Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket, 35214-35216 [2017-15900]
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Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2562]
Drug Products That Present
Demonstrable Difficulties for
Compounding Under the Federal Food,
Drug, and Cosmetic Act;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; establishment of public
docket.
The Food and Drug
Administration (FDA or Agency) is
developing a list of drug products and
categories of drug products that present
demonstrable difficulties for
compounding (the Difficult to
Compound List). The Agency previously
solicited nominations for this list and
received approximately 71 unique
nominations. FDA is establishing a new
public docket so that interested parties
can nominate drug products or
categories of drug products that were
not previously nominated for inclusion
on the Difficult to Compound List,
resubmit previous nominations with
additional supporting information, or
submit comments.
DATES: Nominations for the Difficult to
Compound List and comments may be
submitted to this docket at any time.
ADDRESSES: You may submit
nominations or comments as follows:
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Electronic Submissions
Submit electronic nominations or
comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting nominations
or comments. Nominations or comments
submitted electronically, including
attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
nomination or comment will be made
public, you are solely responsible for
ensuring that your nomination or
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
nomination or comments, that
information will be posted on https://
www.regulations.gov.
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18:50 Jul 27, 2017
Jkt 241001
• If you want to submit a nomination
or comment with confidential
information that you do not wish to be
made available to the public, submit the
nomination or 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 nominations or
comments submitted to the Division of
Dockets Management, FDA will post
your nomination or 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. [Docket
No. FDA–2017–N–2562] for ‘‘Drug
Products That Present Demonstrable
Difficulties for Compounding Under
Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act;
Establishment of a Public Docket.’’
Received nominations and 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 nomination or comment with
confidential information that you do not
wish to be made publicly available,
submit your nomination or 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 nominations or
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 nomination or
comments and you must identify this
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper
nominations and 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.
FOR FURTHER INFORMATION CONTACT:
Pawanprit Singh, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5206,
Silver Spring, MD 20993–0002, 240–
402–8866.
SUPPLEMENTARY INFORMATION:
I. Background
Section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353a) describes the conditions
under which a human drug product
compounded for an identified
individual patient based on a
prescription qualifies for exemption
from three sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs); (2)
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of human drug products
under new drug applications or
abbreviated new drug applications). One
of the conditions for these exemptions
is that the compounded drug product is
not ‘‘a drug product identified by the
Secretary by regulation as a drug
product that presents demonstrable
difficulties for compounding that
reasonably demonstrate an adverse
effect on the safety or effectiveness of
that drug product’’ (section
503A(b)(3)(A) of the FD&C Act). Section
503A(c)(1) of the FD&C Act requires
that, before issuing regulations to
implement section 503A(b)(3)(A) of the
FD&C Act, an advisory committee on
compounding be convened and
consulted ‘‘unless the Secretary
determines that the issuance of such
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
regulations before consultation is
necessary to protect the public health.’’
Section 503B of the FD&C Act (21
U.S.C. 353b) describes the conditions
that must be met for human drugs
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility to qualify for
exemptions from three sections of the
FD&C Act: (1) Section 502(f)(1) (21
U.S.C. 352(f)(1)); (2) section 505 (21
U.S.C. 355); and section 582 (21 U.S.C.
360eee–1) (concerning drug supply
chain security requirements). Section
503B does not provide an exemption
from section 501(a)(2)(B).
One of the conditions in section 503B
that must be satisfied for a compounded
drug to qualify for the exemptions in
that section is that the drug either (1) is
not identified (directly or as part of a
category of drugs) on a list published by
the Secretary, of drugs or categories of
drugs that present demonstrable
difficulties for compounding that are
reasonably likely to lead to an adverse
effect on the safety or effectiveness of
the drug or category of drugs, taking into
account the risks and benefits to
patients, or (2) is compounded in
accordance with all applicable
conditions identified on the list as
conditions that are necessary to prevent
the drug or category of drugs from
presenting such demonstrable
difficulties (see section 503B(a)(6)(A)
and (a)(6)(B) of the FD&C Act). Section
503B(c)(2) of the FD&C Act requires that
before issuing regulations to implement
section 503B(a)(6) of the FD&C Act, an
advisory committee on compounding be
convened and consulted.
At a meeting on July 13 and 14, 2000,
an advisory committee on compounding
(specifically, the Pharmacy
Compounding Advisory Committee
(PCAC)) discussed and provided FDA
with advice about the Agency’s efforts
to develop a list of drugs that present
demonstrable difficulties for
compounding under section 503A of the
FD&C Act. FDA published a notice of
that meeting in the Federal Register on
June 29, 2000 (65 FR 40104). In the
Federal Register of December 4, 2013
(78 FR 72840), FDA invited all
interested persons to nominate drug
products or categories of drug products
for inclusion on the Difficult to
Compound List. Nominators were asked
to include the name of the drug product
or category of drug products being
nominated, as well as the reason the
drug product or category of drug
products should be included on the list,
taking into account the risks and
benefits to patients. The notice also
included a list of factors that may be
relevant to determining whether or not
VerDate Sep<11>2014
18:50 Jul 27, 2017
Jkt 241001
a drug product or category of drug
products should or should not be
included on the Difficult to Compound
List. Approximately 71 unique drug
products or categories of drug products
were nominated for this list.
On June 18, 2015, the PCAC reviewed
and discussed FDA’s proposed criteria
for evaluating whether drug products or
categories of drug products are
demonstrably difficult to compound
under sections 503A and 503B of the
FD&C Act. After considering the PCAC’s
discussion, FDA refined the criteria and
presented the changes to the PCAC on
March 9, 2016. The six criteria
presented to the PCAC for evaluating
whether a drug product or category of
drug products is demonstrably difficult
to compound are the following: (1) The
complexity of the formulation; (2) the
complexity of the drug delivery
mechanism; (3) the complexity of the
dosage form; (4) the complexity of
achieving bioavailability; (5) the
complexity of the compounding
process; and (6) the complexity of
physicochemical or analytical testing.
Additional information regarding these
criteria can be found in the briefing
package for the March 2016 PCAC
meeting. See https://www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PharmacyCompounding
AdvisoryCommittee/UCM486146.pdf.
II. Establishment of a Public Docket
FDA is establishing a public docket so
that interested parties can nominate
drug products or categories of drug
products for inclusion on the Difficult to
Compound List, resubmit previous
nominations with additional supporting
information, or submit comments.
Nominations should include the
following two items for each drug
product or category of drug products
nominated, and any other relevant
additional information available:
• The name of the drug product or
drug product category;
• The reason the drug product or drug
product category should be included on
the list, taking into account any risks
and benefits to patients.
To facilitate FDA’s review,
nominations may include responses to
the following six questions, which are
related to the criteria FDA presented to
the PCAC for evaluating whether drug
products and categories of drug
products are difficult to compound
under sections 503A and 503B of the
FD&C Act:
1. Does the drug product or category
of drug products have a complex
formulation that presents a
demonstrable difficulty for
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compounding that is reasonably likely
to lead to an adverse effect on the safety
or effectiveness of the drug product?
2. Does the drug product or category
of drug products have a complex drug
delivery mechanism that presents a
demonstrable difficulty for
compounding that is reasonably likely
to lead to an adverse effect on the safety
or effectiveness of the drug product?
3. Does the drug product or category
of drug products involve a complex
dosage form that presents a
demonstrable difficulty for
compounding that is reasonably likely
to lead to an adverse effect on the safety
or effectiveness of the drug product?
4. Does the drug product or category
of drug products involve complexities
in achieving and/or assessing
bioavailability that present a
demonstrable difficulty for
compounding that is reasonably likely
to lead to an adverse effect on the safety
or effectiveness of the drug product?
5. Does compounding the drug
product or category of drug products
involve a complex compounding
process that presents a demonstrable
difficulty for compounding that is
reasonably likely to lead to an adverse
effect on the safety or effectiveness of
the drug product?
6. Does compounding the drug
product or category of drug products
necessitate complex physicochemical or
analytical testing that presents a
demonstrable difficulty for
compounding that is reasonably likely
to lead to an adverse effect on the safety
or effectiveness of the drug product?
It is not necessary for a previously
nominated drug product or category of
drug products to be renominated to this
docket. Previously nominated drug
products or categories of drug products
may be renominated to this docket if the
nominator wants to provide additional
supporting information, e.g.,
information specific to the six questions
listed above related to FDA’s proposed
evaluation criteria. Interested parties
can also submit comments on
nominated drug products or categories
of drug products, or on this document,
via this docket.
Previous nominations to the Difficult
to Compound List or comments
submitted in response to the December
4, 2013 Federal Register notice can be
viewed on https://www.regulations.gov
under docket number FDA–2013–N–
1523, or by going to the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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35216
Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
Dated: July 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15900 Filed 7–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4301]
Fostering Medical Innovation: A Plan
for Digital Health Devices; Software
Precertification Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA, the Agency, or
we) Center for Devices and Radiological
Health (CDRH or Center) is announcing
its Software Precertification Pilot
Program. The program aims to evaluate
a new approach toward software
products, including a precertification
program for the assessment of
companies that perform high-quality
software design and testing. This
voluntary pilot program is part of FDA’s
ongoing efforts to develop pragmatic
approaches to balance benefits and risks
of digital health products. FDA intends
to develop a precertification program
that could replace the need for a
premarket submission in some cases
and allow for decreased submission
content and/or faster review of
marketing applications for software
products in other cases. During the pilot
program, FDA customers, including
pilot participants, will have the
opportunity to provide input on the
development of the precertification
program.
SUMMARY:
FDA is seeking participation in
the voluntary Software Precertification
pilot program beginning August 1, 2017.
See the ‘‘Participation’’ section for
instructions on how to submit a request
to participate. The voluntary Software
Precertification pilot program will select
up to nine participants who best match
the selection criteria. This pilot program
will begin September 1, 2017.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
18:50 Jul 27, 2017
Jkt 241001
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–4301 for ‘‘Fostering Medical
Innovation: A Plan for Digital Health
Devices; Software Precertification Pilot
Program.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Bakul Patel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5458, Silver Spring,
MD 20993, 301–796–5528, Bakul.Patel@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA recognizes that an efficient, riskbased approach to regulating digital
health technology will foster innovation
of digital health products. FDA’s
traditional approach to moderate and
higher risk hardware-based medical
devices is not well suited for the faster
iterative design, development, and type
of validation used for software products.
An agile paradigm is necessary to
accommodate the faster rate of
development and innovation of software
devices as compared to other types of
devices. Traditional implementation of
the premarket requirements may impede
or delay patient access to critical
evolutions of software technology,
particularly those presenting a lower
risk to patients. To evaluate a new
approach toward software, FDA is
launching a pilot of a precertification
program for the assessment of
companies that perform high-quality
software design and testing. The
Software Precertification (Pre-Cert) pilot
program is part of FDA’s ongoing efforts
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]]>Agencies
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Pages 35214-35216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15900]
[[Page 35214]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2562]
Drug Products That Present Demonstrable Difficulties for
Compounding Under the Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of public docket.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is developing
a list of drug products and categories of drug products that present
demonstrable difficulties for compounding (the Difficult to Compound
List). The Agency previously solicited nominations for this list and
received approximately 71 unique nominations. FDA is establishing a new
public docket so that interested parties can nominate drug products or
categories of drug products that were not previously nominated for
inclusion on the Difficult to Compound List, resubmit previous
nominations with additional supporting information, or submit comments.
DATES: Nominations for the Difficult to Compound List and comments may
be submitted to this docket at any time.
ADDRESSES: You may submit nominations or comments as follows:
Electronic Submissions
Submit electronic nominations or comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting nominations or comments.
Nominations or comments submitted electronically, including
attachments, to https://www.regulations.gov will be posted to the
docket unchanged. Because your nomination or comment will be made
public, you are solely responsible for ensuring that your nomination or
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 nomination or comments, that
information will be posted on https://www.regulations.gov.
If you want to submit a nomination or comment with
confidential information that you do not wish to be made available to
the public, submit the nomination or 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 nominations or comments submitted to the
Division of Dockets Management, FDA will post your nomination or
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.
[Docket No. FDA-2017-N-2562] for ``Drug Products That Present
Demonstrable Difficulties for Compounding Under Sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public
Docket.'' Received nominations and 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 nomination or
comment with confidential information that you do not wish to be made
publicly available, submit your nomination or 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 nominations or
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 nomination
or 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper nominations and 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.
FOR FURTHER INFORMATION CONTACT: Pawanprit Singh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5206, Silver Spring, MD 20993-0002, 240-
402-8866.
SUPPLEMENTARY INFORMATION:
I. Background
Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes the conditions under which a human drug
product compounded for an identified individual patient based on a
prescription qualifies for exemption from three sections of the FD&C
Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice for drugs); (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and (3) section 505 (21 U.S.C. 355) (concerning
the approval of human drug products under new drug applications or
abbreviated new drug applications). One of the conditions for these
exemptions is that the compounded drug product is not ``a drug product
identified by the Secretary by regulation as a drug product that
presents demonstrable difficulties for compounding that reasonably
demonstrate an adverse effect on the safety or effectiveness of that
drug product'' (section 503A(b)(3)(A) of the FD&C Act). Section
503A(c)(1) of the FD&C Act requires that, before issuing regulations to
implement section 503A(b)(3)(A) of the FD&C Act, an advisory committee
on compounding be convened and consulted ``unless the Secretary
determines that the issuance of such
[[Page 35215]]
regulations before consultation is necessary to protect the public
health.''
Section 503B of the FD&C Act (21 U.S.C. 353b) describes the
conditions that must be met for human drugs compounded by or under the
direct supervision of a licensed pharmacist in an outsourcing facility
to qualify for exemptions from three sections of the FD&C Act: (1)
Section 502(f)(1) (21 U.S.C. 352(f)(1)); (2) section 505 (21 U.S.C.
355); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements). Section 503B does not provide an
exemption from section 501(a)(2)(B).
One of the conditions in section 503B that must be satisfied for a
compounded drug to qualify for the exemptions in that section is that
the drug either (1) is not identified (directly or as part of a
category of drugs) on a list published by the Secretary, of drugs or
categories of drugs that present demonstrable difficulties for
compounding that are reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug or category of drugs, taking
into account the risks and benefits to patients, or (2) is compounded
in accordance with all applicable conditions identified on the list as
conditions that are necessary to prevent the drug or category of drugs
from presenting such demonstrable difficulties (see section
503B(a)(6)(A) and (a)(6)(B) of the FD&C Act). Section 503B(c)(2) of the
FD&C Act requires that before issuing regulations to implement section
503B(a)(6) of the FD&C Act, an advisory committee on compounding be
convened and consulted.
At a meeting on July 13 and 14, 2000, an advisory committee on
compounding (specifically, the Pharmacy Compounding Advisory Committee
(PCAC)) discussed and provided FDA with advice about the Agency's
efforts to develop a list of drugs that present demonstrable
difficulties for compounding under section 503A of the FD&C Act. FDA
published a notice of that meeting in the Federal Register on June 29,
2000 (65 FR 40104). In the Federal Register of December 4, 2013 (78 FR
72840), FDA invited all interested persons to nominate drug products or
categories of drug products for inclusion on the Difficult to Compound
List. Nominators were asked to include the name of the drug product or
category of drug products being nominated, as well as the reason the
drug product or category of drug products should be included on the
list, taking into account the risks and benefits to patients. The
notice also included a list of factors that may be relevant to
determining whether or not a drug product or category of drug products
should or should not be included on the Difficult to Compound List.
Approximately 71 unique drug products or categories of drug products
were nominated for this list.
On June 18, 2015, the PCAC reviewed and discussed FDA's proposed
criteria for evaluating whether drug products or categories of drug
products are demonstrably difficult to compound under sections 503A and
503B of the FD&C Act. After considering the PCAC's discussion, FDA
refined the criteria and presented the changes to the PCAC on March 9,
2016. The six criteria presented to the PCAC for evaluating whether a
drug product or category of drug products is demonstrably difficult to
compound are the following: (1) The complexity of the formulation; (2)
the complexity of the drug delivery mechanism; (3) the complexity of
the dosage form; (4) the complexity of achieving bioavailability; (5)
the complexity of the compounding process; and (6) the complexity of
physicochemical or analytical testing. Additional information regarding
these criteria can be found in the briefing package for the March 2016
PCAC meeting. See https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM486146.pdf.
II. Establishment of a Public Docket
FDA is establishing a public docket so that interested parties can
nominate drug products or categories of drug products for inclusion on
the Difficult to Compound List, resubmit previous nominations with
additional supporting information, or submit comments.
Nominations should include the following two items for each drug
product or category of drug products nominated, and any other relevant
additional information available:
The name of the drug product or drug product category;
The reason the drug product or drug product category
should be included on the list, taking into account any risks and
benefits to patients.
To facilitate FDA's review, nominations may include responses to
the following six questions, which are related to the criteria FDA
presented to the PCAC for evaluating whether drug products and
categories of drug products are difficult to compound under sections
503A and 503B of the FD&C Act:
1. Does the drug product or category of drug products have a
complex formulation that presents a demonstrable difficulty for
compounding that is reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug product?
2. Does the drug product or category of drug products have a
complex drug delivery mechanism that presents a demonstrable difficulty
for compounding that is reasonably likely to lead to an adverse effect
on the safety or effectiveness of the drug product?
3. Does the drug product or category of drug products involve a
complex dosage form that presents a demonstrable difficulty for
compounding that is reasonably likely to lead to an adverse effect on
the safety or effectiveness of the drug product?
4. Does the drug product or category of drug products involve
complexities in achieving and/or assessing bioavailability that present
a demonstrable difficulty for compounding that is reasonably likely to
lead to an adverse effect on the safety or effectiveness of the drug
product?
5. Does compounding the drug product or category of drug products
involve a complex compounding process that presents a demonstrable
difficulty for compounding that is reasonably likely to lead to an
adverse effect on the safety or effectiveness of the drug product?
6. Does compounding the drug product or category of drug products
necessitate complex physicochemical or analytical testing that presents
a demonstrable difficulty for compounding that is reasonably likely to
lead to an adverse effect on the safety or effectiveness of the drug
product?
It is not necessary for a previously nominated drug product or
category of drug products to be renominated to this docket. Previously
nominated drug products or categories of drug products may be
renominated to this docket if the nominator wants to provide additional
supporting information, e.g., information specific to the six questions
listed above related to FDA's proposed evaluation criteria. Interested
parties can also submit comments on nominated drug products or
categories of drug products, or on this document, via this docket.
Previous nominations to the Difficult to Compound List or comments
submitted in response to the December 4, 2013 Federal Register notice
can be viewed on https://www.regulations.gov under docket number FDA-
2013-N-1523, or by going to the Division of Dockets Management between
9 a.m. and 4 p.m., Monday through Friday.
[[Page 35216]]
Dated: July 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15900 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P
