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March 3, 2008
SILVER SPRING, Md.On Feb. 27, FDA responded to a letter from the American Herbal Products Association (AHPA), clarifying determinants of compliance dates for the final rule on dietary supplement GMPs (good manufacturing practices). The final rule is effective at various dates over the next three years, with compliance dates based on company size by employee count. While FDA previously had suggested a company's employee count would include not only direct, but also indirect employees, including those of contracted companies, the Feb. 27 letter clarified the compliance date will be determined by the number of employees [a company] directly employs.
FDAs letter further acknowledged its earlier statements seem[s] to be contrary to the intent of the regulation, and noted, the general rule is that a firm that hires an independent contractor to perform any of its manufacturing functions does not add the number of the contractors employees to its total for compliance purposes.
AHPA initially queried FDA about the issue after an October 2007 FDA webinar indicated a supplement company would have to count its own employees as well as employees from any of the company's contract manufacturers.
In AHPAs view this interpretation was simply wrong, noted Michael McGuffin, AHPAs president. There is no precedent for such an approach, and it would have resulted in many more small manufacturers being forced into accelerated compliance with the rule.
As it stands, compliance dates for the GMP rule are as follows:
Companies directly employing 500 or more FTEEs: June 25, 2008;
Companies directly employing fewer than 500, but 20 or more FTEEs: June 25, 2009;
Companies directly employing fewer than 20 FTEEs: June 25, 2010.
Fda's letter can be found on AHPA's Web site.
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