Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 18148-18150 [2017-07667]
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18148
Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
303–S; Section 73.3555(d), Daily
Newspaper Cross-Ownership.
Form Number: FCC Form 303–S.
Type of Review: Revision of a
currently approved collection.
Respondents: Business or other for
profit entities; Not for profit institutions;
State, Local or Tribal Governments.
Number of Respondent and
Responses: 4,023 respondents, 4,023
responses.
Obligation to Respond: Required to
obtain benefits—Statutory authority for
this collection of information is
contained in Sections 154(i), 303, 307
and 308 of the Communications Act of
1934, as amended, and Section 204 of
the Telecommunications Act of 1996.
Estimated Time per Response: 1.25–
12 hours.
Frequency of Response: Every eight
year reporting requirement; Third party
disclosure requirement.
Total Annual Burden: 10,797 hours.
Total Annual Costs: $5,073,271.
Nature of Response: Required to
obtain or retain benefits. The statutory
authority for the collection is contained
Sections 154(i), 303, 307 and 308 of the
Communications Act of 1934, as
amended, and Section 204 of the
Telecommunications Act of 1996.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this information collection.
Privacy Act Impact Assessment: No
impact(s).
Needs and Uses: FCC Form 303–S is
used in applying for renewal of license
for commercial or noncommercial AM,
FM, TV, FM translator, TV translator,
Class A TV, or Low Power TV, and Low
Power FM broadcast station licenses.
Licensees of broadcast stations must
apply for renewal of their licenses every
eight years. The Commission is revising
this collection to reflect the adoption of
a Report and Order (‘‘R&O’’) in MB
Docket No. 16–161, FCC 17–3, In the
Matter of Revisions to Public Inspection
File Requirements—Broadcaster
Correspondence File and Cable
Principal Headend Location, adopted
and released on January 31, 2017. The
R&O eliminated the requirement that
commercial TV stations retain in their
public inspection file copies of letters
and emails from the public. As the
Commission noted in the R&O, because
commercial TV licensees will no longer
be required to maintain correspondence
under our rules, under the terms of 47
U.S.C. Section 308(d) they also will not
be required to file a summary of
correspondence received regarding
violent programming with their renewal
application (FCC Form 303–S).
Consistent with this decision, we are
revising Form 303–S to remove the
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references in the form to this
requirement.
We are making the following specific
changes to FCC Form 303–S:
On page 5 of the form, we are
removing item 4 (Violent Programming).
On page 25 of the instructions, we are
removing the paragraph titled ‘‘Item 4:
Violent Programming.’’
Federal Communications Commission.
Katura Jackson,
Federal Register Liaison Officer. Office of the
Secretary.
[FR Doc. 2017–07664 Filed 4–14–17; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1847]
Pharmacy Compounding Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pharmacy Compounding
Advisory Committee (PCAC). The
general function of the committee is to
provide advice on scientific, technical,
and medical issues concerning drug
compounding under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
and, as required, any other product for
which FDA has regulatory
responsibility, and to make appropriate
recommendations to the Agency. The
meeting will be open to the public.
DATES: The meeting will be held on May
8, 2017, from 8:30 a.m. to 4:30 p.m. and
May 9, 2017, from 8:30 a.m. to 12 noon.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–1847.
The docket will close on May 5, 2017.
Comments received on or before April
24, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions,
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
SUMMARY:
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be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. 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–
2017–N–1847 for ‘‘Pharmacy
Compounding Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments.’’
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.
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Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
• 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.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: PCAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
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appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the
FD&C Act (21 U.S.C. 353a) describes the
conditions that must be satisfied for
human drug products compounded by a
licensed pharmacist in a State licensed
pharmacy or a Federal facility, or
licensed physician, to be exempt from
the following 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 (CGMP)); (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 (NDAs) or
abbreviated new drug applications
(ANDAs)).
The Drug Quality and Security Act
added a new section 503B to the FD&C
Act (21 U.S.C. 353b), which created a
new category of compounders termed
‘‘outsourcing facilities.’’ Under section
503B of the FD&C Act, outsourcing
facilities are defined, in part, as
facilities that meet certain conditions
described in section 503B, including
registration with FDA as an outsourcing
facility. If these conditions are satisfied,
a drug product compounded for human
use by or under the direct supervision
of a licensed pharmacist in an
outsourcing facility is exempt from
three sections of the FD&C Act: (1)
Section 502(f)(1) (concerning the
labeling of drugs with adequate
directions for use); (2) section 505
(concerning the approval of human drug
products under NDAs or ANDAs); and
(3) section 582 (21 U.S.C. 360eee–1)
(concerning the drug supply chain
security requirements). Outsourcing
facilities are not exempt from CGMP
requirements in section 501(a)(2)(B) of
the FD&C Act.
One of the conditions that must be
satisfied to qualify for the exemptions
under section 503A of the FD&C Act is
that a bulk drug substance (active
pharmaceutical ingredient) used in a
compounded drug product must meet
one of the following criteria: (1)
Complies with the standards of an
applicable United States Pharmacopoeia
(USP) or National Formulary
monograph, if a monograph exists, and
the USP chapter on pharmacy
compounding; (2) if an applicable
monograph does not exist, is a
component of a drug approved by the
Secretary of Health and Human Services
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18149
(the Secretary); or (3) if such a
monograph does not exist and the drug
substance is not a component of a drug
approved by the Secretary, appears on a
list developed by the Secretary through
regulations issued by the Secretary (the
‘‘503A Bulks List’’) (see section
503A(b)(1)(A)(i) of the FD&C Act).
Another condition that must be
satisfied to qualify for the exemptions
under section 503A of the FD&C Act 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 (see section
503A(b)(3)(A) of the FD&C Act).
A condition that must be satisfied to
qualify for the exemptions in section
503B of the FD&C Act is that the
compounded drug is not identified
(directly or as part of a category of
drugs) on a list, published by the
Secretary by regulation after consulting
with the PCAC, 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 the drug 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 (B) of the FD&C Act).
FDA intends to discuss with the
committee bulk drug substances
nominated for inclusion on the 503A
Bulks List and drug products nominated
for inclusion on the list of drug products
that present demonstrable difficulties
for compounding under sections 503A
and 503B (‘‘Difficult to Compound
List’’).
Agenda: The committee will receive
updates on certain issues to follow up
on discussions from previous meetings,
including quality standards and
conditions at certain compounding
facilities. In addition, the committee
intends to discuss six bulk drug
substances nominated for inclusion on
the section 503A Bulks List. FDA will
discuss the following nominated bulk
drug substances: Nicotinamide adenine
dinucleotide, nicotinamide adenine
dinucleotide disodium reduced, nettle
(Urtica dioica) whole plant, ubiquinol,
vanadyl sulfate, and artemisinin. The
chart below describes which use(s) FDA
reviewed for each of the six bulk drug
substances being discussed at this
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advisory committee meeting. The
nominators of these substances will be
invited to make a short presentation
supporting the nomination.
Use(s) reviewed
Nicotinamide adenine dinucleotide ..........................................
Nicotinamide adenine dinucleotide disodium reduced .............
Nettle (Urtica dioica) whole plant .............................................
Ubiquinol ...................................................................................
Vanadyl sulfate .........................................................................
Artemisinin ................................................................................
mstockstill on DSK30JT082PROD with NOTICES
Drug
Reducing fatigue in multiple sclerosis.
Reduce symptoms of fatigue in chronic fatigue syndrome.
Glycemic control.
Glycemic control.
Diabetes, hypoglycemia, hyperlipidemia, heart disease, preventing cancer.
Malaria, protozoal infections (particularly toxoplasmosis), helminthic infections,
stomach ulcers, cancer.
The committee also intends to discuss
oral solid modified release drug
products that employ coated systems,
which were nominated for the Difficult
to Compound List. The nominators will
be invited to make a short presentation
supporting the nomination.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before April 24, 2017, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 10:15
a.m. and 10:25 a.m., 11:35 a.m. and
11:45 a.m., 1:45 p.m. and 1:55 p.m., 2:50
p.m. and 3 p.m., and 4:10 p.m. and 4:20
p.m. on May 8, 2017, and between
approximately 10 a.m. and 10:10 a.m.
and 11:35 a.m. and 11:50 a.m. on May
9, 2017. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 14, 2017. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
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speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 17, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Cindy Hong at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07667 Filed 4–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of the Secretary, Office
of the Assistant Secretary for Health,
National Vaccine Program Office,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that a
meeting is scheduled to be held for the
National Vaccine Advisory Committee
(NVAC). The meeting will be open to
SUMMARY:
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the public; public comment sessions
will be held during the meeting.
DATES: The meeting will be held on June
6 and 7, 2017. The meeting times and
agenda will be posted on the NVAC
Web site at https://www.hhs.gov/nvpo/
nvac/meetings/ as soon as
they become available.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
Pre-registration is required for
members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
the meeting and/or participate in the
public comment session should register
at https://www.hhs.gov/nvpo/nvac/
meetings/. Participants may
also register by emailing nvpo@hhs.gov
or by calling (202) 690–5566 and
providing their name, organization and
email address.
The meeting can also be accessed
through a live webcast on both days of
the meeting. For more information, visit
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
Phone: (202) 690–5566; email: nvpo@
hhs.gov.
Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The NVAC was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18148-18150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07667]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1847]
Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (PCAC). The general function of the committee is to provide
advice on scientific, technical, and medical issues concerning drug
compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), and, as required, any other product for which FDA has regulatory
responsibility, and to make appropriate recommendations to the Agency.
The meeting will be open to the public.
DATES: The meeting will be held on May 8, 2017, from 8:30 a.m. to 4:30
p.m. and May 9, 2017, from 8:30 a.m. to 12 noon.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1847. The docket will close on May 5,
2017. Comments received on or before April 24, 2017, will be provided
to the committee. Comments received after that date will be taken into
consideration by the Agency.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions, including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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-2017-N-1847 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
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.
[[Page 18149]]
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.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 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: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX:
301-847-8533, email: PCAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist in a State licensed pharmacy or a
Federal facility, or licensed physician, to be exempt from the
following 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
(CGMP)); (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 (NDAs) or abbreviated new drug applications
(ANDAs)).
The Drug Quality and Security Act added a new section 503B to the
FD&C Act (21 U.S.C. 353b), which created a new category of compounders
termed ``outsourcing facilities.'' Under section 503B of the FD&C Act,
outsourcing facilities are defined, in part, as facilities that meet
certain conditions described in section 503B, including registration
with FDA as an outsourcing facility. If these conditions are satisfied,
a drug product compounded for human use by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from three sections of the FD&C Act: (1) Section 502(f)(1)
(concerning the labeling of drugs with adequate directions for use);
(2) section 505 (concerning the approval of human drug products under
NDAs or ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) (concerning
the drug supply chain security requirements). Outsourcing facilities
are not exempt from CGMP requirements in section 501(a)(2)(B) of the
FD&C Act.
One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list developed by the Secretary through
regulations issued by the Secretary (the ``503A Bulks List'') (see
section 503A(b)(1)(A)(i) of the FD&C Act).
Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act 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 (see section 503A(b)(3)(A)
of the FD&C Act).
A condition that must be satisfied to qualify for the exemptions in
section 503B of the FD&C Act is that the compounded drug is not
identified (directly or as part of a category of drugs) on a list,
published by the Secretary by regulation after consulting with the
PCAC, 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
the drug 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 (B) of the FD&C Act).
FDA intends to discuss with the committee bulk drug substances
nominated for inclusion on the 503A Bulks List and drug products
nominated for inclusion on the list of drug products that present
demonstrable difficulties for compounding under sections 503A and 503B
(``Difficult to Compound List'').
Agenda: The committee will receive updates on certain issues to
follow up on discussions from previous meetings, including quality
standards and conditions at certain compounding facilities. In
addition, the committee intends to discuss six bulk drug substances
nominated for inclusion on the section 503A Bulks List. FDA will
discuss the following nominated bulk drug substances: Nicotinamide
adenine dinucleotide, nicotinamide adenine dinucleotide disodium
reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl
sulfate, and artemisinin. The chart below describes which use(s) FDA
reviewed for each of the six bulk drug substances being discussed at
this
[[Page 18150]]
advisory committee meeting. The nominators of these substances will be
invited to make a short presentation supporting the nomination.
------------------------------------------------------------------------
Drug Use(s) reviewed
------------------------------------------------------------------------
Nicotinamide adenine dinucleotide...... Reducing fatigue in multiple
sclerosis.
Nicotinamide adenine dinucleotide Reduce symptoms of fatigue in
disodium reduced. chronic fatigue syndrome.
Nettle (Urtica dioica) whole plant..... Glycemic control.
Ubiquinol.............................. Glycemic control.
Vanadyl sulfate........................ Diabetes, hypoglycemia,
hyperlipidemia, heart disease,
preventing cancer.
Artemisinin............................ Malaria, protozoal infections
(particularly toxoplasmosis),
helminthic infections, stomach
ulcers, cancer.
------------------------------------------------------------------------
The committee also intends to discuss oral solid modified release
drug products that employ coated systems, which were nominated for the
Difficult to Compound List. The nominators will be invited to make a
short presentation supporting the nomination.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
Addresses section) on or before April 24, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:15 a.m. and 10:25 a.m., 11:35 a.m. and 11:45 a.m.,
1:45 p.m. and 1:55 p.m., 2:50 p.m. and 3 p.m., and 4:10 p.m. and 4:20
p.m. on May 8, 2017, and between approximately 10 a.m. and 10:10 a.m.
and 11:35 a.m. and 11:50 a.m. on May 9, 2017. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before April 14, 2017. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by April 17, 2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07667 Filed 4-14-17; 8:45 am]
BILLING CODE 4164-01-P