03-19620. Mercury Compounds in Drugs and Food; List

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.