FDA issues rules on purity of therapeutics, food supply

ROCKVILLE, Md. – The Food and Drug Administration (www.fda.gov) has proposed a rule for cGMPs of radioactive drug treatments, and has issued a final rule on safeguarding food packaging as a deterrent to bioterrorism.

In its proposed regulation for the production of Positron Emission Tomography (PET) drugs-a radioactive therapy typically administered intravenously-the FDA seeks to establish minimum standards for the manufacturing and testing of PET products to meet federal requirements for safety, identity, strength, quality, and purity. The FDA is also publishing a draft guidance PET Drug Products-Current Good Manufacturing Practice (cGMP), which describes acceptable approaches that would enable PET drug producers to meet requirements listed in the proposed regulation.

PET is a medical diagnostic tool used to administer radioactive drug treatments for combating cancer and heart disease. But PET drugs decay quickly and must be used within hours or minutes after production. Since this factor affects how PET therapeutics are produced, the FDA believes that traditional pharmaceutical cGMPs are either inadequate or unnecessary.

The FDA says it has simplified the approval procedures for some commonly used PET drugs by publishing findings regarding their safety and efficacy, upon which PET producers can rely when submitting new drug applications, and by publishing guidance that explains how to submit an application. Now the FDA is publishing its proposed cGMPs for 90-day comment, after which the agency will prepare a final rule that includes responses to those comments. Two years after the final rule takes effect, PET producers will be required to submit new drug applications before marketing a PET therapeutic.

Meanwhile, information provided to the FDA under a new final rule implementing food facilities registration pertaining to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 will help the agency identify and locate food processors in the event of deliberate or accidental contamination of the food supply. The rule requires domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. to register with the FDA.

Except for specific exemptions, the registration requirements apply to manufacturers and processors of animal feed, dietary supplements, infant formula, beverages, and food additives.


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