[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Notices]
[Pages 71009-71010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28786]


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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.

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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 http://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: [email protected] 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; 
[email protected].
    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: http://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 
http://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 http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://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 
(http://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 (http://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]
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