IA #66-37, REVISED 12/31/97
SUBJ: REVISION TO IMPORT ALERT #66-37, "OXYGEN UNITS"
New information is being added as (***).
TYPE OF ALERT: 100% sampling
(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 : Oxygen Units, especially pocket-sized containers, small recreational units, etc.
PRODUCT CODE: 64J[][]01
PROBLEM : Unapproved new drug (***OASIS CHARGE CODE: UNAPPROVED***)
Misbranding (***OASIS CHARGE CODE: RX LEGEND***)
***PROBLEM AREA
FLAG : AAP, LBL***
PAC : 56002E
COUNTRY : All
MANUFACTURER/
SHIPPER : All
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 pursuant to Section 505(a) and/or the labeling fails to bear the statement:
Caution: Federal law prohibits dispensing without prescription in accordance with
Section503(b)(4)."
REASON FOR
ALERT : The Food and Drug Administration generally regards oxygen to be a prescription drug.
Nevertheless, FDA recognizes that there are many circumstances under which it would be
impractical to insist that oxygen be administered only under the supervision of a physici
an.
Oxygen units may be marketed without a prescription when used for emergency resuscita
tion
and when administered by an individual who is authorized, certified, or licensed by s
tate
authorities. Such units must deliver a minimum flow rate of 6 liters of oxygen per m
inute
for a minimum of 15 minutes (90 liters). Labeling for emergency oxygen for OTC use m
ay
not contain references to any medical conditions, disorders, or diseases.
Recently, small over-the-counter oxygen units imported from Japan have appeared on th
e
market. Many of these over-the-counter units are not suitable for any medical or eme
rgency
use and are being promoted for "recreational" use. Most of these units are incapabl
e of
supplying an oxygen flow rate of at least 6 liters of Oxygen U.S.P.per minute for at
least 15
minutes. These products are regarded as new drugs withoutapproved New Drug
Applications.
***The Center for Drug Evaluation and Research (CDER) was recently made aware of a
Japanese manufacturer of sports oxygen units which appear to meet the guidance provided by
this alert.
The unit is manufactured by Nippon Tansan Gas Co.Ltd., 32-26, Aoi 3-Chome, Adachi-Ku,
Tokyo, Japan FEI# 1000251392.***
GUIDANCE : Districts should review all importation of oxygen units and where appropriate may detain
such units where one or more of the following conditions are observed:
The labeling fails to bear the statement, "Caution: Federal law prohibits dispensing
without
prescription."
The labeling makes claims indicating that the product can be used for the treatment o
f a
medical disease, disorder, or condition.
The units are incapable of supplying at least six liters of Oxygen USP per minute for
at least
15 minutes.
Contact Denis Mackey (HFD-333) at (301) 594-0101 for additional guidance on new drug
issues.
Contact Duane S. Sylvia (HFD-325) at (301) 594-0095 for additional GMP and labeling
guidance.
For questions or issues concerning science, science policy, sample collection, analysis,
preparation, or analytical methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
FOI : No purging is required..
PRIORITIZATION
GUIDANCE : N/A
KEYWORDS : Oxygen, oxygen units, bottled oxygen, NDA
PREPARED BY : Fredda C. Shere-Valenti, DIOP (301) 443-6553
DATE LOADED
INTO FIARS : December 31, 1997
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