H.R. 2181

Affordable and Safe Prescription Drug Importation Act

This bill allows expanded importation of eligible prescription drugs and addresses related issues.

Current law allows the Department of Health and Human Services (HHS) to authorize the importation of certain eligible prescription drugs from Canada if HHS certifies to Congress that doing so would pose no additional risk to public health and safety and would result in significant cost savings for consumers. The bill removes this certification requirement and requires HHS to issue regulations that permit the importation of qualifying prescription drugs from Canada. After a certain amount of time, HHS may authorize importation from certain other countries if it determines that importation from Canada has resulted in cost savings for consumers and increased access to safe medication.

The bill also expands the types of prescription drugs eligible for importation to include, for example, biologics such as insulin.

Furthermore, the bill allows individuals to use an eligible licensed foreign pharmacy to fill a U.S.-issued prescription for a qualifying drug for personal use. Currently, an individual seeking to import a prescription drug generally must acquire a waiver from HHS.

The bill imposes various requirements related to certification of foreign sellers, labeling of imported drugs, and supply chain security.

The bill also (1) prohibits certain acts that discriminate against foreign sellers, such as charging higher prices to foreign sellers than to other sellers in the same country; and (2) imposes criminal penalties for online websites that sell counterfeit drugs or dispense drugs without a required prescription.