Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability, 96011-96013 [2016-31513]
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Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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Clinical pharmacology studies are
part of a stepwise approach for
developing the data and information
needed to support a demonstration of
biosimilarity. These studies can reduce
the residual uncertainty in assessing the
biosimilarity between a proposed
biosimilar product and reference
product and inform the design of
subsequent clinical trials to assess
clinically meaningful differences. This
guidance is intended to assist sponsors
in designing such studies in support of
applications submitted under section
351(k) of the Public Health Service Act
(42 U.S.C. 262(k)), as added by the BPCI
Act.1 In particular, this guidance
discusses certain critical considerations
for using clinical pharmacology testing
to support biosimilarity, approaches for
developing the appropriate clinical
pharmacology database to support a
demonstration of biosimilarity, and the
utility of modeling and simulation for
designing and analyzing clinical trials.
Scientific principles described in the
guidance may also be informative for
the development of certain biological
products under section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(b)(2)).
On May 14, 2014, FDA issued a notice
announcing the availability of a draft
guidance with the same name as the
current guidance to solicit comments
from the public (79 FR 27622). After
carefully reviewing received comments
and in light of increased regulatory
experience and the evolution of the
science in biosimilar product
development and evaluation, FDA has
finalized that guidance with certain
changes. These changes are for clarity,
however, and are not substantive.
This guidance is one in a series that
FDA is developing to implement the
BPCI Act and is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidance represents the current thinking
of FDA on conducting clinical
pharmacology studies in support of
proposed biosimilar 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.
II. The Paperwork Reduction Act of
1995
The guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
1 The BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010.
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information submitted under section
351(k) applications for biosimilars is
approved under OMB control number
0910–0719. The collection of
information submitted under 21 CFR
part 312 is approved under OMB control
number 0910–0014.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31511 Filed 12–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4318]
Compounding and Repackaging of
Radiopharmaceuticals by StateLicensed Nuclear Pharmacies and
Federal Facilities; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
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 State-Licensed
Nuclear Pharmacies and Federal
Facilities.’’ This guidance sets forth
FDA’s policy regarding compounding
and repackaging of
radiopharmaceuticals for human use by
State-licensed nuclear pharmacies and
Federal facilities that are not registered
as outsourcing facilities. Because such
radiopharmaceuticals are not eligible for
exemptions from provisions of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) related to the production
of drugs, FDA is issuing this guidance
to describe the conditions under which
it does not intend to take action for
violations of certain provisions of the
FD&C Act when a State-licensed nuclear
pharmacy or Federal facility compounds
or repackages radiopharmaceuticals.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
96011
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:
DATES:
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–4318 for ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by State-Licensed Nuclear Pharmacies
and Federal Facilities.’’ Received
E:\FR\FM\29DEN1.SGM
29DEN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
96012
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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 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.
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
FOR FURTHER INFORMATION CONTACT:
Edisa Gozun, 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
Under current law,
radiopharmaceuticals that are
compounded by entities that are not
registered with FDA as outsourcing
facilities, and radiopharmaceuticals that
are repackaged, are subject to all
applicable provisions of the FD&C Act
related to the production of drugs.
Because Congress explicitly excluded
radiopharmaceuticals from section 503A
of the FD&C Act (21 U.S.C. 353a) (see
section 503A(d)(2)),1 compounded
radiopharmaceuticals are not eligible for
the exemptions under section 503A
from section 505 of the FD&C Act (21
U.S.C. 355) (concerning new drug
approval requirements), section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) (concerning labeling with
adequate directions for use), and section
501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)B)) (concerning current good
manufacturing practice (CGMP)
requirements). In addition, Congress did
not exempt repackaged
radiopharmaceuticals from any
provisions of the FD&C Act.
Because State-licensed nuclear
pharmacies and Federal facilities
sometimes compound or repackage
radiopharmaceuticals for patients, but
radiopharmaceuticals are not eligible for
the exemptions in section 503A of the
FD&C Act, FDA is issuing this guidance
to describe the conditions under which
the Agency does not intend to take
action for violations of sections 505,
502(f)(1), and 501(a)(2)(B) of the FD&C
Act when a State-licensed nuclear
pharmacy or a Federal facility that is not
an outsourcing facility compounds or
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
outsourcing facilities entitled
‘‘Compounding and Repackaging of
1 Section 503A of the FD&C Act describes the
conditions that must be met for drug products
compounded by a licensed pharmacist in a Statelicensed pharmacy or Federal facility, or by a
licensed physician, to qualify for exemptions from
sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C
Act. Section 503A(d)(2) of the FD&C Act states that
‘‘this section shall not apply to . . .
radiopharmaceuticals.’’
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Radiopharmaceuticals by Outsourcing
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 State-Licensed
Nuclear Pharmacies and Federal
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
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information that they conduct or
sponsor. Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) 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, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this
document, FDA invites 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.
One of the conditions of the draft
guidance is that the compounded
radiopharmaceutical is not essentially a
copy of an approved
radiopharmaceutical. If a compounder
intends to rely on a determination from
a prescriber that there is a change
between the compounded
radiopharmaceutical and the
E:\FR\FM\29DEN1.SGM
29DEN1
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
comparable approved
radiopharmaceutical that produces for
an identified individual patient a
clinical difference, the determination is
documented on the prescription or
order in writing by either (1) the
prescribing practitioner, or (2) the
compounder, reflecting a conversation
with the prescribing practitioner. The
compounder maintains records of the
prescription or order documenting this
determination.
We estimate that annually a total of
approximately 10 compounders (‘‘No. of
Respondents’’ in table 1, line 1) will
consult a prescriber to determine
whether he or she has made a
determination that the compounded
radiopharmaceutical has a change that
produces a clinical difference for an
identified individual patient as
compared to the comparable approved
radiopharmaceutical. We estimate that
compounders will document this
determination on approximately 250
prescriptions or orders for compounded
radiopharmaceuticals ‘‘Total Annual
Disclosures’’ in table 1, line 1). We
estimate that the consultation between
the compounder and the prescriber and
noting this determination on each
prescription or order that does not
already document this determination
will take approximately 3 minutes per
prescription or order.
96013
A compounder also maintains records
of prescriptions or orders noting the
determination that a prescriber has
determined that the compounded
radiopharmaceutical has a change that
produces a clinical difference for an
identified individual patient. We
estimate that the compounder will take
approximately 2.1 hours to maintain the
records of 250 prescriptions or orders
documenting the prescriber’s
determination of clinical difference
(‘‘Total Hours’’ in table 2). We estimate
that maintaining such records will take
approximately 30 seconds per
prescription or order.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of reporting
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Consultation between the compounder and prescriber or
health care facility, and the notation on the prescription or
order documenting the prescriber’s determination of clinical difference.
10
25
250
3 minutes ....
12.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of reporting
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden
per
recordkeeping
Total hours
Maintenance of records of prescriptions or orders documenting the prescriber’s determination of clinical difference.
10
25
250
30 seconds ..
2.1
1 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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31513 Filed 12–28–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1953]
Providing Regulatory Submissions in
Electronic Format—Submission of
Manufacturing Establishment
Information; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Submission of
Manufacturing Establishment
Information.’’ This guidance discusses
the requirements for a valid electronic
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
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PO 00000
Frm 00058
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Sfmt 4703
submission of manufacturing
establishment information (MEI) under
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act). This action will
streamline the review of all
manufacturing establishments involved
in the preparation of a drug or biological
product by consolidating information in
one location and eliminating the
inclusion of erroneous and/or outdated
information from other Agency files.
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.
DATES:
ADDRESSES:
You may submit comments
as follows:
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96011-96013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31513]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4318]
Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies and Federal 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 State-Licensed
Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth
FDA's policy regarding compounding and repackaging of
radiopharmaceuticals for human use by State-licensed nuclear pharmacies
and Federal facilities that are not registered as outsourcing
facilities. Because such radiopharmaceuticals are not eligible for
exemptions from provisions of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) related to the production of drugs, FDA is issuing this
guidance to describe the conditions under which it does not intend to
take action for violations of certain provisions of the FD&C Act when a
State-licensed nuclear pharmacy or Federal facility compounds or
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-4318 for ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal
Facilities.'' Received
[[Page 96012]]
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 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: Edisa Gozun, 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
Under current law, radiopharmaceuticals that are compounded by
entities that are not registered with FDA as outsourcing facilities,
and radiopharmaceuticals that are repackaged, are subject to all
applicable provisions of the FD&C Act related to the production of
drugs. Because Congress explicitly excluded radiopharmaceuticals from
section 503A of the FD&C Act (21 U.S.C. 353a) (see section
503A(d)(2)),\1\ compounded radiopharmaceuticals are not eligible for
the exemptions under section 503A from section 505 of the FD&C Act (21
U.S.C. 355) (concerning new drug approval requirements), section
502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning labeling
with adequate directions for use), and section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)B)) (concerning current good manufacturing
practice (CGMP) requirements). In addition, Congress did not exempt
repackaged radiopharmaceuticals from any provisions of the FD&C Act.
---------------------------------------------------------------------------
\1\ Section 503A of the FD&C Act describes the conditions that
must be met for drug products compounded by a licensed pharmacist in
a State-licensed pharmacy or Federal facility, or by a licensed
physician, to qualify for exemptions from sections 505, 502(f)(1),
and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act
states that ``this section shall not apply to . . .
radiopharmaceuticals.''
---------------------------------------------------------------------------
Because State-licensed nuclear pharmacies and Federal facilities
sometimes compound or repackage radiopharmaceuticals for patients, but
radiopharmaceuticals are not eligible for the exemptions in section
503A of the FD&C Act, FDA is issuing this guidance to describe the
conditions under which the Agency does not intend to take action for
violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act
when a State-licensed nuclear pharmacy or a Federal facility that is
not an outsourcing facility compounds or 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 outsourcing
facilities entitled ``Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing 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 State-Licensed Nuclear
Pharmacies and Federal 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
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) 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, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the collection of information associated with this
document, FDA invites 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.
One of the conditions of the draft guidance is that the compounded
radiopharmaceutical is not essentially a copy of an approved
radiopharmaceutical. If a compounder intends to rely on a determination
from a prescriber that there is a change between the compounded
radiopharmaceutical and the
[[Page 96013]]
comparable approved radiopharmaceutical that produces for an identified
individual patient a clinical difference, the determination is
documented on the prescription or order in writing by either (1) the
prescribing practitioner, or (2) the compounder, reflecting a
conversation with the prescribing practitioner. The compounder
maintains records of the prescription or order documenting this
determination.
We estimate that annually a total of approximately 10 compounders
(``No. of Respondents'' in table 1, line 1) will consult a prescriber
to determine whether he or she has made a determination that the
compounded radiopharmaceutical has a change that produces a clinical
difference for an identified individual patient as compared to the
comparable approved radiopharmaceutical. We estimate that compounders
will document this determination on approximately 250 prescriptions or
orders for compounded radiopharmaceuticals ``Total Annual Disclosures''
in table 1, line 1). We estimate that the consultation between the
compounder and the prescriber and noting this determination on each
prescription or order that does not already document this determination
will take approximately 3 minutes per prescription or order.
A compounder also maintains records of prescriptions or orders
noting the determination that a prescriber has determined that the
compounded radiopharmaceutical has a change that produces a clinical
difference for an identified individual patient. We estimate that the
compounder will take approximately 2.1 hours to maintain the records of
250 prescriptions or orders documenting the prescriber's determination
of clinical difference (``Total Hours'' in table 2). We estimate that
maintaining such records will take approximately 30 seconds per
prescription or order.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Type of reporting Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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Consultation between the compounder and 10 25 250 3 minutes.......................... 12.5
prescriber or health care facility, and the
notation on the prescription or order
documenting the prescriber's determination of
clinical difference.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Type of reporting Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records of prescriptions or 10 25 250 30 seconds......................... 2.1
orders documenting the prescriber's
determination of clinical difference.
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\1\ 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. 2016-31513 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P
