Is my pharmacy required to comply with DSCSA?
Typically, yes! Most pharmacies dispensing prescription-only drugs to humans are “dispensers” under DSCSA.
DSCSA defines a dispenser as:
- a retail pharmacy
- a hospital pharmacy
- a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor
- any other person authorized by law to dispense or administer prescription drugs and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.
Also, DSCSA does not include a person who dispenses only products to be used in animals in accordance with Section 512(a)(5) of the Federal Food, Drug, and Cosmetic Act.