![]() ![]() One drug manufacturer was an animal health corporation providing information on a veterinary drug product, and two manufacturers of homeopathic products included information on five veterinary drug products as well as human drug products. Five of the drug manufacturers informed the agency that they had no products containing any mercury compounds. Of the38 responses from manufacturers, 15 were from manufacturers of homeopathic drug products, and 23 were from manufacturers of drug and/or biologic products (13 drug manufacturers, 8 biologic manufacturers, and 2 manufacturers of both types of products). The agency received 41 responses to the request-for-data notices 38 from manufacturers of products, 1 from an association of homeopathic pharmacists, and 2 from consumers. General comments on the subject could also be submitted. The agency requested the following information for each product: (1) its commercial name, (2) the chemical name of the mercury compound present in the product, the Chemical Abstract Service (CAS) registry (Reg.) Number (No.) and the CAS preferred chemical name of the mercury compound(s), (3) the quantitative amount present in the product, (4) the purpose of the mercury compound in the product, (5) a copy of the product's labeling, and (6) an estimate of the amount of the mercury compound used annually in manufacturing the product. ![]() The agency asked all manufacturers of any food, including dietary supplements, and human and veterinary drug products (prescription or over-the-counter (OTC)) containing any intentionally introduced mercury compounds, whether used as an active or inactive ingredient, to provide information about the products to the agency. In the FEDERAL REGISTERs of Decem(63 FR 68775) and Ap(64 FR 23083), FDA published requests for data and information on mercury compounds in drugs and food. The statute did not differentiate between mercury as an active or an inactive ingredient. 105-115), entitled "Food and Drug Administration Study of Mercury Compounds in Drugs and Food," the Food and Drug Administration (FDA) is required 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. Under section 413(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. ![]()
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |