SEC. 121. POSITRON EMISSION TOMOGRAPHY.
(a) Regulation of Compounded Positron Emission Tomography Drugs.--
Section 201 (21 U.S.C. 321) is amended by adding at the end the
following:
``(ii) The term `compounded positron emission tomography drug'--
``(1) means a drug that--
``(A) exhibits spontaneous disintegration of
unstable nuclei by the emission of positrons and is used
for the purpose of providing dual photon positron
emission tomographic diagnostic images; and
``(B) has been compounded by or on the order of a
practitioner who is licensed by a State to compound or
order compounding for a drug described in subparagraph
(A), and is compounded in accordance with that State's
law, for a patient or for research, teaching, or quality
control; and
``(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program
to be used in the preparation of such a drug.''.
(b) Adulteration.--
(1) In general.--Section 501(a) (21 U.S.C. 351(a)) is
amended by striking ``; or (3)'' and inserting the following:
``; or (C) if it is a compounded positron emission tomography
drug and the methods used in, or the facilities and controls
used for, its compounding, processing, packing, or holding do
not conform to or are not operated or administered in conformity
with the positron emission tomography compounding standards and
the official monographs of the United States Pharmacopoeia to
assure that such drug meets the requirements of this Act as to
safety and has the identity and strength, and meets the quality
and purity characteristics, that it purports or is represented
to possess; or (3)''.
<<NOTE: 21 USC 351 note.>> (2) Sunset.--Section
501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of
enactment of this Act or 2 years after the date on which the
Secretary of Health and Human Services establishes the
requirements described in subsection (c)(1)(B), whichever is
later.
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<<NOTE: 21 USC 355 note.>> (c) Requirements for Review of Approval
Procedures and Current Good Manufacturing Practices for Positron
Emission Tomography.--
(1) Procedures and requirements.--
(A) In general.--In order to take account of the
special characteristics of positron emission tomography
drugs and the special techniques and processes required
to produce these drugs, not later than 2 years after the
date of enactment of this Act, the Secretary of Health
and Human Services shall establish--
(i) appropriate procedures for the approval of
positron emission tomography drugs pursuant to
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355); and
(ii) appropriate current good manufacturing
practice requirements for such drugs.
(B) Considerations and consultation.--In
establishing the procedures and requirements required by
subparagraph (A), the Secretary of Health and Human
Services shall take due account of any relevant
differences between not-for-profit institutions that
compound the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing the
procedures and requirements, the Secretary of Health and
Human Services shall consult with patient advocacy
groups, professional associations, manufacturers, and
physicians and scientists licensed to make or use
positron emission tomography drugs.
(2) Submission of new drug applications and abbreviated new
drug applications.--
(A) In general.--Except as provided in subparagraph
(B), the Secretary of Health and Human Services shall
not require the submission of new drug applications or
abbreviated new drug applications under subsection (b)
or (j) of section 505 (21 U.S.C. 355), for compounded
positron emission tomography drugs that are not
adulterated drugs described in section 501(a)(2)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) (as amended by subsection (b)), for a
period of 4 years after the date of enactment of this
Act, or for 2 years after the date on which the
Secretary establishes procedures and requirements under
paragraph (1), whichever is longer.
(B) Exception.--Nothing in this Act shall prohibit
the voluntary submission of such applications or the
review of such applications by the Secretary of Health
and Human Services. Nothing in this Act shall constitute
an exemption for a positron emission tomography drug
from the requirements of regulations issued under
section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)).
<<NOTE: Federal Register, publication.>> (d) Revocation of Certain
Inconsistent Documents.--Within 30 days after the date of enactment of
this Act, the Secretary of Health and Human Services shall publish in
the Federal Register a notice terminating the application of the
following notices and rule:
(1) A notice entitled ``Regulation of Positron Emission
Tomography Radiopharmaceutical Drug Products; Guidance; Public
Workshop'', published in the Federal Register on February 27,
1995, 60 Fed. Reg. 10594.
[[Page 111 STAT. 2322]]
(2) A notice entitled ``Draft Guideline on the Manufacture
of Positron Emission Tomography Radiopharmaceutical Drug
Products; Availability'', published in the Federal Register on
February 27, 1995, 60 Fed. Reg. 10593.
(3) A final rule entitled ``Current Good Manufacturing
Practice for Finished Pharmaceuticals; Positron Emission
Tomography'', published in the Federal Register on April 22,
1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code
of Federal Regulations).
<<NOTE: 21 USC 355 note.>> (e) Definition.--As used in this
section, the term ``compounded positron emission tomography drug'' has
the meaning given the term in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).