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cable subsequent determination by the Sec-
retary, the general requirements for non-
prescription drugs, and conditions or re-
quirements under subsections (b), (c), and 
(k); and 
‘‘(iii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
extent and for a material time under sec-
tion 201(p)(2). 
‘‘(2) TREATMENT
OF
SUNSCREEN
DRUGS.— 
With respect to sunscreen drugs subject to this sec-
tion, the applicable requirements in terms of con-
formity with a final monograph, for purposes of 
paragraph (1)(A)(i), shall be the requirements speci-
fied in part 352 of title 21, Code of Federal Regula-
tions, as published on May 21, 1999, beginning on 
page 27687 of volume 64 of the Federal Register, 
except that the applicable requirements governing ef-
fectiveness and labeling shall be those specified in 
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HR 269 PCS 
section 201.327 of title 21, Code of Federal Regula-
tions. 
‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN-
TATIVE
FINAL
MONOGRAPH; CATEGORY
I
DRUGS 
SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE 
NOTICE OF PROPOSED RULEMAKING.—A drug that 
is not described in paragraph (1), (2), or (4) is not 
required to be the subject of an application approved 
under section 505, and is not subject to section 
503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) classified in category III for safe-
ty or effectiveness in the preamble of a 
proposed rule establishing a tentative final 
monograph that is the most recently appli-
cable proposal or determination for such 
drug issued under part 330 of title 21, 
Code of Federal Regulations; 
‘‘(ii) in conformity with— 
‘‘(I) the conditions of use, includ-
ing indication and dosage strength, if 
any, described for such category III 
drug in such preamble or in an appli-
cable subsequent proposed rule; 
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‘‘(II) the proposed requirements 
for drugs classified in such tentative 
final monograph in category I in the 
most recently proposed rule estab-
lishing requirements related to such 
tentative final monograph and in any 
final rule establishing requirements 
that are applicable to the drug; and 
‘‘(III) the general requirements 
for nonprescription drugs and condi-
tions or requirements under sub-
section (b) or (k); and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, had been used to a material 
extent and for a material time under sec-
tion 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a proposed mono-
graph or advance notice of proposed rule-
making that is the most recently applicable 
proposal or determination for such drug 
issued under part 330 of title 21, Code of 
Federal Regulations; 
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‘‘(ii) in conformity with the require-
ments for nonprescription use of such pro-
posed monograph or advance notice of pro-
posed rulemaking, any applicable subse-
quent determination by the Secretary, the 
general requirements for nonprescription 
drugs, and conditions or requirements 
under subsection (b) or (k); and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
extent and for a material time under sec-
tion 201(p)(2). 
‘‘(4) CATEGORY
II
DRUGS
DEEMED
NEW 
DRUGS.—A drug that is classified in category II for 
safety or effectiveness under a tentative final mono-
graph or that is subject to a determination to be not 
generally recognized as safe and effective in a pro-
posed rule that is the most recently applicable pro-
posal issued under part 330 of title 21, Code of Fed-
eral Regulations, shall be deemed to be a new drug 
under section 201(p), misbranded under section 
502(ee), and subject to the requirement for an ap-
proved new drug application under section 505 be-
ginning on the day that is 180 calendar days after 
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the date of the enactment of this section, unless, be-
fore such day, the Secretary determines that it is in 
the interest of public health to extend the period 
during which the drug may be marketed without 
such an approved new drug application. 
‘‘(5) 
DRUGS
NOT
GRASE
DEEMED
NEW 
DRUGS.—A drug that the Secretary has determined 
not to be generally recognized as safe and effective 
under section 201(p)(1) under a final determination 
issued under part 330 of title 21, Code of Federal 
Regulations, shall be deemed to be a new drug under 
section 201(p), misbranded under section 502(ee), 
and subject to the requirement for an approved new 
drug application under section 505. 
‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 
Except as provided in subsection (m), a drug is 
deemed to be a new drug under section 201(p) and 
misbranded under section 502(ee) if the drug— 
‘‘(A) is not subject to section 503(b)(1); 
and 
‘‘(B) is not described in paragraph (1), 
(2), (3), (4), or (5), or subsection (b)(1)(B). 
‘‘(b) ADMINISTRATIVE ORDERS.— 
‘‘(1) IN GENERAL.— 
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‘‘(A) 
DETERMINATION.—The 
Secretary 
may, on the initiative of the Secretary or at the 
request of one or more requestors, issue an ad-
ministrative order determining whether there 
are conditions under which a specific drug, a 
class of drugs, or a combination of drugs, is de-
termined to be— 
‘‘(i) not subject to section 503(b)(1); 
and 
‘‘(ii) generally recognized as safe and 
effective under section 201(p)(1). 
‘‘(B) EFFECT.—A drug or combination of 
drugs shall be deemed to not require approval 
under section 505 if such drug or combination 
of drugs— 
‘‘(i) is determined by the Secretary to 
meet the conditions specified in clauses (i) 
and (ii) of subparagraph (A); 
‘‘(ii) is marketed in conformity with 
an administrative order under this sub-
section; 
‘‘(iii) meets the general requirements 
for nonprescription drugs; and 
‘‘(iv) meets the requirements under 
subsections (c) and (k). 
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‘‘(C) STANDARD.—The Secretary shall find 
that a drug is not generally recognized as safe 
and effective under section 201(p)(1) if— 
‘‘(i) the evidence shows that the drug 
is not generally recognized as safe and ef-
fective under section 201(p)(1); or 
‘‘(ii) the evidence is inadequate to 
show that the drug is generally recognized 
as 
safe 
and 
effective 
under 
section 
201(p)(1). 
‘‘(2) ADMINISTRATIVE
ORDERS
INITIATED
BY 
THE SECRETARY.— 
‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) upon the 
Secretary’s initiative, the Secretary shall— 
‘‘(i) make reasonable efforts to notify 
informally, not later than 2 business days 
before the issuance of the proposed order, 
the sponsors of drugs who have a listing in 
effect under section 510(j) for the drugs or 
combination of drugs that will be subject 
to the administrative order; 
‘‘(ii) after any such reasonable efforts 
of notification— 
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‘‘(I) issue a proposed administra-
tive order by publishing it on the 
website of the Food and Drug Admin-
istration and include in such order the 
reasons for the issuance of such order; 
and 
‘‘(II) publish a notice of avail-
ability of such proposed order in the 
Federal Register; 
‘‘(iii) except as provided in subpara-
graph (B), provide for a public comment 
period with respect to such proposed order 
of not less than 45 calendar days; and 
‘‘(iv) if, after completion of the pro-
ceedings specified in clauses (i) through 
(iii), the Secretary determines that it is ap-
propriate to issue a final administrative 
order— 
‘‘(I) issue the final administrative 
order, together with a detailed state-
ment of reasons, which order shall not 
take effect until the time for request-
ing judicial review under paragraph 
(3)(D)(ii) has expired; 
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‘‘(II) publish a notice of such 
final administrative order in the Fed-
eral Register; 
‘‘(III) afford requestors of drugs 
that will be subject to such order the 
opportunity for formal dispute resolu-
tion up to the level of the Director of 
the Center for Drug Evaluation and 
Research, which initially must be re-
quested within 45 calendar days of 
the issuance of the order, and, for 
subsequent levels of appeal, within 30 
calendar days of the prior decision; 
and 
‘‘(IV) except with respect to 
drugs described in paragraph (3)(B), 
upon completion of the formal dispute 
resolution procedure, inform the per-
sons which sought such dispute reso-
lution of their right to request a hear-
ing. 
‘‘(B) EXCEPTIONS.—When issuing an ad-
ministrative order under paragraph (1) on the 
Secretary’s initiative proposing to determine 
that a drug described in subsection (a)(3) is not 
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generally recognized as safe and effective under 
section 201(p)(1), the Secretary shall follow the 
procedures in subparagraph (A), except that— 
‘‘(i) the proposed order shall include 
notice of— 
‘‘(I) the general categories of 
data the Secretary has determined 
necessary to establish that the drug is 
generally recognized as safe and effec-
tive under section 201(p)(1); and 
‘‘(II) the format for submissions 
by interested persons; 
‘‘(ii) the Secretary shall provide for a 
public comment period of no less than 180 
calendar days with respect to such pro-
posed order, except when the Secretary de-
termines, for good cause, that a shorter pe-
riod is in the interest of public health; and 
‘‘(iii) any person who submits data in 
such comment period shall include a cer-
tification that the person has submitted all 
evidence created, obtained, or received by 
that person that is both within the cat-
egories of data identified in the proposed 
order and relevant to a determination as to 
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whether the drug is generally recognized as 
safe and effective under section 201(p)(1). 
‘‘(3) HEARINGS; JUDICIAL REVIEW.— 
‘‘(A) IN
GENERAL.—Only a person who 
participated in each stage of formal dispute res-
olution under subclause (III) of paragraph 
(2)(A)(iv) of an administrative order with re-
spect to a drug may request a hearing con-
cerning a final administrative order issued 
under such paragraph with respect to such 
drug. If a hearing is sought, such person must 
submit a request for a hearing, which shall be 
based solely on information in the administra-
tive record, to the Secretary not later than 30 
calendar days after receiving notice of the final 
decision of the formal dispute resolution proce-
dure. 
‘‘(B) NO
HEARING
REQUIRED
WITH
RE-
SPECT
TO
ORDERS
RELATING
TO
CERTAIN 
DRUGS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall not be required to provide notice and 
an opportunity for a hearing pursuant to 
paragraph (2)(A)(iv) if the final adminis-
trative order involved relates to a drug— 
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‘‘(I) that is described in sub-
section (a)(3)(A); and 
‘‘(II) with respect to which no 
human or non-human data studies rel-
evant to the safety or effectiveness of 
such drug have been submitted to the 
administrative 
record 
since 
the 
issuance of the most recent tentative 
final monograph relating to such 
drug. 
‘‘(ii) HUMAN
DATA
STUDIES
AND 
NON-HUMAN DATA DEFINED.—In this sub-
paragraph: 
‘‘(I) The term ‘human data stud-
ies’ means clinical trials of safety or 
effectiveness (including actual use 
studies), pharmacokinetics studies, or 
bioavailability studies. 
‘‘(II) The term ‘non-human data’ 
means data from testing other than 
with human subjects which provides 
information concerning safety or ef-
fectiveness. 
‘‘(C) HEARING PROCEDURES.— 
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