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U.S. Department of Health and Human Services

Import Alert 66-43
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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 # 66-43
Published Date: 11/29/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of THA" (Investigational New Drug)"

Reason for Alert:
Although Alzheimer's disease is clearly a serious disease, the Commissioner stated at a July 28, 1988, meeting that FDA would not exercise its discretion to allow patients to import "THA" for their personal use under the newly instituted mail import policy. This is because "THA" is known to be a potent hepatotoxin and widespread exposure to the drug could result in many cases of serious liver injury. We have been advised by the Division of Neurological Drug Products that a problem exists in the recruitment of people for these active IND's because of the large amounts of "THA" currently being imported illegally.

Guidance:
Districts may detain, without physical examination, all shipments of the unapproved investigational new drug, "THA" to determine if it is covered by a currently active IND.

The following is a list of other names under which the drug may be entering the country:

* Tetrahydroaminoacridine
* 1,2,3,4 Tetrahydro-5 Aminoacridine
* 5-Amino-1, 2, 3,4 Tetrahydroacridine
* 1,2,3,4 tetrahydro-9-Acridinamine
* 9-Amino-1,2,3,4 Tetrahydroacridine
* Tacrine
* Robotal

Product Description:
THA (tetrahydroaminoacridine)

Charge:
"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 201(p), without an approved new drug application pursuant to Section 505(a)."

OASIS charge code - UNAPPROVED

Countries

MULTIPLE COUNTRIES (PODS ONLY)
(66 - - - --) Human and Animal Drugs
Notes:THA
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