) 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. “(cc) The Attorney General shall ensure that— “(AA) 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 “(BB) 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. “(dd) (AA) 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). “(BB) 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. “(ee) 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— “(AA) does impact the source of the marijuana or cannabidiol or the conditions under which the marijuana or cannabidiol is stored, tracked, or administered; or “(BB) necessitates that the registrant implement additional security measures to safeguard against diversion or abuse. “(IV) 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— “(aa) the method of administration of marijuana or cannabidiol; “(bb) the dosing of marijuana or cannabidiol; and “(cc) the number of individuals or patients involved in research.” .

40. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(g)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

41. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(h)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

42. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(3) · 136 Stat. 2257

    Substituted · 21 U.S.C. § 823(h)(2)

    Pub. L. 117–215, § 103(a)(3), substituted “subsection (g)” for “subsection (f)” wherever appearing

    Source evidence

    Code amendment note
    Subsec. (h)(2). Pub. L. 117–215, § 103(a)(3), substituted “subsection (g)” for “subsection (f)” wherever appearing.

    Enacted provision · exact public law section
    (3) in subsection (h)(2), as so redesignated, by striking “subsection (f)” each place it appears and inserting “subsection (g)”;

43. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(i)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

44. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(j)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 117–215, § 103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

45. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(4) · 136 Stat. 2257

    Substituted · 21 U.S.C. § 823(j)(1)

    Pub. L. 117–215, § 103(a)(4), substituted “subsection (e)” for “subsection (d)”

    Source evidence

    Code amendment note
    Subsec. (j)(1). Pub. L. 117–215, § 103(a)(4), substituted “subsection (e)” for “subsection (d)”.

    Enacted provision · exact public law section
    (4) in subsection (j)(1), as so redesignated, by striking “subsection (d)” and inserting “subsection (e)”; and

46. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    1. Redesignated · 21 U.S.C. § 823(k)

       Pub. L. 117–215, § 103(a)(1), (5), redesignated subsec. (j) as (k)

    2. Redesignated · 21 U.S.C. § 823(k)

       Pub. L. 117–215, § 103(a)(1), (5), substituted “subsection (g)” for “subsection (f)” wherever appearing. Former subsec. (k) redesignated (l)

    Source evidence

    Code amendment note
    Subsec. (k). Pub. L. 117–215, § 103(a)(1), (5), redesignated subsec. (j) as (k) and substituted “subsection (g)” for “subsection (f)” wherever appearing. Former subsec. (k) redesignated (l).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

47. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 § 103(a)(1) · 136 Stat. 2257

    Redesignated · 21 U.S.C. § 823(l)

    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (k) as (l)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–215, § 103(a)(1), redesignated subsec. (k) as (l).

    Enacted provision · exact public law section
    (1) by redesignating subsections (c) through (k) as subsections (d) through (l), respectively;

48. 2022

    Restoring Hope for Mental Health and Well-Being Act of 2022

    Pub. L. 117–328 § 1262(a) · 136 Stat. 4459

    1. Amended · 21 U.S.C. § 823(h)

       Pub. L. 117–328, § 1262(a), as amended by Pub. L. 119–26, § 4(2)(A)

    2. Substituted · 21 U.S.C. § 823(h)

       Pub. L. 117–328, § 1262(a), as substituted “Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment” for “(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment”

    3. Redesignated · 21 U.S.C. § 823(h)

       Pub. L. 117–328, § 1262(a), as redesignated subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively

    4. Redesignated · 21 U.S.C. § 823(h)

       Pub. L. 117–328, § 1262(a), as redesignated cls. (i) and (ii) of par. (2) as subpars. (A) and (B), respectively

    5. Struck · 21 U.S.C. § 823(h)

       Pub. L. 117–328, § 1262(a), as struck out former par. (2) which related to waiver of registration requirements

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 117–328, § 1262(a), as amended by Pub. L. 119–26, § 4(2)(A), substituted “Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment” for “(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment”, redesignated subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively, redesignated cls. (i) and (ii) of par. (2) as subpars. (A) and (B), respectively, and struck out former par. (2) which related to waiver of registration requirements.

    Enacted provision · exact public law section
    (a) In General.— Section 303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) is amended— (1) by striking paragraph (2); (2) by striking “(g)(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment” and inserting “(g) Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment”; (3) by redesignating subparagraphs (A), (B), and (C) as paragraphs (1), (2), and (3), respectively; and (4) in paragraph (2), as so redesignated— (A) by striking “(i) security of stocks” and inserting “(A) security of stocks”; and (B) by striking “(ii) the maintenance of records” and inserting “(B) the maintenance of records”.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

49. 2022

    Restoring Hope for Mental Health and Well-Being Act of 2022

    Pub. L. 117–328 § 1263(a) · 136 Stat. 4459

    Added · 21 U.S.C. § 823(l)

    Pub. L. 117–328, § 1263(a), added subsec. (l) relating to required training for prescribers

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 117–328, § 1263(a), added subsec. (l) relating to required training for prescribers.

    Enacted provision · exact public law section
    (a) In General.— Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: “(l) Required Training for Prescribers.— “(1) Training required.— As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner, to meet the following: “(A) If the practitioner is a physician (as defined under section 1861(r) of the Social Security Act) and the practitioner meets one or more of the following conditions: “(i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties. “(ii) The physician holds a board certification from the American Board of Addiction Medicine. “(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association. “(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by— “(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Commission for Continuing Education Provider Recognition (CCEPR); “(II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR; “(III) any organization accredited by the American Osteopathic Association to provide continuing medical education; or “(IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR. “(v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, dental surgery, or dental medicine in the United States during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental medicine curriculum that included not less than 8 hours of training on— “(I) treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or “(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders. “(B) If the practitioner is not a physician (as defined under section 1861(r) of the Social Security Act), the practitioner is legally authorized by the State to dispense controlled substances under schedule II, III, IV, or V and is dispensing such substances within such State in accordance with all applicable State laws, and the practitioner meets one or more of the following conditions: “(i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of patients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use or the Accreditation Council for Continuing Medical Education. “(ii) The practitioner has graduated in good standing from an accredited physician assistant school or accredited school of advanced practice nursing in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder. “(2) One-time training.— “(A) In general.— The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of paragraph (1)(B) more than once. “(B) Notification.— Not later than 90 days after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Attorney General shall provide to qualified practitioners a single written, electronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B). “(3) Rule of construction.— Nothing in this subsection shall be construed— “(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or “(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V. “(4) Definitions.— In this section: “(A) First applicable registration.— The term ‘first applicable registration’ means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022. “(B) Qualified practitioner.— In this subsection, the term ‘qualified practitioner’ means a practitioner who— “(i) is licensed under State law to prescribe controlled substances; and “(ii) is not solely a veterinarian.” .

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

50. 2025

    Pub. L. 119–26 § 4(2)(A) · 139 Stat. 411

    Amended · 21 U.S.C. § 823(h)

    Pub. L. 119–26, § 4(2)(A), amended Pub. L. 117–328, § 1262(a). See 2022 Amendment note below

    Unresolved: Pub. L. 119–26 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 119–26, § 4(2)(A), amended Pub. L. 117–328, § 1262(a). See 2022 Amendment note below.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

51. 2025

    Pub. L. 119–26 § 3(a)(1) · 139 Stat. 411

    Redesignated · 21 U.S.C. § 823(l); 21 U.S.C. § 823(m)

    Pub. L. 119–26, § 3(a)(1), and Pub. L. 119–44, § 402(a)(1), made identical amendments, redesignating subsec. (l) relating to required training for prescribers as (m)

    Unresolved: Pub. L. 119–26 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsecs. (l), (m). Pub. L. 119–26, § 3(a)(1), and Pub. L. 119–44, § 402(a)(1), made identical amendments, redesignating subsec. (l) relating to required training for prescribers as (m).

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

52. 2025

    Pub. L. 119–26 § 3(a)(2) · 139 Stat. 411

    Added · 21 U.S.C. § 823(n)

    Pub. L. 119–26, § 3(a)(2), added subsec. (n)

    Unresolved: Pub. L. 119–26 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 119–26, § 3(a)(2), added subsec. (n).

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

53. 2025

    Pub. L. 119–26 § 3(g) · 139 Stat. 411

    Added · 21 U.S.C. § 823(o)

    Pub. L. 119–26, § 3(g), added subsec. (o)

    Unresolved: Pub. L. 119–26 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 119–26, § 3(g), added subsec. (o).

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

54. 2025

    Pub. L. 119–44 § 402(a)(2)(A)(i)(I) · 139 Stat. 690

    1. Inserted · 21 U.S.C. § 823(m)(1)(A)(iv)(I)

       Pub. L. 119–44, § 402(a)(2)(A)(i)(I), inserted “the American Academy of Family Physicians, the American Podiatric Medical Association, the Academy of General Dentistry, the American Optometric Association,” before “or any other organization”

    2. Substituted · 21 U.S.C. § 823(m)(1)(A)(iv)(I)

       Pub. L. 119–44, § 402(a)(2)(A)(i)(I), substituted “, the Commission” for “or the Commission”

    3. Inserted · 21 U.S.C. § 823(m)(1)(A)(iv)(I)

       Pub. L. 119–44, § 402(a)(2)(A)(i)(I), inserted “, or the Council on Podiatric Medical Education” before semicolon at end

    Unresolved: Pub. L. 119–44 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (m)(1)(A)(iv)(I). Pub. L. 119–44, § 402(a)(2)(A)(i)(I), inserted “the American Academy of Family Physicians, the American Podiatric Medical Association, the Academy of General Dentistry, the American Optometric Association,” before “or any other organization”, substituted “, the Commission” for “or the Commission”, and inserted “, or the Council on Podiatric Medical Education” before semicolon at end.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

55. 2025

    Pub. L. 119–44 § 402(a)(2)(A)(i)(II) · 139 Stat. 690

    Inserted · 21 U.S.C. § 823(m)(1)(A)(iv)(III)

    Pub. L. 119–44, § 402(a)(2)(A)(i)(II), inserted “or the American Academy of Family Physicians” after “Association”

    Unresolved: Pub. L. 119–44 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (m)(1)(A)(iv)(III). Pub. L. 119–44, § 402(a)(2)(A)(i)(II), inserted “or the American Academy of Family Physicians” after “Association”.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

56. 2025

    Pub. L. 119–44 § 402(a)(2)(A)(ii) · 139 Stat. 690

    1. Substituted · 21 U.S.C. § 823(m)(1)(A)(v)

       Pub. L. 119–44, § 402(a)(2)(A)(ii), substituted “osteopathic medicine, podiatric medicine, dental surgery” for “osteopathic medicine, dental surgery” in introductory provisions

    2. Substituted · 21 U.S.C. § 823(m)(1)(A)(v)

       Pub. L. 119–44, § 402(a)(2)(A)(ii), substituted “or dental or podiatric medicine curriculum” for “or dental medicine curriculum” in introductory provisions

    Unresolved: Pub. L. 119–44 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (m)(1)(A)(v). Pub. L. 119–44, § 402(a)(2)(A)(ii), substituted “osteopathic medicine, podiatric medicine, dental surgery” for “osteopathic medicine, dental surgery” and “or dental or podiatric medicine curriculum” for “or dental medicine curriculum” in introductory provisions.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

57. 2025

    Pub. L. 119–44 § 402(a)(2)(B)(i) · 139 Stat. 690

    Inserted · 21 U.S.C. § 823(m)(1)(B)(i)

    Pub. L. 119–44, § 402(a)(2)(B)(i), inserted “the American Pharmacists Association, the Accreditation Council on Pharmacy Education, the American Psychiatric Nurses Association, the American Academy of Nursing, the American Academy of Family Physicians,” before “or any other organization” and “, the American Academy of Family Physicians,” before “or the Accreditation Council”

    Unresolved: Pub. L. 119–44 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (m)(1)(B)(i). Pub. L. 119–44, § 402(a)(2)(B)(i), inserted “the American Pharmacists Association, the Accreditation Council on Pharmacy Education, the American Psychiatric Nurses Association, the American Academy of Nursing, the American Academy of Family Physicians,” before “or any other organization” and “, the American Academy of Family Physicians,” before “or the Accreditation Council”.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

58. 2025

    Pub. L. 119–44 § 402(a)(2)(B)(ii) · 139 Stat. 690

    1. Substituted · 21 U.S.C. § 823(m)(1)(B)(ii)

       Pub. L. 119–44, § 402(a)(2)(B)(ii), substituted “, an accredited school” for “or accredited school”

    2. Inserted · 21 U.S.C. § 823(m)(1)(B)(ii)

       Pub. L. 119–44, § 402(a)(2)(B)(ii), inserted “, or an accredited school of pharmacy” before “in the United States”

    Unresolved: Pub. L. 119–44 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (m)(1)(B)(ii). Pub. L. 119–44, § 402(a)(2)(B)(ii), substituted “, an accredited school” for “or accredited school” and inserted “, or an accredited school of pharmacy” before “in the United States”.

    Effective date note
    Pub. L. 119–44, title IV, § 402(b), Dec. 1, 2025, 139 Stat. 691, provided that: “The amendment made by subsection (a) [amending this section] shall take effect as if enacted on December 29, 2022.” Pub. L. 119–26, § 4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(A) is effective as if included in the enactment of Pub. L. 117–328.

69 of 82 references resolved to an enrolled provision · 13 unresolved