Papich Mark G
Veterinary Clinical Pharmacology, North Carolina State University, College of Veterinary Medicine, Raleigh, NC 27606, USA.
AAPS J. 2005 Sep 22;7(2):E281-7. doi: 10.1208/aapsj070229.
Drugs have been compounded for veterinary practice for many years because it has been necessary in the course of routine practice. However, regulations and compliance policy guidelines (CPGs) should be recognized. A new CPG issued in July 2003 listed the current Food and Drug Administration (FDA) limitations on compounding for veterinary medicine. To summarize the guideline: drugs must not be compounded from bulk substances, and the compounding must not constitute manufacture of a new animal drug. Drug compounding on a case-by-case basis is allowed under the CPG. However, veterinarians and pharmacists must be aware of potential incompatibilities and practices that may interfere with the drug's stability, purity, and/or potency.
多年来,药物一直被配制用于兽医实践,因为这在常规实践过程中是必要的。然而,法规和合规政策指南(CPGs)应该得到认可。2003年7月发布的一项新的CPG列出了美国食品药品监督管理局(FDA)目前对兽药配制的限制。总结该指南如下:不得用散装物质配制药物,并且配制不得构成新动物药品的生产。根据CPG,允许逐案配制药物。然而,兽医和药剂师必须意识到可能会干扰药物稳定性、纯度和/或效力的潜在不相容性和操作。