Import Alert 61-07

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 61-07
Published Date: 04/23/2019
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Domperidone"

Reason for Alert:

*** Revision of this Import Alert, dated March 12, 2012, includes exception criteria for Domperidone intended for patients enrolled in an active IND program. A revision to the product description has also been made. Changes are noted and bracketed by three asterisks (***).

The agency has learned that Domperidone, also known by the product names contained in this alert, is being imported as a bulk API for pharmacy compounding and as a finished dosage form. The importation of this drug presents a public health risk and violates the Federal Food, Drug, and Cosmetic Act (the Act). Note: Charge statement revised on 04/23/2019.

Guidance:

Districts may detain without physical examination all shipments of any finished drug products and all shipments of bulk drug substances identified as containing Domperidone.

Exceptions include situations where: (1) the bulk drug substance is intended solely for tests in vitro or in animals used only for laboratory research, under conditions set forth in 21 CFR 312.160(a)(1)(i); (2) the bulk drug substance is to be used for non-clinical research and development and product development, under the conditions set forth in 21 CFR 201.125; *** or (3) finished drug products which are intended for use as part of an IND program in effect under 21 CFR 312.40. ***

Importers of bulk Domperidone may obtain release of the detained substance by providing documentation establishing that the substance meets the conditions set forth in 21 CFR 312.160 or 201.125.

*** FDAs Center for Drug Evaluation and Research has indicated domperidone is not appropriate for pharmacy compounding use because this bulk active ingredient is not a component of an FDA approved drug, or is a component of a drug that was withdrawn or removed from the market for safety reasons. ***

                                                                                                                                                                                                                                                                                                                                                                   

                                                                                                                                                                                                                                                                                                                                  

                                                                                                                                                                                                                            


CDER inquires should be sent to the CDER, Office of Compliance, Office of Drug Security, Integrity and Recalls, Imports and Exports Team at CDERImportsExports@fda.hhs.gov.

Product Description:

*** Domperidone is marketed worldwide and there are more than 200 known names. Common tradenames include: Domper, Doridone, Euciton, Mirax, Moperidona, Motilium, Oroperidys, Peridon, Rabugen, Vomistop, etc. ***

Charge:

For finished products that appear to be intended for use as drugs:

"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, including active pharmaceutical ingredients that appear to be intended for use in pharmaceutical compounding:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) because it appears to be a drug that is misbranded in that it lacks adequate directions for its intended use and it is not exempt from this requirement. [Misbranding, section 502(f)(1)]"

OASIS charge code - DIRECTIONS

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (61 T - - --) A-Emetic/Nauseant