II 

Calendar No. 318 

118TH CONGRESS 

2D SESSION S. 644 

To expand the take-home prescribing of methadone through pharmacies. 

IN THE SENATE OF THE UNITED STATES 

MARCH 2, 2023 

Mr. MARKEY (for himself, Mr. PAUL, Mr. SANDERS, Mr. BRAUN, Mr. BOOKER, Ms. HASSAN, Mr. LUJA ́N, Mr. WELCH, Mr. LEE, Ms. WARREN, Mr. 

CASEY, and Mr. HEINRICH) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

FEBRUARY 1, 2024 

Reported by Mr. SANDERS, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To expand the take-home prescribing of methadone through 

pharmacies. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Modernizing Opioid 

5 Treatment Access Act’’. 


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1 SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS2 ORDER THROUGH PRESCRIBING AND PHAR3 MACIES. 

4 (a) REGISTRATION; OTHER CARE BY TELE5 HEALTH.— 

6 (1) DEFINITIONS.—In this subsection: 

7 (A) CONTROLLED SUBSTANCE; DETOXI8 FICATION TREATMENT; DISPENSE; MAINTE9 NANCE TREATMENT; OPIOID.—The terms ‘‘con10 trolled substance’’, ‘‘detoxification treatment’’, 

11 ‘‘dispense’’, ‘‘maintenance treatment’’, and 

12 ‘‘opioid’’ have the meanings given the terms in 

13 section 102 of the Controlled Substances Act 

14 (21 U.S.C. 802). 

15 (B) SECRETARY.—The term ‘‘Secretary’’ 

16 means the Secretary of Health and Human 

17 Services. 

18 (2) WAIVER.— 

19 (A) IN GENERAL.—The requirements of 

20 section 303(h) of Controlled Substances Act (21 

21 U.S.C. 823(h)) applicable to methadone medica22 tion for opioid use disorder are waived, and the 

23 Attorney General, in consultation with the Sec24 retary, shall register persons described in sub25 paragraph (B) to prescribe methadone for 


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1 opioid use disorder to be dispensed through a 

2 pharmacy for individuals for unsupervised use. 

3 (B) PERSONS DESCRIBED.—Persons de4 scribed in this subparagraph are persons who— 

5 (i) are licensed, registered, or other6 wise permitted, by the United States or the 

7 jurisdiction in which they practice, to pre8 scribe controlled substances in the course 

9 of professional practice; and 

10 (ii) are— 

11 (I) employees or contractors of 

12 an opioid treatment program; or 

13 (II) addiction medicine physi14 cians or addiction psychiatrists who 

15 hold a subspecialty board certification 

16 in addiction medicine from the Amer17 ican Board of Preventive Medicine, a 

18 board certification in addiction medi19 cine from the American Board of Ad20 diction Medicine, a subspecialty board 

21 certification in addiction psychiatry 

22 from the American Board of Psychi23 atry and Neurology, or a subspecialty 

24 board certification in addiction mediVerDate Sep 11 2014 23:21 Feb 01, 2024 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S644.RS S644

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1 cine from the American Osteopathic 

2 Association. 

3 (C) REQUIREMENTS FOR PRESCRIBING

4 METHADONE.—The prescribing of methadone 

5 pursuant to subparagraph (A) shall be— 

6 (i) exclusively by electronic prescribing 

7 and dispensed to the patient treated pursu8 ant to subparagraph (A); 

9 (ii) for a supply of not more than 30 

10 days pursuant to each prescription; and 

11 (iii) subject to the restrictions listed 

12 in section 8.12(i)(3) of title 42, Code of 

13 Federal Regulations, or successor regula14 tion or guidance. 

15 (D) REQUIREMENTS FOR DISPENSING

16 METHADONE.—The dispensing of methadone to 

17 an individual pursuant to subparagraph (A) 

18 shall be in addition to the other care that the 

19 individual continues to have access to through 

20 an opioid treatment program. 

21 (E) REGISTRATION REQUIREMENTS.—Per22 sons registered in a State pursuant to subpara23 graph (A) shall— 

24 (i) ensure and document, with respect 

25 to each patient treated pursuant to subVerDate Sep 11 2014 23:21 Feb 01, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S644.RS S644

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1 paragraph (A), informed consent to treat2 ment; and 

3 (ii) include in such informed consent, 

4 specific informed consent regarding dif5 ferences in confidentiality protections ap6 plicable when dispensing through an opioid 

7 treatment program versus dispensing 

8 through a pharmacy pursuant to subpara9 graph (A). 

10 (F) CESSATION AND WITHDRAWAL OF

11 REGISTRATION.—At the request of a State, the 

12 Attorney General, in consultation with the Sec13 retary, shall— 

14 (i) cease registering persons in the 

15 State pursuant to subparagraph (A); and 

16 (ii) withdraw any such registration in 

17 effect for a person in the State. 

18 (G) MAINTENANCE AND DETOXIFICATION

19 TREATMENT.—Maintenance treatment or de20 toxification treatment provided pursuant to sub21 paragraph (A) and other care provided in con22 junction with such treatment, such as coun23 seling and other ancillary services, may be pro24 vided by means of telehealth, as determined 


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1 jointly by the State and the Secretary to be fea2 sible and appropriate. 

3 (b) ANNUAL REPORTING.—Not later than 180 days 

4 after the date of enactment of this Act, and annually 

5 thereafter, the Assistant Secretary for Mental Health and 

6 Substance Use and the Administrator of the Drug En7 forcement Administration shall jointly submit a report to 

8 Congress that includes— 

9 (1) the number of persons registered pursuant 

10 to subsection (a); 

11 (2) the number of patients being prescribed 

12 methadone pursuant to subsection (a); and 

13 (3) a list of the States in which persons are 

14 registered pursuant to such subsection (a). 

15 SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BAR16 RIERS TO PATIENT CARE THROUGH OPIOID 

17 TREATMENT PROGRAMS. 

18 It is the sense of Congress that— 

19 (1) patients receiving services through opioid 

20 treatment programs face barriers to their care; and 

21 (2) each State should align the regulation of 

22 opioid treatment programs in a manner that is con23 sistent with the intent of this Act. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Modernizing Opioid 

3 Treatment Access Act’’. 

4 SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS5 ORDER THROUGH PRESCRIBING AND PHAR6 MACIES. 

7 Section 303(h) of the Controlled Substances Act (21 

8 U.S.C. 823(h)), is amended— 

9 (1) in paragraph (1)— 

10 (A) in the matter preceding subparagraph 

11 (A), in the first sentence, by inserting ‘‘(other 

12 than narcotic drugs in schedule III, IV, or V)’’ 

13 after ‘‘drugs’’; and 

14 (B) by striking subparagraph (B) and in15 serting the following: 

16 ‘‘(B) if the Attorney General determines that the 

17 applicant will comply with standards established by 

18 the Attorney General respecting— 

19 ‘‘(i) security of stocks of narcotic drugs for 

20 such treatment; and 

21 ‘‘(ii) the maintenance of records (in accord22 ance with section 307) on such drugs; and’’; and 

23 (2) by striking paragraph (2) and inserting the 

24 following: 

25 ‘‘(2)(A) The requirements of paragraph (1) applicable 

26 to methadone medication for opioid use disorder are 


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1 waived, and the Attorney General, in consultation with the 

2 Secretary, shall separately register persons described in sub3 paragraph (B) to prescribe methadone for opioid use dis4 order to be dispensed through a pharmacy for individuals 

5 for unsupervised use. 

6 ‘‘(B) Persons described in this subparagraph are per7 sons who— 

8 ‘‘(i) are licensed, registered, or otherwise per9 mitted, by the United States or the jurisdiction in 

10 which they practice, to prescribe controlled substances 

11 in the course of professional practice; and 

12 ‘‘(ii) are addiction medicine physicians or ad13 diction psychiatrists who hold a subspecialty board 

14 certification in addiction medicine from the Amer15 ican Board of Preventive Medicine, a board certifi16 cation in addiction medicine from the American 

17 Board of Addiction Medicine, a subspecialty board 

18 certification in addiction psychiatry from the Amer19 ican Board of Psychiatry and Neurology, or a sub20 specialty board certification in addiction medicine 

21 from the American Osteopathic Association. 

22 ‘‘(C) The prescribing of methadone pursuant to sub23 paragraph (A) shall be— 


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1 ‘‘(i) exclusively by electronic prescribing and dis2 pensed to the patient treated pursuant to subpara3 graph (A); 

4 ‘‘(ii) for a supply of not more than 30 days pur5 suant to each prescription; and 

6 ‘‘(iii) subject to the restrictions listed in section 

7 8.12(i)(3) of title 42, Code of Federal Regulations, or 

8 successor regulation or guidance. 

9 ‘‘(D) The dispensing of methadone to an individual 

10 pursuant to subparagraph (A) shall be in addition to the 

11 other care that the individual continues to have access to 

12 through an opioid treatment program. 

13 ‘‘(E) Persons registered pursuant to subparagraph (A) 

14 shall— 

15 ‘‘(i) ensure and document, with respect to each 

16 patient treated pursuant to subparagraph (A), in17 formed consent to treatment; and 

18 ‘‘(ii) include in such informed consent, specific 

19 informed consent regarding differences in confiden20 tiality protections applicable when dispensing 

21 through an opioid treatment program versus dis22 pensing through a pharmacy pursuant to subpara23 graph (A). 

24 ‘‘(F) At the request of a State, the Attorney General 

25 shall— 


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1 ‘‘(i) cease registering persons in the State pursu2 ant to subparagraph (A); and 

3 ‘‘(ii) withdraw any such registration in effect for 

4 a person in the State. 

5 ‘‘(G) Maintenance treatment or detoxification treat6 ment provided pursuant to subparagraph (A) and other 

7 care provided in conjunction with such treatment, such as 

8 counseling and other ancillary services, may be provided 

9 by means of telehealth. 

10 ‘‘(3) Not later than 180 days after the date of enact11 ment of this paragraph, and annually thereafter, the Assist12 ant Secretary for Mental Health and Substance Use and 

13 the Administrator of the Drug Enforcement Administration 

14 shall jointly submit to Congress a report that includes— 

15 ‘‘(A) the number of persons registered pursuant 

16 to paragraph (2); 

17 ‘‘(B) a list of States in which persons are reg18 istered pursuant to paragraph (2).’’. 


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Calendar No. 318 

118TH CONGRESS 

2D SESSION S. 644 

A BILL 

To expand the take-home prescribing of methadone 

through pharmacies. 

FEBRUARY 1, 2024 

Reported with an amendment 


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