Pharmacy Compounding Advisory Committee; Notice of Meeting, 7351-7352 [2016-02786]
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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices
ensure their efficiency and
effectiveness, and ensuring that these
entities conform to federal laws,
regulations, policies, and procedures
governing the programs.
V. Continuation of Policy. Except as
inconsistent with this reorganization, all
statements of policy and interpretations
with respect to organizational
components affected by this notice
within ACF, heretofore issued and in
effect on this date of this reorganization
are continued in full force and effect.
VI. Delegation of Authority. All
delegations and re-delegations of
authority made to officials and
employees of affected organizational
components will continue in them, or
their successors, pending further redelegations, provided they are
consistent with this reorganization.
VII. Funds, Personnel, and
Equipment. Transfer of organizations
and functions affected by this
reorganization shall be accompanied in
each instance by direct and support
funds, positions, personnel, records,
equipment, supplies, and other
resources.
FOR FURTHER INFORMATION CONTACT:
Linda K. Smith, Office of the Deputy
Assistant Secretary for Early Childhood
Development, 901 D Street SW.,
Washington, DC 20447, (202) 401–9200.
This reorganization will be effective
upon date of signature.
Dated: February 5, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016–02784 Filed 2–10–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Pharmacy Compounding Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a
forthcoming meeting of a public
advisory committee of the Food and
Drug Administration (FDA). The
meeting will be open to the public.
Name of Committee: Pharmacy
Compounding Advisory Committee
(PCAC).
General Function of the Committee:
To provide advice on scientific,
technical, and medical issues
concerning drug compounding under
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SUMMARY:
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sections 503A and 503B (21 U.S.C. 353A
and 353B) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), and, as
required, any other product for which
FDA has regulatory responsibility, and
make appropriate recommendations to
the Commissioner of Food and Drugs.
Date and Time: The meeting will be
held on March 8, 2016, from 8:30 a.m.
to 4:30 p.m., and on March 9, 2016,
from 8:30 a.m. to 1 p.m.
Location: 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/AboutAdvisory
Committees/ucm408555.htm.
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 describes the conditions that
must be satisfied for human drug
products compounded by a licensed
pharmacist or licensed physician to be
exempt from the following three
sections of the FD&C Act: (1) Section
501(a)(2)(B) (concerning current good
manufacturing practice (CGMP)); (2)
section 502(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
adds a new section, 503B, to the FD&C
Act that creates a new category of
‘‘outsourcing facilities.’’ Outsourcing
facilities, as defined in section 503B of
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
7351
the FD&C Act, are 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, concerning the track and
trace requirements in the Drug Supply
Chain Security Act (Pub. L. 113–53).
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 (the ‘‘section 503A bulk drug
substances list’’) developed by the
Secretary through regulations issued by
the Secretary (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 Pharmacy Compounding
Advisory Committee, of drugs or
categories of drugs that present
demonstrable difficulties for
compounding that are reasonably likely
E:\FR\FM\11FEN1.SGM
11FEN1
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7352
Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices
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 will discuss with the committee
drugs proposed for inclusion on the
section 503A bulk drug substances list
and on the demonstrably difficult to
compound list under sections 503A and
503B of the FD&C Act.
Agenda: On March 8, 2016, the
committee will discuss six bulk drug
substances nominated for inclusion on
the section 503A bulk drug substances
list. FDA will discuss the following
nominated bulk drug substances:
Quinacrine hydrochloride, boswellia,
aloe vera 200:1 freeze dried, D-ribose,
chondroitin sulfate, and acetyl-Lcarnitine. The nominators of these
substances will be invited to make a
short presentation supporting the
nomination.
On March 9, 2016, the committee will
discuss two categories of drug products
nominated for the list of drug products
that present demonstrable difficulties
for compounding. These categories of
drug products are metered dose inhalers
and dry powder inhalers. The
nominators who nominated the category
of drugs or specific drug products in the
category 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. Written
submissions may be made to the contact
person on or before March 1, 2016. Oral
presentations from the public will be
scheduled between approximately 11
a.m. to 11:15 a.m. and 3:15 p.m. to 3:30
p.m. on March 8, 2016, and between
approximately 11:30 a.m. to 12 noon on
March 9, 2016. Those individuals
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16:52 Feb 10, 2016
Jkt 238001
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 February
24, 2016. 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 February 25, 2016.
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/Advisory
Committees/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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–02786 Filed 2–8–16; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
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Fmt 4703
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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Career Award and
Conference Grant Review (2016/05).
Date: March 18, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Mark Martin, Ph.D.,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 920, Bethesda, MD 20892,
(240) 447–2148, mark.martin@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; P41 BTRC review
(2016/05).
Date: March 23–25, 2016.
Time: 6:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Boston Beacon Hill, 5
Blossom Street, Boston, MA 02114.
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Bethesda, MD 20892, (301)
451–4794, dennis.hlasta@nih.gov.
Dated: February 4, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02709 Filed 2–10–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7351-7352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02786]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pharmacy Compounding Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). The
meeting will be open to the public.
Name of Committee: Pharmacy Compounding Advisory Committee (PCAC).
General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), and, as required, any other product
for which FDA has regulatory responsibility, and make appropriate
recommendations to the Commissioner of Food and Drugs.
Date and Time: The meeting will be held on March 8, 2016, from 8:30
a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m.
Location: 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.
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 describes the conditions
that must be satisfied for human drug products compounded by a licensed
pharmacist or licensed physician to be exempt from the following three
sections of the FD&C Act: (1) Section 501(a)(2)(B) (concerning current
good manufacturing practice (CGMP)); (2) section 502(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 adds a new section, 503B, to the
FD&C Act that creates a new category of ``outsourcing facilities.''
Outsourcing facilities, as defined in section 503B of the FD&C Act, are
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, concerning the track
and trace requirements in the Drug Supply Chain Security Act (Pub. L.
113-53). 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 (the ``section 503A bulk drug
substances list'') developed by the Secretary through regulations
issued by the Secretary (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
Pharmacy Compounding Advisory Committee, of drugs or categories of
drugs that present demonstrable difficulties for compounding that are
reasonably likely
[[Page 7352]]
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 will discuss with the committee drugs proposed for inclusion on
the section 503A bulk drug substances list and on the demonstrably
difficult to compound list under sections 503A and 503B of the FD&C
Act.
Agenda: On March 8, 2016, the committee will discuss six bulk drug
substances nominated for inclusion on the section 503A bulk drug
substances list. FDA will discuss the following nominated bulk drug
substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze
dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The
nominators of these substances will be invited to make a short
presentation supporting the nomination.
On March 9, 2016, the committee will discuss two categories of drug
products nominated for the list of drug products that present
demonstrable difficulties for compounding. These categories of drug
products are metered dose inhalers and dry powder inhalers. The
nominators who nominated the category of drugs or specific drug
products in the category 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.
Written submissions may be made to the contact person on or before
March 1, 2016. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m.
on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on
March 9, 2016. 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 February 24, 2016. 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 February
25, 2016.
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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02786 Filed 2-8-16; 4:15 pm]
BILLING CODE 4164-01-P
