Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 37500-37502 [2016-13798]
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
asabaliauskas on DSK3SPTVN1PROD with RULES
is codifying the classification of the
device by adding 21 CFR 886.5838.
The device is assigned the generic
name nasolacrimal compression device,
and it is identified as a prescription
device that is fitted to apply mechanical
pressure to the nasal aspect of the
orbital rim to reduce outflow through
the nasolacrimal ducts.
The risks to health that may be
associated with use of the nasolacrimal
compression device are improper fit of
the device (extended or aggressive use
of this device may cause sequelae such
as bruising and/or soreness) and
improper use of the device (for the
uncoordinated, a corneal abrasion may
occur inadvertently). General controls of
the FD&C Act, including compliance
with the labeling requirements in 21
CFR part 801 and the Quality System
Regulation (21 CFR part 820), are
sufficient to mitigate these risks and
reasonably assure safety and
effectiveness. FDA believes that the
general controls provide reasonable
assurance of safety and effectiveness.
The nasolacrimal compression device
is not safe for use except under the
supervision of a practitioner licensed by
law to direct the use of the device. As
such, the device is a prescription device
and must satisfy prescription labeling
requirements (see 21 CFR 801.109,
Prescription devices).
Section 510(l) of the FD&C Act
provides that a class I device is not
subject to the premarket notification
requirements under section 510(k) of the
FD&C Act, unless the device is of
substantial importance in preventing
impairment of human health or presents
a potential unreasonable risk of illness
or injury. FDA has determined that the
device does meet these criteria and,
therefore, premarket notification is not
required for the device. Thus, persons
who intend to market this device need
not submit a premarket notification
containing information on the
nasolacrimal compression device they
intend to market prior to marketing the
device, subject to the limitations on
exemptions in 21 CFR 886.9.
II. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
III. Paperwork Reduction Act of 1995
This final order refers to previously
approved collections of information
found in other FDA regulations. These
VerDate Sep<11>2014
16:32 Jun 09, 2016
Jkt 238001
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 807, subpart E, regarding premarket
notification submissions, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 820,
regarding the quality system regulation,
have been approved under OMB control
number 0910–0073; and the collections
of information in 21 CFR part 801,
regarding labeling, have been approved
under OMB control number 0910–0485.
IV. Reference
The following reference is on display
in the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; it is also
available electronically at https://
www.regulations.gov.
1. DEN140022: De novo request from
Innovatex, Inc., dated June 27, 2014.
List of Subjects in 21 CFR Part 886
Medical devices, Ophthalmic goods
and services.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 886 is
amended as follows:
PART 886—OPHTHALMIC DEVICES
1. The authority citation for 21 CFR
part 886 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Add § 886.5838 to subpart F to read
as follows:
■
§ 886.5838
device.
Nasolacrimal compression
(a) Identification. A nasolacrimal
compression device is a prescription
device that is fitted to apply mechanical
pressure to the nasal aspect of the
orbital rim to reduce outflow through
the nasolacrimal ducts.
(b) Classification. Class I (general
controls). The device is exempt from the
premarket notification procedures in
subpart E of part 807 of this chapter,
subject to the limitations in § 886.9.
Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13788 Filed 6–9–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2015–D–3539]
Interim Policy on Compounding Using
Bulk Drug Substances Under Section
503B of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Interim
Policy on Compounding Using Bulk
Drug Substances Under Section 503B of
the Federal Food, Drug, and Cosmetic
Act.’’ The guidance describes FDA’s
interim regulatory policy regarding
outsourcing facilities that compound
human drug products using bulk drug
substances while FDA develops the list
of bulk drug substances that can be used
in compounding under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
DATES: Submit 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
E:\FR\FM\10JNR1.SGM
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
asabaliauskas on DSK3SPTVN1PROD with RULES
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–
2015–D–3539 for ‘‘Interim Policy on
Compounding Using Bulk Drug
Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act’’.
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/
VerDate Sep<11>2014
16:32 Jun 09, 2016
Jkt 238001
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 this 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 20993–0002, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Interim Policy on Compounding Using
Bulk Drug Substances Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.’’ A new section 503B (21
U.S.C. 353b), added to the FD&C Act by
the Drug Quality and Security Act in
2013, describes the conditions that must
be satisfied for human drug products
compounded by an outsourcing facility
to be exempt from the following three
sections of the FD&C Act: Section 505
(21 U.S.C. 355) (concerning the approval
of drugs under new drug applications or
abbreviated new drug applications);
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and section
582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security
requirements). One of the conditions
that must be met for a drug product
compounded by an outsourcing facility
to qualify for these exemptions is that
the outsourcing facility does not
compound drug products using a bulk
drug substance unless: It appears on a
list established by the Secretary
identifying bulk drug substances for
which there is a clinical need (see
section 503B(a)(2)(A)(i) of the FD&C
Act); or the drug compounded from
such bulk drug substances appears on
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37501
the drug shortage list in effect under
section 506E of the FD&C Act (21 U.S.C.
356e) at the time of compounding,
distribution, and dispensing (see section
503B(a)(2)(A)(ii) of the FD&C Act).
This guidance describes the
conditions under which FDA does not
intend to take action against an
outsourcing facility for compounding a
drug product from a bulk drug
substance that does not appear on a list
of bulk drug substances that can be used
in compounding and is not used to
compound a drug product that appears
on the FDA drug shortage list at the time
of compounding, distribution, and
dispensing, while FDA develops the list
of bulk drug substances that can be used
in compounding pursuant to section
503B(a)(2)(A)(i) of the FD&C Act (503B
bulks list).1
The guidance also describes FDA’s
process to establish the 503B bulks list,
and it describes categories of substances
that were nominated for inclusion on
the 503B bulks list. These categories
include:
• 503B Category 1—Bulk Drug
Substances Under Evaluation: These
bulk drug substances may be eligible for
inclusion on the 503B bulks list, were
nominated with sufficient supporting
information for FDA to evaluate them,
and do not appear on any other list.
• 503B Category 2—Bulk Drug
Substances That Raise Significant Safety
Risks: These bulk drug substances were
nominated with sufficient supporting
information to permit FDA to evaluate
them and they may be eligible for
inclusion on the 503B bulks list.
However, FDA has identified significant
safety risks relating to the use of these
bulk substances in compounding, and
therefore does not intend to adopt the
policy described for the bulk substances
in Category 1.
• 503B Category 3—Bulk Drug
Substances Nominated Without
Adequate Support: These bulk drug
substances may be eligible for inclusion
on the 503B bulks list but were
nominated with insufficient supporting
information for FDA to evaluate them.
These substances can be re-nominated
with sufficient supporting information
1 Elsewhere in this issue of the Federal Register,
the Agency is making available a guidance entitled
‘‘Interim Policy on Compounding Using Bulk Drug
Substances Under Section 503A of the Federal
Food, Drug, and Cosmetic Act,’’ which describes
the conditions under which FDA does not intend
to take action against a licensed pharmacist in a
State-licensed pharmacy or Federal facility, or a
licensed physician, for compounding a drug
product from a bulk drug substance that cannot
otherwise be used in compounding under section
503A of the FD&C Act while FDA develops the list
of bulk drug substances that can be used in
compounding under section 503A(b)(1)(A)(i)(III).
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
through a docket that FDA has
established.
In the Federal Register of October 27,
2015 (80 FR 65768), FDA issued a notice
announcing the availability of the draft
version of this guidance. The comment
period on the draft guidance ended on
December 28, 2015. FDA received 11
comments on the draft guidance. In
response to received comments or on its
own initiative, FDA made several
changes to the guidance to clarify
particular points. In addition, FDA has
made the following updates to the lists
on its Web site of bulk drug substances
that were nominated for inclusion on
the 503A bulks list: 2
• 503B Category 2: FDA has added
one bulk drug substances to Category 2,
germanium sesquioxide, because FDA
identified significant safety risks
relating to the use of this bulk drug
substance in compounding.
• 503B Category 4: The draft interim
guidance included a fourth category of
bulk drug substances that would have
identified substances that FDA
evaluated for inclusion on the 503B
bulks list but, after obtaining and
considering public comments, decided
not to place on the 503B bulks list. In
the final interim guidance, FDA
removed this fourth category because
the Agency intends to identify the bulk
drug substances that will not be placed
on the 503B bulks list in the Federal
Register notice that establishes the 503B
bulks list. Therefore, we do not believe
it is necessary to also include them in
the categories identified in this
guidance.
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13798 Filed 6–9–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with RULES
BILLING CODE 4164–01–P
2 In the future, if FDA makes changes to the
categories of bulk drug substances on its Web site,
we intend to follow the procedure identified in the
guidance.
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Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2015–D–3517]
Interim Policy on Compounding Using
Bulk Drug Substances Under Section
503A of the Federal Food, Drug, and
Cosmetic Act; 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 ‘‘Interim
Policy on Compounding Using Bulk
Drug Substances Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act.’’ The guidance describes FDA’s
interim regulatory policy regarding the
use of bulk drug substances by licensed
pharmacists in State-licensed
pharmacies or Federal facilities and by
licensed physicians to compound
human drug products while FDA
develops the list of bulk drug substances
that can be used in compounding under
section 503A of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
DATES: Submit 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
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
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–
2015–D–3517 for ‘‘Interim Policy on
Compounding Using Bulk Drug
Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act.’’
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
E:\FR\FM\10JNR1.SGM
10JNR1
]]>Agencies
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37500-37502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2015-D-3539]
Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food, Drug, and Cosmetic Act; 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 guidance for industry entitled
``Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The
guidance describes FDA's interim regulatory policy regarding
outsourcing facilities that compound human drug products using bulk
drug substances while FDA develops the list of bulk drug substances
that can be used in compounding under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
DATES: Submit 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
[[Page 37501]]
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-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic
Act''. 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 this 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 20993-0002, 301-
796-3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Interim Policy on Compounding Using Bulk Drug Substances
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' A new
section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug
Quality and Security Act in 2013, describes the conditions that must be
satisfied for human drug products compounded by an outsourcing facility
to be exempt from the following three sections of the FD&C Act: Section
505 (21 U.S.C. 355) (concerning the approval of drugs under new drug
applications or abbreviated new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements). One of the conditions that
must be met for a drug product compounded by an outsourcing facility to
qualify for these exemptions is that the outsourcing facility does not
compound drug products using a bulk drug substance unless: It appears
on a list established by the Secretary identifying bulk drug substances
for which there is a clinical need (see section 503B(a)(2)(A)(i) of the
FD&C Act); or the drug compounded from such bulk drug substances
appears on the drug shortage list in effect under section 506E of the
FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and
dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).
This guidance describes the conditions under which FDA does not
intend to take action against an outsourcing facility for compounding a
drug product from a bulk drug substance that does not appear on a list
of bulk drug substances that can be used in compounding and is not used
to compound a drug product that appears on the FDA drug shortage list
at the time of compounding, distribution, and dispensing, while FDA
develops the list of bulk drug substances that can be used in
compounding pursuant to section 503B(a)(2)(A)(i) of the FD&C Act (503B
bulks list).\1\
---------------------------------------------------------------------------
\1\ Elsewhere in this issue of the Federal Register, the Agency
is making available a guidance entitled ``Interim Policy on
Compounding Using Bulk Drug Substances Under Section 503A of the
Federal Food, Drug, and Cosmetic Act,'' which describes the
conditions under which FDA does not intend to take action against a
licensed pharmacist in a State-licensed pharmacy or Federal
facility, or a licensed physician, for compounding a drug product
from a bulk drug substance that cannot otherwise be used in
compounding under section 503A of the FD&C Act while FDA develops
the list of bulk drug substances that can be used in compounding
under section 503A(b)(1)(A)(i)(III).
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The guidance also describes FDA's process to establish the 503B
bulks list, and it describes categories of substances that were
nominated for inclusion on the 503B bulks list. These categories
include:
503B Category 1--Bulk Drug Substances Under Evaluation:
These bulk drug substances may be eligible for inclusion on the 503B
bulks list, were nominated with sufficient supporting information for
FDA to evaluate them, and do not appear on any other list.
503B Category 2--Bulk Drug Substances That Raise
Significant Safety Risks: These bulk drug substances were nominated
with sufficient supporting information to permit FDA to evaluate them
and they may be eligible for inclusion on the 503B bulks list. However,
FDA has identified significant safety risks relating to the use of
these bulk substances in compounding, and therefore does not intend to
adopt the policy described for the bulk substances in Category 1.
503B Category 3--Bulk Drug Substances Nominated Without
Adequate Support: These bulk drug substances may be eligible for
inclusion on the 503B bulks list but were nominated with insufficient
supporting information for FDA to evaluate them. These substances can
be re-nominated with sufficient supporting information
[[Page 37502]]
through a docket that FDA has established.
In the Federal Register of October 27, 2015 (80 FR 65768), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on
December 28, 2015. FDA received 11 comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes to the guidance to clarify particular points. In
addition, FDA has made the following updates to the lists on its Web
site of bulk drug substances that were nominated for inclusion on the
503A bulks list: \2\
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\2\ In the future, if FDA makes changes to the categories of
bulk drug substances on its Web site, we intend to follow the
procedure identified in the guidance.
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503B Category 2: FDA has added one bulk drug substances to
Category 2, germanium sesquioxide, because FDA identified significant
safety risks relating to the use of this bulk drug substance in
compounding.
503B Category 4: The draft interim guidance included a
fourth category of bulk drug substances that would have identified
substances that FDA evaluated for inclusion on the 503B bulks list but,
after obtaining and considering public comments, decided not to place
on the 503B bulks list. In the final interim guidance, FDA removed this
fourth category because the Agency intends to identify the bulk drug
substances that will not be placed on the 503B bulks list in the
Federal Register notice that establishes the 503B bulks list.
Therefore, we do not believe it is necessary to also include them in
the categories identified in this guidance.
II. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13798 Filed 6-9-16; 8:45 am]
BILLING CODE 4164-01-P
