Import Alert 61-07
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(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: 03/12/2012
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).
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).
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because this bulk active ingredient is not a component of an FDA approved drug, or is a component of a drug that was withdrawn or removed from the market for safety reasons.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.
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 under the meaning of section 201(p) without an effective new drug application, as required by section 505. [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)]"
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a new drug under the meaning of section 201(p) without an effective new drug application, as required by section 505. [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)]"
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(61 T - - --) A-Emetic/Nauseant
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