Import Alert 66-49
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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 # 66-49
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of All Polidocanol Finished Dosage Form Products And Active Pharmaceutical Ingredients (APIs) From All Sources Under All Brand Names Including Aetoxisclerol, Aethoxysklerol, And Sclerovein"
Reason for Alert:
Drugs containing polidocanol are brought into the U.S. by private physicians for the treatment of spider veins. No products containing polidocanol are currently approved for marketing in the United States. Aetoxisclerol, manufactured by 1(B) , has been identified as labeled solely in French.
*** CDER has new information that polidocanol finished dosage form products are being imported from additional countries, and that the API is being imported for use in pharmacy compounding. Polidocanol is not an active ingredient contained in any FDA-approved drug product, and FDA does not sanction its use in pharmacy compounding. ***
*** CDER has new information that polidocanol finished dosage form products are being imported from additional countries, and that the API is being imported for use in pharmacy compounding. Polidocanol is not an active ingredient contained in any FDA-approved drug product, and FDA does not sanction its use in pharmacy compounding. ***
Guidance:
*** Districts may detain without physical examination, all shipments of polidocanol finished dosage products and APIs from all sources. [Note: Shipments of polidocanol that are covered under existing active INDs are not subject to this IA.] ***
Product Description:
Polidocanol - also known as * Aetoxisclerol 0.5% * Aethoxysklerol injection 1% and 3% * Sclerovein 5%
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 (NDA). [Unapproved new drug, section 505(a)]"
OASIS Charge Code - UNAPPROVED
*** For active pharmaceutical ingredient intended for pharmacy compounding: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because it lacks adequate directions for its intended use. [Misbranding, Section 502(f)(1)]."
OASIS Charge Code - DIRECTIONS
For products labeled in language other than English: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because it lacks an English language label. [Misbranding, Section 502(c]."
*** OASIS Charge Code - NO ENGLISH
OASIS Charge Code - UNAPPROVED
*** For active pharmaceutical ingredient intended for pharmacy compounding: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because it lacks adequate directions for its intended use. [Misbranding, Section 502(f)(1)]."
OASIS Charge Code - DIRECTIONS
For products labeled in language other than English: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because it lacks an English language label. [Misbranding, Section 502(c]."
*** OASIS Charge Code - NO ENGLISH
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(65 U - - 04) Polidocanol
Notes:Aetoxisclerol 0.5%; Aethoxysklerol injection 1% and 3%; Sclerovein
(65 U - - 99) Sclerosing Agent N.E.C.
Notes:Aetoxisclerol 0.5%; Aethoxysklerol injection 1% and 3%; Sclerovein
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