82 FR 37229 - Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 152 (August 9, 2017)

Page Range		37229-37230
FR Document		2017-16719

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.''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 This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration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.

Federal Register, Volume 82 Issue 152 (Wednesday, August 9, 2017)

[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37229-37230]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-16719]

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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Drug Products; Revised Draft Guidance for Industry; Availability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.

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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the availability of a revised draft guidance for industry entitled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.thefederalregister.org/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 http://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

37230 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices

entitled ‘‘Expiration Dating of Unit-Dose guidance practices regulation (21 CFR risk assessments, approaches to
Repackaged Solid Oral Dosage Form 10.115). The revised draft guidance, incorporating patient perspectives into
Drug Products.’’ FDA’s current good when finalized, will represent the structured benefit-risk assessment, and
manufacturing practice (CGMP) current thinking of FDA on expiration exploration of methods to advance
regulations for finished pharmaceuticals dating of unit-dose repackaged solid structured benefit-risk assessment. The
require that each drug product bear an oral dosage form drug products. It does format of the meeting will include a
expiration date determined by not establish any rights for any person series of presentations on the above
appropriate stability testing and that the and is not binding on FDA or the public. topics related to structured assessment
date must be related to any storage You can use an alternative approach if of benefits and risks, followed by a
conditions stated on the labeling, as it satisfies the requirements of the discussion on those topics with invited
determined by stability studies (21 CFR applicable statutes and regulations. panelists and audience members. This
211.137(a) and (b)). Samples used for The current Compliance Policy Guide meeting satisfies an FDA commitment
stability testing must be in the same 480.200, ‘‘Expiration Dating of Unit- that is part of the fifth authorization of
container-closure system as that in Dose Repackaged Drugs,’’ issued the Prescription Drug User Fee Act
which the drug product is marketed (21 February 1, 1984, revised March 1995, (PDUFA V).
CFR 211.166(a)(4)). For unit-dose will be withdrawn when the revised DATES: The public meeting will be held
repackaged products, U.S. draft guidance is finalized. on September 18, 2017, from 9 a.m. to
Pharmacopeial Convention (USP) 5 p.m. Registration to attend the meeting
General Chapter <1178> recommends II. The Paperwork Reduction Act of
1995 must be received by September 11, 2017
that the expiration date ‘‘not exceed (1) (see the SUPPLEMENTARY INFORMATION
6 months from the date of repackaging; This revised draft guidance refers to
section for instructions). Public
or (2) the manufacturer’s expiration previously approved collections of
comments will be accepted through
date; or (3) 25% of the time between the information that are subject to review by
November 18, 2017. See the ADDRESSES
date of repackaging and the expiration the Office of Management and Budget
section for information about submitting
date shown on the manufacturer’s bulk (OMB) under the Paperwork Reduction
comments to the public docket.
article container of the drug being Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR ADDRESSES: The public meeting will be
repackaged, whichever is earlier.’’
For solid oral dosage forms parts 210 and 211 have been approved held on September 18, 2017, at the FDA
repackaged in unit-dose containers, the under OMB control number 0910–0139. White Oak Campus, 10903 New
revised draft guidance states that FDA Hampshire Ave., Bldg. 31 Conference
III. Electronic Access Center (the Great Room), Silver Spring,
does not intend to take action regarding
the requirements of §§ 211.137 and Persons with access to the internet MD 20993–0002. Entrance for the public
211.166 (i.e., expiration dating may obtain the draft guidance at either meeting participants (non-FDA
determined by stability studies) under http://www.fda.gov/Drugs/Guidance employees) is through Building 1 where
certain conditions. This revised draft ComplianceRegulatoryInformation/ routine security check procedures will
guidance describes these conditions. Guidances/default.htm or https:// be performed. For more information on
This draft guidance revises an earlier www.regulations.gov. parking and security procedures, please
draft guidance for industry, ‘‘Expiration refer to https://www.fda.gov/AboutFDA/
Dated: August 3, 2017.
Dating of Unit-Dose Repackaged Drugs: WorkingatFDA/BuildingsandFacilities/
Anna K. Abram,
Compliance Policy Guide.’’ Changes WhiteOakCampusInformation/
Deputy Commissioner for Policy, Planning, ucm241740.htm.
include the following: Legislation, and Analysis.
• Shortens the expiration date to be You may submit comments as
[FR Doc. 2017–16719 Filed 8–8–17; 8:45 am] follows. Please note that late, untimely
used under certain conditions for solid
BILLING CODE 4164–01–P filed comments will not be considered.
oral dosage forms repackaged in unit-
dose containers from 12 months to 6 Electronic comments must be submitted
months or 25 percent of the time on or before November 18, 2017. The
DEPARTMENT OF HEALTH AND https://www.regulations.gov electronic
remaining until the expiration date on HUMAN SERVICES
the container of the original filing system will accept comments
manufacturer’s product, whichever time Food and Drug Administration until midnight Eastern Time at the end
period is shorter. of November 18, 2017. Comments
• Provides for an expiration date [Docket No. FDA–2017–N–4076] received by mail/hand delivery/courier
exceeding 6 months if supportive data (for written/paper submissions) will be
Benefit-Risk Assessments in Drug considered timely if they are
from appropriate studies are available Regulatory Decision-Making; Public
and other conditions are met. postmarked or the delivery service
Meeting; Request for Comments
• Excludes from the scope of the acceptance receipt is on or before that
guidance products repackaged by State- AGENCY: Food and Drug Administration, date.
licensed pharmacies, Federal facilities, HHS. Electronic Submissions
and outsourcing facilities as defined ACTION: Notice of public meeting;
under section 503B of the Federal Food, request for comments. Submit electronic comments in the
Drug, and Cosmetic Act (21 U.S.C. following way:
353b). SUMMARY: The Food and Drug • Federal eRulemaking Portal:
• Excludes from the scope of the Administration (FDA or the Agency) is https://www.regulations.gov. Follow the
sradovich on DSK3GMQ082PROD with NOTICES

guidance all dosage forms other than announcing a public meeting to convene instructions for submitting comments.
solid oral dosage forms. a discussion of topics related to the Comments submitted electronically,
• Provides for the use of containers structured assessment of benefits and including attachments, to https://
meeting USP <671> Class B standards if risks in drug regulatory decision- www.regulations.gov will be posted to
certain conditions are met. making. This meeting will focus on the docket unchanged. Because your
This revised draft guidance is being regulatory and industry experiences comment will be made public, you are
issued consistent with FDA’s good with approaches to structured benefit- solely responsible for ensuring that your

VerDate Sep<11>2014 17:00 Aug 08, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1

Document Created: 2017-08-09 02:18:21
Document Modified: 2017-08-09 02:18:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		82 FR 37229

82 FR 37229 - Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 152 (August 9, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration