The final rule permits the importation of an “eligible prescription drug,” which the rule defines as a drug that both is approved by the Canadian Health Products and Food Branch (HFPB), and “but for the fact it deviates from the required U.S. labeling, also meets the conditions in an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for a drug that is currently commercially marketed in the United States, including those relating to the drug substance, drug product, production process, quality controls, equipment, and facilities.” Final Rule at 122 (to be codified at 21 C.F.R. § 251.2). The final rule further excludes the importation of controlled substances; biological products; infused drugs; intravenously, intrathecally, or intraocularly administered drug; drugs that are inhaled during surgery, risk evaluation and mitigation strategy drugs; and drugs that are not considered products for purposes of the Federal Food, Drug, and Cosmetic Act (FDCA) section 582. Id. at 123 (to be codified at 21 C.F.R. § 251.2).
Under the final rule, manufacturers must provide Section 804 Importation Program (SIP) sponsors with sufficient information to demonstrate whether a drug is equivalent to an FDA approved drug. In particular, the manufacturer must either test the imported drugs for authenticity, degradation, and compliance with the applicable NDA or ANDA or must provide the SIP sponsors with the information and data necessary for a third-party laboratory to perform the required testing. Id. at 128, 162–62 (to be codified at 21 C.F.R. §§ 251.2, 251.16(b), (e)). The manufacturer also must provide, upon request, an attestation and information statement establishing that “the drug proposed for import, but for the fact that it bears the HPFB-approved labeling, meets the conditions in the FDA-approved NDA or ANDA, including any process-related or other requirements for which compliance cannot be established through laboratory testing.” Id. at 141 (to be codified at 21 C.F.R. § 251.5(c)(4)(xii)). Finally, the manufacturer must authorize the SIP sponsor to use the drug’s FDA approved labeling at no cost. Id. at 150 (to be codified at 21 C.F.R. § 251.13(a)). The preamble to the final rule states that a manufacturer that fails or refuses to comply with these obligations can face a civil enforcement action or criminal sanctions. Id. at 36–37.
A SIP sponsor that wishes to import prescription drugs must submit an application to FDA that specifies the eligible prescription drug for importation, as well as identify the foreign seller and importer. Id. at 5 (to be codified at 21 C.F.R. § 251.3). The final rule states that FDA “may authorize a SIP, modify a SIP, or extend the authorization period of a SIP” that meets the requirements of the rule, but does not assign a timeframe for review. See id. at 137–38 (to be codified at 21 C.F.R. § 251.4). The agency may also deny a request for authorization of a SIP for several reasons, including if it does not meet requirements of the rule because of “potential safety concerns with the SIP” or based on the “relative likelihood that the SIP proposal or supplemental proposal would not result in a significant cost savings to the American consumer.” After a SIP application is approved, the importer must relabel the eligible prescription drug upon importation from Canada with the following statement: “[This drug was/These drugs were] imported from Canada without the authorization of [Name of Applicant] under the [Name of SIP Sponsor] Section 804 Importation Program.” Id. at 7 (to be codified at 21 C.F.R. § 251.13). Finally, a SIP sponsor must provide data and information to FDA following importation, including cost savings to the American consumer. Id. at 7 (to be codified at 21 C.F.R. § 251.18).
FDA simultaneously published a final guidance on importation of prescription drugs, including biological products and combination products under section 801(d)(1)(B) of the FDCA. SeeFDA, Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (Sept. 2020).
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