Monday, June 29, 2009

FDA - June 2009 Supplement Manufacturer Compliance

The federal government is taking a tiered approach to enforcement: companies with more than 500 employees were required to become GMP (good manufacturing practices) compliant by June 2008; companies with 21-499 employees must become compliant before June 2009; and companies with fewer than 20 employees will need to be compliant by 2010, according to this Lab Science News post, New FDA Regulations for Dietary Supplements.

Well, June 2009 is upon is. Lorraine Heller reports that with two weeks to go before mid-sized supplement firms need to comply with new GMPs, the US Food and Drug Administration (FDA) has said it aims to inspect 200 facilities this fiscal year, in her post, FDA aims for 200 GMP inspection this year.

Time is up, and here are some additional references:
FDA Issues Dietary Supplements Final Rule
FDA 21 CFR part 111


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