(FDA: Rockville, Maryland) – In light of recent peanut butter and peanut products recalls, and to help ensure the safety of regulated products in the supply chain, the Food and Drug Administration (FDA) issued three guidances that include the following:
- Final guidance for industry on "Voluntary Third-Party Certification Programs for Foods and Feeds"
- Draft guidance for industry on "Submission of Laboratory Packages by Accredited Laboratories"
- Draft guidance for industry on "Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages"
“The guidance documents reflect the FDA's continued vigorous efforts to minimize the chances of unsafe products reaching American consumers," says Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.
The final guidance for industry on "Voluntary Third-Party Certification Programs for Foods and Feeds" discusses the attributes of a third-party certification program that would merit the FDA's confidence in the quality of the program's audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA's future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local, or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.
The draft guidance for industry on "Submission of Laboratory Packages by Accredited Laboratories" is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited, rather than nonaccredited, laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA.
Draft guidance for industry on "Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages" is the first of several guidance’s and regulations that the FDA may issue to implement Section 913 of the FDA Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. Both draft guidance’s have a 90-day comment period.
All three guidance’s support the FDA's import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
For further information, visit www.fda.gov/bbs/topics/NEWS/2009/NEW01945.html.
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