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FDA Explains New Rules On Drug Importation From Canada

The FDA released a compliance guide May 25 featuring 12 questions and answers to provide small entities with a better understanding of the Importation of Prescription Drugs Final Rule.

The rule, which became effective Nov. 30, 2020, is aimed at reducing costs by allowing the importation of certain prescription drugs from Canada. 

The new guidance explains how importers can obtain supplies from authorized Section 804 Importation Programs (SIP). The supply chain for each drug must be limited to three entities: one manufacturer, one foreign seller and one importer. Foreign sellers must be licensed to wholesale drugs by Health Canada and registered with the FDA.

The agency retains the authority to not authorize or discontinue a SIP if a foreign seller does not meet all requirements. 

The guidance also outlines testing and labeling requirements for all imported drugs.

Read the full guidance here.

Youn can also find useful information on Why Is Amlodipine Banned In Canada?

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Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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