Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability, 37229-37230 [2017-16719]
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
As the steward of the NORA process,
NIOSH invites comments on the draft
National Occupational Research Agenda
for CRC. A copy of the draft Agenda is
available at https://www.regulations.gov
(see Docket Number CDC–2017–0068,
NIOSH–299).
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2017–16801 Filed 8–8–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0829]
Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products; Revised Draft
Guidance for Industry; Availability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draft guidance for industry entitled
‘‘Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products.’’ The last few decades
have seen an increasing demand in
various health care settings for solid oral
dosage form drug products repackaged
into unit-dose containers, which hold a
quantity of drug for administration as a
single dose. The increase in unit-dose
repackaging has led to questions
regarding stability studies and
appropriate expiration dates for these
repackaged products. This revised draft
guidance describes the conditions under
which FDA does not intend to take
action regarding required stability
studies for these repackaged products
and the expiration date to assign under
those conditions. Through this notice,
FDA is hoping to decrease the
regulatory burdens of drug regulations
on manufacturers of these products,
while at the same time ensuring patient
safety. Since FDA’s guidance documents
do not bind the public or FDA to any
requirements, they have not been
considered to be subject to Executive
Order 12866.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this revised
draft guidance before it begins work on
the final version of the guidance, submit
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:00 Aug 08, 2017
Jkt 241001
either electronic or written comments
on the draft guidance by October 10,
2017.
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): 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–
2017–D–0829 for ‘‘Expiration Dating of
Unit-Dose Repackaged Solid Oral
Dosage Form Drug Products.’’ 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
37229
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.
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: Bill
Harvey, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 4214, Silver Spring,
MD 20993–0002, 240–402–4180.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
E:\FR\FM\09AUN1.SGM
09AUN1
sradovich on DSK3GMQ082PROD with NOTICES
37230
Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
entitled ‘‘Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products.’’ FDA’s current good
manufacturing practice (CGMP)
regulations for finished pharmaceuticals
require that each drug product bear an
expiration date determined by
appropriate stability testing and that the
date must be related to any storage
conditions stated on the labeling, as
determined by stability studies (21 CFR
211.137(a) and (b)). Samples used for
stability testing must be in the same
container-closure system as that in
which the drug product is marketed (21
CFR 211.166(a)(4)). For unit-dose
repackaged products, U.S.
Pharmacopeial Convention (USP)
General Chapter <1178> recommends
that the expiration date ‘‘not exceed (1)
6 months from the date of repackaging;
or (2) the manufacturer’s expiration
date; or (3) 25% of the time between the
date of repackaging and the expiration
date shown on the manufacturer’s bulk
article container of the drug being
repackaged, whichever is earlier.’’
For solid oral dosage forms
repackaged in unit-dose containers, the
revised draft guidance states that FDA
does not intend to take action regarding
the requirements of §§ 211.137 and
211.166 (i.e., expiration dating
determined by stability studies) under
certain conditions. This revised draft
guidance describes these conditions.
This draft guidance revises an earlier
draft guidance for industry, ‘‘Expiration
Dating of Unit-Dose Repackaged Drugs:
Compliance Policy Guide.’’ Changes
include the following:
• Shortens the expiration date to be
used under certain conditions for solid
oral dosage forms repackaged in unitdose containers from 12 months to 6
months or 25 percent of the time
remaining until the expiration date on
the container of the original
manufacturer’s product, whichever time
period is shorter.
• Provides for an expiration date
exceeding 6 months if supportive data
from appropriate studies are available
and other conditions are met.
• Excludes from the scope of the
guidance products repackaged by Statelicensed pharmacies, Federal facilities,
and outsourcing facilities as defined
under section 503B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
353b).
• Excludes from the scope of the
guidance all dosage forms other than
solid oral dosage forms.
• Provides for the use of containers
meeting USP <671> Class B standards if
certain conditions are met.
This revised draft guidance is being
issued consistent with FDA’s good
VerDate Sep<11>2014
17:00 Aug 08, 2017
Jkt 241001
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on expiration
dating of unit-dose repackaged solid
oral dosage form drug products. 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.
The current Compliance Policy Guide
480.200, ‘‘Expiration Dating of UnitDose Repackaged Drugs,’’ issued
February 1, 1984, revised March 1995,
will be withdrawn when the revised
draft guidance is finalized.
II. The Paperwork Reduction Act of
1995
This revised draft guidance refers to
previously approved 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 in 21 CFR
parts 210 and 211 have been approved
under OMB control number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16719 Filed 8–8–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4076]
Benefit-Risk Assessments in Drug
Regulatory Decision-Making; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public meeting to convene
a discussion of topics related to the
structured assessment of benefits and
risks in drug regulatory decisionmaking. This meeting will focus on
regulatory and industry experiences
with approaches to structured benefit-
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
risk assessments, approaches to
incorporating patient perspectives into
structured benefit-risk assessment, and
exploration of methods to advance
structured benefit-risk assessment. The
format of the meeting will include a
series of presentations on the above
topics related to structured assessment
of benefits and risks, followed by a
discussion on those topics with invited
panelists and audience members. This
meeting satisfies an FDA commitment
that is part of the fifth authorization of
the Prescription Drug User Fee Act
(PDUFA V).
DATES: The public meeting will be held
on September 18, 2017, from 9 a.m. to
5 p.m. Registration to attend the meeting
must be received by September 11, 2017
(see the SUPPLEMENTARY INFORMATION
section for instructions). Public
comments will be accepted through
November 18, 2017. See the ADDRESSES
section for information about submitting
comments to the public docket.
ADDRESSES: The public meeting will be
held on September 18, 2017, at the FDA
White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center (the Great Room), Silver Spring,
MD 20993–0002. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 18, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 18, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
E:\FR\FM\09AUN1.SGM
09AUN1
Agencies
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37229-37230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16719]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-0829]
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form
Drug Products; 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
``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug
Products.'' The last few decades have seen an increasing demand in
various health care settings for solid oral dosage form drug products
repackaged into unit-dose containers, which hold a quantity of drug for
administration as a single dose. The increase in unit-dose repackaging
has led to questions regarding stability studies and appropriate
expiration dates for these repackaged products. This revised draft
guidance describes the conditions under which FDA does not intend to
take action regarding required stability studies for these repackaged
products and the expiration date to assign under those conditions.
Through this notice, FDA is hoping to decrease the regulatory burdens
of drug regulations on manufacturers of these products, while at the
same time ensuring patient safety. Since FDA's guidance documents do
not bind the public or FDA to any requirements, they have not been
considered to be subject to Executive Order 12866.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by October 10, 2017.
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): 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-2017-D-0829 for ``Expiration Dating of Unit-Dose Repackaged Solid
Oral Dosage Form Drug Products.'' 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.
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: Bill Harvey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-4180.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry
[[Page 37230]]
entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage
Form Drug Products.'' FDA's current good manufacturing practice (CGMP)
regulations for finished pharmaceuticals require that each drug product
bear an expiration date determined by appropriate stability testing and
that the date must be related to any storage conditions stated on the
labeling, as determined by stability studies (21 CFR 211.137(a) and
(b)). Samples used for stability testing must be in the same container-
closure system as that in which the drug product is marketed (21 CFR
211.166(a)(4)). For unit-dose repackaged products, U.S. Pharmacopeial
Convention (USP) General Chapter <1178> recommends that the expiration
date ``not exceed (1) 6 months from the date of repackaging; or (2) the
manufacturer's expiration date; or (3) 25% of the time between the date
of repackaging and the expiration date shown on the manufacturer's bulk
article container of the drug being repackaged, whichever is earlier.''
For solid oral dosage forms repackaged in unit-dose containers, the
revised draft guidance states that FDA does not intend to take action
regarding the requirements of Sec. Sec. 211.137 and 211.166 (i.e.,
expiration dating determined by stability studies) under certain
conditions. This revised draft guidance describes these conditions.
This draft guidance revises an earlier draft guidance for industry,
``Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy
Guide.'' Changes include the following:
Shortens the expiration date to be used under certain
conditions for solid oral dosage forms repackaged in unit-dose
containers from 12 months to 6 months or 25 percent of the time
remaining until the expiration date on the container of the original
manufacturer's product, whichever time period is shorter.
Provides for an expiration date exceeding 6 months if
supportive data from appropriate studies are available and other
conditions are met.
Excludes from the scope of the guidance products
repackaged by State-licensed pharmacies, Federal facilities, and
outsourcing facilities as defined under section 503B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353b).
Excludes from the scope of the guidance all dosage forms
other than solid oral dosage forms.
Provides for the use of containers meeting USP <671> Class
B standards if certain conditions are met.
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
expiration dating of unit-dose repackaged solid oral dosage form drug
products. 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.
The current Compliance Policy Guide 480.200, ``Expiration Dating of
Unit-Dose Repackaged Drugs,'' issued February 1, 1984, revised March
1995, will be withdrawn when the revised draft guidance is finalized.
II. The Paperwork Reduction Act of 1995
This revised draft guidance refers to previously approved
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 in 21 CFR parts
210 and 211 have been approved under OMB control number 0910-0139.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16719 Filed 8-8-17; 8:45 am]
BILLING CODE 4164-01-P