[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] ----------------------------------------------------------------------- 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.
-----------------------------------------------------------------------
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 ``https://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