115TH CONGRESS 
2D SESSION 
H. R. 5333 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
clarify the regulatory framework with respect to certain 
nonprescription drugs that are marketed without an ap-
proved new drug application, and for other purposes. 
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 ‘‘Over-the-Counter 
Monograph Safety, Innovation, and Reform Act of 2018’’. 
TITLE I—OTC DRUG REVIEW 
SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED NEW DRUG APPLICATION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355g) the following: 
‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED NEW DRUG APPLICATION. 
‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH-
OUT
AN
APPROVED
APPLICATION.—Nonprescription 
drugs marketed without an approved new drug application 
under section 505, as of the date of the enactment of the 
Over-the-Counter Monograph Safety, Innovation, and Re-
form Act of 2018, shall be treated in accordance with this 
subsection. 
‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 
CATEGORY
I
DRUGS
SUBJECT
TO
A
TENTATIVE 
FINAL MONOGRAPH.—A drug is deemed to be gen-
erally recognized as safe and effective within the 
meaning of section 201(p)(1), not a new drug under
section 201(p), and not subject to section 503(b)(1), 
if— 
‘‘(A) the drug is— 
‘‘(i) in conformity with the require-
ments for nonprescription use of a final 
monograph issued under part 330 of title 
21, Code of Federal Regulations (except as 
provided in paragraph (2)), the general re-
quirements for nonprescription drugs, and 
requirements under subsections (b), (c), 
and (k); and 
‘‘(ii) 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 within the 
meaning of section 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a tentative final 
monograph that is the most recently appli-
cable proposal or determination issued
under part 330 of title 21, Code of Federal 
Regulations; 
‘‘(ii) in conformity with the proposed 
requirements for nonprescription use of 
such tentative final monograph, any appli-
cable subsequent determination by the Sec-
retary, the general requirements for non-
prescription drugs, and requirements 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 within the 
meaning of section 201(p)(2). 
‘‘(2) TREATMENT
OF
SUNSCREEN
DRUGS.— 
With respect to sunscreen drugs subject to this sec-
tion, the applicable requirements shall be the re-
quirements specified in part 352 of title 21, Code of 
Federal Regulations, as published on May 21, 1999, 
beginning on page 27687 of volume 64 of the Fed-
eral Register, except that the applicable require-
ments governing effectiveness and labeling shall be 
those specified in section 201.327 of title 21, Code 
of Federal Regulations, subject to the requirements 
of subsections (b), (c), and (k). 
‘‘(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 paragraphs (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; 
‘‘(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 require-
ments under subsections (b) or (k); 
and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, was not required to have 
satisfied 
the 
requirements 
of 
section 
330.14 of title 21, Code of Federal Regula-
tions (as in effect at that time), in order 
for such drug to be lawfully marketed 
without an application approved under sec-
tion 505; 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; 
‘‘(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 requirements under subsections 
(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 within the 
meaning of section 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 
safe or effective in a proposed rule that is the most
recently applicable proposal issued under part 330 of 
title 21, Code of Federal Regulations, shall be 
deemed to be a new drug within the meaning of sec-
tion 201(p), misbranded under section 502(ee), and 
subject to the requirement for an approved new drug 
application under section 505 beginning on the day 
that is 180 calendar days after the date of the en-
actment of this section, unless, before 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 
within the meaning of 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 within the meaning of section 201(p), 
misbranded under section 502(ee), and subject to 
the requirement for an approved new drug applica-
tion under section 505. 
‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 
Except as provided in subsection (m), a drug is 
deemed to be a new drug within the meaning of sec-
tion 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 paragraphs (1), 
(2), (3), (4), or (5), or subsection (b)(1)(B). 
‘‘(b) ADMINISTRATIVE ORDERS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) 
DETERMINATION.—The 
Secretary 
may, on the initiative of the Secretary or at the 
request of one or more requestors, issue admin-
istrative orders determining whether there are 
conditions under which specific drugs, classes of 
such drugs, or combinations of such drugs are 
determined to be— 
‘‘(i) not subject to section 503(b)(1); 
and 
‘‘(ii) generally recognized as safe and 
effective within the meaning of 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). 
‘‘(C) STANDARD.—The Secretary shall find 
that a drug is not generally recognized as safe 
and effective within the meaning of section 
201(p)(1) if— 
‘‘(i) the evidence shows that the drug 
is not generally recognized as safe and ef-
fective within the meaning of section 
201(p)(1); or 
‘‘(ii) the evidence is inadequate to 
show that the drug is generally recognized 
as safe and effective within the meaning of 
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— 
‘‘(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; 
‘‘(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 
generally recognized as safe and effective within 
the meaning of 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 within the meaning of 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 interests 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 
whether the drug is generally recognized as 
safe and effective within the meaning of 
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. Such person must submit a request for a 
hearing, which shall be based solely on informa-
tion in the administrative record, to the Sec-
retary not later than 30 calendar days after re-
ceiving notice of the final decision of the formal 
dispute resolution procedure. 
‘‘(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— 
‘‘(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.— 
‘‘(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— 
‘‘(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-
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 
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-
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.— 
‘‘(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 
‘‘(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-
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) 
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— 
‘‘(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.— 
‘‘(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 within the meaning of section 
201(p)(1), 
exempt 
from 
section 
503(b)(1), and not required to be the 
subject of an approved 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 within the meaning of section 
201(p)(1), 
exempt 
from 
section 
503(b)(1), and not required to be the 
subject of an approved application 
under section 505, if, absent such a 
changed condition of use, such drug 
is— 
‘‘(aa) generally recognized 
as safe and effective within the 
meaning of section 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 within the 
meaning of 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 within the meaning of section 
201(p)(1) under paragraph (1) and issues 
a final order announcing that determina-
tion. 
‘‘(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, to market drugs— 
‘‘(I) incorporating changes de-
scribed in clause (ii); 
‘‘(II) beginning on the date the 
requestor (or any such licensees, as-
signees, or successors in interest) may 
lawfully market such drugs pursuant 
to the order; and 
‘‘(III) 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; 
‘‘(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 pe-
riod of exclusivity shall be granted, 
under each order described in clause 
(i), with respect 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— 
‘‘(aa) the subject of a Tier 2 
OTC monograph order request 
(as defined in section 744N); 
‘‘(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 subclauses (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective within the 
meaning of section 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 subclauses (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective within the 
meaning of section 201(p)(1); or 
‘‘(bb) approval of a drug 
that was approved under section 
505. 
‘‘(vi) 
EFFECTIVE
DATE.—A 
final 
order subject to clause (i) shall take effect 
on the date when the order requestor (or 
the licensees, assignees, or successors in 
interest of such requestor with respect to 
such order) submits updated drug listing 
information under subsection (e) with re-
spect to the change which is permitted 
under such order. 
‘‘(vii) GAO STUDY.—Not later than 4 
years after the date of enactment of the 
Over-the-Counter Monograph, Safety, In-
novation, and Reform Act of 2018, the 
Comptroller General of the United States 
shall submit a study to the Committee on 
Energy and Commerce of the House of
Representatives and the Committee on 
Health, Education, Labor, and Pensions of 
the Senate addressing the effectiveness and 
overall impact of exclusivity under this sec-
tion, including its impact on consumer ac-
cess. Such study shall include— 
‘‘(I) the number of nonprescrip-
tion drug products that were granted 
exclusivity and the indication for 
which the nonprescription drug prod-
ucts were determined to be generally 
recognized as safe and effective; 
‘‘(II) whether the exclusivity for 
such drug products was granted for— 
‘‘(aa) a new active ingre-
dient (including any ester or salt 
of the active ingredient); or 
‘‘(bb) changes in the condi-
tions of use of a drug, for which 
new human data studies con-
ducted or sponsored by the re-
questor were essential; 
‘‘(III) whether, and to what ex-
tent, the exclusivity impacted the re-
questor’s or sponsor’s decision to de-
velop the drug product; 
‘‘(IV) an analysis of the imple-
mentation of the exclusivity provision 
in this subparagraph, including— 
‘‘(aa) the resources used by 
the Food and Drug Administra-
tion; 
‘‘(bb) the impact of such 
provision on innovation, as well 
as research and development in 
the nonprescription drug market; 
‘‘(cc) the impact of such 
provision on competition in the 
nonprescription drug market; 
‘‘(dd) the impact of such 
provision on consumer access to 
nonprescription drug products; 
‘‘(ee) the impact of such 
provision on the prices of non-
prescription drug products; and 
‘‘(ff) whether the adminis-
trative orders initiated by reques-
tors under this section have been 
sufficient to encourage the devel-
opment of nonprescription drug 
products that would likely not be 
otherwise developed, or developed 
in as timely a manner; and 
‘‘(V) whether the administrative 
orders initiated by requestors under 
this section have been sufficient incen-
tive to encourage innovation in the 
nonprescription drug market. 
‘‘(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— 
‘‘(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 
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 of time as 
needed to provide reasonable assur-
ances concerning the safe nonprescrip-
tion use of the drug; and 
‘‘(II) during such time was sub-
ject to sufficient monitoring by a reg-
ulatory body considered acceptable by 
the Secretary for such monitoring 
purposes, including for adverse events 
associated with nonprescription use of 
the drug; or 
‘‘(iii) if the Secretary determines that 
information described in clauses (i) or (ii) 
is not needed to provide a prima facie dem-
onstration that the drug can be safely mar-
keted and used as a nonprescription drug, 
such other information the Secretary deter-
mines is sufficient for such purposes. 
‘‘(D) MARKETING
PURSUANT
TO
NEW 
DRUG APPLICATION.—In the case of a request 
described in subparagraph (A)(ii), the drug 
subject to such request may be re-submitted for 
filing only if— 
‘‘(i) the drug is marketed as a non-
prescription drug, under conditions of use 
comparable to the conditions specified in 
the request, for such period of time as the 
Secretary determines appropriate (not to 
exceed 5 consecutive years) pursuant to an 
application approved under section 505; 
and 
‘‘(ii) during such time period, one mil-
lion retail packages of the drug, or an 
equivalent quantity as determined by the 
Secretary, were distributed for retail sale, 
as determined in such manner as the Sec-
retary finds appropriate. 
‘‘(E) RULE OF APPLICATION.—Except in 
the case of a request involving a drug described 
in section 586(9), as in effect on January 1,
2017, if the Secretary refuses to file a request 
under this paragraph, the requestor may not 
file such request over protest under paragraph 
(5)(A)(iii). 
‘‘(7) PACKAGING.—An administrative order 
issued under paragraph (2), (4)(A), or (5) may in-
clude requirements for the packaging of a drug to 
encourage use in accordance with labeling. Such re-
quirements may include unit dose packaging, re-
quirements for products intended for use by chil-
dren, requirements to reduce risk of harm from un-
supervised ingestion, and other appropriate require-
ments. This paragraph does not authorize the Food 
and Drug Administration to require standards or 
testing procedures as described in part 1700 of title 
16, Code of Federal Regulations. 
‘‘(8) FINAL
AND
TENTATIVE
FINAL
MONO-
GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL 
ADMINISTRATIVE ORDERS.— 
‘‘(A) IN GENERAL.—A final monograph or 
tentative final monograph described in subpara-
graph (B) shall be deemed to be a final admin-
istrative order under this subsection and may 
be amended, revoked, or otherwise modified in
accordance with the procedures of this sub-
section. 
‘‘(B) MONOGRAPHS DESCRIBED.—For pur-
poses of subparagraph (A), a final monograph 
or tentative final monograph is described in this 
subparagraph if it— 
‘‘(i) establishes conditions of use for a 
drug described in paragraph (1) or (2) of 
subsection (a); and 
‘‘(ii) represents the most recently pro-
mulgated version of such conditions, in-
cluding as modified, in whole or in part, by 
any proposed or final rule. 
‘‘(C) DEEMED ORDERS INCLUDE HARMO-
NIZING
TECHNICAL
AMENDMENTS.—The 
deemed establishment of a final administrative 
order under subparagraph (A) shall be con-
strued to include any technical amendments to 
such order as the Secretary determines nec-
essary to ensure that such order is appro-
priately harmonized, in terms of terminology or 
cross-references, with the applicable provisions 
of this Act (and regulations thereunder) and 
any other orders issued under this section. 
‘‘(c) PROCEDURE FOR MINOR CHANGES.—
‘‘(1) IN GENERAL.—Minor changes in the dos-
age form of a drug that is described in paragraph 
(1) or (2) of subsection (a) or the subject of an 
order issued under subsection (b) may be made by 
a requestor without the issuance of an order under 
subsection (b) if— 
‘‘(A) the requestor maintains such infor-
mation as is necessary to demonstrate that the 
change— 
‘‘(i) will not affect the safety or effec-
tiveness of the drug; and 
‘‘(ii) will not materially affect the ex-
tent of absorption or other exposure to the 
active ingredient in comparison to a suit-
able reference product; and 
‘‘(B) the change is in conformity with the 
requirements of an applicable administrative 
order issued by the Secretary under paragraph 
(3). 
‘‘(2) ADDITIONAL INFORMATION.— 
‘‘(A) ACCESS
TO
RECORDS.—A sponsor 
shall submit records requested by the Secretary 
relating to such a minor change under section 
704(a)(4), within 15 business days of receiving
such a request, or such longer period as the 
Secretary may provide. 
‘‘(B) INSUFFICIENT INFORMATION.—If the 
Secretary determines that the information con-
tained in such records is not sufficient to dem-
onstrate that the change does not affect the 
safety or effectiveness of the drug or materially 
affect the extent of absorption or other expo-
sure to the active ingredient, the Secretary— 
‘‘(i) may so inform the sponsor of the 
drug in writing; and 
‘‘(ii) provide the sponsor of the drug 
with a reasonable opportunity to provide 
additional information. 
‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN-
FORMATION.—If the sponsor fails to provide 
such additional information within the pre-
scribed time, or if the Secretary determines that 
such additional information does not dem-
onstrate that the change does not affect the 
safety or effectiveness of the drug or materially 
affect the extent of absorption or other expo-
sure to the active ingredient, the drug as modi-
fied is a new drug within the meaning of sec-
tion 201(p) and shall be deemed to be mis-
branded under section 502(ee). 
‘‘(3) DETERMINING WHETHER A CHANGE WILL 
AFFECT SAFETY OR EFFECTIVENESS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue one or more administrative orders speci-
fying requirements for determining whether a 
minor change made by a sponsor pursuant to 
this subsection will affect the safety or effective-
ness of a drug or materially affect the extent of 
absorption or other exposure to an active ingre-
dient in the drug in comparison to a suitable 
reference product, together with guidance for 
applying those orders to specific dosage forms. 
‘‘(B) STANDARD PRACTICES.—The orders 
and guidance issued by the Secretary under 
subparagraph (A) shall take into account rel-
evant public standards and standard practices 
for evaluating the quality of drugs, and may 
take into account the special needs of popu-
lations, including children. 
‘‘(d) CONFIDENTIALITY
OF
INFORMATION
SUB-
MITTED TO THE SECRETARY.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
any information, including reports of testing con-
ducted on the drug or drugs involved, that is sub-
mitted by a requestor in connection with proceedings 
on an order under this section (including any minor 
change under subsection (c)) and is a trade secret 
or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code, shall not be 
disclosed to the public unless the requestor consents 
to that disclosure. 
‘‘(2) PUBLIC AVAILABILITY.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall— 
‘‘(i) make any information submitted 
by a requestor in support of a request 
under subsection (b)(5)(A) available to the 
public not later than the date on which the 
proposed order is issued; and 
‘‘(ii) make any information submitted 
by any other person with respect to an 
order requested (or initiated by the Sec-
retary) under subsection (b), available to 
the public upon such submission. 
‘‘(B) LIMITATIONS
ON
PUBLIC
AVAIL-
ABILITY.—Information described in subpara-
graph (A) shall not be made public if—
‘‘(i) the information pertains to phar-
maceutical quality information, unless such 
information is necessary to establish stand-
ards under which a drug is generally rec-
ognized as safe and effective within the 
meaning of section 201(p)(1); 
‘‘(ii) the information is submitted in a 
requestor-initiated request, but the re-
questor withdraws such request, in accord-
ance with withdrawal procedures estab-
lished by the Secretary, before the Sec-
retary issues the proposed order; 
‘‘(iii) the Secretary requests and ob-
tains the information under subsection (c) 
and such information is not submitted in 
relation to an order under subsection (b); 
or 
‘‘(iv) the information is of the type 
contained in raw datasets. 
‘‘(e) UPDATES TO DRUG LISTING INFORMATION.— 
A sponsor who makes a change to a drug subject to this 
section shall submit updated drug listing information for 
the drug in accordance with section 510(j) within 30 cal-
endar days of the date when the drug is first commercially 
marketed, except that a sponsor who was the order re-
questor with respect to an order subject to subsection 
(b)(5)(C) (or a licensee, assignee, or successor in interest 
of such requestor) shall submit updated drug listing infor-
mation on or before the date when the drug is first com-
mercially marketed. 
‘‘(f) APPROVALS UNDER SECTION 505.—The provi-
sions of this section shall not be construed to preclude a 
person from seeking or maintaining the approval of a drug 
under sections 505(b)(1), 505(b)(2), and 505(j). A deter-
mination under this section that a drug is not subject to 
section 503(b)(1), is generally recognized as safe and ef-
fective within the meaning of section 201(p)(1), and is not 
a new drug under section 201(p) shall constitute a finding 
that the drug is safe and effective that may be relied upon 
for purposes of an application under section 505(b)(2), so 
that the applicant shall be required to submit for purposes 
of such application only information needed to support any 
modification of the drug that is not covered by such deter-
mination under this section. 
‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR-
DERS.—The Secretary shall establish, maintain, update 
(as determined necessary by the Secretary but no less fre-
quently than annually), and make publicly available, with 
respect to orders issued under this section—
‘‘(1) a repository of each final order and in-
terim final order in effect, including the complete 
text of the order; and 
‘‘(2) a listing of all orders proposed and under 
development under subsection (b)(2), including— 
‘‘(A) a brief description of each such order; 
and 
‘‘(B) the Secretary’s expectations, if re-
sources permit, for issuance of proposed orders 
over a 3-year period. 
‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures 
under which sponsors or requestors may meet with appro-
priate officials of the Food and Drug Administration to 
obtain advice on the studies and other information nec-
essary to support submissions under this section and other 
matters relevant to the regulation of nonprescription 
drugs and the development of new nonprescription drugs 
under this section. 
‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures to 
facilitate efficient participation by multiple sponsors or re-
questors in proceedings under this section, including provi-
sion for joint meetings with multiple sponsors or reques-
tors or with organizations nominated by sponsors or re-
questors to represent their interests in a proceeding. 
‘‘(j) ELECTRONIC FORMAT.—All submissions under 
this section shall be in electronic format. 
‘‘(k) EFFECT
ON EXISTING REGULATIONS GOV-
ERNING NONPRESCRIPTION DRUGS.— 
‘‘(1) REGULATIONS
OF
GENERAL
APPLICA-
BILITY
TO
NONPRESCRIPTION
DRUGS.—Except as 
provided in this subsection, nothing in this section 
supersedes regulations establishing general require-
ments for nonprescription drugs, including regula-
tions of general applicability contained in parts 201, 
250, and 330 of title 21, Code of Federal Regula-
tions, or any successor regulations. The Secretary 
shall establish or modify such regulations by means 
of rulemaking in accordance with section 553 of title 
5, United States Code. 
‘‘(2) REGULATIONS
ESTABLISHING
REQUIRE-
MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 
‘‘(A) The provisions of section 310.545 of 
title 21, Code of Federal Regulations, as in ef-
fect on the day before the date of the enact-
ment of this section, shall be deemed to be a 
final order under subsection (b).
‘‘(B) Regulations in effect on the day be-
fore the date of the enactment of this section, 
establishing requirements for specific non-
prescription drugs marketed pursuant to this 
section (including such requirements in parts 
201 and 250 of title 21, Code of Federal Regu-
lations), shall be deemed to be final orders 
under subsection (b), only as they apply to 
drugs— 
‘‘(i) subject to paragraph (1), (2), (3), 
or (4) of subsection (a); or 
‘‘(ii) otherwise subject to an order 
under this section. 
‘‘(3) WITHDRAWAL
OF
REGULATIONS.—The 
Secretary shall withdraw regulations establishing 
final monographs and the procedures governing the 
over-the-counter drug review under part 330 and 
other relevant parts of title 21, Code of Federal 
Regulations (as in effect on the day before the date 
of the enactment of this section), or make technical 
changes to such regulations to ensure conformity 
with appropriate terminology and cross references. 
Notwithstanding subchapter II of chapter 5 of title 
5, United States Code, any such withdrawal or tech-
nical changes shall be made without public notice
and comment and shall be effective upon publication 
through notice in the Federal Register (or upon such 
date as specified in such notice). 
‘‘(l) GUIDANCE.—The Secretary shall issue guidance 
that specifies— 
‘‘(1) the procedures and principles for formal 
meetings between the Secretary and sponsors or re-
questors for drugs subject to this section; 
‘‘(2) the format and content of data submis-
sions to the Secretary under this section; 
‘‘(3) the format of electronic submissions to the 
Secretary under this section; 
‘‘(4) consolidated proceedings and the proce-
dures for such proceedings where appropriate; and 
‘‘(5) for minor changes in drugs, recommenda-
tions on how to comply with the requirements in or-
ders issued under subsection (c)(3). 
‘‘(m) RULE OF CONSTRUCTION.— 
‘‘(1) IN GENERAL.—This section shall not af-
fect the treatment or status of a nonprescription 
drug— 
‘‘(A) that is marketed without an applica-
tion approved under section 505 as of the date 
of the enactment of this section;
‘‘(B) that is not subject to an order issued 
under this section; and 
‘‘(C) to which paragraphs (1), (2), (3), (4), 
or (5) of subsection (a) do not apply. 
‘‘(2) TREATMENT
OF
PRODUCTS
PREVIOUSLY 
FOUND TO BE SUBJECT TO TIME AND EXTENT RE-
QUIREMENTS.— 
‘‘(A) Notwithstanding subsection (a), a 
drug described in subparagraph (B) may only 
be lawfully marketed, without an application 
approved under section 505, pursuant to an 
order issued under this section. 
‘‘(B) A drug described in this subpara-
graph is a drug which, prior to the date of the 
enactment of this section, the Secretary had de-
termined in a proposed or final rule to be ineli-
gible for review under the OTC drug review (as 
such phrase ‘OTC drug review’ was used in sec-
tion 330.14 of title 21, Code of Federal Regula-
tions, as in effect on the day before the date of 
the enactment of this section). 
‘‘(3) PRESERVATION OF AUTHORITY.— 
‘‘(A) Nothing in paragraph (1) shall be 
construed to preclude or limit the applicability 
of any other provision of this Act.
‘‘(B) Nothing in subsection (a) shall be 
construed to prohibit the Secretary from issuing 
an order under this section finding a drug to be 
not generally recognized as safe and effective 
within the meaning of section 201(p)(1), as the 
Secretary determines appropriate. 
‘‘(n) INVESTIGATIONAL NEW DRUGS.—A drug is not 
subject to this section if an exemption for investigational 
use under section 505(i) is in effect for such drug. 
‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION 
ACT.—Chapter 35 of title 44, United States Code, shall 
not apply to collections of information made under this 
section. 
‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT 
RULEMAKING
AND OTHER REQUIREMENTS.—The re-
quirements of subsection (b) shall apply with respect to 
orders issued under this section instead of the require-
ments of subchapter II of chapter 5 of title 5, United 
States Code. 
‘‘(q) DEFINITIONS.—In this section: 
‘‘(1) The term ‘nonprescription drug’ refers to 
a drug not subject to the requirements of section 
503(b)(1).
‘‘(2) The term ‘sponsor’ refers to any person 
marketing, manufacturing, or processing a drug 
that— 
‘‘(A) is listed pursuant to section 510(j); 
and 
‘‘(B) is or will be subject to an administra-
tive order of the Food and Drug Administra-
tion. 
‘‘(3) The term ‘requestor’ refers to any person 
or group of persons marketing, manufacturing, proc-
essing, or developing a drug.’’. 
SEC. 102. MISBRANDING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(ee) If it is a nonprescription drug that is subject 
to section 505G, is not the subject of an application ap-
proved under section 505, and does not comply with the 
requirements under section 505G. 
‘‘(ff) If it is a drug and it was manufactured, pre-
pared, propagated, compounded, or processed in a facility 
for which fees have not been paid as required by section 
744O.’’.
SEC. 
103. 
DRUGS 
EXCLUDED 
FROM 
THE 
OVER-THE- 
COUNTER DRUG REVIEW. 
(a) IN GENERAL.—Nothing in this Act (or the 
amendments made by this Act) shall apply to any non-
prescription drug which was excluded by the Food and 
Drug Administration from the Over-the-Counter Drug Re-
view in accordance with the statement set out at page 
9466 of volume 37 of the Federal Register, published on 
May 11, 1972. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to preclude or limit the applica-
bility of any other provision of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.). 
SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 
(a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC-
TIVE INGREDIENTS.— 
(1) APPLICABILITY
OF
SECTION
505G
FOR 
PENDING SUBMISSIONS.— 
(A) IN GENERAL.—A sponsor of a non-
prescription sunscreen active ingredient or com-
bination of nonprescription sunscreen active in-
gredients that, as of the date of enactment of 
this Act, is subject to a proposed sunscreen 
order under section 586C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360fff–3) 
may elect, by means of giving written notifica-
tion to the Secretary of Health and Human 
Services within 180 calendar days of the enact-
ment of this Act, to transition into the review 
of such ingredient or combination of ingredients 
pursuant to the process set out in section 505G 
of the Federal Food, Drug, and Cosmetic Act, 
as added by section 101 of this Act. 
(B) ELECTION EXERCISED.—Upon receipt 
by the Secretary of Health and Human Services 
of a timely notification under subparagraph 
(A)— 
(i) the proposed sunscreen order in-
volved is deemed to be a request for an 
order under subsection (b) of section 505G 
of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101 of this Act; 
and 
(ii) such order is deemed to have been 
accepted 
for 
filing 
under 
subsection 
(b)(6)(A)(i) of such section 505G. 
(C) ELECTION NOT EXERCISED.—A spon-
sor of a nonprescription sunscreen active ingre-
dient or combination of nonprescription sun-
screen active ingredients described in subpara-
graph (A) that does not elect for such ingre-
dient or combination of ingredients to be re-
viewed under section 505G of the Federal Food, 
Drug, and Cosmetic Act, as added by section 
101 of this Act, shall continue to have such in-
gredient or combination of ingredients reviewed 
in accordance with section 586C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360fff–3) and may not subsequently elect to 
transition into the review of such ingredient or 
combination of ingredients pursuant to the 
process set out in section 505G of such Act, as 
added by section 101 of this Act. 
(2) DEFINITIONS.—In this subsection, the 
terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac-
tive ingredient’’, and ‘‘proposed sunscreen order’’ 
have the meanings given to those terms in section 
586 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff). 
(b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 
(1) FINAL
SUNSCREEN
ORDERS.—Paragraph 
(3) of section 586C(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend-
ed to read as follows: