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Regulatory Status of Pancreatic Enzyme Preparations

Peter H. Rheinstein, MD, JD, MS
JAMA. 1990;263(18):2491-2492. doi:10.1001/jama.1990.03440180097042.
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Hendeles and colleagues1 report on three patients, each of whom took the same defective pancreatic enzyme product and each of whom obtained an unsatisfactory result. The product consisted of capsules of pancrelipase, US Pharmacopeia (USP) formulated into enteric-coated spheres. The product was sold under various names, but all brands were manufactured by and were labeled as having been manufactured by Anabolic, Inc of Irvine, Calif.

Information regarding the defective product, including reports of testing conducted by the independent laboratory (Pharmichem Testing Services) and by a competitor, had been received at the Food and Drug Administration (FDA) by May 1989. The FDA's inspection of the firm revealed that there was no validation for the enteric coating process. Testing conducted by the firm confirmed that the enteric coating was ineffective. All lots were either subpotent or superpotent for one or more active ingredients.

On June 14,1989, the manufacturer voluntarily instituted a


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