Description
Book SynopsisError-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will ne
Table of Contents
H.R. 3204 – The Journey and Expected Destination. The World of Human Drug Compounding – Hope and Change! Pharmacy Compounding – The Supply Chain World. Track and Trace – Not Hide & Seek! Land of the Giants – and Land of the Totes! The Customer/Patient Touchpoint – Literally and Electronically! When Things Go Bump In The Night: Reverse Logistics. All Those "Lettered" Government Agencies. Pulling It All Together: Public Policy and Other Items of Note. Drug Quality and Security Hall of Fame.
