The SUPPORT (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment [SUPPORT] for Patients and Communities) Act was enacted on October 24, 2018. This new law grants FDA additional import authorities that FDA believes will meaningfully advance efforts to stop illegal and unsafe drugs from being imported into the United States. For example, the SUPPORT Act includes:
Improvements to the infrastructure and resources of International Mail Facilities (IMFs);
Authority to treat an FDA-regulated article as a drug if that article contains an active ingredient that is found in an FDA-approved drug or licensed biologic, and the ingredient presents a significant public health concern;
Authority for FDA to debar people who have been convicted of a felony involving illegal importation of drugs or controlled substances, or who have engaged in a pattern of illegally importing controlled substances or certain adulterated or misbranded drugs; and
Authority for FDA to treat any imported drugs as illegal from a person who has engaged in a pattern of importing adulterated or misbranded drugs if the shipments are from the same manufacturer, distributor, or importer.
The following is an overview of certain key import-related provisions of the SUPPORT Act:
Improved Operations at International Mail Facilities
Section 3014 of the SUPPORT Act will enhance FDA’s ability to efficiently and effectively detect and stop illegal and unsafe drug imports from entering the United States via international mail. It does this by providing for improvements of IMF facilities and processes, including facility upgrades or renovations, improvements in equipment and information technology, increased laboratory capacity, and security upgrades.
Under section 3022(a) of the SUPPORT Act, FDA and U.S. Customs and Border Protection (CBP) will develop a mutually agreed-upon list of controlled substances that FDA will refer to CBP for disposition under the Controlled Substances Act when such substances have been identified in international mail parcels. The list will be reviewed and updated periodically to remain current and relevant.
Articles Containing API(s) Can be Treated as Drugs
Section 3022(d) of the SUPPORT Act amends section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to give FDA authority to treat an FDA-regulated article as a drug if that article contains at least one of three items:
An active pharmaceutical ingredient (API) that is found in an FDA-approved drug or licensed biologic;
An API in a drug or biologic that has been granted an investigational-use exemption and for which a substantial clinical investigation has been instituted and made public; or
An analog of that active ingredient.
In addition, the ingredient must present a significant public health concern. FDA is currently implementing this authority for articles offered for import via international mail.
For an overview of human drugs and the requirements that FDA verifies at the time they are imported or offered for import into the United States, please visit Human Drugs – General.
Debarment from Importing Drugs
Section 3022(b) of the SUPPORT Act amends section 306(b) of the FD&C Act to give FDA authority to debar a person who has been convicted of a felony involving illegal importation of drugs or controlled substances, or who has engaged in a pattern of importing certain adulterated or misbranded drugs or controlled substances. Once debarred, that person is prohibited from being involved in any future drug importation for up to five years. Violation of a debarment order is a criminal offense.
Multiple Shipments of Drugs Can Be Treated as Adulterated or Misbranded
Section 3013 of the SUPPORT Act amends section 801 of the FD&C Act to give FDA authority to treat as illegal any shipments of drugs from a person whom FDA has determined is engaging in a pattern of illegally importing adulterated or misbranded drugs from the same manufacturer, distributor, or importer.