Framework for Pharmacy Compounding: State and Federal Roles, 71009-71010 [2012-28786]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Notices
FDA is withdrawing this guidance
because it is no longer warranted. FDA
has completed its review of all of the
warning plans for smokeless tobacco
products that were submitted to FDA by
July 22, 2010, and the transition from
FTC to FDA of the responsibility for
reviewing warning plans for smokeless
tobacco products has been
accomplished. Further, this guidance
included an incomplete definition of
smokeless tobacco. Section 101(c) of the
Tobacco Control Act amended the
Smokeless Tobacco Act to give
smokeless tobacco the meaning that
term is given by section 900(18) of the
Federal Food, Drug, and Cosmetic Act.
Under this definition, ‘‘smokeless
tobacco’’ means any tobacco product
that consists of cut, ground, powdered,
or leaf tobacco and that is intended to
be placed in the oral or nasal cavity.
(Emphasis added) Thus, withdrawal of
this guidance on enforcement policy
will also help to prevent any confusion
that may have been created by the
misstatement of this definition.
For information regarding the
submission of warning plans for
smokeless tobacco products, you may
contact the Office of Compliance at
FDA’s Center for Tobacco Products (see
FOR FURTHER INFORMATION CONTACT).
We note that FDA has made available
for public comment a draft guidance
that, when finalized, will represent the
Agency’s current thinking on the
‘‘Submission of Warning Plans for
Cigarettes and Smokeless Tobacco
Products.’’ You can obtain an electronic
version of this draft guidance document
at either https://www.regulations.gov/ or
https://www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm. You can
comment on this or any other guidance
at any time.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28809 Filed 11–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1154]
erowe on DSK2VPTVN1PROD with
Framework for Pharmacy
Compounding: State and Federal
Roles
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
VerDate Mar<15>2010
13:52 Nov 27, 2012
Jkt 229001
The Food and Drug
Administration (FDA) is announcing the
following public meeting entitled
‘‘Framework for Pharmacy
Compounding: State and Federal
Roles.’’ At this public meeting, FDA and
State representatives will share their
perspectives.
Date and Time: The public meeting
will be held on December 19, 2012, from
3 p.m. to 5 p.m. Onsite registration will
be on a first-come, first-served basis
beginning at 2 p.m.
Location: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
If you need special accommodations
due to a disability, please contact Steve
Morin, FDA Office of Special Health
Issues, 301–796–0161, email: Steve.
Morin@fda.hhs.gov no later than
December 14, 2012.
Contact Person: Patricia Kuntze, Food
and Drug Administration, 10903 New H
Ave., Bldg. 32, Rm. 5322, Silver Spring,
MD 20993; patricia.kuntze@fda.hhs.gov.
Streaming Webcast of the Meeting:
This public meeting will also be
Webcast. Persons interested in viewing
the Webcast should use the access
connection at https://collaboration.fda.
gov/pharmacycompounding/. The
Webcast will begin on December 19,
2012, at 3 p.m. ET.
If you have never attended a Connect
Pro meeting before, test your connection
at: https://collaboration.fda.gov/
common/help/en/support/meeting_test.
htm. Get a quick overview at: https://
www.adobe.com/go/connectpro_
overview. Adobe, the Adobe logo,
Acrobat and Acrobat Connect are either
registered trademarks or trademarks of
Adobe Systems Incorporated in the
United States and/or other countries.
If for some reason the test page does
not work, that is not a definite
indicating factor that the actual Webcast
will not work. The test link sometimes
appears to be broken on some
individuals’ computers. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
SUMMARY:
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
71009
This Webcast will be closed
captioned.
Comments: In order to obtain public
comment, FDA is also soliciting either
electronic or written comments on the
issues discussed in section II of this
document. The deadline for submitting
comments is January 18, 2013.
Regardless of attendance at the
meeting, interested persons may submit
either written comments regarding this
document to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852 or electronic
comments to https://www.regulations.
gov. It is only necessary to send one set
of comments. Identify comments with
the docket number found in brackets in
the heading of this document. In
addition, when submitting comments on
issues as outlined in section II of this
document, please identify the issue you
are addressing. Received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://www.
regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://www.regulations.
gov. It may be viewed at the Division of
Dockets Management (see Comments). A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
SUPPLEMENTARY INFORMATION:
I. Background
The recent outbreak of fungal
meningitis associated with drugs
produced and sold by New England
Compounding Center has raised serious
questions about the regulation of
pharmacy compounding (Refs. 1 and 2).
Historically, regulation of pharmacy
compounding has focused on drawing a
line between traditional pharmacy
compounding and other manufacturing.
Generally, day-to-day oversight of
traditional pharmacy compounding has
been seen as the primary responsibility
of the States, which license pharmacies
and regulate the practice of pharmacy,
while other manufacturing falls under
the purview of FDA. Going forward,
FDA believes the focus should be
shifted from attempting to draw a bright
line between traditional pharmacy
compounding and other manufacturing
to clearly defining traditional pharmacy
E:\FR\FM\28NON1.SGM
28NON1
71010
Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Notices
erowe on DSK2VPTVN1PROD with
compounding that should be primarily
overseen by the States and higher risk
non-traditional pharmacy compounding
that would require compliance with
Federal standards. In addition, there are
open questions about whether, and to
what degree States should enforce
Federal standards, what that oversight
should look like, and the appropriate
level of communication and
coordination required to make the
system of State and Federal oversight
seamless and effective.
FDA recognizes that the States play a
critical role in the oversight of
traditional pharmacy compounding,
which can include compounding a
customized medication in response to a
prescription by a licensed practitioner
based on the identified medical need of
a particular patient for the compounded
product. However, a category of ‘‘nontraditional’’ compounding has evolved
in the last decade that FDA believes
requires additional oversight. The
Agency is working with Congress to
consider new authorities regarding
‘‘non-traditional’’ compounding
pharmacies. In recognition of the States’
role, FDA has also reached out to its
State partners by inviting
representatives from all 50 States to an
intergovernmental meeting.
II. Questions for Comment
The intergovernmental meeting will
be an opportunity for the State officials
to discuss a variety of issues regarding
their views on the role of the FDA and
the States in the oversight of
compounding including:
• Given existing authorities and
resources, are the States currently able
to provide the needed oversight of
pharmacy compounding and consumer
protection?
• What should the Federal role be in
regulating higher risk pharmacy
compounding such as compounding
high-volumes of drugs for interstate
distribution? Is there a way to re-balance
Federal and State participation in the
regulation of pharmacy compounding
that would better protect the public
health? What strategies should be
developed to further strengthen Federal/
State communications?
• Do you see a role for the States in
enforcing a Federal standard for ‘‘nontraditional’’ compounding? If so, what
role? What factors would affect a
decision by your State to take on such
responsibility?
The public meeting announced in this
document will be held after the
intergovernmental meeting described
above. FDA is holding this public
meeting to share the results of the
intergovernmental meeting with
VerDate Mar<15>2010
13:52 Nov 27, 2012
Jkt 229001
interested stakeholders. At the public
meeting, FDA representatives and
participants from the intergovernmental
meeting will summarize the results of
the intergovernmental meeting.
III. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. The Fungal Meningitis Outbreak:
Could It Have Been Prevented?
Statement of Margaret A. Hamburg,
M.D., before the House Committee on
Energy and Commerce, Subcommittee
on Oversight and Investigations (https://
www.fda.gov/NewsEvents/Testimony/
ucm327664.htm), November 14, 2012.
2. Pharmacy Compounding:
Implications of the 2012 Meningitis
Outbreak: Margaret A. Hamburg, M.D.,
before the Senate Committee on Health,
Education, Labor, and Pensions (https://
www.fda.gov/NewsEvents/Testimony/
ucm327667.htm), November 15, 2012.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28786 Filed 11–27–12; 8:45 am]
BILLING CODE 4160–01–P
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
There has been a change in the
respondents, estimated burden, and
estimated total annual burden hours
from previous 30 day Notice. This
change is a result of including the time,
effort, and resources to collect
information to be used by respondents
as well as the significant decline in
respondents expected.
DATES: Comments must be submitted on
or before December 28, 2012.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to oira.submission@omb.
eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address FEMA-InformationCollections-Management@dhs.gov.
SUPPLEMENTARY INFORMATON:
Collection of Information
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2012–0027; OMB No.
1660–0054]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request,
Assistance to Firefighters Grant
Program-Grant Application
Supplemental Information
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
SUMMARY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Title: Assistance to Firefighters Grant
Program-Grant Application
Supplemental Information.
Type of Information Collection:
Revision of a currently approved
information collection.
OMB Number: OMB No. 1660–0054.
FEMA Forms: FEMA Form 080–2,
AFG Application (General Questions
and Narrative); FEMA Form 080–2a,
Activity Specific Questions for AFG
Vehicle Applicants; F FEMA Form 080–
2b, Activity Specific Questions for AFG
Operations and Safety Applications;
FEMA Form 080–3, Activity Specific
Questions for Fire Prevention and Safety
Applicants; FEMA Form 080–3a, Fire
Prevention and Safety; and FEMA Form
080–3b, Research and Development
Abstract: The FEMA forms for this
collection are used to objectively
evaluate each of the anticipated
applicants to determine which
applicants’ submission in each of the
AFG activities are close to the
established program priorities. FEMA
also uses the information to determine
eligibility and whether the proposed use
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Notices]
[Pages 71009-71010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28786]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1154]
Framework for Pharmacy Compounding: State and Federal Roles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public meeting entitled ``Framework for Pharmacy Compounding:
State and Federal Roles.'' At this public meeting, FDA and State
representatives will share their perspectives.
Date and Time: The public meeting will be held on December 19,
2012, from 3 p.m. to 5 p.m. Onsite registration will be on a first-
come, first-served basis beginning at 2 p.m.
Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993.
Entrance for the public meeting participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
If you need special accommodations due to a disability, please
contact Steve Morin, FDA Office of Special Health Issues, 301-796-0161,
email: Steve.Morin@fda.hhs.gov no later than December 14, 2012.
Contact Person: Patricia Kuntze, Food and Drug Administration,
10903 New H Ave., Bldg. 32, Rm. 5322, Silver Spring, MD 20993;
patricia.kuntze@fda.hhs.gov.
Streaming Webcast of the Meeting: This public meeting will also be
Webcast. Persons interested in viewing the Webcast should use the
access connection at https://collaboration.fda.gov/pharmacycompounding/. The Webcast will begin on December 19, 2012, at 3
p.m. ET.
If you have never attended a Connect Pro meeting before, test your
connection at: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview at: https://www.adobe.com/go/connectpro_overview. Adobe, the Adobe logo, Acrobat and Acrobat
Connect are either registered trademarks or trademarks of Adobe Systems
Incorporated in the United States and/or other countries.
If for some reason the test page does not work, that is not a
definite indicating factor that the actual Webcast will not work. The
test link sometimes appears to be broken on some individuals'
computers. (FDA has verified the Web site addresses in this document,
but FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
This Webcast will be closed captioned.
Comments: In order to obtain public comment, FDA is also soliciting
either electronic or written comments on the issues discussed in
section II of this document. The deadline for submitting comments is
January 18, 2013.
Regardless of attendance at the meeting, interested persons may
submit either written comments regarding this document to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to
https://www.regulations.gov. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when submitting comments on
issues as outlined in section II of this document, please identify the
issue you are addressing. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
The recent outbreak of fungal meningitis associated with drugs
produced and sold by New England Compounding Center has raised serious
questions about the regulation of pharmacy compounding (Refs. 1 and 2).
Historically, regulation of pharmacy compounding has focused on drawing
a line between traditional pharmacy compounding and other
manufacturing. Generally, day-to-day oversight of traditional pharmacy
compounding has been seen as the primary responsibility of the States,
which license pharmacies and regulate the practice of pharmacy, while
other manufacturing falls under the purview of FDA. Going forward, FDA
believes the focus should be shifted from attempting to draw a bright
line between traditional pharmacy compounding and other manufacturing
to clearly defining traditional pharmacy
[[Page 71010]]
compounding that should be primarily overseen by the States and higher
risk non-traditional pharmacy compounding that would require compliance
with Federal standards. In addition, there are open questions about
whether, and to what degree States should enforce Federal standards,
what that oversight should look like, and the appropriate level of
communication and coordination required to make the system of State and
Federal oversight seamless and effective.
FDA recognizes that the States play a critical role in the
oversight of traditional pharmacy compounding, which can include
compounding a customized medication in response to a prescription by a
licensed practitioner based on the identified medical need of a
particular patient for the compounded product. However, a category of
``non-traditional'' compounding has evolved in the last decade that FDA
believes requires additional oversight. The Agency is working with
Congress to consider new authorities regarding ``non-traditional''
compounding pharmacies. In recognition of the States' role, FDA has
also reached out to its State partners by inviting representatives from
all 50 States to an intergovernmental meeting.
II. Questions for Comment
The intergovernmental meeting will be an opportunity for the State
officials to discuss a variety of issues regarding their views on the
role of the FDA and the States in the oversight of compounding
including:
Given existing authorities and resources, are the States
currently able to provide the needed oversight of pharmacy compounding
and consumer protection?
What should the Federal role be in regulating higher risk
pharmacy compounding such as compounding high-volumes of drugs for
interstate distribution? Is there a way to re-balance Federal and State
participation in the regulation of pharmacy compounding that would
better protect the public health? What strategies should be developed
to further strengthen Federal/State communications?
Do you see a role for the States in enforcing a Federal
standard for ``non-traditional'' compounding? If so, what role? What
factors would affect a decision by your State to take on such
responsibility?
The public meeting announced in this document will be held after
the intergovernmental meeting described above. FDA is holding this
public meeting to share the results of the intergovernmental meeting
with interested stakeholders. At the public meeting, FDA
representatives and participants from the intergovernmental meeting
will summarize the results of the intergovernmental meeting.
III. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.)
1. The Fungal Meningitis Outbreak: Could It Have Been Prevented?
Statement of Margaret A. Hamburg, M.D., before the House Committee on
Energy and Commerce, Subcommittee on Oversight and Investigations
(https://www.fda.gov/NewsEvents/Testimony/ucm327664.htm), November 14,
2012.
2. Pharmacy Compounding: Implications of the 2012 Meningitis
Outbreak: Margaret A. Hamburg, M.D., before the Senate Committee on
Health, Education, Labor, and Pensions (https://www.fda.gov/NewsEvents/Testimony/ucm327667.htm), November 15, 2012.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28786 Filed 11-27-12; 8:45 am]
BILLING CODE 4160-01-P
