Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products, 63947-63948 [2022-22876]
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Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Rules and Regulations
Lists of Subjects in 14 CFR 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11G,
Airspace Designations and Reporting
Points, dated August 19, 2022, and
effective September 15, 2022, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ACE KS E5 Ellsworth, KS [Establish]
Ellsworth Municipal Airport, KS
(Lat. 38°45′02″ N, long. 98°13′49″ W)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of Ellsworth Municipal Airport.
Issued in Fort Worth, Texas, on October 7,
2022.
Martin A. Skinner,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2022–22291 Filed 10–20–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 216
[Docket No. FDA–2015–N–0030]
jspears on DSK121TN23PROD with RULES
Extension of the Period Before the
Food and Drug Administration Intends
To Begin Enforcing the Statutory 5
Percent Limit on Out-of-State
Distribution of Compounded Human
Drug Products
AGENCY:
Food and Drug Administration,
HHS.
Notification; extension of period
before enforcement.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
SUMMARY:
VerDate Sep<11>2014
16:05 Oct 20, 2022
Jkt 259001
extending the period before FDA
intends to begin enforcing the statutory
5 percent limit on distribution of
compounded human drug products out
of the State in which they are
compounded in States that have not
entered into a standard memorandum of
understanding (MOU) with FDA
addressing certain distributions of
compounded human drug products.
FDA is extending the period, which was
scheduled to end on October 27, 2022,
until the effective date of a final rule
regarding certain distributions of
compounded human drug products and
publication of an updated standard
MOU.
DATES: FDA is extending the period
before FDA intends to begin enforcing
the statutory 5 percent limit on
distribution of compounded human
drug products out of the State in which
they are compounded in States that
have not entered into a standard MOU
with FDA as of October 21, 2022.
FOR FURTHER INFORMATION CONTACT:
Dominic Markwordt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104,
Silver Spring, MD 20993–0002, 301–
796–9349.
SUPPLEMENTARY INFORMATION: Section
503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
353a) describes the conditions that must
be satisfied for drug products
compounded by a licensed pharmacist
in a State licensed pharmacy or a
Federal facility, or a licensed physician,
to be exempt from the following
sections of the FD&C Act: (1) section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing
practice (CGMP) requirements), (2)
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use), and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug
applications or abbreviated new drug
applications).
One of the conditions to qualify for
the exemptions listed in section 503A of
the FD&C Act is that: (1) the drug
product is compounded in a State that
has entered into an MOU with the FDA
that addresses the distribution of
inordinate amounts of compounded
drug products interstate and provides
for appropriate investigation by a State
agency of complaints relating to
compounded drug products distributed
outside such State or (2) if the drug
product is compounded in a State that
has not entered into such an MOU, the
licensed pharmacist, pharmacy, or
physician does not distribute, or cause
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
63947
to be distributed, compounded drug
products out of the State in which they
are compounded in quantities that
exceed 5 percent of the total
prescription orders dispensed or
distributed by such pharmacy or
physician (statutory 5 percent limit) (see
section 503A(b)(3)(B)(i) and (ii) of the
FD&C Act).
In the Federal Register of October 27,
2020 (85 FR 68074), FDA announced the
availability of a standard MOU
describing the responsibilities of a State
Board of Pharmacy or other appropriate
State agency that chooses to sign the
standard MOU in investigating and
responding to complaints related to
drug products compounded in such
State and distributed outside such State
and in addressing the interstate
distribution of inordinate amounts of
compounded human drug products.
In the October 27, 2020, Federal
Register notice, FDA stated that it was
providing a 365-day period that was
scheduled to end on October 27, 2021,
for States to decide whether to sign the
standard MOU before FDA intended to
begin enforcing the statutory 5 percent
limit in States that do not sign the
standard MOU. Soon after announcing
the availability of the standard MOU,
FDA was sued by several compounding
pharmacies regarding the standard MOU
in the U.S. District Court for the District
of Columbia (Wellness Pharmacy, Inc. v.
Becerra (D.D.C. Sep. 21, 2021)).
In the Federal Register of August 9,
2021 (86 FR 43550), FDA extended the
period to October 27, 2022, before FDA
intends to begin enforcing the statutory
5 percent limit in States that do not sign
the standard MOU.
On September 21, 2021, the Court
remanded the standard MOU to FDA to
either certify that it will not have a
significant economic effect on small
businesses or prepare a regulatory
flexibility analysis. To undertake this
analysis more fully and ensure a robust
framework for these important public
health protections, FDA intends to
engage in notice-and-comment
rulemaking regarding certain
distributions of compounded human
drug products under section 503A of the
FD&C Act. FDA considers the standard
MOU published in October 2020 to be
suspended. This means that during the
rulemaking process, FDA will not enter
into new agreements with States based
on the October 2020 standard MOU.
FDA does not expect States that have
signed the October 2020 standard MOU
to carry out the activities described in
the MOU. The October 2020 standard
MOU will be updated based on the
content of a final rule, and FDA intends
to announce a new opportunity for all
E:\FR\FM\21OCR1.SGM
21OCR1
63948
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Rules and Regulations
States to consider and sign the updated
standard MOU.
FDA is now extending the period
before FDA intends to begin enforcing
the statutory 5 percent limit in States
that have not entered into a standard
MOU with FDA until the effective date
of a final rule regarding certain
distributions of compounded human
drug products under section 503A of the
FD&C Act and publication of an
updated standard MOU.1
Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22876 Filed 10–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2022–0870]
Special Local Regulations Northern
California and Lake Tahoe Area Annual
Marine Events; Sacramento Ironman
Swim, Sacramento, CA
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Notification of enforcement of
regulation.
AGENCY:
The Coast Guard will enforce
the special local regulations for the
annual Sacramento Ironman Triathlon
marine event on October 23, 2022, to
provide for the safety of life on
navigable waterways in the Sacramento
River during this event. Our regulation
for marine events in Northern California
identifies the regulated area for this
event. During the enforcement period,
unauthorized persons or vessels are
prohibited from entering into, transiting
through, or loitering or anchoring in the
regulated area, unless authorized by the
designated Patrol Commander
(PATCOM) or other Federal, State, or
local law enforcement agencies on scene
to assist the Coast Guard in enforcing
the regulated area.
DATES: The regulations in 33 CFR
100.1103 will be enforced for the
location listed in Table 1 to § 100.1103,
Item number 5 from 6 a.m. to 10 a.m.
on October 23, 2022.
jspears on DSK121TN23PROD with RULES
SUMMARY:
1 The
Office of the Federal Register has published
this document under the category ‘‘Rules and
Regulations’’ pursuant to 1 CFR 5.9(b). We note that
the categorization as such for purposes of
publication in the Federal Register does not affect
the legal content or intent of the document. See, 1
CFR 5.1(c).
VerDate Sep<11>2014
16:05 Oct 20, 2022
Jkt 259001
If
you have questions about this
notification of enforcement, call or
email Lieutenant Anthony I. Solares,
Sector San Francisco Waterways
Management, U.S. Coast Guard;
telephone 415–399–3585, email
SFWaterways@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
The Coast
Guard will enforce the special local
regulations in 33 CFR 100.1103, Table 1
to § 100.1103, Item number 5 for the
Sacramento Ironman Swim regulated
area from 6 a.m. to 10 a.m. on October
23, 2022. This action is being taken to
provide for the safety of life on
navigable waterways during this event.
Our regulation for marine events within
Northern California, § 100.1103,
specifies the location of the regulated
area for the Sacramento Ironman Swim
which encompasses portions of the
American River and Sacramento River.
During the enforcement period, the
regulated area will be in effect in the
navigable waters of the American River
and Sacramento River from Township 9
Park to North of Tower Bridge.
During the enforcement period, under
the provisions of 33 CFR 100.1103(b), if
you are the operator of a vessel in the
regulated area you must comply with
directions from the Patrol Commander
(PATCOM) or any other Official Patrol,
defined as a Federal, State, or local law
enforcement agency on scene to assist
the Coast Guard in enforcing the
regulated area. During the enforcement
period, if you are the operator of a
vessel that participates in the marine
event within the regulated area, you
must follow the route established by the
marine event sponsor, and comply with
directions from the Patrol Commander
or other Official Patrol. The PATCOM or
Official Patrol may, upon request, allow
the transit of commercial vessels
through regulated areas when it is safe
to do so.
In addition to this notification of
enforcement in the Federal Register, the
Coast Guard plans to provide
notification of this enforcement period
via Local Notice to Mariners. If the
Captain of the Port determines that the
regulated area need not be enforced for
the full duration stated in this
notification, a Broadcast Notice to
Mariners may be used to grant general
permission to enter the regulated area.
SUPPLEMENTARY INFORMATION:
Dated: October 17, 2022.
Jordan M. Baldueza,
Captain, U.S. Coast Guard, Alternate Captain
of the Port, San Francisco.
[FR Doc. 2022–22950 Filed 10–20–22; 8:45 am]
BILLING CODE 9110–04–P
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2022–0853]
RIN 1625–AA11
Safety Zone; Oil Pipeline Repairs, San
Pedro Bay, CA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone for
the oil pipeline repair operations in the
vicinity of a damaged pipeline, off the
coast of Orange County and near San
Pedro Bay, CA. The safety zone is
necessary to reduce significant hazards
to vessels, the harbor, and the public
during ongoing pipeline repair. Entry of
persons or vessels into this temporary
safety zone is prohibited unless
specifically authorized by the Captain of
the Port Sector Los Angeles—Long
Beach, or his designated representative.
DATES: This rule is effective without
actual notice from October 21, 2022
through December 24, 2022. For the
purposes of enforcement, actual notice
will be used from October 10, 2022,
until October 21, 2022.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2022–
0853 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email LCDR Maria Wiener, Waterways
Management, U.S. Coast Guard Sector
Los Angeles—Long Beach; telephone
(310) 357–1603, email Maria.C.Wiener@
uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
E:\FR\FM\21OCR1.SGM
21OCR1
Agencies
[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63947-63948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22876]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 216
[Docket No. FDA-2015-N-0030]
Extension of the Period Before the Food and Drug Administration
Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-
State Distribution of Compounded Human Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; extension of period before enforcement.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the period before FDA intends to begin enforcing the
statutory 5 percent limit on distribution of compounded human drug
products out of the State in which they are compounded in States that
have not entered into a standard memorandum of understanding (MOU) with
FDA addressing certain distributions of compounded human drug products.
FDA is extending the period, which was scheduled to end on October 27,
2022, until the effective date of a final rule regarding certain
distributions of compounded human drug products and publication of an
updated standard MOU.
DATES: FDA is extending the period before FDA intends to begin
enforcing the statutory 5 percent limit on distribution of compounded
human drug products out of the State in which they are compounded in
States that have not entered into a standard MOU with FDA as of October
21, 2022.
FOR FURTHER INFORMATION CONTACT: Dominic Markwordt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993-0002, 301-
796-9349.
SUPPLEMENTARY INFORMATION: Section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that
must be satisfied for drug products compounded by a licensed pharmacist
in a State licensed pharmacy or a Federal facility, or a licensed
physician, to be exempt from the following sections of the FD&C Act:
(1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice (CGMP) requirements), (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications).
One of the conditions to qualify for the exemptions listed in
section 503A of the FD&C Act is that: (1) the drug product is
compounded in a State that has entered into an MOU with the FDA that
addresses the distribution of inordinate amounts of compounded drug
products interstate and provides for appropriate investigation by a
State agency of complaints relating to compounded drug products
distributed outside such State or (2) if the drug product is compounded
in a State that has not entered into such an MOU, the licensed
pharmacist, pharmacy, or physician does not distribute, or cause to be
distributed, compounded drug products out of the State in which they
are compounded in quantities that exceed 5 percent of the total
prescription orders dispensed or distributed by such pharmacy or
physician (statutory 5 percent limit) (see section 503A(b)(3)(B)(i) and
(ii) of the FD&C Act).
In the Federal Register of October 27, 2020 (85 FR 68074), FDA
announced the availability of a standard MOU describing the
responsibilities of a State Board of Pharmacy or other appropriate
State agency that chooses to sign the standard MOU in investigating and
responding to complaints related to drug products compounded in such
State and distributed outside such State and in addressing the
interstate distribution of inordinate amounts of compounded human drug
products.
In the October 27, 2020, Federal Register notice, FDA stated that
it was providing a 365-day period that was scheduled to end on October
27, 2021, for States to decide whether to sign the standard MOU before
FDA intended to begin enforcing the statutory 5 percent limit in States
that do not sign the standard MOU. Soon after announcing the
availability of the standard MOU, FDA was sued by several compounding
pharmacies regarding the standard MOU in the U.S. District Court for
the District of Columbia (Wellness Pharmacy, Inc. v. Becerra (D.D.C.
Sep. 21, 2021)).
In the Federal Register of August 9, 2021 (86 FR 43550), FDA
extended the period to October 27, 2022, before FDA intends to begin
enforcing the statutory 5 percent limit in States that do not sign the
standard MOU.
On September 21, 2021, the Court remanded the standard MOU to FDA
to either certify that it will not have a significant economic effect
on small businesses or prepare a regulatory flexibility analysis. To
undertake this analysis more fully and ensure a robust framework for
these important public health protections, FDA intends to engage in
notice-and-comment rulemaking regarding certain distributions of
compounded human drug products under section 503A of the FD&C Act. FDA
considers the standard MOU published in October 2020 to be suspended.
This means that during the rulemaking process, FDA will not enter into
new agreements with States based on the October 2020 standard MOU. FDA
does not expect States that have signed the October 2020 standard MOU
to carry out the activities described in the MOU. The October 2020
standard MOU will be updated based on the content of a final rule, and
FDA intends to announce a new opportunity for all
[[Page 63948]]
States to consider and sign the updated standard MOU.
FDA is now extending the period before FDA intends to begin
enforcing the statutory 5 percent limit in States that have not entered
into a standard MOU with FDA until the effective date of a final rule
regarding certain distributions of compounded human drug products under
section 503A of the FD&C Act and publication of an updated standard
MOU.\1\
---------------------------------------------------------------------------
\1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to 1
CFR 5.9(b). We note that the categorization as such for purposes of
publication in the Federal Register does not affect the legal
content or intent of the document. See, 1 CFR 5.1(c).
Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22876 Filed 10-20-22; 8:45 am]
BILLING CODE 4164-01-P