Pharmaceutical wholesalers are licensed to supply hospital pharmacies—but not gene therapies
Gene therapy pushers haven't thought this through
The role of Pharmaceutical Wholesalers
Pharmaceutical manufacturers handed over their finished product distribution role to pharmaceutical wholesalers many moons ago. Those wholesalers must hold a wholesale distribution authorisation (WDA(H)), which confirm they comply with Good Distribution Practice.
These are the 11 provisions a company would need to satisfy regulatory inspectors on:
The Pharmaceutical Quality System
Personnel
Premises and Equipment
Documentation
Operations
Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
Outsourced Activities
Self-Inspections
Transportation
Specific Provisions for Brokers
Final Provisions
If they are successful in an application, the company may purchase, store, sell and distribute fully finished pharmaceutical products. Note, the licence only applies to products that require no further processing of any kind. Activities carried out that convert the product from one state to another, must be carried out under a manufactu…