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Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting, life-sustaining, or for prevention of certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.
Rockville, MD (Oct. 17)-Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting or life-sustaining or that prevent certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.
The revision applies to a proposed rule announced Nov. 7, 2000 to implement section 506(c) of the Federal Food, Drug, and Cosmetic Act. This rule applied to companies that are the sole manufacturers of drugs that meet the following criteria:
The amended, final rule modifies the reporting procedure for these drugs whether regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Manufacturers are required to send notifications of discontinuance or requests for reduction to the following offices:
The proposed requirement to notify the Director of CBER was eliminated. Under certain circumstances, including economic hardship and public-health risks, the six-month notification period may be reduced.
FDA announced the amendment in the Oct. 18 issue of the Federal Register, and the final rule will take effect 60 days after this date.
The full document can be viewed here.