Import Alert 57-17

"Detention Without Physical Examination of Unlicensed Botulinum Toxin"

Unlicensed botulinum toxin has been imported into the United States via international express mail services without proper declaration of contents by the sender. These shipments are small and are generally shipped cooled using a cold pack. Several foreign pharmacies have sent unlicensed product directly to physicians.

Only Botulinum toxin manufactured under U.S. license and bearing the U.S. license number on its labeling may be imported into the United States unless the unlicensed version has an Investigational New Drug (IND) application accepted by the Center for Drug Evaluation and Research.

As of the last revision, BOTOX COSMETIC manufactured by Allergan, Inc. (U.S. License # 1145, BLA# 103000), MYOBLOC manufactured by Elan Pharmaceuticals (U.S. License # 1579, BLA# 103846), *** DYSPORT manufactured by Ipsen Biopharm Ltd (BLA# 125274), and Xeomin manufactured by Merz Pharmaceuticals (U.S. License # 1830, BLA 125360)*** are the only U.S. licensed botulinum toxins.

Districts may detain without physical examination the specified biologic products from the firms identified on the Red List of this alert, unless they are covered by a valid IND.

*** For shipments containing unlicensed sources of botulinum toxin (other than those firms/products on the Red List), Districts should submit a MARCS-CMS case to the CDER/OC/Imports Exports Compliance Branch for review.

In order to remove a firm from detention without physical examination, information should be provided to adequately demonstrate the firm and product are licensed by FDA.

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

For questions or issues concerning import operations, contact DIO Import Operations and Maintenance Branch at (301) 796-0356.

For questions or issues related to the status of an IND, contact CDER/OC/Imports Exports Compliance Branch at cderimportsexports@fda.hhs.gov and/or (301) 796-3010.

Import Alert Language last updated: October, 2012 ***

Botulinum Toxin, Botulinum Toxin type A and Clostridium Botulinum Type A Toxin-Haemagglutin Complex, BTXA, CBTXA, *** onabotulinumtoxin A, abobotulinumtoxinA, Botulinum Toxin type B, incobotulinumtoxinA ***

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a biological drug for which a biologics license is not in effect under Section 351 of the Public Health Service Act [PHS act, Section 351(a)].

OASIS charge code - NO LICENSE

And,

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the labeling of the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements. [Misbranding, Section 502(f)(1)].

OASIS Charge Code - DIRECTIONS