MAR-2-05 CO:R:C:V 734232 GRV
Mr. Ara S. Khachaturian
Associate, Research and Regulatory Affairs
Sigma-tau
Pharmaceuticals, Inc.
200 Orchard Ridge Drive
Gaithersburg, MD 20878
RE: Country of origin marking requirements applicable to
prescription drug injections packages on which appear a
locality marking other than the country of origin of
the articles' manufacture. 134.1(d); ultimate purchas-
er; C.S.D. 89-56; C.S.D. 88-26; C.S.D. 79-351; 19 CFR
134.32(d); article excepted; 19 CFR 134.22(a); package
marking; 19 CFR 134.46; 19 CFR 134.11; sufficiency of
marking (foreign address); abstract 34263
Dear Mr. Khachaturian:
This is in response to your letter of June 27, 1991,
requesting a ruling regarding the country of origin marking
requirements applicable to packages containing prescription drug
injections on which appear a locality marking other than the
country of origin of the articles' manufacture. A sample of the
labeling was submitted for examination. In a telephone conver-
sation with a member of my staff on November 5, 1991, you added
and clarified certain information which was considered in this
ruling.
FACTS:
Your company manufactures a certain pharmaceutical drug
(Carnitor (Levocarnitine)--an orphan drug for prescription use
only) in Italy. The drug is packaged in ampoules for interven-
ous use--dispensed by doctors and nurses--only. Five ampoules
are packaged in a disposable package, which designates the
foreign manufacturer, its address, and product use information on
the back panel, and the U.S. distributor and its address on the
back and side panels. The country of origin ("Made in Italy") is
conspicuously designated only on the side panel. The ampoule
5-packs are packaged 200 to a shipping carton for export to the
U.S. and this shipping carton is marked with its country of
origin.
In the U.S., ten ampoule 5-packs will be shrink-wrapped for
distribution to hospital pharmacies. You indicate that although
the ampoule ten-packs are the customary unit for institutional
sales, sales of single 5-packs occasionally occur.
You seek a ruling letter addressing whether the country of
origin marking on the disposable 5-pack packages meets the
marking requirements of 19 U.S.C. 1304.
ISSUE:
Whether the one country of origin marking on the side-panel
of ampoule 5-pack packages is sufficient to meet the marking
requirements of 19 U.S.C. 1304 and 19 CFR 134.46, given that the
U.S. distributor is referenced twice--on the side and back panels
of the 5-pack packages.
LAW AND ANALYSIS:
The marking statute, 304 of the Tariff Act of 1930, as
amended (19 U.S.C. 1304), provides that, unless excepted, every
article of foreign origin (or its container) imported into the
U.S. shall be marked in a conspicuous place as legibly, indelibly
and permanently as the nature of the article (or its container)
will permit in such a manner as to indicate to the ultimate pur-
chaser the English name of the country of origin of the article.
Part 134, Customs Regulations (19 CFR Part 134), implements the
country of origin marking requirements and exceptions of 19
U.S.C. 1304. As provided at section 134.41(b), the country of
origin marking is considered conspicuous if the ultimate purchas-
er in the U.S. is able to find the marking easily and read it
without strain.
The primary purpose of the country of origin marking statute
is to "mark the goods so that at the time of purchase the ulti-
mate purchaser may, by knowing where the goods were produced, be
able to buy or refuse to buy them, if such marking should influ-
ence his will." United States v. Friedlaender & Co., 27 CCPA
297, 302, C.A.D. 104 (1940).
The "Ultimate Purchaser" Consideration
The "ultimate purchaser" is defined generally as the last
person in the U.S. who will receive the article in the form in
which it was imported. 19 CFR 134.1(d). In this case, the
hospital pharmacy will be the ultimate purchaser, as it consti-
tutes the last person(s) in the U.S. to receive the 5-pack pack-
ages in the form in which it will be imported. See C.S.D.s 89-56
(hospitals the ultimate purchasers of surgical towels), 88-26
(hospitals the ultimate purchasers of patient identification
bracelets), and 79-351 (surgeons and medical personnel the
ultimate purchasers of laparotomy gauze sponges); cf.,
Headquarter Ruling Letter (HRL) 708375 dated March 17, 1987
(individual patients, not hospital, was ultimate purchaser of
toothbrushes).
The Article Marking Exception
Section 134.32(d) provides that if the marking of the
containers will reasonably indicate the origin of the enclosed
imported articles, then the articles themselves need not be
individually marked. This exception is applicable in cases where
the article is imported in a properly marked container and
Customs officials at the port of entry are satisfied that in all
reasonably foreseeable circumstances the ultimate purchasers will
receive the article in its original, unopened and properly marked
container. See HRLs 732437 dated October 4, 1989 (dental impres-
sion trays), 733325 dated August 8, 1990 (intervenous drip sets),
733678 dated August 30, 1990 (surgical towels), and 733566 dated
July 1, 1991 (bulk sanitary paper products and liquid hand
cleaner). As the ampoules are packaged in 5-packs and these con-
stitute the only form in which they are sold to hospital pharma-
cies, the individual ampoules need not be marked, so long as the
ultimate purchasers--the hospital pharmacies--receive the
imported ampoule articles in the marked packages. See also,
C.S.D. 79-351 (laparotomy gauze sponges excepted from individual
marking as package of five will reach the ultimate purchaser--
surgeons and medical personnel).
The Package Marking Requirements
As the imported article is excepted from individual marking
by application of subpart D--19 CFR 134.32(d), the outermost
container in which the article ordinarily reaches the ultimate
purchaser must be marked to indicate the country of origin of the
article. 19 CFR 134.22 and 134.24(d)(1). However, where
locations other than the country of origin of the merchandise
appear, 134.46 imposes further marking requirements. This
section provides that:
[i]n any case in which the words "United States," or
"American," the letters "U.S.A.," any variation of such
words or letters, or the name of any city or locality in the
United States, or the name of any foreign country or
locality other than the country or locality in which the
article was manufactured or produced, appear on an imported
article or its container, there shall appear, legibly and
permanently, in close proximity to such words, letters or
name, and in at least a comparable size, the name of the
country of origin preceded by "Made in," "Product of," or
other words of similar meaning. (Emphasis added).
The purpose of this regulation is to prevent the possibility
of misleading or deceiving the ultimate purchaser as to the
origin of the imported article. See, 19 CFR 134.36(b); C.S.D.
88-24 (concerning baby booties). Although no issue respecting
the comparable size requirement is present in this case, as the
country of origin is only indicated once--on the end panel,
whereas, the U.S. Distributorship information is presented on
two panels--the end and back panels, the close proximity
requirement must be addressed.
We have previously ruled that in order to satisfy the close
proximity requirement of this regulation, the country of origin
marking must appear on the same side(s) or surface(s) on which
the name of the locality other than the country of origin
appears. See, Headquarters Ruling Letters (HRLs) 708994 dated
April 24, 1978 (concerning product labels), 733084 dated March
19, 1990 (concerning keywound alarm clocks), 732191 dated April
27, 1990 (concerning paint brush sets), and 733618 dated July 26,
1990 (concerning soccer balls). Thus, for the packaging in this
case to meet the marking requirements of 134.46, the country of
origin marking--"Made in Italy"--must be further indicated on the
back panel where a second reference to the U.S. distributor is
located, as well as maintained at its present location on the end
panel. [The address of the Italian manufacturer appearing on the
back panel does not constitute a sufficient country of origin
marking, as it does not necessarily indicate that the merchandise
originated in the country in which the firm is located. Bern-
stein Sons & Forman, Inc., v. United States, Abstract 34263, 69
Treas.Dec. 1317 (1936); HRL 729800 dated October 10, 1986
(country of origin marking must appear as a distinct and
independent word or phrase denoting the article's country of
origin)].
HOLDING:
Although the one country of origin marking on the side-panel
of the ampoule 5-pack packages meets the marking requirements of
19 U.S.C. 1304 and 19 CFR 134.46, given that the U.S. distributor
is referenced twice--on the side and back panels of the 5-pack
packages, the country of origin ("Made in Italy") must be clearly
designated a second time on the back panel to meet the marking
requirements of 19 U.S.C. 1304 and 19 CFR 134.46.
Sincerely,
John Durant, Director
Commercial Rulings Division