Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability, 4343-4345 [2017-00723]
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
not reached, each party may use its statutory
and other rights as specified in the
‘‘Preservation of Rights’’ section below. This
decision making process will be evaluated by
the Committee after one full year of its
operation.
Meeting Schedule and Logistics: The
Committee will meet on a quarterly basis or
more frequently by consensus of its members.
The Committee will normally meet at ACF
Central Office in Washington, DC, but may
also meet at another location by consensus.
If a Committee member is unable to
physically attend a meeting, he/she may
participate by phone or video
teleconferencing. The date and time for any
meetings will be established by mutual
agreement. Committee meetings may be held
in conjunction with other meetings where it
is deemed cost effective and there is
consensus.
Working Groups: The Committee has the
authority to form workgroups that may
include individuals who are not members of
the Committee. Any such workgroups will be
given their charge and/or responsibilities
from the LMC in writing. Non-Committee
member bargaining unit participants on such
groups will be appointed by NTEU and will
be provided appropriate official time to
participate in workgroup activities.
Support: The Committee will use the
services of a facilitator trained in interestbased bargaining techniques as needed. The
appointed Executive Secretary will provide
administrative support to the Committee.
Such support shall include creation and
dissemination of meeting agenda and
minutes, announcements of meetings, and
other matters as determined by the
Committee. The Agency will make available
the use of video and telephone conferencing
for the participation of all committee
members at meetings. The Agency will
provide meeting rooms for LMC meetings.
Participation: The Agency encourages the
use of video and telephone conferencing for
the participation of those members who are
domiciled outside the 50 mile radius of
Washington, DC, and will provide the
necessary equipment to facilitate the process.
Union representatives will be granted official
time for preparation and participation in the
meetings, pursuant to Article 10 of the
Collective Bargaining Agreement. The
Agency will pay for all reasonable local
travel expenses, namely transportation and
parking. For those participants domiciled
outside the 50 mile radius, the Agency agrees
to reimburse the Union representatives 50
percent of reasonable travel expenses,
including transportation, lodging, and per
diem.
In the interest of facilitating the working
relations among the members, the Agency
agrees to assume the full costs associated
with travel, including transportation, lodging
and per diem for participants for the first
scheduled meeting of the Committee. For all
subsequent meetings, the Agency will
reimburse the Union representatives for 50
percent as stated above.
Agenda Development and Dissemination:
The LMC’s potential agenda items will be
submitted to the Co-Chairs who will
mutually establish a formal agenda for the
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next LMC meeting. The formal agenda will be
distributed to all LMC members at least three
work days prior to the next LMC meeting. For
issues requiring a decision by the LMC, all
proposals or related materials will be
distributed to the LMC members as soon as
possible but no later than seven work days
prior to the meeting at which the decision
will need to be made.
Communication: Final, approved minutes
of the Committee will be disseminated and
made available to all ACF employees via
methods determined by the Committee.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Evaluation
The Committee will evaluate its progress
on an annual basis. It will determine whether
to renew its procedures and/or to make
changes in any aspect of the LMC.
AGENCY:
4343
Preservation of Rights
Cooperation is not intended to supplant
the decision-making authority, or to usurp
the responsibility of agency management, but
to further involve ACF employees in
developing ACF decisions through the active
and systematic participation of NTEU and
those it represents who perform ACF’s work.
This LMC is based on the belief that NTEU
participation in ACF decision-making will
promote decisions of such a nature that the
need for formal bargaining will be reduced
and, where bargaining becomes necessary,
will inform and facilitate the negotiations.
Accordingly, subject to statute, executive
orders, and the collective bargaining
agreement, ACF reserves the right to
determine whether to implement
recommendations arising from the
cooperation endeavor, and NTEU reserves
the right to bargain concerning the substance,
impact and implementation of final ACF
decisions prior to implementation. The ACF
recognizes its statutory, regulatory, and/or
contractual obligations to provide
notification to NTEU and to bargain.
Effective Date, Duration, and Modifications
This LMC shall be instituted upon the date
the parties have signed the Charter. The
partners may amend or supplement this
Agreement at any time upon consensus. This
Agreement may be terminated by either of
the parties to this Agreement. Termination by
either party shall be provided in writing and
shall be considered effective exactly 30
calendar days after receipt by the recipient
party. Notification of termination shall be
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within 10 days of the termination and shall
be published in the Federal Register within
30 days of the termination.
On behalf of NTEU and ACF, the
undersigned execute this Agreement on this
30th day of December, 2016, by Anthony
Reardon, NTEU National President; Mark H.
Greenberg, Acting Assistant Secretary for
Children and Families; and Benjamin
Goldhaber, Deputy Assistant Secretary for
Administration, Administration for Children
and Families.
Dated: January 6, 2017.
Mark H. Greenberg,
Assistant Secretary for Children and Families.
[FR Doc. 2017–00655 Filed 1–12–17; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2014–D–1524]
Repackaging of Certain Human Drug
Products by Pharmacies and
Outsourcing Facilities; Final Guidance
for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Repackaging of Certain Human Drug
Products by Pharmacies and
Outsourcing Facilities.’’ This guidance
describes the conditions under which
FDA does not intend to take action for
violations of certain provisions of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), when a State-licensed
pharmacy, a Federal facility, or an
outsourcing facility repackages certain
human drug products.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
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,
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’’).
E:\FR\FM\13JAN1.SGM
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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–
2014–D–1524 for ‘‘Repackaging of
Certain Human Drug Products by
Pharmacies and Outsourcing 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
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
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
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19:06 Jan 12, 2017
Jkt 241001
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 the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the 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 final guidance for industry entitled
‘‘Repackaging of Certain Human Drug
Products by Pharmacies and
Outsourcing Facilities.’’ FDA regards
repackaging as the act of taking a
finished drug product from the
container in which it was distributed by
the original manufacturer and placing it
into a different container without
further manipulation of the drug. If a
drug is manipulated in any other way,
including if the drug is reconstituted,
diluted, mixed, or combined with
another ingredient, that act is not
considered repackaging.
Repackaged drugs are generally not
exempt from any of the provisions of the
FD&C Act related to the production of
drugs. For example, repackaged drugs
are generally subject to the premarket
approval, misbranding, adulteration,
and drug supply chain security
provisions of the FD&C Act, including
section 505 (concerning new drug
applications), section 502(f)(1)
(concerning labeling with adequate
directions for use), section 501(a)(2)(B)
(concerning current good manufacturing
practice (CGMP)), and section 582 (drug
supply chain security requirements) (21
U.S.C. 355, 352(f)(1), 351(a)(2)(B), and
360eee–1).
Further, drugs that are repackaged are
not subject to sections 503A and 503B
of the FD&C Act (21 U.S.C. 353a and
353b). Therefore, drugs repackaged by
state-licensed pharmacies, Federal
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facilities, or outsourcing facilities are
not eligible for the exemptions provided
under those sections.
This guidance describes the
conditions under which FDA does not
intend to take action for violations of
sections 505, 502(f)(1), 582, and, where
specified in the guidance, section
501(a)(2)(B) of the FD&C Act, when a
state-licensed pharmacy, Federal
facility, or outsourcing facility
repackages certain drug products.
In the Federal Register of February
19, 2015 (80 FR 8884), FDA issued a
notice announcing the availability of the
draft version of this guidance. The
comment period on the draft guidance
ended on May 20, 2015. FDA received
approximately 625 comments on the
draft guidance. In response to received
comments or on its own initiative, FDA
made several changes. For example,
FDA removed from the guidance the
condition concerning ‘‘anticipatory
repackaging’’ (repackaging before the
receipt of a patient-specific
prescription) of no more than a 14-day
supply. FDA made this change partly in
response to comments indicating that
pharmacies sometimes need to
repackage more than a 14-day supply of
repackaged drug products in advance of
a prescription. FDA also revised the
conditions concerning beyond-use-dates
(BUDs) for repackaged drugs to reflect
BUDs for compounded drugs in, as
applicable, United States Pharmacopeia
(USP) Chapter <795>, the USP’s
proposed revision to Chapter <797>,
and FDA’s guidance concerning current
good manufacturing practice
requirements for outsourcing facilities.
FDA received comments on the draft
guidance from hospital organizations
regarding the potential implications of
the proposed policies in the draft
guidance concerning patient-specific
prescriptions for drugs repackaged for
in-patient settings. The final guidance
notes that FDA is considering the
applicability of the policies described in
this guidance to in-patient settings,
including long-term care facilities and
hospitals, and intends to address these
issues in separate guidance.
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 repackaging human
drug products by pharmacies, Federal
facilities, and 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.
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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. Section 3506(c)(2)(A) of
the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, in the
Federal Register of February 19, 2015,
we gave interested persons 60 days to
comment on the information collection
provisions in the draft guidance (80 FR
8884 at 8885).
After publishing the 60-day notice
requesting public comment, section
3507 of the PRA (44 U.S.C. 3507)
requires Federal Agencies to submit the
proposed collection to OMB for review
and clearance. In compliance with 44
U.S.C. 3507, we will be submitting a
proposed collection of information to
OMB for review and clearance. FDA is
issuing this guidance as final with
portions of it subject to OMB approval
of the collection of information and
shaded gray. Those provisions that are
shaded gray and subject to OMB
approval will be final if the collection
of information is approved. If the
collection is approved, FDA will
publish a notice in the Federal Register
concerning OMB approval and
providing an OMB control number for
these provisions.
The guidance also references
registration and adverse event reporting
for outsourcing facilities. The
collections of information for
outsourcing facility registration have
been approved by OMB under OMB
control number 0910–0777. The
collections of information for adverse
event reporting by outsourcing facilities
have been approved by OMB under
OMB control number 0910–0800.
III. Electronic Access
Persons with access to the Internet
can obtain the document at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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19:06 Jan 12, 2017
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Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00723 Filed 1–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1543]
Nonproprietary Naming of Biological
Products; 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
guidance for industry entitled
‘‘Nonproprietary Naming of Biological
Products.’’ The guidance describes our
current thinking on the need for
biological products previously and
newly licensed under the Public Health
Service Act (PHS Act) to bear
nonproprietary names that include
FDA-designated suffixes. Accordingly,
we intend to designate nonproprietary
names for originator biological products,
related biological products, or
biosimilar products which will include
a core name and a distinguishing suffix
that is devoid of meaning and composed
of four lowercase letters. This guidance
finalizes the draft guidance issued on
August 28, 2015.
FDA is also announcing that a
proposed collection of information has
been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit either electronic or
written comments on Agency guidances
at any time. Submit written comments
on the collection of information by
February 13, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘Nonproprietary Naming of
Biological Products.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
You may submit comments as
follows:
SUMMARY:
PO 00000
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4345
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–D–1543 for ‘‘Nonproprietary
Naming of Biological 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
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
E:\FR\FM\13JAN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4343-4345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00723]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1524]
Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities; Final 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 final guidance for industry entitled
``Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities.'' This guidance describes the conditions under
which FDA does not intend to take action for violations of certain
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
when a State-licensed pharmacy, a Federal facility, or an outsourcing
facility repackages certain human drug products.
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'').
[[Page 4344]]
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-2014-D-1524 for ``Repackaging of Certain Human Drug Products by
Pharmacies and Outsourcing 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 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 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 the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the 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 final guidance for industry
entitled ``Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities.'' FDA regards repackaging as the act of taking
a finished drug product from the container in which it was distributed
by the original manufacturer and placing it into a different container
without further manipulation of the drug. If a drug is manipulated in
any other way, including if the drug is reconstituted, diluted, mixed,
or combined with another ingredient, that act is not considered
repackaging.
Repackaged drugs are generally not exempt from any of the
provisions of the FD&C Act related to the production of drugs. For
example, repackaged drugs are generally subject to the premarket
approval, misbranding, adulteration, and drug supply chain security
provisions of the FD&C Act, including section 505 (concerning new drug
applications), section 502(f)(1) (concerning labeling with adequate
directions for use), section 501(a)(2)(B) (concerning current good
manufacturing practice (CGMP)), and section 582 (drug supply chain
security requirements) (21 U.S.C. 355, 352(f)(1), 351(a)(2)(B), and
360eee-1).
Further, drugs that are repackaged are not subject to sections 503A
and 503B of the FD&C Act (21 U.S.C. 353a and 353b). Therefore, drugs
repackaged by state-licensed pharmacies, Federal facilities, or
outsourcing facilities are not eligible for the exemptions provided
under those sections.
This guidance describes the conditions under which FDA does not
intend to take action for violations of sections 505, 502(f)(1), 582,
and, where specified in the guidance, section 501(a)(2)(B) of the FD&C
Act, when a state-licensed pharmacy, Federal facility, or outsourcing
facility repackages certain drug products.
In the Federal Register of February 19, 2015 (80 FR 8884), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on May
20, 2015. FDA received approximately 625 comments on the draft
guidance. In response to received comments or on its own initiative,
FDA made several changes. For example, FDA removed from the guidance
the condition concerning ``anticipatory repackaging'' (repackaging
before the receipt of a patient-specific prescription) of no more than
a 14-day supply. FDA made this change partly in response to comments
indicating that pharmacies sometimes need to repackage more than a 14-
day supply of repackaged drug products in advance of a prescription.
FDA also revised the conditions concerning beyond-use-dates (BUDs) for
repackaged drugs to reflect BUDs for compounded drugs in, as
applicable, United States Pharmacopeia (USP) Chapter <795>, the USP's
proposed revision to Chapter <797>, and FDA's guidance concerning
current good manufacturing practice requirements for outsourcing
facilities.
FDA received comments on the draft guidance from hospital
organizations regarding the potential implications of the proposed
policies in the draft guidance concerning patient-specific
prescriptions for drugs repackaged for in-patient settings. The final
guidance notes that FDA is considering the applicability of the
policies described in this guidance to in-patient settings, including
long-term care facilities and hospitals, and intends to address these
issues in separate guidance.
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 repackaging human drug products by
pharmacies, Federal facilities, and 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.
[[Page 4345]]
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. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, in the
Federal Register of February 19, 2015, we gave interested persons 60
days to comment on the information collection provisions in the draft
guidance (80 FR 8884 at 8885).
After publishing the 60-day notice requesting public comment,
section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to
submit the proposed collection to OMB for review and clearance. In
compliance with 44 U.S.C. 3507, we will be submitting a proposed
collection of information to OMB for review and clearance. FDA is
issuing this guidance as final with portions of it subject to OMB
approval of the collection of information and shaded gray. Those
provisions that are shaded gray and subject to OMB approval will be
final if the collection of information is approved. If the collection
is approved, FDA will publish a notice in the Federal Register
concerning OMB approval and providing an OMB control number for these
provisions.
The guidance also references registration and adverse event
reporting for outsourcing facilities. The collections of information
for outsourcing facility registration have been approved by OMB under
OMB control number 0910-0777. The collections of information for
adverse event reporting by outsourcing facilities have been approved by
OMB under OMB control number 0910-0800.
III. Electronic Access
Persons with access to the Internet can obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00723 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P
