[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52474-52478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0952]
Final Administrative Orders for Over-the-Counter Monographs;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability on its website of certain final administrative orders
(final orders), including for over-the-counter (OTC) drug monographs,
that were deemed to be final orders by the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act), which added a new section to the
Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is also announcing
the process for making these final orders available. Finally, FDA is
announcing its plan for withdrawing regulations that established final
OTC drug monographs prior to the passage of the CARES act, and
withdrawing or making technical changes to the procedures governing the
OTC drug review.
DATES: The announcement of the availability on FDA's website of certain
final orders as deemed by section 505G of the FD&C Act and other
actions related to section 505G is published in the Federal Register on
September 21, 2021.
ADDRESSES: You may view the final orders in the OTC Monographs@FDA
portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm.
Instructions: For access to the final orders, go to
https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. Under the
``Administrative Orders'' banner, click on the desired link under the
``Order ID'' heading and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6848.
SUPPLEMENTARY INFORMATION:
I. Background
On March 27, 2020, the CARES Act was signed into law. The CARES Act
includes provisions that govern the way certain OTC drugs are regulated
in the United States. In particular, the CARES Act added section 505G
to the FD&C Act (21 U.S.C. 355g), which reforms and modernizes the OTC
drug review process that was established in 1972. Under the OTC drug
review, OTC drug monographs (also referred to as OTC monographs) for
different therapeutic categories are established. OTC drugs are
generally recognized as safe and effective (GRASE) if they meet the
conditions of an OTC monograph, including the specified active
ingredients, uses (indications), doses, routes of administration,
labeling, and testing, along with other applicable requirements.
A. Regulatory Framework for OTC Monograph Drugs Prior to the Passage of
the CARES Act
Prior to passage of the CARES Act, OTC monographs were established,
revised, and amended using the rulemaking process set out by the
Administrative Procedure Act in 21 U.S.C. 553. Final OTC monographs
(final monographs) were codified in regulations under title 21 of the
CFR. The OTC monograph process was set forth in 21 CFR part 330 (part
330). Prior to establishment of a final monograph, GRASE conditions for
a therapeutic category were set forth in proposed rules as tentative
final monographs. At the time of the passage of the CARES Act, certain
OTC monographs were still at the proposed rulemaking stage, either in
whole or in part.
In the course of the OTC drug review, FDA also determined when
there was not sufficient evidence to demonstrate certain conditions
(e.g., active ingredients for specific uses) were GRASE. In such cases,
FDA often expressly codified these determinations that certain
conditions were not GRASE (see, e.g., Sec. 310.545 (21 CFR 310.545)).
In addition, part 201, subpart G (21 CFR part 201, subpart G), includes
specific labeling requirements for certain drugs, including OTC
monograph drugs (see, e.g., Sec. 201.326, requiring warnings and other
labeling for OTC drug products containing internal analgesic and
antipyretic active ingredients).
B. Regulatory Framework for OTC Monograph Drugs Under the CARES Act
The CARES Act added section 505G to the FD&C Act, which revised the
framework for the regulation of OTC
[[Page 52475]]
monograph drugs.\1\ Under section 505G of the FD&C Act, the rulemaking
process for establishing, revising, and amending OTC monographs was
replaced with an administrative order process. In addition, among other
things, section 505G of the FD&C Act provides a baseline status that,
as of the date of enactment of the CARES Act, a drug that satisfies
certain requirements described in section 505G(a)(1) or (2) is: (1)
Deemed to be generally recognized as safe and effective under section
201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1); (2) not a new drug
under section 201(p) of the FD&C Act; and (3) not subject to section
503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). To obtain this status,
among other things, a drug either must be one that is in conformity
with the requirements for nonprescription use of a final monograph
issued under part 330 (except as provided in section 505G(a)(2) of the
FD&C Act),\2\ as well as other requirements; \3\ or must be one that
is: (1) Classified in category I for safety and effectiveness under a
tentative final monograph that is the most recently applicable proposal
or determination issued under part 330 and (2) in conformity with the
proposed requirements for nonprescription use of such tentative final
monograph and any applicable subsequent determination by FDA, as well
as other requirements.\4\ Other applicable requirements in section
505G(a)(1) of the FD&C Act include conditions or requirements under
section 505G(b), (c), and (k) of the FD&C Act.
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\1\ OTC drugs that are governed by the provisions of section
505G of the FD&C Act are referred to as OTC monograph drugs.
\2\ Section 505G(a)(2) of the FD&C Act provides specific
requirements for sunscreen drugs in terms of conformity with a final
monograph, for purposes of section 505G(a)(1)(A)(i) of the FD&C Act.
\3\ Section 505G(a)(1)(A) of the FD&C Act.
\4\ Section 505G(a)(1)(B) of the FD&C Act.
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Complementary to the requirements for conformity to tentative final
or final monographs described in section 505G(a)(1) and (2) of the FD&C
Act, Congress provided that, under section 505G(b)(8) of the FD&C Act,
a final monograph or tentative final monograph that establishes
conditions of use for a drug described in section 505G(a)(1) or (2) of
the FD&C Act and that represents the most recently issued version of
the conditions of use, including as modified, in whole or in part, by
any proposed or final rule, is deemed to be a final order. These deemed
final orders provide the current OTC drug monograph conditions that are
in effect for each therapeutic category addressed by them. Final orders
may be amended, revoked, or otherwise modified in accordance with the
procedures of section 505G of the FD&C Act. Under section 505G(b)(8)(C)
of the FD&C Act, the deemed establishment of a final order is construed
to include technical amendments necessary to ensure that the final
order is appropriately harmonized, in terms of terminology or cross-
references, with the applicable provisions of the FD&C Act (and
regulations) and any other final orders issued under section 505G.
Congress also deemed certain regulations, as in effect on the day
before the date of the enactment of the CARES Act (i.e., March 26,
2020), to be final orders under section 505G(b) of the FD&C Act. In
particular, section 505G(k)(2)(A) of the FD&C Act deemed the provisions
of Sec. 310.545 to be a final order under section 505G(b). Also,
section 505G(k)(2)(B) of the FD&C Act deemed regulations establishing
requirements for specific nonprescription drugs marketed pursuant to
section 505G (including such requirements in 21 CFR parts 201 and 250)
to be final orders under section 505G(b), as they apply to drugs
subject to section 505G(a)(1) through (4) or otherwise subject to an
order under section 505G.
In addition, section 505G(k)(3) of the FD&C Act provides that
regulations establishing final monographs and the procedures governing
the OTC drug review under part 330 and other relevant parts of title 21
of the CFR, shall be withdrawn or revised to make technical changes to
ensure conformity with appropriate terminology and cross-references.
Section 505G(k)(3) of the FD&C Act also provides that any such
withdrawal or technical 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).
II. Procedures for Posting Final Orders as Deemed by Section 505G of
the FD&C Act
The final orders as deemed by section 505G of the FD&C Act were
made effective upon enactment of the CARES Act on March 27, 2020. By
this notice, FDA is announcing the availability on its website of
certain deemed final orders and providing the public information on the
process for making available deemed final orders, including details on
how the public can access and view the final orders. FDA is posting
these final orders to provide the public a convenient resource to view
OTC monographs and non-monograph conditions. The process for FDA
issuing proposed, final, and interim final orders under section 505G(b)
of the FD&C Act to add, modify, or remove OTC monograph conditions is
generally described in section 505G(b) and is not addressed in this
Notice. Additional information, including questions and answers on this
process, can be found on FDA's OTC monograph web page at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act, and further information
will be provided when FDA issues its first proposed order.
A. Process for Making Available Final Orders as Deemed by Section
505G(b)(8) of the FD&C Act
FDA is announcing its process for making available final orders as
deemed by section 505G(b)(8) of the FD&C Act. FDA reviewed all final
monographs published in the CFR, beginning with 21 CFR part 331, and
the rulemaking histories for each OTC monograph therapeutic category,
to identify all relevant final monographs and tentative final
monographs that established conditions of use for a drug described in
section 505G(a)(1) of the FD&C Act and that represented the most
recently issued version of the conditions of use, including as
modified, in whole or in part, by any proposed or final rule. As noted
above, the relevant requirements for sunscreen drugs subject to section
505G of the FD&C Act, in terms of conformity with a final monograph for
purposes of section 505G(a)(1)(A)(i), were set forth in section
505G(a)(2) and consist of the requirements specified in 21 CFR part
352, as published on May 21, 1999, except that the applicable
requirements governing effectiveness and labeling are those specified
in Sec. 201.327. Altogether, as indicated in table 1 below, FDA
identified 32 final orders created by section 505G(b)(8) of the FD&C
Act.
As further discussed below, FDA also identified certain regulations
that established requirements for specific nonprescription drugs
marketed pursuant to section 505G of the FD&C Act and, therefore, were
deemed final orders by section 505G(k)(2)(B), only as they apply to
drugs subject to section 505G(a)(1) through (4) or otherwise subject to
an order under section 505G (e.g., Sec. 201.326, which set forth
certain labeling requirements regarding warnings for OTC drug products
containing internal analgesic and antipyretic active ingredients). To
the extent regulations that were deemed to be final orders by section
505G(k)(2)(B) of the FD&C Act apply to OTC drugs addressed by a final
order embodying an
[[Page 52476]]
OTC monograph, as deemed by section 505G(b)(8) of the FD&C Act, the
relevant provisions may be incorporated into the final order(s)
embodying the OTC monograph(s).
FDA assigned OTC monograph numbers to the resulting deemed final
orders (see table 1). Table 1 provides the corresponding OTC monograph
number and title for each of these OTC monographs and identifies the
CFR citation, if applicable. Additionally, an order ID will be assigned
in sequential order upon posting of all orders, including the deemed
final orders.
Each OTC monograph embodied by a deemed final order is accompanied
by a summary and a background section. In the background section, FDA
describes the relevant proposed and final rules that constitute the
deemed final order. Additionally, pursuant to section 505G(b)(8)(C) of
the FD&C Act, OTC monographs embodied by deemed final orders include
any technical amendments that are determined to be necessary to ensure
that they are appropriately harmonized, in terms of terminology and
cross-references, with applicable provisions of the FD&C Act, FDA
regulations, and any other orders issued under section 505G. The
background section generally describes any differences between the
deemed final order and the proposed and final rules that constitute the
order.
Some OTC monographs incorporate by reference specified material,
published by an entity other than the United States government (e.g.,
an ISO standard). This incorporated material is available for
inspection at FDA. For further information about inspecting
incorporated materials, see https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. Copies of incorporated material may also be available
from its publisher.
Table 1--OTC Monographs as Represented by Final Orders Deemed by Section
505G(b)(8) of the FD&C Act
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CFR citation in
OTC monograph number title 21 OTC monograph title
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M001................. Part 331........ Antacid Products for OTC Human
Use.
M002................. Part 332........ Antiflatulent Products for OTC
Human Use.
M003................. N/A \1\......... First Aid Antiseptic Drug
products for OTC Human Use.
M004................. Part 333, First Aid Antibiotic Drug
subpart B. Products for OTC Human Use.
M005................. Part 333, Topical Antifungal Drug
subpart C. Products for OTC Human Use.
M006................. Part 333, Topical Acne Drug Products for
subpart D. OTC Human Use.
M007................. N/A\1\.......... Laxative Drug Products for OTC
Human Use.
M008................. Part 335........ Antidiarrheal Drug Products for
OTC Human Use.
M009................. Part 336........ Antiemetic Drug Products for
OTC Human Use.
M010................. Part 338........ Nighttime Sleep Aid Drug
Products for OTC Human Use.
M011................. Part 340........ Stimulant Drug Products for OTC
Human Use.
M012................. Part 341........ Cold, Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug Products
for OTC Human Use.
M013................. Part 343........ Internal Analgesic,
Antipyretic, and Antirheumatic
Drug Products for OTC Human
Use.
M014................. Part 344........ Topical Otic Drug Products for
OTC Human Use.
M015................. Part 346........ Anorectal Drug Product for OTC
Human Use.
M016................. Part 347........ Skin Protectant Drug Products
for OTC Human Use.
M017................. Part 348........ External Analgesic Drug Product
for OTC Human Use.
M018................. Part 349........ Ophthalmic Drug Products for
OTC Human Use.
M019................. Part 350........ Antiperspirant Drug Products
for OTC Human Use.
M020................. Part 352........ Sunscreen Drug Products for OTC
Human Use.
M021................. Part 355........ Anticaries Drug Products for
OTC Human Use.
M022................. N/A \1\......... Oral Health Care Drug Products
for OTC Human Use.
M023................. N/A \1\......... Poison Treatment Drug Products
for OTC Human Use.
M024................. Part 357, Anthelminic Drug Products for
subpart B. OTC Human Use.
M025................. Part 357, Cholecystokinetic Drug Products
subpart C. for OTC Human Use.
M026................. Part 357, Deodorant Drug Products for
subpart I. Internal Use for OTC Human
Use.
M027................. N/A \1\......... Orally Administered Menstrual
Drug Products for OTC Human
Use.
M028................. Part 358, Wart Remover Drug Products for
subpart B. OTC Human Use.
M029................. Part 358, Ingrown Toenail Relief Drug
subpart D. Products for OTC Human Use.
M030................. Part 358, Corn and Callus Remover Drug
subpart F. Products for OTC Human Use.
M031................. Part 358, Pediculicide Drug Products for
subpart G. OTC Human Use.
M032................. Part 358, Drug Products for the Control
subpart H. of Dandruff, Seborrheic
Dermatitis, and Psoriasis for
OTC Human Use.
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\1\ Not applicable as there is no relevant CFR citation (i.e., there
were no final monographs at the time of enactment of the CARES Act).
B. Process for Making Available Final Orders as Deemed by Section
505G(k)(2) of the FD&C Act
Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph
conditions in Sec. 310.545 in effect on the day before the date of
enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a
final order under section 505G(b). The provisions of Sec. 310.545 list
active ingredients for which there is not sufficient data to establish
general recognition of the safety and effectiveness for the specified
use in OTC drug products. Before posting the deemed final order
containing these provisions, FDA intends to remove the compliance dates
found in the regulation because the dates are no longer relevant, since
any current product would have been introduced or delivered for
introduction into interstate commerce well after the compliance date.
FDA also intends to rearrange the listed active ingredients within each
provision regarding a particular therapeutic category so that they
generally appear in alphabetical order. When posting this final order,
FDA will assign a final order ID and OTC non-monograph conditions
number.
In addition, under section 505G(k)(2)(B) of the FD&C Act,
regulations in effect on March 26, 2020, establishing requirements for
specific
[[Page 52477]]
nonprescription drugs marketed pursuant to section 505G of the FD&C Act
were deemed final orders under section 505G(b), only as they apply to
drugs subject to section 505G(a)(1) through (4) of the FD&C Act or
otherwise subject to a final order under section 505G. As discussed
above, provisions from a regulation that was deemed to be a final order
by section 505G(k)(2)(B) of the FD&C Act may be incorporated into a
relevant final order embodying an OTC monograph under section
505G(b)(8). A deemed final order under section 505G(k)(2)(B) of the
FD&C Act may also be posted as a separate, standalone final order. In
the latter case, FDA intends to issue an accompanying notice in the
Federal Register announcing its availability on our website.
Regulations deemed to be final orders by section 505G(k)(2)(B) of the
FD&C Act will remain in the CFR to the extent they also apply to drugs
that are not subject to section 505G(a)(1) through (4) or otherwise
subject to an order under section 505G.
C. Availability of Final Orders Including Those Deemed by Section 505G
of the FD&C Act
FDA has established a new IT system with a web portal, OTC
Monographs@FDA, which can be accessed through FDA's website. The portal
will provide access to a repository of final orders under section 505G
of the FD&C Act and is available at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. To access the final orders, go to the OTC
Monographs@FDA portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. Under the ``Administrative Orders'' banner, click on
the desired link under the ``Order ID'' heading and follow the prompts.
For ease of reference, FDA also is posting in the OTC
Monographs@FDA portal the individual OTC monographs embodied by final
orders under section 505G(b) of the FD&C Act, without any sections that
accompany the monograph, such as the background section. To access just
the OTC monographs, under the ``OTC Monographs'' banner, click on the
desired link under the ``OTC Monograph ID'' heading and follow the
prompts.
FDA will make available deemed final orders embodying OTC
monographs in batches on a rolling basis until all 32 such orders,
discussed above in section II.A (see also table 1), are available in
the repository. FDA will also make available in the repository the
final order that reflects the provisions of Sec. 310.545, as deemed by
section 505G(k)(2)(A) of the FD&C Act, and final orders regarding
requirements for specific nonprescription drugs, as deemed by section
505G(k)(2)(B).
FDA is announcing that the OTC Monographs@FDA portal currently
includes an initial batch of four deemed final orders embodying OTC
monographs (see table 2). The posting of the remainder of these 32
deemed final orders, as well as the deemed final order under section
505G(k)(2)(A) of the FD&C Act, will not be announced in the Federal
Register but will be announced on FDA's OTC monograph web page, https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. FDA plans to issue a
notice of availability in the Federal Register when posting in the
repository final orders deemed by section 505G(k)(2)(B) of the FD&C
Act.
Table 2--Initial Batch of Posted Final Orders Deemed by Section 505G of the FD&C Act
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CFR citation in
Order ID OTC monograph number Title 21 OTC monograph title
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OTC000001................. M002..................... Part 332............ Antiflatulent Products for OTC
Human Use.
OTC000002................. M010..................... Part 338............ Nighttime Sleep-Aid Drug Products
for OTC Human Use.
OTC000003................. M014..................... Part 344............ Topical Otic Drug Products for OTC
Human Use.
OTC000004................. M030..................... Part 358, Subpart F. Corn and Callus Remover Drug
Products for OTC Human Use.
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FDA encourages the public to frequently view our website at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act and the OTC
Monographs@FDA portal for the most up-to-date information about the
status of posted final orders as deemed by section 505G of the FD&C
Act. Questions regarding these final orders can be submitted to FDA at
[email protected].
In the future, the repository will also include proposed orders,
final orders, and interim final orders to add, amend, or remove OTC
monograph conditions that are issued by FDA either on its own
initiative or pursuant to an OTC monograph order request under section
505G(b)(5) of the FD&C Act. Information on the process for FDA issuing
proposed, final, and interim final orders is provided in section
505G(b) of the FD&C Act. Additional information, including questions
and answers on this process, can be found on FDA's OTC monograph web
page (https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act), which
will continue to be updated as FDA issues new orders.
III. Procedures for Withdrawing Regulations for Final Monographs and
the Procedures Governing the OTC Drug Review, and Withdrawing and
Making Technical Changes to Regulations in Part 330 and Other Relevant
Parts of Title 21 of the CFR
Under section 505G(k)(3) of the FD&C Act, regulations establishing
final monographs and the procedures governing the OTC drug review under
part 330 and other relevant parts of title 21 of the CFR (as in effect
on March 26, 2020) shall be withdrawn or revised to make technical
changes to ensure conformity with appropriate terminology and cross-
references. Section 505G(k)(3) of the FD&C Act also provides that any
such withdrawal or technical 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).
FDA intends to issue a notice to withdraw the regulations
establishing final monographs in title 21 of the CFR at a later date
once all the relevant deemed final orders have been posted on FDA's OTC
monographs@FDA web portal (i.e., 21 CFR parts 331, 332, 333, 335, 336,
338, 340, 341, 343, 344, 346, 347, 348, 349, 350, 352, 355, 357, and
358). Prior to the withdrawal of such regulations, the public should
reference the OTC monographs posted in the OTC
[[Page 52478]]
Monographs@FDA portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm, to the extent the corresponding deemed final order has
been added to the portal. Additionally, in either the same notice or a
separate notice in the Federal Register, pursuant to section 505G(k)(3)
of the FD&C Act, FDA intends to withdraw certain portions of the
regulations governing the OTC drug review, and to make certain
technical changes.
IV. Paperwork Reduction Act of 1995
Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 (Chapter 35 of title 44, United States Code) does not apply to
collections of information made under section 505G of the FD&C Act.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required for collections of
information, if any, in orders deemed to be final orders by section
505G of the FD&C Act.
Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20393 Filed 9-20-21; 8:45 am]
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