[Federal Register Volume 64, Number 55 (Tuesday, March 23, 1999)]
[Notices]
[Page 13997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-1265]
Federal/State Memorandum of Understanding on Interstate
Distribution of Compounded Drug Products; Draft; Availability;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to June 1,
1999, the comment period for the draft standard memorandum of
understanding entitled ``Memorandum of Understanding on Interstate
Distribution of Compounded Drug Products'' (draft standard MOU) that
States may enter into with FDA. FDA published a notice of availability
of the draft standard MOU in the Federal Register of January 21, 1999
(64 FR 3301). The agency is taking this action in response to a request
for an extension.
DATES: Written comments on the draft standard MOU may be submitted by
June 1, 1999.
ADDRESSES: Copies of the draft standard MOU are available on the
Internet at ``http://www.fda.gov/cder/pharmcomp/default.htm''. Submit
written requests for single copies of the draft standard MOU entitled
``Memorandum of Understanding on Interstate Distribution of Compounded
Drug Products'' to the Drug Information Branch (HFD-210), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your request. Submit written
comments to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Fred Richman, Center for Drug
Evaluation and Research (HFD-332), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855-2737, 301-827-7292.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 21, 1999
(64 FR 3301), FDA published a notice announcing the availability of a
draft standard MOU that States may enter into with FDA. The draft
standard MOU describes the responsibilities of the States and FDA in
investigating and responding to complaints related to compounded drug
products distributed interstate and addresses the interstate
distribution of inordinate amounts of compounded drug products. FDA has
developed this MOU in consultation with the National Association of
Boards of Pharmacy, under provisions of the Food and Drug
Administration Modernization Act of 1997. Interested persons were given
until March 22, 1999, to submit written comments on the draft standard
MOU.
FDA received a letter dated February 12, 1999, from the South
Carolina Board of Pharmacy (the Board) requesting that the agency
extend the comment period on the draft standard MOU by 60 to 120 days
to allow the Board time to finalize and submit its comments and for
other State boards of pharmacy to respond to those comments.
In response to this request, FDA has decided to extend the comment
period on the draft standard MOU to June 1, 1999.
Interested persons may, on or before June 1, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
standard MOU. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments should be identified
with the docket number found in brackets in the heading of this
document. The draft standard MOU and received comments may be seen in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 17, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-7056 Filed 3-22-99; 8:45 am]
BILLING CODE 4160-01-F