How is it possible that a drug is approved while neither the company nor the FDA knows exactly what is in the formulation, and exactly how much of the product is the/an active ingredient?

Courtesy of Citron Reports 

Citron Reports Further Results from Laboratory Testing:

Questcor is Deceiving the FDA and Investors

H.P. Acthar Gel’s Specified Active Ingredient Less Than 20% of the Label Specification

Bioactivity of Deamidated Hormone Fragment Far Lower than Pure ACTH

The FDA has been Notified

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Citron reports on further lab data submitted to FDA, that the contents Questcor's only revenue-generating drug product, H.P. Acthar Gel, does not match its label or the official product insert the label.  Questcor spins one story for Wall Street, and another for the medical community, but the regulatory risk here cannot be overstated.  

(As always, Citron recommends that you download the .PDF file locally, and click to follow the links.)