Import Alert 66-72

Import Alert # 66-72

Published Date: 07/31/2023

Type: DWPE

"Detention Without Physical Examination Of Misbranded Drugs And Marketed New Drugs Without Approved Applications"

Note: The revision of this Import Alert (IA) dated 07/28/2023 updates the reason for alert, guidance, agency contacts, and PAC. Changes to the import alert are bracketed by asterisks (***).

***Federal law requires that all new prescription drugs in the U.S. be shown to be safe and effective for their intended uses prior to marketing. However, FDA may permit some unapproved prescription drug products to be marketed if: 1) the drug is subject to an open drug efficacy study implementation (DESI) program proceeding, 2) the drug is medically necessary because it is relied on by health care professionals to treat serious medical conditions when there is no FDA-approved drug to treat the condition, or 3) the drug is or has the potential to be in short supply in the U.S.

Federal law also allows some unapproved prescription drugs to be lawfully marketed if they meet the criteria of generally recognized as safe and effective (GRASE) or are grandfathered. However, the agency is not aware of any human prescription drug that is lawfully marketed as grandfathered.

FDA's Unapproved Drugs Program employs a two-pronged approach to help assure patient safety. First, the agency encourages manufacturers of unapproved drugs to obtain approval to be legally marketed in the U.S. Second, FDA has worked to remove unapproved new drugs from the market. Still, many marketed unapproved new drugs are imported into the U.S. while others are manufactured domestically using imported active pharmaceutical ingredients (APIs).

As unapproved new drug products are identified and selected for enforcement action and/or removal from the market, they are added to this import alert. The finished drug products and APIs listed in the alert should not be allowed entry into the U.S. unless they comply with the exceptions listed below. ***

***Divisions may detain without physical examination all shipments of drugs listed on this Alert when the drug is an unapproved finished drug product, or an API intended for the manufacture of unapproved finished drug product.

Exceptions include:

(1) Finished drug products or APIs that are intended for use in the manufacture of finished drug products that are subject to an open DESI program proceeding or that claim grandfather status. Compliance should forward a CMS case to the CDER Office of Compliance (OC)/Office of Drug Security, Integrity, and Response (ODSIR)/Division of Global Drug Distribution and Policy (DGDDP)/Imports Compliance Branch (ICB) for review if unsure about the DESI or grandfather status.

(2) APIs that are intended for use in pharmaceutical compounding by licensed pharmacists or physicians, or in registered outsourcing facilities. Verify:
a) The API foreign manufacturer is registered, including identification of the known importer;
b) The drug is listed and the listing matches the API offered for import; and
c) The drug to be compounded has not been removed or withdrawn from the market for reasons of safety or effectiveness pursuant to 21 CFR 216.24.

(3) APIs that are intended for use in the manufacture of drugs for laboratory or non-human research and development, such as for generation of data to support submission of an application or supplement to an application (pre-submission batch). Verify: The API is accompanied by an intended use letter. If an intended use letter is not provided, consider requesting the intended use letter with an explanation of the type of research and development to be conducted.

Personal Importations:
Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2, "Coverage of Personal Importation." When personal shipments of drugs and biologics that appear violative are brought to FDA's attention by CBP, FDA personnel will use their discretion to decide on a case-by-case basis whether to detain, refuse, or allow entry of the product. Generally, drugs and biologics subject to Import Alerts are not amenable to these procedures. Please contact CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov with questions on Personal Importation of drug products subject to this IA.

Release of Articles Subject to Detention Without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment falls into one of the Exceptions listed in this IA. This evidence should be made available to FDA at the time the offer to import is made. CDER/OC/ODSIR/DGDDP/ICB will evaluate each shipment on a case-by-case basis.

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving compliance of imported drug products or APIs should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov.

                                                                                                                                                                        ***

Finished drug products and active pharmaceutical ingredients (APIs)

For finished drug products:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). [Unapproved new drug, Section 505(a)]

OASIS charge code: UNAPPROVED

For active pharmaceutical ingredients (APIs):

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranding, Section 502(f)(1)]

OASIS charge code: DIRSEXMPT