As drug products are shipped to wholesalers, pharmacies or other intermediaries, the pharmaceutical industry uses multiple
controls to mitigate the risk of contamination or adulteration. Careful planning of drug shipments, along with strict supply-chain
custody and controls, are part of the logistical operations that provide accountability and oversight of products moving through
the supply channels. These judicious controls enable manufacturers to determine any deviation from the predetermined agenda
for shipment and custody.
Overlaying these industry efforts is an extra level of protection provided by the FDA through its oversight of raw materials
and finished dose suppliers. Although unfortunate events undoubtedly will occur from time to time, FDA's high standards for
API and prescription drug production are the most rigorous in the world.
The pharmaceutical industry, including GPhA members, strongly supports FDA's vision of a safe and secure prescription drug
supply chain based on transparency and accountability by all persons who handle prescription medicines throughout the supply
chain. As the industry continues to expand its global footprint, no shortcuts in drug-product quality or supply-chain security
can be allowed. FDA and industry must remain unyielding in their commitment to the delivery of safe and effective medicines
to all Americans.
Overall, GPhA is committed to supporting ongoing FDA supply-chain security initiatives as well as voluntary industry efforts
such as Rx–360 and other programs to ensure that all products are safe and effective for the consumer.
Bob Billings is vice-president for policy and interim executive director of the Generic Pharmaceutical Association (GPhA).