FDA Posts Advance GMP Rule for Dietary Supplements

The US Food and Drug Administration (FDA) has posted an advance copy of the final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The 815 page rule "establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement."

According to the rule, the compliance date is 12 months after publication in the Federal Register, while businesses with fewer than 500 but more than 20 employees will have 24 months, and business of fewer than 20 employees will have 36 months.

Of special note, is a communication that describes that published elsewhere in this issue of the Federal Register, FDA is "issuing an interim final rule that sets forth a procedure for requesting an exception to a CGMP requirement in this final rule. The interim final rule allows for submission to, and review by, FDA of an alternative to the required 100-percent identity testing of components that are dietary ingredients (as discussed in section X of this document (subpart E)), provided certain conditions are met. The interim final rule also includes a requirement for retention of records related to the FDA grant of an exception request.." (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0790.pdf - Comment due September 24, 2007)

The advance copy of the GMP rule is posted at: http://www.fda.gov/ohrms/dockets/98fr/cf0441.pdf

The rule will officially publish on June 25, 2007 with an effective date of August 24, 2007.

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