Monday, September 26

Immediate GMP Compliance for Dietary Supplements – What is the cost of Compliance?

The FDA calculated the price of Good Manufacturing Practices (GMP) if they first drafted the Dietary Supplement Health and Education Act (DSHEA). protetox dietary supplement (relevant web site) product GMP regulations, located in the Federal Register, encompass all estimated expenses, concerning compliance, that a business would incur based on small business size. The FDA believed that altogether dietary supplement makers will spend 56,000 hours as an one time burden in development of written procedures. Additionally, 930,000 hours was estimated as the sum total for those businesses to do adequate record keeping. The FDA then used the data to compute the economic impact for various sized companies.

protetox nsCost per Establishment by Size

Little Establishments (Less than 20 employees with annual revenue below $1M)

Little Establishments

Set up Costs = $26,000

Annual Costs = $46,000

Moderate Establishments (20 – 500 employees with annual revenue of $5M – $10M)

Moderate Establishments

Set up Costs = $20,000

protetox adAnnual Costs = $184,000

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