FDA’s new guidance details a pathway to importation for MMA products approved in a new drug application or biologics license application.
On September 24, 2020, the Food and Drug Administration (FDA) released new guidance regarding the procedures to obtain a National Drug Code (NDC) number for imported drugs. The guidance specifically applies to FDA-approved drugs authorized for sale in a foreign country in which the drugs were originally intended to be marketed, also known as multimarket approved (MMA) products. The new guidance accompanies a final rule on the importation of prescription drugs, which implements directives issued by President Trump in a July 24, 2020, executive order and follows the Safe Importation Action Plan released by the FDA in July 2019.
FDA’s new guidance details a pathway to importation for MMA products including prescription drugs, biological products and combination products approved in a new drug application (NDA) or biologics license application (BLA). Following these procedures, manufacturers may import such products in compliance with section 801 of the Federal Food, Drug and Cosmetic Act (FD&C Act). The MMA products must meet FDA-approved labeling requirements, including features that clearly distinguish MMA products from non-MMA products. Specifically, FDA recommends that container label and carton or package labeling for MMA products include “a narrow, transparent colored stripe… generally recommend[ed] to be yellow, printed horizontally within the top one-half of the container label and carton or package labeling.” Additionally, the labeling must include a statement that the product is “Imported following the procedures recommended in FDA Guidance” along with the link to the current guidance on the FDA’s website.
The guidance also addresses the process by which a manufacturer may obtain marketing approval for an MMA product under an NDA or BLA through submission of an appropriate supplement for labeling changes to the approved application. The supplement must be provided by attestation and must identify the application as an “MMA supplement.” In order to obtain NDCs for MMA products, manufacturers must follow the same procedures for registering, listing and proposing NDCs for all FDA-approved drugs. The guidance indicates that an MMA product differs from other FDA-approved drugs only with regard to the required labeling statements.
In addition to the labeling requirements, the FDA recommends that manufacturers issue a “Dear Healthcare Provider Letter” with MMA products. Such letters are intended to assist pharmacists and other healthcare providers in readily identifying MMA products from other FDA-approved drugs. The guidance included a suggested template letter, which may be distributed through email or made available on the internet.
FDA’s guidance also indicates that MMA products should be imported in accordance with the Drug Supply Chain Security Act requirements for product identification, tracing and verification to ensure appropriate supply chain integrity. Finally, the guidance also sets out FDA’s recommendations for the process importers of MMA products should follow to assist the agency in determining that importation is authorized.
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