[Federal Register Volume 68, Number 148 (Friday, August 1, 2003)]
[Notices]
[Page 45257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998N-1109]


Mercury Compounds in Drugs and Food; List

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is updating a list of 
drug and biologic products that contain intentionally introduced 
mercury compounds, e.g., phenylmercuric acetate, phenylmercuric 
nitrate, thimerosal. This list is part of the implementation of the 
Food and Drug Administration Modernization Act of 1997 (FDAMA).

DATES: Comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Mercury in Drug and Biologic Products; 2003 Update'' 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 requests. Copies of the document are available on 
the Internet at http://www.fda.gov/cder/fdama/mercury300.htm. Submit 
written comments on the document to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    FDAMA (Public Law 105-115) was enacted on November 21, 1997. 
Section 413 of FDAMA, entitled ``Food and Drug Administration Study of 
Mercury Compounds in Drugs and Food,'' required FDA to: (1) Compile a 
list of drugs and foods that contain intentionally introduced mercury 
compounds, and (2) provide a quantitative and qualitative analysis of 
the mercury compounds in this list. The statute did not differentiate 
whether the mercury compound was present in the products as an active 
or an inactive ingredient and required FDA to compile the list and 
provide the analysis within 2 years after the date of its enactment.
    FDA prepared this list and announced its availability in the 
Federal Register of November 19, 1999 (64 FR 63323). The list is 
entitled ``Mercury in Drug and Biologic Products'' and is available on 
the Internet at http://www.fda.gov/cder/fdama/mercury300.htm.
    Five manufacturers and distributors subsequently informed FDA that 
10 products had been reformulated to delete the mercury ingredients or 
were no longer being marketed. However, FDA did not update the list at 
that time.

II. Updating the List

    In the Federal Register of February 3, 2003 (68 FR 5299), FDA 
published a notice requesting information to update this list. FDA was 
aware that other manufacturers or distributors with products on the 
list had reformulated their products since 1999. FDA requested any 
affected manufacturer or distributor to inform us which product(s) on 
the list had been reformulated and no longer contain mercury 
ingredients. Eleven manufacturers provided information, which resulted 
in 39 additional products being deleted from the list and one product 
being added to the list. The new list now includes 171 products. The 
list continues to provide information and does not set forth any 
requirements.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. A copy of the list and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: July 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19620 Filed 7-31-03; 8:45 am]
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