FDA to publish GMP compliance guide in 2009
The final rule of the GMP legislation was passed last year, in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June this year. Mid-sized firms have until June 2009, while small firms (less than 20 employees) have until June 2010 to comply.
So far, industry has had very little guidance on how FDA interprets the new GMPs – the only information that has come close to guidance is FDA’s preamble to the legislation.
Guided by compliance guides
However, the director of the agency’s Division of Dietary Supplement Programs, Dr Vasilios Frankos said that more guidelines are in the making.
“Next year we’ll publish a compliance guide for small companies,” he told industry members at the Supply Side West trade show in Las Vegas last month.
FDA confirmed to NutraIngredients-USA.com that the Small Entity Compliance Guide will be issued in compliance with the requirement in Section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
“That act requires that we make available to small entities affected by a substantial rule, a Small Entity Compliance Guide stating in plain language the requirements of the regulation. We routinely issue these documents for all final rules that impact a substantial number of small businesses,” wrote the agency in an e-mail.
Such information would provide crucial guidance to small companies, which are already struggling to step up to the new stringent standards with their limited resources.