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Executive Summary

FDA enforcement activity in the bulk drug area will increase during 1993, FDA Mid-Atlantic Region Director Richard Davis told a University of Georgia Good Manufacturing Practices (GMP) conference in Athens, Ga. March 17. Noting that FDA has "moved slowly" in the past in levying enforcement actions such as seizures and injunctions in the bulk drug area, Davis emphasized that "that time is over," and the agency is "going to start taking those kinds of actions on bulk pharmaceutical chemicals...before the year is over." The enforcement crackdown reflects agency concern with the number of recalls and finished product problems stemming from out- of-compliance active ingredients. In "ratcheting up" its response to bulk drug GMP compliance, Davis explained, FDA will have five "priority concerns": counterfeiting impurities process validation cross-contamination and release of products failing specifications. These areas, Davis noted, have been recurrent issues raised during recent FDA inspections, and "the agency has lost patience." In the wake of "increasing concern" at FDA with counterfeit bulk drugs coming into the U.S. from abroad, Davis said the agency began a sampling program six months ago to help determine the extent of the problem. About 200 samples have been collected to date from various dosage form manufacturers and are being subjected to forensic analysis at agency laboratories; actions may follow from the results, Davis said. FDA has been training investigators to look harder during field inspections for evidence of bulk drug counterfeiting problems, Davis said. FDA will be working with a "number of other agencies," including the U.S. Customs Service, on the counterfeiting initiative. A recent seizure of veterinary bulk drug product from a foreign supplier intended for U.S. distribution under a counterfeit label indicates the strong response FDA will take when evidence of counterfeiting is uncovered, Davis said. That response may involve the recall and/or destruction of the implicated bulk supply and of products made from it. Davis asserted that "millions of dollars" of products may be involved in the bulk drug counterfeiting problem. "We are talking about a high impact on industry" from the enforcement crackdown, he said. The FDAer urged drug product manufacturers to pay extra attention to unexplained variations in bulk labeling, packaging and analytical results that may indicate a counterfeiting problem. Addressing the FDA concern with bulk process validation, Davis explained that the agency began giving notice to the industry two years ago that "it is time to get on with validation." However, he emphasized, in many cases bulk manufacturers have not taken heed and "are moving too slow in getting processes under the validation umbrella." FDA also will be coming down hard on firms that have not developed adequate drug substance impurity profiles, do not have adequate controls to prevent dust and cross-contamination and are releasing products without adequate investigations into failing test results -- three other recurrent GMP trouble spots uncovered during recent inspections, Davis said. Bulk drug inspections, the FDAer told the conference, will be increasing in depth and number, both in the U.S. and abroad, and the regulatory actions will be recommended based on those inspections (see related item, T&G-16). Davis cautioned companies not to wait for an FDA inspection before addressing the agency's concerns. The problems are being found both in in-house bulk operations for dosage firms and external suppliers, Davis said. He urged dosage manufacturers to make sure that their bulk suppliers are meeting GMP requirements.

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