Back to all Thought Leadership

Importation of Prescription Drugs Final Rule Questions and Answers

May 25, 2022

Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada

Guidance for Industry

Today, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription drugs from Canada. On October 1, 2020, the Secretary of Health and Human Services issued the final rule to implement section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. The final rule became effective November 30, 2020. The guidance issued today does not include any new policy. It clarifies in plain language the legal requirements in the final rule.

Download Small Entity Compliance Guide

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.
FDA North America Agency Alerts Prescription Drugs from Canada Final Rule Regulatory Sciences



Related Articles

Compliance Life Science Consulting

May 21, 2014

Risk Assessments Mitigate Risk for Bigger and Smaller Companies Alike

Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...

Read the Full Article
Compliance Life Science Consulting

September 18, 2013

Government Aims its Sights on Smaller Pharmaceutical Companies

Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning.  In the past few months, settlements with ISTA...

Read the Full Article
Clinical Research Solutions

May 5, 2020

5 of the Most Common Biopharma Risks Today

Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...

Read the Full Article