IB 
Union Calendar No. 640 
115TH CONGRESS 
2D SESSION 
H. R. 5333 
[Report No. 115–827] 
To amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory 
framework with respect to certain nonprescription drugs that are mar-
keted without an approved new drug application, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 19, 2018 
Mr. LATTA (for himself, Mr. BURGESS, Mr. GENE GREEN of Texas, Ms. 
DEGETTE, Mr. GUTHRIE, and Mrs. DINGELL) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
JULY 16, 2018 
Additional sponsors: Ms. MATSUI, Mr. FLEISCHMANN, and Mr. SCHRADER 
JULY 16, 2018 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 19, 2018] 
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A BILL 
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. 
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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 Mono-
graph 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 WITHOUT 
AN APPROVED APPLICATION.—Nonprescription drugs mar-
keted without an approved new drug application under sec-
tion 505, as of the date of the enactment of the Over-the- 
Counter Monograph Safety, Innovation, and Reform 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 generally rec-
ognized as safe and effective within the meaning of 
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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 ex-
tent 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 
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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 applicable 
subsequent determination by the Secretary, 
the general requirements for nonprescription 
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 ex-
tent 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 section, the 
applicable requirements shall be the requirements 
specified in part 352 of title 21, Code of Federal Reg-
ulations, as published on May 21, 1999, beginning on 
page 27687 of volume 64 of the Federal Register, ex-
cept that the applicable requirements governing effec-
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tiveness and labeling shall be those specified in section 
201.327 of title 21, Code of Federal Regulations, sub-
ject to the requirements of subsections (b), (c), and 
(k). 
‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN-
TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS SUB-
JECT TO PROPOSED MONOGRAPH OR ADVANCE NOTICE 
OF PROPOSED RULEMAKING.—A drug that is not de-
scribed 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 safety 
or effectiveness in the preamble of a pro-
posed 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 
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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 satis-
fied the requirements of section 330.14 of 
title 21, Code of Federal Regulations (as in 
effect at that time), in order for such drug 
to be lawfully marketed without an applica-
tion approved under section 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-
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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 ex-
tent 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 section 
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201(p), misbranded under section 502(ee), and subject 
to the requirement for an approved new drug applica-
tion under section 505 beginning on the day that is 
180 calendar days after the date of the enactment of 
this section, unless, before such day, the Secretary de-
termines that it is in the interest of public health to 
extend the period during which the drug may be mar-
keted without such an approved new drug applica-
tion. 
‘‘(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 deter-
mination 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 application under section 
505. 
‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.—Ex-
cept as provided in subsection (m), a drug is deemed 
to be a new drug within the meaning of section 
201(p) and misbranded under section 502(ee) if the 
drug— 
‘‘(A) is not subject to section 503(b)(1); and 
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‘‘(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 adminis-
trative orders determining whether there are con-
ditions 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); 
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‘‘(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 effective 
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 Sec-
retary’s initiative, the Secretary shall— 
‘‘(i) make reasonable efforts to notify 
informally, not later than 2 business days 
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before the issuance of the proposed order, the 
sponsors of drugs who have a listing in ef-
fect 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 Adminis-
tration 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— 
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‘‘(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 effective 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 proposed 
order, except when the Secretary determines, 
for good cause, that a shorter period is in 
the interests of public health; and 
‘‘(iii) any person who submits data in 
such comment period shall include a certifi-
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cation that the person has submitted all evi-
dence created, obtained, or received by that 
person that is both within the categories 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 reso-
lution 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 hear-
ing, which shall be based solely on information 
in the administrative record, to the Secretary 
not later than 30 calendar days after receiving 
notice of the final decision of the formal dispute 
resolution procedure. 
‘‘(B) NO
HEARING
REQUIRED
WITH
RE-
SPECT
TO
ORDERS
RELATING
TO
CERTAIN 
DRUGS.— 
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‘‘(i) IN GENERAL.—The Secretary shall 
not be required to provide notice and an op-
portunity for a hearing pursuant to para-
graph (2)(A)(iv) if the final administrative 
order involved relates to a drug— 
‘‘(I) that is described in subsection 
(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 subpara-
graph: 
‘‘(I) The term ‘human data stud-
ies’ means clinical trials of safety or 
effectiveness (including actual use stud-
ies), pharmacokinetics studies, or bio-
availability studies. 
‘‘(II) The term ‘non-human data’ 
means data from testing other than 
with human subjects which provides 
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information concerning safety or effec-
tiveness. 
‘‘(C) HEARING PROCEDURES.— 
‘‘(i) DENIAL OF REQUEST FOR HEAR-
ING.—If the Secretary determines that in-
formation submitted in a request for a hear-
ing under subparagraph (A) with respect to 
a final administrative order issued under 
paragraph (2)(A)(iv), does not identify the 
existence of a genuine and substantial ques-
tion of material fact, the Secretary may 
deny such request. In making such a deter-
mination, the Secretary may consider only 
information and data that are based on rel-
evant and reliable scientific principles and 
methodologies. 
‘‘(ii) SINGLE HEARING FOR MULTIPLE 
RELATED REQUESTS.—If more than one re-
quest 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 conducted in 
which all persons whose hearing requests 
were granted may participate. 
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‘‘(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 testimony of 
expert witnesses, and to cross-examine wit-
nesses presented by other parties. Where ap-
propriate, the presiding officer may require 
that cross-examination by parties rep-
resenting substantially the same interests be 
consolidated to promote efficiency and avoid 
duplication. 
‘‘(v) FINAL DECISION.— 
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‘‘(I) At the conclusion of a hear-
ing requested under subparagraph (A), 
the presiding officer of the hearing 
shall issue a decision containing find-
ings of fact and conclusions of law. The 
decision of the presiding officer 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 ADMINIS-
TRATIVE ORDER.— 
‘‘(i) IN GENERAL.—The procedures de-
scribed in section 505(h) shall apply with 
respect to judicial review of final adminis-
trative orders issued under this subsection 
in the same manner and to the same extent 
as such section applies to an order described 
in such section except that the judicial re-
view shall be taken by filing in an appro-
priate district court of the United States in 
lieu of the appellate courts specified in such 
section. 
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‘‘(i) IN GENERAL.—In the case of a de-
termination by the Secretary that a drug, 
class of drugs, or combination of drugs sub-
ject to this section poses an imminent haz-
ard to the public health, the Secretary, after 
first making reasonable efforts to notify, not 
later than 48 hours before issuance of such 
order under this subparagraph, 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 reasons 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 calendar 
days with respect to such interim final 
order. 
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‘‘(ii) NONDELEGATION.—The Secretary 
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 de-
termination 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 mitigate a signifi-
cant or unreasonable risk of a serious ad-
verse event associated with use of the drug, 
the Secretary may— 
‘‘(I) make reasonable efforts to no-
tify informally, not later than 48 hours 
before the issuance of the interim 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 no-
tification, 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; 
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‘‘(III) publish in the Federal Reg-
ister 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 subpara-
graph 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 
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‘‘(iii) afford sponsors of such drugs 
that will be subject to such an order the op-
portunity for formal dispute resolution up 
to the level of the Director of the Center 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 calendar days of 
the prior decision. 
‘‘(E) HEARINGS.—A sponsor of a drug sub-
ject to a final order issued under subparagraph 
(D) and that participated in each stage of for-
mal 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 respect to a hear-
ing on such order in the same manner and to the 
same extent as such provisions apply with re-
spect to a hearing on an administrative order 
issued under paragraph (2)(A)(iv). 
‘‘(F) TIMING.— 
‘‘(i) FINAL ORDER AND HEARING.—The 
Secretary shall— 
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‘‘(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 accordance 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 subparagraph. 
‘‘(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 request 
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of a requestor with respect to certain drugs, 
classes of drugs, or combinations of drugs— 
‘‘(i) the Secretary shall, after receiving 
a request under this subparagraph, deter-
mine 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 fil-
ing or is not sufficiently complete and for-
matted 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 request in 
accordance with paragraph (2)(A). 
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‘‘(B) 
REQUEST
TO
INITIATE
PRO-
CEEDINGS.— 
‘‘(i) IN GENERAL.—A requestor seeking 
an administrative order under paragraph 
(1) with respect to certain drugs, classes of 
drugs, or combinations of drugs, shall sub-
mit to the Secretary a request to initiate 
proceedings for such order in the form and 
manner as specified by the Secretary. Such 
requestor may submit a request under this 
subparagraph for the issuance of an admin-
istrative 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 
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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 sub-
section; 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 request 
for a change described in clause (i)(II) if 
the Secretary determines that there is an 
inadequate basis to find the drug is gen-
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erally recognized as safe and effective with-
in the meaning of section 201(p)(1) under 
paragraph (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). Notwith-
standing any other provision of this section, 
if such request is withdrawn, the Secretary 
may cease proceedings under this subpara-
graph. 
‘‘(C) EXCLUSIVITY.— 
‘‘(i) IN GENERAL.—A final adminis-
trative order issued in response to a request 
under this section shall have the effect of au-
thorizing solely the order requestor (or the 
licensees, assignees, or successors 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); 
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‘‘(II) beginning on the date the re-
questor (or any such licensees, assign-
ees, or successors in interest) may law-
fully 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— 
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‘‘(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 sunscreen 
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 EXCLUSIVITY.— 
‘‘(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 ei-
ther— 
‘‘(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. 
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‘‘(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 
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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 licens-
ees, assignees, or successors in interest of 
such requestor with respect to such order) 
submits updated drug listing information 
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under subsection (e) with respect 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, Inno-
vation, and Reform Act of 2018, the Comp-
troller General of the United States shall 
submit a study to the Committee on Energy 
and Commerce of the House of Representa-
tives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate 
addressing the effectiveness and overall im-
pact of exclusivity under this section, in-
cluding its impact on consumer access. 
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— 
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‘‘(aa) a new active ingredient 
(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 pro-
vision on innovation, as well as 
research and development in the 
nonprescription drug market; 
‘‘(cc) the impact of such pro-
vision on competition in the non-
prescription drug market; 
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‘‘(dd) the impact of such pro-
vision on consumer access to non-
prescription drug products; 
‘‘(ee) the impact of such pro-
vision on the prices of non-
prescription drug products; and 
‘‘(ff) whether the administra-
tive orders initiated by requestors 
under this section have been suffi-
cient to encourage the development 
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 request 
under this section that a drug described in sub-
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paragraph (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 re-
quire that nonprescription marketing of the 
drug be pursuant to a new drug application 
as described in subparagraph (D). 
‘‘(B) DRUG DESCRIBED.—A drug described 
in this subparagraph is a nonprescription drug 
which contains an active ingredient not pre-
viously 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 MARKETING AND 
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USE.—Information specified in this subpara-
graph, with respect to a request described in sub-
paragraph (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 consumers in 
the United States as a nonprescription drug 
under comparable conditions of use; 
‘‘(ii) if the drug has not been pre-
viously marketed in the United States as a 
nonprescription drug, information sufficient 
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 Secretary in accord-
ance 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 regu-
latory body considered acceptable by 
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the Secretary for such monitoring pur-
poses, including for adverse events as-
sociated 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 five 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 
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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 en-
courage use in accordance with labeling. Such re-
quirements may include unit dose packaging, require-
ments for products intended for use by children, re-
quirements to reduce risk of harm from unsupervised 
ingestion, and other appropriate requirements. This 
paragraph does not authorize the Food and Drug Ad-
ministration to require standards or testing proce-
dures as described in part 1700 of title 16, Code of 
Federal Regulations. 
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‘‘(8) FINAL AND TENTATIVE FINAL MONOGRAPHS 
FOR CATEGORY I DRUGS DEEMED FINAL ADMINISTRA-
TIVE ORDERS.— 
‘‘(A) IN GENERAL.—A final monograph or 
tentative final monograph described in subpara-
graph (B) shall be deemed to be a final adminis-
trative order under this subsection and may be 
amended, revoked, or otherwise modified in ac-
cordance with the procedures of this subsection. 
‘‘(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, includ-
ing 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 construed to in-
clude any technical amendments to such order as 
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the Secretary determines necessary to ensure that 
such order is appropriately 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 dosage 
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 informa-
tion 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 
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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 Sec-
retary 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 exposure 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 prescribed 
time, or if the Secretary determines that such 
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additional information does not demonstrate 
that the change does not affect the safety or effec-
tiveness of the drug or materially affect the ex-
tent of absorption or other exposure to the active 
ingredient, the drug as modified is a new drug 
within the meaning of section 201(p) and shall 
be deemed to be misbranded 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 ap-
plying those orders to specific dosage forms. 
‘‘(B) STANDARD
PRACTICES.—The orders 
and guidance issued by the Secretary under sub-
paragraph (A) shall take into account relevant 
public standards and standard practices for 
evaluating the quality of drugs, and may take 
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into account the special needs of populations, in-
cluding children. 
‘‘(d) CONFIDENTIALITY OF INFORMATION SUBMITTED 
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 pro-
posed order is issued; and 
‘‘(ii) make any information submitted 
by any other person with respect to an 
order requested (or initiated by the Sec-
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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 recog-
nized as safe and effective within the mean-
ing of section 201(p)(1); 
‘‘(ii) the information is submitted in a 
requestor-initiated request, but the requestor 
withdraws such request, in accordance with 
withdrawal procedures established by the 
Secretary, before the Secretary 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 
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shall submit updated drug listing information for the drug 
in accordance with section 510(j) within 30 calendar days 
of the date when the drug is first commercially marketed, 
except that a sponsor who was the order requestor with re-
spect to an order subject to subsection (b)(5)(C) (or a li-
censee, assignee, or successor in interest of such requestor) 
shall submit updated drug listing information on or before 
the date when the drug is first commercially 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 effec-
tive 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 frequently 
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than annually), and make publicly available, with respect 
to orders issued under this section— 
‘‘(1) a repository of each final order and interim 
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 three-year period. 
‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures under 
which sponsors or requestors may meet with appropriate 
officials of the Food and Drug Administration to obtain 
advice on the studies and other information necessary 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 sec-
tion. 
‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures to fa-
cilitate efficient participation by multiple sponsors or re-
questors in proceedings under this section, including provi-
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sion for joint meetings with multiple sponsors or requestors 
or with organizations nominated by sponsors or requestors 
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 GOVERNING 
NONPRESCRIPTION DRUGS.— 
‘‘(1) REGULATIONS OF GENERAL APPLICABILITY 
TO NONPRESCRIPTION DRUGS.—Except as provided in 
this subsection, nothing in this section supersedes reg-
ulations establishing general requirements for non-
prescription drugs, including regulations of general 
applicability contained in parts 201, 250, and 330 of 
title 21, Code of Federal Regulations, or any successor 
regulations. The Secretary shall establish or modify 
such regulations by means of rulemaking in accord-
ance 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 effect 
on the day before the date of the enactment of 
this section, shall be deemed to be a final order 
under subsection (b). 
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‘‘(ii) the addition of information to the 
other information section of the drug facts label 
of an OTC monograph drug, as limited by sec-
tion 201.66(c)(7) of title 21, Code of Federal 
Regulations (or any successor regulations); 
‘‘(iii) modification to the directions for use 
section of the drug facts label of an OTC mono-
graph drug, if such changes conform to changes 
made pursuant to section 505G(c)(3)(A); 
‘‘(iv) the standardization of the concentra-
tion or dose of a specific finalized ingredient 
within a particular finalized monograph; 
‘‘(v) a change to ingredient nomenclature to 
align with nomenclature of a standards-setting 
organization; or 
‘‘(vi) addition of an interchangeable term in 
accordance with section 330.1 of title 21, Code of 
Federal Regulations (or any successor regula-
tions). 
‘‘(B) The Secretary may, based on program im-
plementation experience or other factors found appro-
priate by the Secretary, characterize any OTC mono-
graph order request as a Tier 2 OTC monograph 
order request (including recharacterizing a request 
from Tier 1 to Tier 2) and publish such determina-
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BEFORE FILING.—An OTC monograph order re-
quest that was submitted but was refused for fil-
ing, or was withdrawn before being accepted or 
refused for filing, shall be subject to the full fee 
under subparagraph (A) upon being resubmitted 
or filed over protest. 
‘‘(G) REFUND OF FEE IF ORDER REQUEST 
WITHDRAWN.—If an order request is withdrawn 
after the order request was filed, the Secretary 
may refund the fee or a portion of the fee if no 
substantial work was performed on the order re-
quest after the application was filed. The Sec-
retary shall have the sole discretion to refund a 
fee or a portion of the fee under this subpara-
graph. A determination by the Secretary con-
cerning a refund under this subparagraph shall 
not be reviewable. 
‘‘(3) REFUNDS.— 
‘‘(A) IN
GENERAL.—Other than refunds 
provided in subparagraphs (D) through (G) of 
paragraph (2), the Secretary shall not refund 
any fee paid under paragraph (1) except as pro-
vided in subparagraph (B). 
‘‘(B) DISPUTES
CONCERNING
FEES.—To 
qualify for the return of a fee claimed to have 
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