FDA on Bulk Drugs

Erik Swain

FDA has released a brief question-and-answer list to clarify some issues—particularly about containers used for storing bulk drug products—raised by the 1999 guidance document "Container Closure Systems for Packaging Human Drugs and Biologics."

In the new document, published May 10, 2002, FDA says that information about bulk drug containers does not have to be included in an application, unless the product is a biologic or protein drug. Rather, firms should maintain data showing the containers are suitable for their intended use and present it at inspections if requested. The same applies for shipping containers between the applicant’s own facilities, or between the applicant’s facility and a contract packager’s site.

However, information on storage and shipping containers for biologics and proteins should be included in an application, because, according to the agency, "in general, there is greater potential for adverse effects on the identity, strength, quality, purity, or potency of biologics and proteins during storage and shipping."

The new document can be viewed at www.fda.gov/cder/guidance/4828fnl.PDF.

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