Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability, 48631-48633 [2018-20903]
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Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
an outsourcing facility to qualify for
exemptions from the following three
sections of the FD&C Act:
• Section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning labeling with
adequate directions for use);
• section 505 (21 U.S.C. 355)
(concerning drug approval
requirements); and
• section 582 (21 U.S.C. 360eee–1)
(concerning drug supply chain security
requirements).
In contrast to section 503A (21 U.S.C.
353a), section 503B of the FD&C Act
does not exclude radiopharmaceuticals.
Therefore, FDA’s overall policies
regarding section 503B apply to the
compounding of radiopharmaceutical
drug products. However, we have
developed specific policies that apply
only to the compounding of
radiopharmaceuticals by outsourcing
facilities using bulk drug substances and
to the compounding of
radiopharmaceuticals by outsourcing
facilities that are essentially copies of
approved drugs when such
compounding is limited to minor
deviations, as that term is defined in the
guidance. FDA is also issuing this
guidance in part to describe the
conditions under which the Agency
does not generally intend to take action
for violations of sections 505 and
502(f)(1) of the FD&C Act when an
outsourcing facility repackages
radiopharmaceuticals for human use.
Elsewhere in this issue of the Federal
Register, FDA has announced the
availability of a separate guidance
document concerning compounding and
repackaging of radiopharmaceuticals by
State-licensed nuclear pharmacies,
Federal facilities, and other facilities
that are not registered as outsourcing
facilities, entitled ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by State-Licensed Nuclear Pharmacies,
Federal Facilities, and Certain Other
Entities.’’
In the Federal Register of December
29, 2016 (81 FR 96005), FDA issued a
notice announcing the availability of the
draft version of this guidance. The
comment period on the draft guidance
ended on February 27, 2017. FDA
received approximately three comments
on the draft guidance. In response to
received comments or on its own
initiative, FDA made certain changes to
the guidance to clarify particular points.
For example, the reference to the
syringe as an example of primary
packaging was deleted in response to a
comment stating that a syringe
containing a radiopharmaceutical
should not be described as ‘‘primary
packaging’’ for labeling purposes
because of the unique risks associated
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
with radioactive drug products. In
addition, FDA made revisions to align
language used in this guidance with
language used in the guidance entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities,
and Certain Other Entities.’’
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by Outsourcing Facilities.’’ 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. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance contains collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act (PRA) of 1995 (44 U.S.C. 3501–
3520). Under the PRA, Federal Agencies
must obtain approval from OMB for
each collection of information they
conduct or sponsor. ‘‘Collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3 and includes
Agency requests or requirements that
members of the public submit reports,
keep records, or provide information to
a third party.
Specifically, the guidance references
registration, adverse event reporting,
product reporting, and current good
manufacturing practices (CGMP)
requirements for outsourcing facilities.
The collections of information for
outsourcing facility registration have
been approved under OMB control
number 0910–0777 (79 FR 69859,
November 24, 2014). The collections of
information for adverse event reporting
by outsourcing facilities have been
approved under OMB control number
0910–0800 (80 FR 60917, October 8,
2015). The collections of information for
electronic drug product reporting by
outsourcing facilities have been
approved under OMB control number
0910–0827 (82 FR 129, January 3, 2017).
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
PO 00000
Frm 00047
Fmt 4703
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48631
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20901 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2268]
Insanitary Conditions at Compounding
Facilities; Revised Draft 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 revised
draft 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 revised
draft guidance to help compounding
facilities identify insanitary conditions
so that they can implement appropriate
corrective actions. This revised draft
guidance is also intended to help 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. This
guidance revises the draft guidance
entitled ‘‘Insanitary Conditions at
Compounding Facilities’’ that was
published on August 4, 2016.
DATES: Submit either electronic or
written comments on the draft guidance
by November 26, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins works on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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,
E:\FR\FM\26SEN1.SGM
26SEN1
48632
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
‘‘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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 revised draft 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 revised draft guidance
document.
Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993, 301–796–3110.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Insanitary Conditions at
Compounding Facilities.’’ 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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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 a 2012 fungal meningitis
outbreak associated with injectable drug
products that a pharmacy compounded
and shipped to patients and health care
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 temporarily or
permanently ceased sterile operations
because of these findings. FDA does not
inspect the vast majority of
compounding facilities in the United
States because they generally do not
register with FDA unless they are
outsourcing facilities. Therefore, unless
FDA receives a complaint, such as a
report of a serious adverse event or
visible contamination, the Agency is
often not aware of these facilities, their
conditions and practices, and potential
problems with the quality and safety of
their drug products. It is critical that
compounding facilities identify and
remediate any insanitary conditions at
their facilities before the conditions
result in drug contamination and patient
injury.
In the Federal Register of August 4,
2016 (81 FR 51449), FDA announced the
availability of a draft guidance for
industry entitled, ‘‘Insanitary
Conditions at Compounding Facilities.’’
The draft guidance provided examples
of insanitary conditions that the Agency
has observed at compounding facilities
it has inspected and considers to be
insanitary conditions. The 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 draft guidance
including feedback from various
stakeholders (e.g., physicians,
pharmacies), particularly concerning the
implications of the policies described in
the draft guidance for physicians who
prepare drugs in their offices. FDA is
revising the draft guidance to address
the stakeholders’ feedback and to
provide further clarification on the
insanitary conditions described in the
guidance, as well as the actions FDA
intends to take with respect to
insanitary conditions. FDA is issuing
this revised draft guidance to enable the
public to further review and comment
before finalization of FDA’s policies
concerning insanitary conditions. We
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
expect that the guidance will help
compounding facilities to identify
insanitary conditions so that they can
implement appropriate corrective
actions, and will assist states in
identifying insanitary conditions during
their inspections of compounding
facilities.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Insanitary
Conditions at Compounding Facilities.’’
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. This guidance is not subject
to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the revised draft guidance at
either https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20903 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4318]
Compounding and Repackaging of
Radiopharmaceuticals by StateLicensed Nuclear Pharmacies, Federal
Facilities, and Certain Other Entities;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies, Federal Facilities,
and Certain Other Entities.’’ This
guidance sets forth FDA’s policy
regarding compounding and
repackaging of radiopharmaceuticals for
human use by State-licensed nuclear
pharmacies, Federal facilities, and other
entities that hold a radioactive materials
(RAM) license for medical use issued by
the Nuclear Regulatory Commission
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
(NRC) or by an Agreement State.
Because such radiopharmaceuticals are
not eligible for exemptions from
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) related to
the production of drugs, FDA is issuing
this guidance to describe the conditions
under which it generally does not
intend to take action for violations of
certain provisions of the FD&C Act
when these entities compound or
repackage radiopharmaceuticals.
DATES: The announcement of the
guidance is published in the Federal
Register on September 26, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
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–
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
48633
2016–D–4318 for ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by State-Licensed Nuclear Pharmacies,
Federal Facilities, and Certain Other
Entities.’’ 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 this 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–
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48631-48633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2268]
Insanitary Conditions at Compounding Facilities; Revised Draft
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 revised draft 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 revised draft guidance to help compounding facilities
identify insanitary conditions so that they can implement appropriate
corrective actions. This revised draft guidance is also intended to
help 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. This guidance revises the
draft guidance entitled ``Insanitary Conditions at Compounding
Facilities'' that was published on August 4, 2016.
DATES: Submit either electronic or written comments on the draft
guidance by November 26, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins works on the final
version of the guidance.
ADDRESSES: You may submit comments 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,
[[Page 48632]]
such as medical information, your or anyone else's Social Security
number, or confidential business information, such 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.gpo.gov/fdsys/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 revised draft
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 revised draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Insanitary Conditions at Compounding Facilities.''
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.
Since a 2012 fungal meningitis outbreak associated with injectable
drug products that a pharmacy compounded and shipped to patients and
health care 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 temporarily or permanently ceased
sterile operations because of these findings. FDA does not inspect the
vast majority of compounding facilities in the United States because
they generally do not register with FDA unless they are outsourcing
facilities. Therefore, unless FDA receives a complaint, such as a
report of a serious adverse event or visible contamination, the Agency
is often not aware of these facilities, their conditions and practices,
and potential problems with the quality and safety of their drug
products. It is critical that compounding facilities identify and
remediate any insanitary conditions at their facilities before the
conditions result in drug contamination and patient injury.
In the Federal Register of August 4, 2016 (81 FR 51449), FDA
announced the availability of a draft guidance for industry entitled,
``Insanitary Conditions at Compounding Facilities.'' The draft guidance
provided examples of insanitary conditions that the Agency has observed
at compounding facilities it has inspected and considers to be
insanitary conditions. The 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 draft
guidance including feedback from various stakeholders (e.g.,
physicians, pharmacies), particularly concerning the implications of
the policies described in the draft guidance for physicians who prepare
drugs in their offices. FDA is revising the draft guidance to address
the stakeholders' feedback and to provide further clarification on the
insanitary conditions described in the guidance, as well as the actions
FDA intends to take with respect to insanitary conditions. FDA is
issuing this revised draft guidance to enable the public to further
review and comment before finalization of FDA's policies concerning
insanitary conditions. We
[[Page 48633]]
expect that the guidance will help compounding facilities to identify
insanitary conditions so that they can implement appropriate corrective
actions, and will assist states in identifying insanitary conditions
during their inspections of compounding facilities.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Insanitary Conditions at Compounding Facilities.'' 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. This guidance
is not subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet may obtain the revised draft
guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20903 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P
