Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability, 96005-96007 [2016-31512]
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Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
96005
Application No.
Drug
Applicant
NDA 019080 ........................
ProSom (estazolam) Tablets, 1 milligram (mg) and 2
mg.
Fentanyl Oralet (fentanyl citrate) Troche/Lozenge,
Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base,
EQ 0.3 mg base, and EQ 0.4 mg base.
Niravam (alprazolam) Orally Disintegrating Tablets,
0.25 mg, 0.5 mg, 1 mg, and 2 mg.
Methyltestosterone Tablets USP, 10 mg ........................
Abbott Laboratories, 200 Abbott Park Rd., Abbott Park,
IL 60064.
Cephalon, Inc., 41 Moores Rd., Frazer, PA 19355.
NDA 020195 ........................
NDA 021726 ........................
ANDA 084287 ......................
ANDA 084310 ......................
NDA 205208 ........................
Methyltestosterone Tablets USP, 25 mg ........................
Desvenlafaxine Fumarate Extended-Release Tablets,
EQ 50 mg base and EQ 100 mg base.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and under
authority delegated to the Director,
Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in the
table, and all amendments and
supplements thereto, is hereby
withdrawn, effective January 30, 2017.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
the table that are in inventory on the
date that this notice becomes effective
(see the DATES section) may continue to
be dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
UCB, Inc., 1950 Lake Park Dr., Building 2100, Smyrna,
GA 30080.
Impax Laboratories, Inc., 31047 Genstar Rd., Hayward,
CA 94544.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
sets forth FDA’s policy regarding
compounding and repackaging of
radiopharmaceuticals for human use by
entities that are registered with FDA as
outsourcing facilities. This guidance
describes how FDA intends to apply
section 503B of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to
radiopharmaceuticals compounded by
outsourcing facilities, and it describes
the conditions under which FDA does
not intend to take action for violations
of certain provisions of the FD&C Act
when an outsourcing facility repackages
radiopharmaceuticals.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
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 draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 27,
2017. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by February 27, 2017.
[FR Doc. 2016–31625 Filed 12–28–16; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
as follows:
DATES:
You may submit comments
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4317]
Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities.’’ Specifically, this guidance
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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
PO 00000
Frm 00050
Fmt 4703
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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–
2016–D–4317 for ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by 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
E:\FR\FM\29DEN1.SGM
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96006
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
In 2013, the Drug Quality and
Security Act created a new section 503B
of the FD&C Act (21 U.S.C. 353b), which
describes a new category of
compounders called outsourcing
facilities. Section 503B of the FD&C Act
describes the conditions that must be
satisfied for human drug products
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility to qualify for
exemptions from the following three
sections of the FD&C Act:
• Section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning labeling with
adequate directions for use);
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
• section 505 (21 U.S.C. 355)
(concerning drug approval
requirements); and
• section 582 (21 U.S.C. 360eee–1
(concerning drug supply chain security
requirements).
In contrast to section 503A (21 U.S.C.
353a), section 503B of the FD&C Act
does not exclude radiopharmaceuticals.
In general, FDA’s policies regarding
section 503B of the FD&C Act apply to
the compounding of
radiopharmaceutical drug products.
However, the Agency has developed
specific policies, applicable only to the
compounding of radiopharmaceuticals
by outsourcing facilities, with respect to
bulk drug substances for use in
compounding radiopharmaceuticals and
compounding radiopharmaceuticals that
are essentially copies of approved drugs
when such compounding is limited to
minor deviations, as that term is defined
in the guidance.
In addition, because outsourcing
facilities may sometimes repackage
radiopharmaceuticals for patients, but
repackaged radiopharmaceuticals are
not eligible for the exemptions in
section 503B of the FD&C Act, the draft
guidance describes the conditions under
which the Agency does not intend to
take action for violations of sections 505
and 502(f)(1) of the FD&C Act when an
outsourcing facility repackages
radiopharmaceuticals for human use.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a separate draft guidance
document concerning compounding and
repackaging of radiopharmaceuticals by
State-licensed nuclear pharmacies and
Federal facilities that are not registered
as outsourcing facilities entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies and Federal
Facilities.’’
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 ‘‘Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501–3520). The title,
PO 00000
Frm 00051
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description, and respondent description
of the information collection are given
under this section with an estimate of
the annual reporting and recordkeeping
burdens. Included in the estimate is the
time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
the collection of information.
We invite comments on the following
topics: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
The draft guidance includes the
following collections of information
under the PRA:
One condition in the draft guidance is
that if a radiopharmaceutical is
repackaged by an outsourcing facility,
the label on the immediate container
(primary packaging, e.g., the syringe) of
the repackaged product includes the
following information:
• The statement ‘‘This
radiopharmaceutical was repackaged by
[name of outsourcing facility].’’;
• the address and phone number of
the outsourcing facility that repackaged
the radiopharmaceutical;
• the established name of the original,
approved radiopharmaceutical that was
repackaged;
• the lot or batch number of the
repackaged radiopharmaceutical;
• the dosage form and radioactive
dose of the repackaged
radiopharmaceutical;
• a statement of either the quantity or
volume of the repackaged
radiopharmaceutical, whichever is
appropriate;
• the date the radiopharmaceutical
was repackaged;
• the beyond-use-date of the
repackaged radiopharmaceutical;
• storage and handling instructions
for the repackaged radiopharmaceutical;
• the National Drug Code (NDC)
number of the repackaged
radiopharmaceutical, if available 1;
1 The NDC number of the original approved drug
product should not be placed on the repackaged
drug product.
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Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
• the statement ‘‘Not for resale,’’ and,
if the repackaged radiopharmaceutical is
distributed by an outsourcing facility
other than pursuant to a prescription for
an individual identified patient, the
statement ‘‘Office Use Only’’; and
• a list of the active and inactive
ingredients, unless such information is
included on the label for the container
from which the individual units are
removed, as described in this document.
Another condition in the draft
guidance is that the label on the
container from which the individual
units are removed for administration
(secondary packaging, e.g., the bag, box,
or other package in which the
repackaged products are distributed)
includes the active and inactive
ingredients, if the immediate product
label is too small to include this
information, and directions for use,
including, as appropriate, dosage and
administration, and the following
information to facilitate adverse event
reporting: https://www.fda.gov/
medwatch and 1–800–FDA–1088.
We estimate that annually a total of
approximately 2 outsourcing facilities
(‘‘No. of Respondents’’ in table 1, row 1)
will each design, test, and produce
approximately 5 different labels (‘‘No. of
Disclosures per Respondent’’ in table 1,
row 1) for a total of 10 labels that
include the information described
previously (including directions for use)
(‘‘Total Annual Disclosures’’ in table 1,
row 1). We also estimate that designing,
testing, and producing each label will
take approximately 0.5 hours for each
repackaged radiopharmaceutical
(‘‘Average Burden Hours per
Disclosure’’ in table 1, row 1). The
provision to add the statement https://
www.fda.gov/medwatch and 1–800–
FDA–1088 is not included in this
burden estimate because it is not
considered a collection of information
under the PRA because the information
is ‘‘originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)).
96007
The draft guidance also references
registration, adverse event reporting,
product reporting, and current good
manufacturing practices (CGMP)
requirements for outsourcing facilities.
The collection of information for
outsourcing facility registration has
been approved by the Office of
Management and Budget (OMB) under
OMB control number 0910–0777 (79 FR
69859, November 24, 2014). The
collection of information for adverse
event reporting by outsourcing facilities
has been approved by OMB under OMB
control number 0910–0800 (80 FR
60917, October 8, 2015). In the Federal
Register of August 1, 2016 (81 FR
50523), FDA estimated the burden
resulting from outsourcing facility
electronic drug product reporting. In the
Federal Register of July 2, 2014 (79 FR
37743), FDA estimated the burden
resulting from outsourcing facility
compliance with CGMP requirements.
The total estimated third-party
disclosure burden resulting from the
draft guidance is as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Repackaging by outsourcing facilities
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
Designing, testing, and producing each label on immediate containers, packages and/or outer containers.
2
5
10
.5 (30 minutes) ....
5
There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
ACTION:
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.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Identification
and Characterization of the Infectious
Disease Risks of Human Cells, Tissues,
and Cellular and Tissue-based
Products.’’ The purpose of the public
workshop is to have a scientific
discussion of the current methods
available for identifying and
characterizing infectious disease risks
associated with human cells, tissues,
and cellular and tissue-based products
(HCT/Ps).
DATES: The public workshop will be
held on February 8, 2017, from 8:30 a.m.
to 4:30 p.m., and February 9, 2017, from
8:30 a.m. to 12:30 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at the Wiley Auditorium located
in the Harvey H. Wiley Federal
Building, 5100 Campus Dr., College
Park, MD 20740.
FOR FURTHER INFORMATION CONTACT:
Monica Kapoor, Center for Biologics
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31512 Filed 12–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Identification and Characterization of
the Infectious Disease Risks of Human
Cells, Tissues, and Cellular and
Tissue-Based Products; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
Notice of public workshop.
SUMMARY:
PO 00000
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3111C,
Silver Spring, MD 20993,
CBERPublicEvents@fda.hhs.gov; or
Stacey Rivette, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm.
3109B, Silver Spring, MD 20993,
CBERPublicEvents@fda.hhs.gov with the
subject line titled ‘‘HCT/P Workshop.’’
SUPPLEMENTARY INFORMATION:
I. Background
Transplantation of HCT/Ps represents
an area of medicine important for saving
and/or enhancing the lives of millions
of individuals every year. In order to
assure the safety of patients receiving
HCT/P transplants, FDA issued
regulations to prevent the introduction,
transmission, or spread of
communicable diseases by HCT/Ps
under part 1271 (21 CFR part 1271)
(May 25, 2004; 69 FR 29786). These
regulations became effective on May 25,
2005. The regulations under part 1271,
subpart C, contain the requirements for
E:\FR\FM\29DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96005-96007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4317]
Compounding and Repackaging of Radiopharmaceuticals by
Outsourcing Facilities; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing
Facilities.'' Specifically, this guidance sets forth FDA's policy
regarding compounding and repackaging of radiopharmaceuticals for human
use by entities that are registered with FDA as outsourcing facilities.
This guidance describes how FDA intends to apply section 503B of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
radiopharmaceuticals compounded by outsourcing facilities, and it
describes the conditions under which FDA does not intend to take action
for violations of certain provisions of the FD&C Act when an
outsourcing facility repackages radiopharmaceuticals.
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
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 27, 2017. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by February 27, 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): 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-2016-D-4317 for ``Compounding and Repackaging of
Radiopharmaceuticals by 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
[[Page 96006]]
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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.
SUPPLEMENTARY INFORMATION:
I. Background
In 2013, the Drug Quality and Security Act created a new section
503B of the FD&C Act (21 U.S.C. 353b), which describes a new category
of compounders called outsourcing facilities. Section 503B of the FD&C
Act describes the conditions that must be satisfied for human drug
products compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility to qualify for exemptions from
the following three sections of the FD&C Act:
Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
labeling with adequate directions for use);
section 505 (21 U.S.C. 355) (concerning drug approval
requirements); and
section 582 (21 U.S.C. 360eee-1 (concerning drug supply
chain security requirements).
In contrast to section 503A (21 U.S.C. 353a), section 503B of the
FD&C Act does not exclude radiopharmaceuticals. In general, FDA's
policies regarding section 503B of the FD&C Act apply to the
compounding of radiopharmaceutical drug products. However, the Agency
has developed specific policies, applicable only to the compounding of
radiopharmaceuticals by outsourcing facilities, with respect to bulk
drug substances for use in compounding radiopharmaceuticals and
compounding radiopharmaceuticals that are essentially copies of
approved drugs when such compounding is limited to minor deviations, as
that term is defined in the guidance.
In addition, because outsourcing facilities may sometimes repackage
radiopharmaceuticals for patients, but repackaged radiopharmaceuticals
are not eligible for the exemptions in section 503B of the FD&C Act,
the draft guidance describes the conditions under which the Agency does
not intend to take action for violations of sections 505 and 502(f)(1)
of the FD&C Act when an outsourcing facility repackages
radiopharmaceuticals for human use.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a separate draft guidance document concerning
compounding and repackaging of radiopharmaceuticals by State-licensed
nuclear pharmacies and Federal facilities that are not registered as
outsourcing facilities entitled ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal
Facilities.''
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 ``Compounding
and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection are given under this section with an estimate of the annual
reporting and recordkeeping burdens. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
We invite comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
The draft guidance includes the following collections of
information under the PRA:
One condition in the draft guidance is that if a
radiopharmaceutical is repackaged by an outsourcing facility, the label
on the immediate container (primary packaging, e.g., the syringe) of
the repackaged product includes the following information:
The statement ``This radiopharmaceutical was repackaged by
[name of outsourcing facility].'';
the address and phone number of the outsourcing facility
that repackaged the radiopharmaceutical;
the established name of the original, approved
radiopharmaceutical that was repackaged;
the lot or batch number of the repackaged
radiopharmaceutical;
the dosage form and radioactive dose of the repackaged
radiopharmaceutical;
a statement of either the quantity or volume of the
repackaged radiopharmaceutical, whichever is appropriate;
the date the radiopharmaceutical was repackaged;
the beyond-use-date of the repackaged radiopharmaceutical;
storage and handling instructions for the repackaged
radiopharmaceutical;
the National Drug Code (NDC) number of the repackaged
radiopharmaceutical, if available \1\;
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\1\ The NDC number of the original approved drug product should
not be placed on the repackaged drug product.
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[[Page 96007]]
the statement ``Not for resale,'' and, if the repackaged
radiopharmaceutical is distributed by an outsourcing facility other
than pursuant to a prescription for an individual identified patient,
the statement ``Office Use Only''; and
a list of the active and inactive ingredients, unless such
information is included on the label for the container from which the
individual units are removed, as described in this document.
Another condition in the draft guidance is that the label on the
container from which the individual units are removed for
administration (secondary packaging, e.g., the bag, box, or other
package in which the repackaged products are distributed) includes the
active and inactive ingredients, if the immediate product label is too
small to include this information, and directions for use, including,
as appropriate, dosage and administration, and the following
information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088.
We estimate that annually a total of approximately 2 outsourcing
facilities (``No. of Respondents'' in table 1, row 1) will each design,
test, and produce approximately 5 different labels (``No. of
Disclosures per Respondent'' in table 1, row 1) for a total of 10
labels that include the information described previously (including
directions for use) (``Total Annual Disclosures'' in table 1, row 1).
We also estimate that designing, testing, and producing each label will
take approximately 0.5 hours for each repackaged radiopharmaceutical
(``Average Burden Hours per Disclosure'' in table 1, row 1). The
provision to add the statement https://www.fda.gov/medwatch and 1-800-
FDA-1088 is not included in this burden estimate because it is not
considered a collection of information under the PRA because the
information is ``originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
The draft guidance also references registration, adverse event
reporting, product reporting, and current good manufacturing practices
(CGMP) requirements for outsourcing facilities. The collection of
information for outsourcing facility registration has been approved by
the Office of Management and Budget (OMB) under OMB control number
0910-0777 (79 FR 69859, November 24, 2014). The collection of
information for adverse event reporting by outsourcing facilities has
been approved by OMB under OMB control number 0910-0800 (80 FR 60917,
October 8, 2015). In the Federal Register of August 1, 2016 (81 FR
50523), FDA estimated the burden resulting from outsourcing facility
electronic drug product reporting. In the Federal Register of July 2,
2014 (79 FR 37743), FDA estimated the burden resulting from outsourcing
facility compliance with CGMP requirements.
The total estimated third-party disclosure burden resulting from
the draft guidance is as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Repackaging by outsourcing facilities Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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Designing, testing, and producing each label 2 5 10 .5 (30 minutes)....................... 5
on immediate containers, packages and/or
outer containers.
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There are no capital costs or operating and maintenance costs associated with this collection of information.
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: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31512 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P
