I 
119TH CONGRESS 
1ST SESSION H. R. 6434 
To establish a special registration under the Controlled Substances Act for 
schedule I eligible investigational drugs under the Federal Right to 
Try law. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 4, 2025 
Ms. DEAN of Pennsylvania (for herself, Ms. MACE, Mr. CORREA, Mr. 
KHANNA, Mr. LIEU, Mr. CRENSHAW, Mr. BERGMAN, and Mr. 
LUTTRELL) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To establish a special registration under the Controlled Sub-
stances Act for schedule I eligible investigational drugs 
under the Federal Right to Try law. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Freedom to Heal Act 
of 2025’’. 
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SEC. 2. SPECIAL REGISTRATION REQUIREMENTS RELATED 
TO RIGHT TO TRY. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended by adding at the end the fol-
lowing: 
‘‘(p) SPECIAL REGISTRATION FOR SCHEDULE I ELI-
GIBLE
INVESTIGATIONAL
DRUGS
UNDER
RIGHT
TO 
TRY.— 
‘‘(1) DEFINITIONS.—In this subsection, the 
terms ‘eligible investigational drug’ and ‘eligible pa-
tient’ have the meanings given those terms in section 
561B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–0a). 
‘‘(2) SPECIAL
REGISTRATION
PROCESS.—The 
Attorney General shall register physicians to directly 
administer eligible investigational drugs in schedule 
I to eligible patients under section 561B of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–0a) in accordance with paragraphs (3) 
through (8) of this subsection. 
‘‘(3) REQUIREMENTS.— 
‘‘(A) APPLICATION.—A physician desiring 
a registration to directly administer an eligible 
investigational drug as described in paragraph 
(2) shall submit to the Attorney General an ap-
plication containing— 
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‘‘(i) evidence of a valid registration to 
dispense or administer controlled sub-
stances in schedules II through V; 
‘‘(ii) evidence of compliance with sec-
tion 561B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb–0a), in-
cluding— 
‘‘(I) documentation from the 
manufacturer or sponsor verifying the 
investigational drug in schedule I is 
an eligible investigational drug; 
‘‘(II) an agreement from the 
manufacturer or sponsor to supply the 
eligible investigational drug, along 
with guidance on its administration, 
to the requesting physician for the 
treatment of eligible patients; and 
‘‘(III) an affirmation that the 
physician will only directly administer 
the eligible investigational drug to 
treat eligible patients in a manner 
consistent with the guidance provided 
by the manufacturer or sponsor; 
‘‘(iii) the quantity of the eligible inves-
tigational drug to be supplied by the man-
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ufacturer or sponsor to the physician to 
treat eligible patients; 
‘‘(iv) evidence that the physician may 
treat eligible patients with eligible inves-
tigational drugs under the laws of the 
State in which the treatment will take 
place; 
‘‘(v) evidence of training, credentials, 
or experience relevant to treating patients 
with the eligible investigational drug; 
‘‘(vi) a description of the site at which 
the physician intends to store and admin-
ister the eligible investigational drug; and 
‘‘(vii) any additional information the 
Attorney General determines necessary to 
prevent diversion. 
‘‘(B) APPROVAL.—Not later than 45 days 
after receiving an application containing the in-
formation required under subparagraph (A), the 
Attorney General shall— 
‘‘(i) register the applicant; or 
‘‘(ii) serve an order to show cause 
upon the applicant in accordance with sec-
tion 304(c). 
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‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 
General shall provide a means for a physician to 
submit an application under paragraph (3)(A) elec-
tronically. 
‘‘(5) LIMITATION ON AMOUNTS.—A physician 
treating eligible patients with an eligible investiga-
tional drug in schedule I under this subsection may 
only possess the amounts of the eligible investiga-
tional drug identified in— 
‘‘(A) the application submitted to the At-
torney General under paragraph (3)(A); or 
‘‘(B) a supplemental notification that the 
physician may submit to the Attorney General 
if the physician needs additional amounts of the 
eligible investigational drug for the treatment of 
eligible patients, which supplemental notifica-
tion— 
‘‘(i) shall include— 
‘‘(I) the name of the physician; 
‘‘(II) the additional quantity of 
the eligible investigational drug need-
ed; and 
‘‘(III) an attestation that the 
treatment with the eligible investiga-
tional drug is consistent with the 
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scope of treatment that was the sub-
ject of the application under para-
graph (3)(A); and 
‘‘(ii) shall be deemed approved on the 
date that is 30 days after the date on 
which the physician submits the supple-
mental notification to the Attorney Gen-
eral, unless the Attorney General serves an 
order to show cause upon the applicant in 
accordance with section 304(c). 
‘‘(6) SINGLE
REGISTRATION
FOR
RELATED 
TREATMENT SITES.—A physician may treat eligible 
patients with an eligible investigational drug in 
schedule I under a single registration under this 
subsection if— 
‘‘(A) the treatment occurs exclusively on 
sites all of which are— 
‘‘(i) within the same city or county; 
and 
‘‘(ii) under the control of the same in-
stitution, organization, or agency; and 
‘‘(B) before commencing the treatment, the 
physician notifies the Attorney General of each 
site where the eligible investigational drug will 
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be stored or administered in accordance with 
paragraph (3)(A)(vi). 
‘‘(7) RULEMAKING.—Notwithstanding the re-
quirements of section 553 of title 5, United States 
Code, not later than 240 days after the date of en-
actment of this subsection, the Attorney General 
shall issue an interim final rule to implement this 
subsection, including with respect to— 
‘‘(A) the manner in which an eligible inves-
tigational drug may be delivered to an approved 
registrant; 
‘‘(B) the storage and security of an eligible 
investigational drug; 
‘‘(C) the maintenance of records for an ap-
proved registrant; 
‘‘(D) the process for renewal, suspension, 
or revocation of a registration; and 
‘‘(E) any other matters necessary to en-
sure effective controls against diversion. 
‘‘(8) FINAL
RULE.—Not later than 2 years 
after issuing an interim final rule under paragraph 
(7), the Attorney General shall issue a final rule to 
implement this subsection in accordance with section 
553 of title 5, United States Code.’’. 
Æ 
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