Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 129-130 [2016-31789]
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Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on Premarket Notification (510(k))
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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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1428]
Electronic Drug Product Reporting for
Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability.
III. Electronic Access
ACTION:
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Premarket Notification (510(k))
Submissions for Bone Anchors’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400005 to
identify the guidance you are
requesting.
SUMMARY:
IV. Paperwork Reduction Act of 1995
sradovich on DSK3GMQ082PROD with NOTICES
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31779 Filed 12–30–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
22:14 Dec 30, 2016
Jkt 241001
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
The final guidance addresses new
provisions in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) added
by the Drug Quality and Security Act
(DQSA) and updates reporting
instructions for drug compounders that
choose to register as outsourcing
facilities. Such compounders must
report information on the drugs they
compounded in Structured Product
Labeling (SPL) format using FDA’s
electronic submissions system unless
FDA grants a request for a waiver of
such requirement because use of
electronic means is not reasonable for
the person requesting the waiver. This
guidance supersedes the revised draft
guidance entitled ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
129
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–N–1428 for ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
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
Division of Dockets Management
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
E:\FR\FM\03JAN1.SGM
03JAN1
130
Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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–
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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Lysette Deshields, Center for Drug
Evaluation and Research Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993 301–
796–3100.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
In the Federal Register of November 24,
2014 (79 FR 69857), FDA announced the
availability of a revised draft guidance
for industry entitled ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ On
November 27, 2013, President Obama
signed the DQSA into law (Pub. L. 113–
54). The DQSA added a new section
503B to the FD&C Act (21 U.S.C. 353b).
Under section 503B(b), a compounder
can register as an outsourcing facility
with FDA. If the conditions outlined in
VerDate Sep<11>2014
22:14 Dec 30, 2016
Jkt 241001
section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or
under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from certain sections
of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
approval of human drug products under
new drug applications or abbreviated
new drug applications). Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
Under section 503B, an outsourcing
facility must, at the time of initial
registration and twice each year, in June
and December, submit to FDA a report
identifying the drugs compounded by
the facility during the previous 6-month
period. For each identified drug, the
outsourcing facility must report the
following information to FDA for each
product that it compounds:
• The active ingredient and strength
of active ingredient per unit;
• the source of the active ingredient
(bulk or finished drug);
• the National Drug Code (NDC)
number of the source drug or bulk active
ingredient, if available;
• the dosage form and route of
administration;
• the package description;
• the number of individual units
produced; and
• the NDC number of the final
product, if assigned.1
This final guidance explains that
registered outsourcing facilities must
provide reports to FDA on compounded
drugs in SPL format using FDA’s
electronic submissions system unless
FDA grants a request for a waiver of
such requirement because use of
electronic means is not reasonable for
the person requesting the waiver. It
supersedes the revised draft guidance
entitled ‘‘Electronic Drug Product
Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
The comment period for the revised
draft guidance ended on January 23,
2015. FDA received three comments on
the draft. In response to received
comments or on its own initiative, FDA
made the following changes and
updates in the final guidance: (1)
Clarified FDA’s definition of the source
of the active ingredient used to
compound the final product and the
1 Section
PO 00000
503B(b)(2)(A)(ii) of the FD&C Act.
Frm 00049
Fmt 4703
Sfmt 4703
information the outsourcing facility
should submit to FDA, including the
appropriate format of the NDC code; (2)
clarified what information submitted as
part of a product report will be made
public; and (3) made grammatical and
other minor editorial changes for clarity.
In some cases, comments raised issues
that were not directly pertinent to the
topics addressed in the revised draft
guidance.
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 ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ 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 collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information have been
approved under OMB control number
0910–0827.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31789 Filed 12–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4308]
Labeling of Red Blood Cell Units With
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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 draft
document entitled ‘‘Labeling of Red
SUMMARY:
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[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 129-130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' The final guidance addresses new provisions in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug
Quality and Security Act (DQSA) and updates reporting instructions for
drug compounders that choose to register as outsourcing facilities.
Such compounders must report information on the drugs they compounded
in Structured Product Labeling (SPL) format using FDA's electronic
submissions system unless FDA grants a request for a waiver of such
requirement because use of electronic means is not reasonable for the
person requesting the waiver. This guidance supersedes the revised
draft guidance entitled ``Electronic Drug Product Reporting for Human
Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.''
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-1428 for ``Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' 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 Division of
Dockets Management 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 Division of Dockets Management. If you do not
wish your name and contact information to be
[[Page 130]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug
Evaluation and Research Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993 301-796-3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' In the Federal Register of November 24, 2014 (79 FR
69857), FDA announced the availability of a revised draft guidance for
industry entitled ``Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' On November 27, 2013, President Obama
signed the DQSA into law (Pub. L. 113-54). The DQSA added a new section
503B to the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a
compounder can register as an outsourcing facility with FDA. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications or abbreviated new drug
applications). Drugs compounded in outsourcing facilities are not
exempt from the requirements of section 501(a)(2)(B) of the FD&C Act
(21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
Under section 503B, an outsourcing facility must, at the time of
initial registration and twice each year, in June and December, submit
to FDA a report identifying the drugs compounded by the facility during
the previous 6-month period. For each identified drug, the outsourcing
facility must report the following information to FDA for each product
that it compounds:
The active ingredient and strength of active ingredient
per unit;
the source of the active ingredient (bulk or finished
drug);
the National Drug Code (NDC) number of the source drug or
bulk active ingredient, if available;
the dosage form and route of administration;
the package description;
the number of individual units produced; and
the NDC number of the final product, if assigned.\1\
---------------------------------------------------------------------------
\1\ Section 503B(b)(2)(A)(ii) of the FD&C Act.
---------------------------------------------------------------------------
This final guidance explains that registered outsourcing facilities
must provide reports to FDA on compounded drugs in SPL format using
FDA's electronic submissions system unless FDA grants a request for a
waiver of such requirement because use of electronic means is not
reasonable for the person requesting the waiver. It supersedes the
revised draft guidance entitled ``Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.''
The comment period for the revised draft guidance ended on January
23, 2015. FDA received three comments on the draft. In response to
received comments or on its own initiative, FDA made the following
changes and updates in the final guidance: (1) Clarified FDA's
definition of the source of the active ingredient used to compound the
final product and the information the outsourcing facility should
submit to FDA, including the appropriate format of the NDC code; (2)
clarified what information submitted as part of a product report will
be made public; and (3) made grammatical and other minor editorial
changes for clarity. In some cases, comments raised issues that were
not directly pertinent to the topics addressed in the revised draft
guidance.
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 ``Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.'' 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 collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information have been approved under OMB control number 0910-0827.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31789 Filed 12-30-16; 8:45 am]
BILLING CODE 4164-01-P