IA #66-73, IMPORT ALERT #66-73,IMPORT ALERT #66-73, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF STERILE EYEWASH SOLUTION"
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: Sterile eyewash solutions
PRODUCT
CODE: 55R[][]70
64W[][]99
65F[][]06
PROBLEM: Unapproved new drug
PAC: 56008H
PAF: AAP (Approvals)
COUNTRY: Canada (CA)
MANUFACTURER/
SHIPPER: Niagara Pharmaceuticals Inc.
60 Innovation Drive
Flamborough, Ontario, L9H7PE, Canada
FEI# 3003093882
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 Section 201(p) without an approved new drug
application [Unapproved New Drug, Section 505(a)]."
OASIS CHARGE
CODE: UNAPPROVED
RECOMMENDING
OFFICE: NYK-DO (HFR-NE3500)
REASON FOR
ALERT: Niagara Pharmaceuticals Inc. manufactures eyewash
preparations that contain purified water as the declared
active ingredient and antimicrobial solutions containing
chlorhexidine gluconate and propylene glycol as
preservatives that are intended to be added to self-
contained eyewash stations. Based on the intended use as an
eyewash and a skin flush solution, these products are drugs
as defined in Section 201(g) of the Food, Drug, and Cosmetic
Act (FD&C Act). As eyewash solutions, these preparations
may also be subject to final regulations covering OTC
ophthalmic drugs found at 21 CFR Part 349.
In September, 2006, FDA conducted an inspection of this firm
and determined that these products are sterilized by gamma
radiation. The Agency has determined by rulemaking
procedures that certain products are new drugs within the
meaning of section 201(p) of the FD&C Act. Drugs that are
sterilized by irradiation are included in this rulemaking
(21 CFR 310.502(a)(11)). Therefore, the eyewash solutions
and the antimicrobial preservative solutions for emergency
eyewash stations are new drugs that may not be legally
marketed in the United States unless they are the subject of
an application that has been approved under Section 505 of
the FD&C Act. Niagara Pharmaceuticals holds no approval for
any of these products.
GUIDANCE: Districts may detain without physical examination all
sterile eyewash solutions manufactured by the firm
identified in this alert.
For questions or issues concerning science, science policy,
or analytical methodology, contact the Division of Field
Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required.
KEYWORDS: Sterility, eyewash solution, preservative
PREPARED BY: Ted Poplawski, DIOP (HFC-170)
DATE LOADED
INTO FIARS: April 20, 2007
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