HQ 734232

November 20, 1991

MAR-2-05 CO:R:C:V 734232 GRV

CATEGORY: MARKING

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