[Federal Register: June 21, 1999 (Volume 64, Number 118)]
[Notices]               
[Page 33100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn99-74]                         

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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