[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.13]
[Page 67-68]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 7 ENFORCEMENT POLICY--Table of Contents
Subpart A General Provisions
Sec. 7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of
the act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered by the
person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking
under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby
guarantees that no article listed herein is adulterated or misbranded
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an
article which may not, under the provisions of section 404, 505, or 512
of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or
undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter
made by (name of person giving the guaranty or undertaking) to, or in
the order of (name and post-office address of person to whom the
guaranty or undertaking is given) is hereby guaranteed,
[[Page 68]]
as of the date of such shipment or delivery, to be, on such date, not
adulterated or misbranded within the meaning of the Federal Food, Drug,
and Cosmetic Act, and not an article which may not, under the provisions
of section 404, 505, or 512 of the act, be introduced into interstate
commerce.
(Signature and post-office address of person giving the guaranty of
undertaking.)
(c) The application of a guaranty or undertaking referred to in
section 303(c)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes adulterated or
misbranded within the meaning of the act, or becomes an article which
may not, under the provisions of section 404, 505, or 512 of the act, be
introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of
the act shall state that the shipment or other delivery of the color
additive covered thereby was manufactured by a signer thereof. It may be
a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such
guaranty or undertaking shall be signed by such manufacturer and by an
agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking
under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives
listed herein were manufactured by him, and (where color additive
regulations require certification) are from batches certified in
accordance with the applicable regulations promulgated under the Federal
Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all
color additives listed herein were manufactured by (name of
manufacturer), and (where color additive regulations require
certification) are from batches certified in accordance with the
applicable regulations promulgated under the Federal Food, Drug, and
Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section
303(c)(3) of the act the manufacturer of a shipment or other delivery of
a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons,
shall state that such persons severally guarantee the article to which
it applies.
(h) No representation or suggestion that an article is guaranteed
under the act shall be made in labeling.
Subpart B [Reserved]
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