Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug Products; Draft; Availability; Extension of Comment Period

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