0910-AA88 200010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation The final rule requires that all aqueous-based drug products for oral inhalation be manufactured sterile. Based on reports of adverse drug experiences from contaminated nonsterile inhalation solution products and recalls of these products, FDA is taking this action to prevent future additional adverse health consequences. Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 200 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 371 21 USC 374 to 375 No NPRM 09/23/1997 62 FR 49638 NPRM Comment Period End 12/22/1997 Final Action 05/26/2000 65 FR 34082 Yes Businesses None NA Not Collected Carol Drew 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002 Not Procurement Related No