美国FDA 指导原则 根据第503B条第2版规定配制某些布洛芬口服混悬剂 英文原版.pdfVIP

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Comments may be submitted at any time for Agency consideration. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket numb