[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Page 33100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15582]
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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;
Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until
August 2, 1999, the comment period for the draft standard memorandum of
understanding (MOU) 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 numerous requests for an extension of the comment period.
DATES: Written comments on the draft standard MOU may be submitted by
August 2, 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 entitled ``Memorandum of Understanding on Interstate
Distribution of Compounded Drug Products'' 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.
In the Federal Register of March 23, 1999 (64 FR 13997), FDA
extended the comment period on the draft standard MOU to June 1, 1999.
In response to numerous requests, FDA has decided to reopen the
comment period on the draft standard MOU until August 2, 1999.
Interested persons may, on or before August 2, 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: June 11, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15582 Filed 6-18-99; 8:45 am]
BILLING CODE 4160-01-F