Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug Products; Draft; Availability; Reopening 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;

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