FDA Personal Use Policy
The FDA has a long-standing policy of enforcement discretion for personal use drug importation. Under this policy, the FDA generally does not take action against individuals importing a 90-day supply of FDA-approved drugs for personal use from Canada or other countries with comparable drug safety standards. This policy has been in place since the 1980s and has been reaffirmed multiple times.
Employer Program Structure
Employer international drug programs operate under the FDA's personal use enforcement discretion policy. The employer's plan covers the cost of drugs obtained from international pharmacies. The employee receives the drug at home or at a designated location. The program is structured as a voluntary opt-in — employees choose whether to participate.
Legal Risk Assessment
Watch Out
The FDA's enforcement discretion policy is not a legal authorization — it is a policy choice that can change. Employers who implement international drug programs should: (1) obtain legal counsel review; (2) use reputable international pharmacy vendors with strong safety records; (3) implement a voluntary opt-in structure; and (4) monitor FDA policy developments. The legal risk is low but not zero.