![]() States and Indian tribes may submit SIP proposals to the FDA for review and authorization under section 804 of the FD&C Act. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution. Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA. The FDA will exercise oversight to help ensure the authorized proposal is followed and that Florida’s program continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.” “The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. In addition, Florida’s Agency for Health Care Administration must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |