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IA #57-17 - 7/31/03, IMPORT ALERT #57-17, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF UNLICENSED BOTULINUM TOXIN"


          NOTE: On June 20, 2003 regulatory jurisdiction of this product was
          transferred from CBER to CDER.  The guidance section is being
          revised to reflect a new point of contact.  Changes are bracketed
          by asterisks (***).

TYPE OF ALERT: Detention Without Physical Examination

               NOTE:     This import alert represents the Agency's current
               guidance to FDA field personnel regarding the manufacturer
               (s) and/or product(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.

PRODUCT:       Botulinum Toxin, Botulinum Toxin type A and Clostridium
               Botulinum Type A Toxin-Haemagglutin Complex, BTXA, CBTXA

PRODUCT CODE:  57AY02

PROBLEM:       No U.S. License and Misbranding

PAC:           45R800

PAF:           REG & LBL

COUNTRIES:          ALL

MANUFACTURER/
SHIPPER:       See Attachment

CHARGE:        "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)]."

                               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
Codes:         NO LICENSE; DIRECTIONS

RECOMMENDING
OFFICE:        CBER, Office of Compliance and Biologics Quality, Division
               of Case Management, HFM-610

REASON FOR
ALERT:         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.***

               Currently BOTOX COSMETIC manufactured by Allergan, Inc.
               (U.S. License # 1145) and MYOBLOC manufactured by Elan
               Pharmaceuticals (U.S. License # 1579) are the only U.S.
               licensed botulinum toxins.

GUIDANCE:      Districts may detain without physical examination the
               specified biologic products from the firms identified on the
               attachment to this alert unless they are covered by a valid
               IND.

               ^




                                    ^

               Districts encountering imported Botulinum toxin should
               contact *** CDER/OC, Import/Export Staff at (301) 827-8968
               *** to verify if an IND is in effect for that product.

               Surveillance of Botulinum toxin from other unapproved
               sources is warranted.

PRIORITIZATION
GUIDANCE:      N/A

FOI:           Purging between ^      ^  is  required.

KEY WORDS:          Botulinum toxin, BTXA, Botulinum Toxin Type A, Clostridium
                    Botulinum Type A Toxin-Haemagglutin Complex, CBTXA

PREPARED BY:   Stella Notzon, DIOP, (301) 443-6553

DATE LOADED
INTO FIARS:         July 31, 2003

                                ATTACHMENT TO IMPORT ALERT #57-17- FIRMS RECOMMENDED FOR DWPE, 11/16/04

Beijing Yasi Scientific & Technology Co., Ltd.
Unknown address
Beijing, China
FEI #3003896596

Hugh Source International Ltd.
Room 2501-4, Wealth Commercial Centre
42-56 Kwong Wa Street
Mongkok, Kowloon, Hong Kong
FEI #3003906957

Lanzhou Institute of Biological Products
178 Yanchang Road
Lanzhou, China
FEI #3003889747

R.L.M. Suministros Medicos
Socorro Sanchez Street # 56
Santo Domingo, Dominican Republic
FEI #3002518133

Welbeck Pharmacy (shipper)
39 Marlebone High St.
London, United Kingdom
FEI #3003211866

Wellington Pharmacy (shipper)
39 Knightsbridge
London, United Kingdom, SWIX 7NL
FEI #3003444015

^









               ^

Pineda Labs                                            11/16/04
Rua Monte Allegre, 1142
Sao Paulo, Brazil
FEI #3004113802

Prollenium Medical Technologies (shipper)                   11/16/04
10670 Yonge St
Richmond Hill, Ontario
Canada  L4C3C9
FEI# 3004423487


NOTE: The above shipper declared and invoiced the products as plant tissue
culture media. Examination of the packages and the labeling clearly showed the
products as being "Linurase (Botulinum Toxin Type A for Therapy)". Districts
should be aware of possible misdeclaration of this product from this firm.