167 
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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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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171 
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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174 
‘‘(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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178 
‘‘(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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179 
‘‘(i) DENIAL OF REQUEST FOR HEAR-
ING.—If the Secretary determines that in-
formation submitted in a request for a 
hearing under subparagraph (A) with re-
spect to a final administrative order issued 
under paragraph (2)(A)(iv), does not iden-
tify the existence of a genuine and sub-
stantial question of material fact, the Sec-
retary may deny such request. In making 
such a determination, the Secretary may 
consider only information and data that 
are based on relevant and reliable scientific 
principles and methodologies. 
‘‘(ii) SINGLE HEARING FOR MULTIPLE 
RELATED
REQUESTS.—If more than one 
request for a hearing is submitted with re-
spect to the same administrative order 
under subparagraph (A), the Secretary 
may direct that a single hearing be con-
ducted in which all persons whose hearing 
requests were granted may participate. 
‘‘(iii) PRESIDING OFFICER.—The pre-
siding officer of a hearing requested under 
subparagraph (A) shall— 
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180 
‘‘(I) be designated by the Sec-
retary; 
‘‘(II) not be an employee of the 
Center for Drug Evaluation and Re-
search; and 
‘‘(III) not have been previously 
involved in the development of the ad-
ministrative order involved or pro-
ceedings relating to that administra-
tive order. 
‘‘(iv) RIGHTS OF PARTIES TO HEAR-
ING.—The parties to a hearing requested 
under subparagraph (A) shall have the 
right to present testimony, including testi-
mony of expert witnesses, and to cross-ex-
amine witnesses presented by other parties. 
Where appropriate, the presiding officer 
may require that cross-examination by par-
ties representing substantially the same in-
terests be consolidated to promote effi-
ciency and avoid duplication. 
‘‘(v) FINAL DECISION.— 
‘‘(I) At the conclusion of a hear-
ing requested under subparagraph 
(A), the presiding officer of the hear-
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181 
ing shall issue a decision containing 
findings of fact and conclusions of 
law. The decision of the presiding offi-
cer shall be final. 
‘‘(II) The final decision may not 
take effect until the period under sub-
paragraph (D)(ii) for submitting a re-
quest for judicial review of such deci-
sion expires. 
‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN-
ISTRATIVE ORDER.— 
‘‘(i) IN
GENERAL.—The procedures 
described in section 505(h) shall apply 
with respect to judicial review of final ad-
ministrative orders issued under this sub-
section in the same manner and to the 
same extent as such section applies to an 
order described in such section except that 
the judicial review shall be taken by filing 
in an appropriate district court of the 
United States in lieu of the appellate 
courts specified in such section. 
‘‘(ii) PERIOD TO SUBMIT A REQUEST 
FOR JUDICIAL REVIEW.—A person eligible 
to request a hearing under this paragraph 
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and seeking judicial review of a final ad-
ministrative order issued under this sub-
section shall file such request for judicial 
review not later than 60 calendar days 
after the latest of— 
‘‘(I) the date on which notice of 
such order is published; 
‘‘(II) the date on which a hearing 
with respect to such order is denied 
under subparagraph (B) or (C)(i); 
‘‘(III) the date on which a final 
decision is made following a hearing 
under subparagraph (C)(v); or 
‘‘(IV) if no hearing is requested, 
the date on which the time for re-
questing a hearing expires. 
‘‘(4) EXPEDITED PROCEDURE WITH RESPECT 
TO
ADMINISTRATIVE
ORDERS
INITIATED
BY
THE 
SECRETARY.— 
‘‘(A) IMMINENT HAZARD TO THE PUBLIC 
HEALTH.— 
‘‘(i) IN GENERAL.—In the case of a 
determination by the Secretary that a 
drug, class of drugs, or combination of 
drugs subject to this section poses an im-
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minent hazard to the public health, the 
Secretary, after first making reasonable ef-
forts to notify, not later than 48 hours be-
fore issuance of such order under this sub-
paragraph, sponsors who have a listing in 
effect under section 510(j) for such drug 
or combination of drugs— 
‘‘(I) may issue an interim final 
administrative order for such drug, 
class of drugs, or combination of 
drugs under paragraph (1), together 
with a detailed statement of the rea-
sons for such order; 
‘‘(II) shall publish in the Federal 
Register a notice of availability of any 
such order; and 
‘‘(III) shall provide for a public 
comment period of at least 45 cal-
endar days with respect to such in-
terim final order. 
‘‘(ii) 
NONDELEGATION.—The 
Sec-
retary may not delegate the authority to 
issue an interim final administrative order 
under this subparagraph. 
‘‘(B) SAFETY LABELING CHANGES.— 
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184 
‘‘(i) IN GENERAL.—In the case of a 
determination by the Secretary that a 
change in the labeling of a drug, class of 
drugs, or combination of drugs subject to 
this section is reasonably expected to miti-
gate a significant or unreasonable risk of 
a serious adverse event associated with use 
of the drug, the Secretary may— 
‘‘(I) make reasonable efforts to 
notify informally, not later than 48 
hours before the issuance of the in-
terim final order, the sponsors of 
drugs who have a listing in effect 
under section 510(j) for such drug or 
combination of drugs; 
‘‘(II) after reasonable efforts of 
notification, issue an interim final ad-
ministrative order in accordance with 
paragraph (1) to require such change, 
together with a detailed statement of 
the reasons for such order; 
‘‘(III) publish in the Federal 
Register a notice of availability of 
such order; and 
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185 
‘‘(IV) provide for a public com-
ment period of at least 45 calendar 
days with respect to such interim final 
order. 
‘‘(ii) CONTENT
OF
ORDER.—An in-
terim final order issued under this sub-
paragraph with respect to the labeling of a 
drug may provide for new warnings and 
other information required for safe use of 
the drug. 
‘‘(C) EFFECTIVE DATE.—An order under 
subparagraph (A) or (B) shall take effect on a 
date specified by the Secretary. 
‘‘(D) FINAL ORDER.—After the completion 
of the proceedings in subparagraph (A) or (B), 
the Secretary shall— 
‘‘(i) issue a final order in accordance 
with paragraph (1); 
‘‘(ii) publish a notice of availability of 
such final administrative order in the Fed-
eral Register; and 
‘‘(iii) afford sponsors of such drugs 
that will be subject to such an order the 
opportunity for formal dispute resolution 
up to the level of the Director of the Cen-
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186 
ter for Drug Evaluation and Research, 
which must initially be within 45 calendar 
days of the issuance of the order, and for 
subsequent levels of appeal, within 30 cal-
endar days of the prior decision. 
‘‘(E) HEARINGS.—A sponsor of a drug 
subject to a final order issued under subpara-
graph (D) and that participated in each stage 
of formal dispute resolution under clause (iii) of 
such subparagraph may request a hearing on 
such order. The provisions of subparagraphs 
(A), (B), and (C) of paragraph (3), other than 
paragraph (3)(C)(v)(II), shall apply with re-
spect to a hearing on such order in the same 
manner and to the same extent as such provi-
sions apply with respect to a hearing on an ad-
ministrative order issued under paragraph 
(2)(A)(iv). 
‘‘(F) TIMING.— 
‘‘(i) FINAL ORDER AND HEARING.— 
The Secretary shall— 
‘‘(I) not later than 6 months 
after the date on which the comment 
period closes under subparagraph (A) 
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187 
or (B), issue a final order in accord-
ance with paragraph (1); and 
‘‘(II) not later than 12 months 
after the date on which such final 
order is issued, complete any hearing 
under subparagraph (E). 
‘‘(ii) 
DISPUTE
RESOLUTION
RE-
QUEST.—The Secretary shall specify in an 
interim final order issued under subpara-
graph (A) or (B) such shorter periods for 
requesting dispute resolution under sub-
paragraph (D)(iii) as are necessary to 
meet the requirements of this subpara-
graph. 
‘‘(G) JUDICIAL
REVIEW.—A final order 
issued pursuant to subparagraph (F) shall be 
subject to judicial review in accordance with 
paragraph (3)(D). 
‘‘(5) ADMINISTRATIVE
ORDER
INITIATED
AT 
THE REQUEST OF A REQUESTOR.— 
‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) at the re-
quest of a requestor with respect to certain 
drugs, classes of drugs, or combinations of 
drugs— 
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188 
‘‘(i) the Secretary shall, after receiv-
ing a request under this subparagraph, de-
termine whether the request is sufficiently 
complete and formatted to permit a sub-
stantive review; 
‘‘(ii) if the Secretary determines that 
the request is sufficiently complete and for-
matted to permit a substantive review, the 
Secretary shall— 
‘‘(I) file the request; and 
‘‘(II) initiate proceedings with re-
spect to issuing an administrative 
order in accordance with paragraphs 
(2) and (3); and 
‘‘(iii) except as provided in paragraph 
(6), if the Secretary determines that a re-
quest does not meet the requirements for 
filing or is not sufficiently complete and 
formatted to permit a substantive review, 
the requestor may demand that the request 
be filed over protest, and the Secretary 
shall initiate proceedings to review the re-
quest in accordance with paragraph (2)(A). 
‘‘(B) 
REQUEST
TO
INITIATE
PRO-
CEEDINGS.— 
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189 
‘‘(i) IN GENERAL.—A requestor seek-
ing an administrative order under para-
graph (1) with respect to certain drugs, 
classes of drugs, or combinations of drugs, 
shall submit to the Secretary a request to 
initiate proceedings for such order in the 
form and manner as specified by the Sec-
retary. Such requestor may submit a re-
quest under this subparagraph for the 
issuance of an administrative order— 
‘‘(I) determining whether a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), ex-
empt from section 503(b)(1), and not 
required to be the subject of an ap-
proved application under section 505; 
or 
‘‘(II) 
determining 
whether 
a 
change to a condition of use of a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), ex-
empt from section 503(b)(1), and not 
required to be the subject of an ap-
proved application under section 505, 
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if, absent such a changed condition of 
use, such drug is— 
‘‘(aa) generally recognized 
as safe and effective under sec-
tion 201(p)(1) in accordance with 
subsection (a)(1), (a)(2), or an 
order under this subsection; or 
‘‘(bb) subject to subsection 
(a)(3), but only if such requestor 
initiates such request in conjunc-
tion with a request for the Sec-
retary to determine whether such 
drug is generally recognized as 
safe and effective under section 
201(p)(1), which is filed by the 
Secretary under subparagraph 
(A)(ii). 
‘‘(ii) EXCEPTION.—The Secretary is 
not required to complete review of a re-
quest for a change described in clause 
(i)(II) if the Secretary determines that 
there is an inadequate basis to find the 
drug is generally recognized as safe and ef-
fective under section 201(p)(1) under para-
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graph (1) and issues a final order an-
nouncing that determination. 
‘‘(iii) WITHDRAWAL.—The requestor 
may withdraw a request under this para-
graph, according to the procedures set 
forth pursuant to subsection (d)(2)(B). 
Notwithstanding any other provision of 
this section, if such request is withdrawn, 
the Secretary may cease proceedings under 
this subparagraph. 
‘‘(C) EXCLUSIVITY.— 
‘‘(i) IN GENERAL.—A final adminis-
trative order issued in response to a re-
quest under this section shall have the ef-
fect of authorizing solely the order re-
questor (or the licensees, assignees, or suc-
cessors in interest of such requestor with 
respect to the subject of such order), for a 
period of 18 months following the effective 
date of such final order and beginning on 
the date the requestor may lawfully market 
such drugs pursuant to the order, to mar-
ket drugs— 
‘‘(I) incorporating changes de-
scribed in clause (ii); and 
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‘‘(II) subject to the limitations 
under clause (iv). 
‘‘(ii) 
CHANGES
DESCRIBED.—A 
change described in this clause is a change 
subject to an order specified in clause (i), 
which— 
‘‘(I) provides for a drug to con-
tain an active ingredient (including 
any ester or salt of the active ingre-
dient) not previously incorporated in a 
drug described in clause (iii); or 
‘‘(II) provides for a change in the 
conditions of use of a drug, for which 
new human data studies conducted or 
sponsored by the requestor (or for 
which the requestor has an exclusive 
right of reference) were essential to 
the issuance of such order. 
‘‘(iii) DRUGS DESCRIBED.—The drugs 
described in this clause are drugs— 
‘‘(I) 
specified 
in 
subsection 
(a)(1), (a)(2), or (a)(3); 
‘‘(II) subject to a final order 
issued under this section; 
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193 
‘‘(III) subject to a final sun-
screen order (as defined in section 
586(2)(A)); or 
‘‘(IV) described in subsection 
(m)(1), other than drugs subject to an 
active enforcement action under chap-
ter III of this Act. 
‘‘(iv) 
LIMITATIONS
ON
EXCLU-
SIVITY.— 
‘‘(I) IN GENERAL.—Only one 18- 
month period under this subpara-
graph shall be granted, under each 
order described in clause (i), with re-
spect to changes (to the drug subject 
to such order) which are either— 
‘‘(aa) changes described in 
clause (ii)(I), relating to active 
ingredients; or 
‘‘(bb) changes described in 
clause (ii)(II), relating to condi-
tions of use. 
‘‘(II) 
NO
EXCLUSIVITY
AL-
LOWED.—No exclusivity shall apply to 
changes to a drug which are— 
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‘‘(aa) the subject of a Tier 2 
OTC monograph order request 
(as defined in section 744L); 
‘‘(bb) safety-related changes, 
as defined by the Secretary, or 
any other changes the Secretary 
considers necessary to assure 
safe use; or 
‘‘(cc) changes related to 
methods of testing safety or effi-
cacy. 
‘‘(v) NEW HUMAN DATA STUDIES DE-
FINED.—In this subparagraph, the term 
‘new human data studies’ means clinical 
trials of safety or effectiveness (including 
actual use studies), pharmacokinetics stud-
ies, or bioavailability studies, the results of 
which— 
‘‘(I) have not been relied on by 
the Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized 
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195 
as safe and effective under sec-
tion 201(p)(1); or 
‘‘(bb) approval of a drug 
that was approved under section 
505; and 
‘‘(II) do not duplicate the results 
of another study that was relied on by 
the Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective under sec-
tion 201(p)(1); or 
‘‘(bb) approval of a drug 
that was approved under section 
505. 
‘‘(6) INFORMATION
REGARDING
SAFE
NON-
PRESCRIPTION MARKETING AND USE AS CONDITION 
FOR FILING A GENERALLY RECOGNIZED AS SAFE 
AND EFFECTIVE REQUEST.— 
‘‘(A) IN GENERAL.—In response to a re-
quest under this section that a drug described 
in subparagraph (B) be generally recognized as 
safe and effective, the Secretary— 
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196 
‘‘(i) may file such request, if the re-
quest includes information specified under 
subparagraph (C) with respect to safe non-
prescription marketing and use of such 
drug; or 
‘‘(ii) if the request fails to include in-
formation specified under subparagraph 
(C), shall refuse to file such request and 
require that nonprescription marketing of 
the drug be pursuant to a new drug appli-
cation as described in subparagraph (D). 
‘‘(B) DRUG
DESCRIBED.—A drug de-
scribed in this subparagraph is a nonprescrip-
tion drug which contains an active ingredient 
not previously incorporated in a drug— 
‘‘(i) specified in subsection (a)(1), 
(a)(2), or (a)(3); 
‘‘(ii) subject to a final order under 
this section; or 
‘‘(iii) subject to a final sunscreen 
order (as defined in section 586(2)(A)). 
‘‘(C) 
INFORMATION
DEMONSTRATING 
PRIMA
FACIE
SAFE
NONPRESCRIPTION
MAR-
KETING
AND
USE.—Information specified in 
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this subparagraph, with respect to a request de-
scribed in subparagraph (A)(i), is— 
‘‘(i) information sufficient for a prima 
facie demonstration that the drug subject 
to such request has a verifiable history of 
being marketed and safely used by con-
sumers in the United States as a non-
prescription drug under comparable condi-
tions of use; 
‘‘(ii) if the drug has not been pre-
viously marketed in the United States as a 
nonprescription drug, information suffi-
cient for a prima facie demonstration that 
the drug was marketed and safely used 
under comparable conditions of marketing 
and use in a country listed in section 
802(b)(1)(A) or designated by the Sec-
retary 
in 
accordance 
with 
section 
802(b)(1)(B)— 
‘‘(I) for such period as needed to 
provide reasonable assurances con-
cerning the safe nonprescription use 
of the drug; and 
‘‘(II) during such time was sub-
ject to sufficient monitoring by a reg-
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