The United States Food and Drug Administration (“FDA") has developed a pathway authorized under Section 804 of the Federal Food, Drug, and Cosmetic Act that allows importation of certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer without imposing additional risk to public health and safety. See 21 U.S.C. § 384. In October 2020, FDA issued a final rule(*1) regarding the importation of prescription drugs, which describes the requirements for Section 804 Importation Program (“SIP") proposals and provides FDA responses to comments about the proposed rule. While several states have taken action to submit a SIP to the FDA, only Florida has received approval from the FDA, which was granted in January 2024. To date, no drugs have been imported from Canada under an FDA-approved SIP.

Pursuant to Chapter 620 of the 2024 Acts of Assembly, the Secretary of Health and Human Resources convened a work group of relevant stakeholders on September 20, 2024 to: (i) investigate wholesale prescription drug importation programs in other states, including the procedures for start-up and continued execution; (ii) evaluate best practices for the establishment and application of such a program; and (iii) consider the effectiveness of implementing such a program in the Commonwealth, while taking into consideration the cost and safety of such a program. A list of participants may be accessed in the draft minutes of the work group meeting. (See Attachment A.) The FDA provided a presentation regarding federal allowances for wholesale prescription drug importation programs. A representative of Florida’s Agency for Health Care Administration provided information regarding Florida’s FDA-approved SIP, and a consultant to Colorado’s drug importation program provided information regarding Colorado’s efforts to submit a SIP for FDA approval.

By consensus, the participants to the work group agreed that Virginia should monitor this subject and take no action until other states have proven that drugs can be successfully imported from Canada under the current federal structure for wholesale prescription drug importation.
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(*1) 21 CFR Parts 1 and 251; see https://www.federalregister.gov/documents/2020/10/01/2020-21522/importation-ofprescription-drugs.