Esta traducción se está preparando. Mientras tanto, mostramos temporalmente la versión original en inglés.
Negocios · 2/7/20141 min de lectura
Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance entitled "Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act (DQSA). The guidance reflects the Agency's current thinking on the issues addressed by the guidance.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →