美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第503A条规定配制某些短缺的贝塔-内酰胺产品 英文原版.pdfVIP

Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act Immediately in Effect Guidance for Industry 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