[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