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Executive Summary

WHOLESALER QUARANTINE AREAS FOR RETURNED, DAMAGED AND OUTDATED items must allow for physical separation from other stock, FDA reiterated in the final state licensing guidelines published in the Sept. 14 Federal Register. Noting that comments had suggested the feasibility of computer quarantining of returned or damaged items, FDA stayed with a physical quarantine requirement. "The agency does not believe," the notice explains, "that a computer-controlled quarantine system which does not provide for physical separation of the drugs, is appropriate." However, FDA has modified the quarantine requirements to clarify that one area can be used as a quarantine for all substandard goods. The final state licensing guidelines made it to the Federal Register almost two years to the day from the original proposal. The guideline is immediately effective, triggering a two-year deadline for states to implement a version of the licensing plan. The licensing requirements are part of the implementation plan for the Prescription Drug Marketing Act of 1987, the Dingell Drug Diversion Act. Responding to comments from the National Wholesale Druggists Association and Rep. Dingell (D-Mich.), FDA removed a requirement that wholesalers include expiration dates in records of their transactions. Dingell had pointed out to the agency in October 1988 that expiration dates do not commonly appear on commercial invoices. Similarly, FDA agreed that inspection of incoming delivery vehicles, as suggested in the initial proposal, goes too far. The agency, instead, is suggesting that the inspection of incoming goods be limited to a "visual examination of shipping containers." FDA specified that "this inspection should be aimed at detecting damage that would suggest possible contamination of the container's contents." FDA will permit reshelving of returned prescription drugs if the wholesaler performs or contracts out for analysis of the product to detect potential problems with safety, identity, strength, quality and purity. If the conditions of return "cast a doubt" on the product's condition, then the wholesaler must destroy the product or return to the supplier "unless examination, testing or other investigation proves that the drug meets appropriate standards," FDA said. As predicted, the revised guidelines will permit an exemption from licensing for chain drug warehouses involved purely in intracompany sales. The agency noted, however, that a "chain drug warehouse that sells prescription drugs to a franchised store or to establishments outside the corporate umbrella...would be engaging in wholesale distribution" and would have to be licensed by a state.



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