SPSFAM Meeting eBook March 2017

3/9/2017

Significance & Implications • The determination of Active Pharmaceutical Ingredients, APIs, have not been fully established  for this industry. • There is no federal oversight to ensure “truth in labeling” that does exist with other finished  products and commodities.

Significance & Implications • The quality of analytical testing laboratories vary from exceptionally good to ….  Not so good.

• One of many questions to answer:  when laboratory testing occurs, is it on the  finished product or tested throughout the stages of production?  Does it make a  difference?

• Consumer – Patient – Safety:   questionable at best.

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