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GMP Gems

from the U.S. cGMPs for Dietary Supplements
by James Prochnow

The CGMPs for dietary supplements do not apply to dietary ingredient manufacturers, labelers, packers and those who hold dietary ingredients unless and only if a dietary ingredient is sold in bulk and then repackaged and, without further processing, is sold as a single component dietary supplement. If the latter occurs, the dietary ingredient supplier, whether in the United States or not, is subject to these cGMPs. Therefore, an ingredient supplier has a duty to find out from its purchaser the intended use of the dietary ingredient. The term “dietary ingredient” has been replaced by “component” throughout the final regulation , also called a Final Rule. The preamble (discussion) of the 70 page regulation is about 750 pages.

The cGMP for dietary supplements will be legally binding on those involved as manufacturers, packers, labelers and holders no sooner than 12 months after the federal regulation is published in the Federal Register. The federal regulation is expected to be published in the Federal Register tomorrow, Monday, June 25, 2007. For most dietary supplement companies, the compliance date will be June 25, 2009.

The Final Rule for CGMPS for dietary supplements was published today in the Federal Register at page 34, 712. The preamble (discussion of the Final Rule which is the actual federal regulation) is found at pages 34, 712 through 34,942 which is 230 pages. The actual regulation is only 16 pages in length and will be cited as 21 CFR Part 111. For very small companies, i.e. those with 20 employees or less, the compliance date is June 25, 2010.
The new cGMPs for dietary supplements will constitute Part 111 of 21 CFR. A violation of Part 111 is an act of adulteration by the person who is responsible for the act in question.

The FDA , by Interim Final Regulation published in the Federal Register on Monday, June 25, 2007, established a procedure for an industry company to request an exemption from the newly issued federal cGMP regulation for dietary supplements.,21 CFR 111..75 (a)(1 ) that compels a manufacturer to conduct at least one test to verify the identity of 100% of alls incoming dietary ingredient ( now called a component). Of course, the exemption does not apply until the Compliance Date for all of the cGMPs with respect to your company.

21 CFR 111.1 (b) clearly states that the cGMPs that apply to the “holding” (i.e. storage) of dietary supplements do NOT apply if “you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers.” “Holding ” is not defined by these regulations.

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