Insanitary Conditions at Compounding Facilities; Guidance for Industry; Availability, 71348-71350 [2020-24807]
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71348
Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: A State Plan is a required
comprehensive narrative description of
the nature and scope of a state’s or
Replacement Designee’s (RD) Refugee
Resettlement Program and provides
assurances that the program will be
administered in conformity with the
specific requirements stipulated in 45
CFR 400.4–400.9. The State Plan must
include all applicable state or RD
procedures, designations, and
certifications for each requirement as
well as supporting documentation. The
plan assures ORR that the state or RD is
capable of administering refugee
assistance and coordinating
employment and other social services
for eligible caseloads in conformity with
specific requirements.
Changes proposed to the previously
approved State Plan for Grants to States
for Refugee Resettlement information
collection are described below. ORR is
proposing:
• Streamlining/formatting changes to
multiple sections of the form including
technical corrections to regulatory
citations and removing a number of
requirements related to the now
obsolete Wilson-Fish Alternative
Program (superseded by the Wilson-Fish
TANF Coordination Program, which
will have its own separate reporting
requirements).
• adding a number of requirements
related to Replacement Designees (RDs)
to ensure that they are administering the
Refugee Resettlement Program with
transparency and equity and to the same
standard as a state, including quarterly
consultation process, Refugee Medical
Assistance, Unaccompanied Refugee
Minors (URM), and emergency planning
to ensure ORR populations receive all
necessary information and services to
the extent possible.
• requesting additional information
related to the Refugee Support Services
(RSS) program; ORR’s current template
does not provide sufficient detailed
information for ORR to ascertain how a
grantee intends to provide RSS services
to its client base.
• improving the URM section to
correct inefficiencies, eliminate
unnecessary items, and address the
needs of victims of trafficking and
Special Immigrant Juveniles now
eligible for the URM program. In
particular, ORR is soliciting states’ and
RDs’ plans for placing children referred
by ORR and ensuring alignment with
federal capacity priorities.
Respondents: State agencies and RDs
under 45 CFR 400.301(c) administering
or supervising the administration of
programs.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
62
3
18
3,348
1,116
State Plan for Grants to States for Refugee Resettlement
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Estimated Total Annual Burden
Hours: 1,116.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522 of the
Immigration and Nationality Act (the Act)
[Title IV, Sec. 412 of the Act] for each state
agency requesting federal funding for refugee
resettlement under 8 U.S.C. 524 [Title IV,
Sec. 414 of the Act].
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24777 Filed 11–6–20; 8:45 am]
BILLING CODE 4184–45–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2268]
Insanitary Conditions at Compounding
Facilities; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ Drug products compounded
under insanitary conditions could
become contaminated and cause serious
adverse events, including death, in
patients. FDA is issuing this guidance to
help compounding facilities and State
regulatory agencies understand some
examples of what FDA considers to be
insanitary conditions that could cause a
drug to become contaminated or
rendered injurious to health. These
examples are intended to help
compounding facilities take action to
SUMMARY:
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prevent the occurrence of these and
other insanitary conditions, as well as to
implement appropriate corrective
actions when such conditions already
exist.
The announcement of the
guidance is published in the Federal
Register on November 9, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances on any guidance at
any time as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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09NON1
Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
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as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2268 for ‘‘Insanitary Conditions
at Compounding Facilities.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
VerDate Sep<11>2014
16:35 Nov 06, 2020
Jkt 253001
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the final guidance document.
FOR FURTHER INFORMATION CONTACT:
Jinhee Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5225, Silver Spring,
MD 20993, 301–796–6770.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ 1 Under section 501(a)(2)(A)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 351(a)(2)(A)),
a drug is adulterated if it has been
prepared, packed, or held under
insanitary conditions whereby it may
have been contaminated with filth or
rendered injurious to health. Drug
products compounded under insanitary
conditions could become contaminated
and cause serious adverse events,
including death, in patients. Although
sections 503A and 503B of the FD&C
Act (21 U.S.C. 353a and 353b) provide
exemptions for compounded drugs from
specified provisions of the FD&C Act if
certain conditions are met, neither
section provides an exemption from
1 For the purpose of this guidance, FDA regards
compounding facilities as pharmacies, Federal
facilities, and outsourcing facilities that compound
or repackage drugs, or that mix, dilute, or repackage
biological products.
PO 00000
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71349
section 501(a)(2)(A) of the FD&C Act.
Any drug that is prepared, packed, or
held under insanitary conditions is
deemed to be adulterated under the
FD&C Act, including drugs produced by
a compounding facility.
Since the 2012 fungal meningitis
outbreak associated with injectable drug
products that a pharmacy compounded
and shipped to patients and healthcare
providers across the country, the
Agency has identified insanitary
conditions at many of the compounding
facilities that it has inspected, and
numerous compounders have
voluntarily recalled drug products
intended to be sterile and also
temporarily or permanently ceased
sterile operations because of these
findings. Generally, State licensed
pharmacies do not register with FDA
unless they are outsourcing facilities. As
a result, the Agency is often not aware
of these pharmacies, their conditions
and practices, and potential problems
with the quality of their drug products.
Although FDA does conduct some
surveillance inspections, FDA does not
inspect the vast majority of State
licensed pharmacies in the United
States unless, for example, FDA receives
a complaint, such as a report of a
serious adverse event or product quality
issue. FDA does, however, routinely
inspect outsourcing facilities registered
with FDA.2 Regardless of whether a
facility is routinely inspected by FDA, it
is critical that both State licensed
pharmacies and outsourcing facilities
identify and remediate, as well as work
to prevent, the occurrence of insanitary
conditions within their facilities.
Because insanitary conditions can result
in drug contamination and patient
injury, corrective action should be
implemented expeditiously in order to
prevent the recurrence of such
conditions.
In the Federal Register of September
26, 2018 (83 FR 48631), FDA announced
the availability of a revised draft
guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ The revised draft guidance
provided examples of conditions that
the Agency has observed at
compounding facilities it has inspected
and considers to be insanitary
conditions. The revised draft guidance
also described corrective actions that
compounding facilities should take
when they identify such conditions and
the regulatory actions FDA may take in
response to identified insanitary
conditions.
FDA received comments on the
revised draft guidance from various
2 See
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section 503B(b)(4) of the FD&C Act.
09NON1
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71350
Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
stakeholders (e.g., physicians,
pharmacies, outsourcing facilities).
Several comments were submitted
concerning the implications of the
policies described in the revised draft
guidance for physicians who compound
or repackage drug products or mix,
dilute, or repackage FDA-licensed
biological products in their offices. In
response to these comments, FDA made
changes, where appropriate, in the final
guidance. The changes include adding a
footnote to state that ‘‘processing of
beta-lactams’’ does not refer to mixing,
reconstituting, or other such acts that
are performed in accordance with the
directions contained in FDA-approved
labeling; adding a footnote to reflect that
the FDA does not generally object to
rapid movement temporary blocking or
disruption of first air in the ISO 5 area
when necessary for the safe handling of
radiopharmaceuticals to minimize
radiation exposure, and revising the
language in a footnote concerning the
scope of physician compounding or
repackaging activities to state that FDA
generally does not intend to take action
under section 501(a)(2)(A) of the FD&C
Act against a physician who is
compounding a drug product,
repackaging an FDA-approved drug
product, or who is mixing, diluting, or
repackaging an FDA-licensed biological
product, provided that it occurs in the
physician’s office for in-office
administration to the physician’s
patients; and adding recommendations
encouraging compounders to use risk
evaluation strategies and risk
management tools to develop
appropriate controls necessary to
prevent the occurrence of insanitary
conditions at their facilities. In addition,
editorial changes were made to the
guidance for clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Insanitary
Conditions at Compounding Facilities.’’
The examples described in the final
guidance do not constitute an
exhaustive list of conditions FDA
considers to be insanitary conditions. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
VerDate Sep<11>2014
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Jkt 253001
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this guidance refers to a
previously approved FDA collection of
information. This collection of
information is subject to review by OMB
under the PRA. The collections of
information in 21 CFR part 7 pertaining
to FDA’s recall regulations have been
approved under OMB control number
0910–0249.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 3, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24807 Filed 11–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Request for Comments on Draft
Recommendation Statement on
Preventing Obesity in Midlife Women,
as Part of the HRSA-Supported
Women’s Preventive Services
Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice seeks public
comments on a draft recommendation
statement on preventing obesity in
midlife women, as part of the HRSAsupported Women’s Preventive Services
Guidelines (‘‘Guidelines’’), through a
national cooperative agreement, the
Women’s Preventive Services Initiative
(WPSI). The WPSI recommends
counseling midlife women, aged 40 to
60 years, with normal or overweight
BMI (18.5–29.9 kg/m2) to maintain
weight or limit weight gain to prevent
obesity. Counseling may include
individualized discussion of healthy
eating and physical activity. Under
Section 2713 of the Public Health
Service Act, as added by the Patient
Protection and Affordable Care Act,
non-grandfathered group health plans
and non-grandfathered group and
individual health insurance issuers
must include coverage, without cost
sharing, for certain preventive services
SUMMARY:
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under that section, including those
provided for in the Guidelines.
DATES: Members of the public are
invited to provide written comments no
later than December 9, 2020. All
comments received on or before this
date will be reviewed and considered by
the WPSI Multidisciplinary Steering
Committee, and provided to HRSA for
further consideration in determining the
recommended updates that it will
support.
Members of the public
interested in providing comments can
do so by accessing the initiative’s web
page at https://www.womenspreventive
health.org/.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283 or email:
wellwomancare@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
HRSA-supported Women’s Preventive
Services Guidelines were originally
established in 2011 based on
recommendations from an HHS
commissioned study by the Institute of
Medicine, now known as the National
Academy of Medicine (NAM). Since
then, there have been advancements in
science and gaps identified in the
existing guidelines, including a greater
emphasis on practice-based clinical
considerations. HRSA awarded a 5-year
cooperative agreement in March 2016
(HRSA–16–057) to convene a coalition
representing clinicians, academics, and
consumer-focused health professional
organizations to conduct a rigorous
review of current scientific evidence
and recommend updates to existing
guidelines, in accordance with the
framework created by the NAM Clinical
Practice Guidelines We Can Trust expert
committee. The American College of
Obstetricians and Gynecologists was
awarded the cooperative agreement and
formed an expert panel called the
Women’s Preventive Services Initiative.
Under section 2713 of the Public
Health Service Act, non-grandfathered
group health plans and issuers of nongrandfathered group and individual
health insurance coverage are required
to cover specified preventive services
without a copayment, coinsurance,
deductible, or other cost sharing,
including preventive care and
screenings for women as provided for in
comprehensive guidelines supported by
HRSA for this purpose. Nongrandfathered group health plans and
health insurance issuers offering nongrandfathered group or individual
coverage are required to provide
coverage without cost sharing for
ADDRESSES:
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]]>Agencies
[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71348-71350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24807]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2268]
Insanitary Conditions at Compounding Facilities; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Insanitary
Conditions at Compounding Facilities.'' Drug products compounded under
insanitary conditions could become contaminated and cause serious
adverse events, including death, in patients. FDA is issuing this
guidance to help compounding facilities and State regulatory agencies
understand some examples of what FDA considers to be insanitary
conditions that could cause a drug to become contaminated or rendered
injurious to health. These examples are intended to help compounding
facilities take action to prevent the occurrence of these and other
insanitary conditions, as well as to implement appropriate corrective
actions when such conditions already exist.
DATES: The announcement of the guidance is published in the Federal
Register on November 9, 2020.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such
[[Page 71349]]
as a manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-2268 for ``Insanitary Conditions at Compounding
Facilities.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the final guidance document.
FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 5225, Silver Spring, MD 20993, 301-796-6770.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Insanitary Conditions at Compounding Facilities.'' \1\ Under
section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has been
prepared, packed, or held under insanitary conditions whereby it may
have been contaminated with filth or rendered injurious to health. Drug
products compounded under insanitary conditions could become
contaminated and cause serious adverse events, including death, in
patients. Although sections 503A and 503B of the FD&C Act (21 U.S.C.
353a and 353b) provide exemptions for compounded drugs from specified
provisions of the FD&C Act if certain conditions are met, neither
section provides an exemption from section 501(a)(2)(A) of the FD&C
Act. Any drug that is prepared, packed, or held under insanitary
conditions is deemed to be adulterated under the FD&C Act, including
drugs produced by a compounding facility.
---------------------------------------------------------------------------
\1\ For the purpose of this guidance, FDA regards compounding
facilities as pharmacies, Federal facilities, and outsourcing
facilities that compound or repackage drugs, or that mix, dilute, or
repackage biological products.
---------------------------------------------------------------------------
Since the 2012 fungal meningitis outbreak associated with
injectable drug products that a pharmacy compounded and shipped to
patients and healthcare providers across the country, the Agency has
identified insanitary conditions at many of the compounding facilities
that it has inspected, and numerous compounders have voluntarily
recalled drug products intended to be sterile and also temporarily or
permanently ceased sterile operations because of these findings.
Generally, State licensed pharmacies do not register with FDA unless
they are outsourcing facilities. As a result, the Agency is often not
aware of these pharmacies, their conditions and practices, and
potential problems with the quality of their drug products. Although
FDA does conduct some surveillance inspections, FDA does not inspect
the vast majority of State licensed pharmacies in the United States
unless, for example, FDA receives a complaint, such as a report of a
serious adverse event or product quality issue. FDA does, however,
routinely inspect outsourcing facilities registered with FDA.\2\
Regardless of whether a facility is routinely inspected by FDA, it is
critical that both State licensed pharmacies and outsourcing facilities
identify and remediate, as well as work to prevent, the occurrence of
insanitary conditions within their facilities. Because insanitary
conditions can result in drug contamination and patient injury,
corrective action should be implemented expeditiously in order to
prevent the recurrence of such conditions.
---------------------------------------------------------------------------
\2\ See section 503B(b)(4) of the FD&C Act.
---------------------------------------------------------------------------
In the Federal Register of September 26, 2018 (83 FR 48631), FDA
announced the availability of a revised draft guidance for industry
entitled ``Insanitary Conditions at Compounding Facilities.'' The
revised draft guidance provided examples of conditions that the Agency
has observed at compounding facilities it has inspected and considers
to be insanitary conditions. The revised draft guidance also described
corrective actions that compounding facilities should take when they
identify such conditions and the regulatory actions FDA may take in
response to identified insanitary conditions.
FDA received comments on the revised draft guidance from various
[[Page 71350]]
stakeholders (e.g., physicians, pharmacies, outsourcing facilities).
Several comments were submitted concerning the implications of the
policies described in the revised draft guidance for physicians who
compound or repackage drug products or mix, dilute, or repackage FDA-
licensed biological products in their offices. In response to these
comments, FDA made changes, where appropriate, in the final guidance.
The changes include adding a footnote to state that ``processing of
beta-lactams'' does not refer to mixing, reconstituting, or other such
acts that are performed in accordance with the directions contained in
FDA-approved labeling; adding a footnote to reflect that the FDA does
not generally object to rapid movement temporary blocking or disruption
of first air in the ISO 5 area when necessary for the safe handling of
radiopharmaceuticals to minimize radiation exposure, and revising the
language in a footnote concerning the scope of physician compounding or
repackaging activities to state that FDA generally does not intend to
take action under section 501(a)(2)(A) of the FD&C Act against a
physician who is compounding a drug product, repackaging an FDA-
approved drug product, or who is mixing, diluting, or repackaging an
FDA-licensed biological product, provided that it occurs in the
physician's office for in-office administration to the physician's
patients; and adding recommendations encouraging compounders to use
risk evaluation strategies and risk management tools to develop
appropriate controls necessary to prevent the occurrence of insanitary
conditions at their facilities. In addition, editorial changes were
made to the guidance for clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Insanitary Conditions at Compounding
Facilities.'' The examples described in the final guidance do not
constitute an exhaustive list of conditions FDA considers to be
insanitary conditions. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
However, this guidance refers to a previously approved FDA
collection of information. This collection of information is subject to
review by OMB under the PRA. The collections of information in 21 CFR
part 7 pertaining to FDA's recall regulations have been approved under
OMB control number 0910-0249.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 3, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24807 Filed 11-6-20; 8:45 am]
BILLING CODE 4164-01-P
