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Quality Digest

FDA Compliance

Manufacturer of Adulterated Drugs Agrees to Stop

Published: Tuesday, May 22, 2007 - 22:00

(FDA: Washington) -- The U.S. Food and Drug Administration announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab’s president, and Russ McMahen, PFab’s vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they aren’t produced according to the required current good manufacturing practice (cGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

“Drug approval and cGMP compliance are part of the foundation of drug safety,” says Steven K. Galson, M.D., M.P.H, director of FDA’s Center for Drug Evaluation and Research (CDER). “When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively.”

PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.

The unapproved drugs manufactured by PharmaFab include, but are not limited to:

  • De-Congestine Sustained Release Capsules
  • GFN 1200/DM 60/PSE 60 Extended-Release Tablets
  • Rhinacon A Tablets
  • Sudal 12 Chewable Tablets
  • Histex PD 12 Suspension
  • Atuss HX CII
  • Ergotrate Tablets; and Hyoscyamine Sulfate Time-Release Capsules

Because these drugs haven’t undergone FDA approval, their safety and effectiveness have not been established, and FDA hasn’t reviewed the adequacy and accuracy of the directions and warnings in their labeling.

According to the complaint filed with the court, PharmaFab didn’t comply with cGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with cGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality and purity.

The consent decree requires the defendants to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain required FDA approval and fully comply with cGMP. If they resume distributing drugs, the defendants are required to retain an auditor to conduct inspections of their facilities for a period of five years and to provide reports to FDA analyzing compliance with cGMP and labeling requirements. The decree also allows FDA to require recall or shutdown in the event of future violations and provides for damages of $5,000 per day and $1,000 per violation, up to a maximum of $5 million per year, if the defendants fail to comply with its terms.

“FDA will not hesitate to pursue enforcement action when necessary,” reports Margaret O’K. Glavin, FDA’s associate commissioner for regulatory affairs. “We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs.”

In June 2006, FDA issued a guidance document entitled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG). The CPG makes clear that firms may not market drugs that require approval without first establishing in applications that the products are safe and effective. One of the priorities in this CPG is enforcement actions against manufacturers that violate other provisions of the Federal Food, Drug and Cosmetic Act.

For more information on FDA’s ongoing efforts on marketing unapproved drugs, visit www.fda.gov/cder/drug/unapproved_drugs.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.