# Importation of Prescription Drugs
> **Food and Drug Administration** · Final rule. · Published 2020-10-01 · Effective 2020-11-30 · 85 FR 62094
## Document
- **Document number:** 2020-21522
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 85 FR 62094
- **CFR reference:** 21 CFR 1
- **Publication date:** 2020-10-01
- **Effective date:** 2020-11-30
- **HHS docket:** Docket No. FDA-2019-N-5711
## Abstract

The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization. An importation program may be cosponsored by a State, Indian Tribe, pharmacist, or wholesaler. The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2020/10/01/2020-21522/importation-of-prescription-drugs)
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