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MedGuide burden is increasing, FDA acknowledges

Executive Summary

FDA has increased its estimate on the amount of time that it takes a pharmacist to dispense a Medication Guide, boosting the time from 5 seconds to 3 minutes - a 3,600 percent increase - in response to pharmacy industry comments. FDA is also increasing its estimate for the number of guides FDA receives per year to 25 from 10. Pharmacy groups have been pressing FDA to overhaul how MedGuides are distributed, and the proliferation in MedGuides stemming from Risk Evaluation and Mitigation Strategies will likely make their demands grow louder (1"The Pink Sheet," Aug. 25, 2008, p. 9). The agency also said it agrees with a comment that there are distributor costs to complying with MedGuide requirements and its burden to distributors and packers should be included in the overall analysis. However, the agency is asking for more specific estimates before making a precise burden estimate. Increased burden estimates could help entities in the distribution chain seek more reimbursement for handling MedGuides

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