"Certificate of Free Sale Request Form" - Illinois

Certificate of Free Sale Request Form is a legal document that was released by the Illinois Department of Public Health - a government authority operating within Illinois.

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IMPORTANT NOTIFICATION
To all users of the
Illinois Department of Public Health
Certificate of Free Sale Program
As of November 14, 2014, the governing
program code [77 Ill. Adm. Code 720] has been
amended and the procedure for obtaining a
certificate has changed. Please review the
attachments carefully before submitting another
request.
All requests received after November
14, 2014, shall follow the new rules and
guidelines, and requestors shall utilize the new
request form and template.
IMPORTANT NOTIFICATION
To all users of the
Illinois Department of Public Health
Certificate of Free Sale Program
As of November 14, 2014, the governing
program code [77 Ill. Adm. Code 720] has been
amended and the procedure for obtaining a
certificate has changed. Please review the
attachments carefully before submitting another
request.
All requests received after November
14, 2014, shall follow the new rules and
guidelines, and requestors shall utilize the new
request form and template.
November 19, 2014
Dear Certificate of Free Sale Requestor:
On November 14, 2014, the Food, Drug and Cosmetic Code [77 Ill Admin. Code 720] was amended. A
version of the Code preceded by sections of the associated law is attached to this communication and will
soon be available on the Illinois Department of Public Health website.
The following is a summary of important changes that all certificates of free sale requestors should be
aware of:
Definitions for the following terms were added
the
to
Code:
Act
Apostille
Certificate of Free Sale
Certificate of Good Manufacturing Practices
Certificate of Origin
Certificate of Sanitation
Difference of Opinion Among Experts
Item
Labeling
Single-service plant
A summary of the changes to the Code by section follows;
A new section, 720.35, contains the requirements for the application and issuance of certificates of free
sale.
Special Notice
Attached are the new instructions and request form, effective November 14, 2014. Please review the
information and follow the instructions carefully. Incorrect or incomplete requests will be
returned. If you have any questions, feel free to contact the program staff by email at
dph.freesale@illinois.gov.
Sincerely,
Melissa Estes
Export Program Officer
Division of Food, Drugs and Dairies
Illinois Department of Public Health
PUBLIC HEALTH (410 ILCS 620/) Illinois Food, Drug and Cosmetic Act.
(410 ILCS 620/1) (from Ch. 56 1/2, par. 501)
Sec. 1. This Act shall be known and may be cited as the Illinois Food, Drug and Cosmetic Act. (Source: Laws
1967, p. 959.)
(410 ILCS 620/2) (from Ch. 56 1/2, par. 502)
Sec. 2. In this Act unless the context otherwise requires, the words and phrases defined in Sections 2.1 through
2.39, have the meanings set forth therein. (Source: P.A. 84-891.)
(410 ILCS 620/2.1) (from Ch. 56 1/2, par. 502.1)
Sec. 2.1. "Director" means the Director of Public Health; except that in regard to new animal drugs, animal feed,
meat and poultry and meat and poultry food products other than those sold at retail, "Director" means the Director of
Agriculture. (Source: P.A. 84-891.)
(410 ILCS 620/2.2) (from Ch. 56 1/2, par. 502.2)
Sec. 2.2. "Person" includes individual, partnership, corporation and association. (Source: Laws 1967, p. 959.)
(410 ILCS 620/2.3) (from Ch. 56 1/2, par. 502.3)
Sec. 2.3. "Food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3)
articles used for components of any such article. (Source: Laws 1967, p. 959.)
(410 ILCS 620/2.4) (from Ch. 56 1/2, par. 502.4)
Sec. 2.4. (a) "Drug" means (1) articles recognized in the official United States Pharmacopoeia - National
Formulary, official Homeopathic Pharmacopoeia of the United States, United States Dispensatory, or Remington's
Practice of Pharmacy, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to
affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a
component of any article specified in clause (1), (2) or (3); but does not include devices or their components, parts or
accessories.
(b) "Synthetic drug product" means any product that contains a substance defined as a controlled
substance under subsections (d) and (e) of Section 204 of the Illinois Controlled Substances Act. Products approved
by the U.S. Food and Drug Administration for human consumption are not synthetic drug products. (Source: P.A.
97-872, eff. 7-31-12.)
(410 ILCS 620/2.5) (from Ch. 56 1/2, par. 502.5)
Sec. 2.5. "Device" (except when used in Sections 2.11 and 3.10 and subsection (f) of Section 11, subsections (c)
and (p) of Section 15, and subsection (c) of Section 19) means instruments, implements, machines, implants, in vitro
reagents, apparatus and contrivances, including their components, parts and accessories, or other similar or related
articles which are (1) recognized in the official United States Pharmacopoeia - National Formulary or any supplement
thereto; (2) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or
other conditions in man or other animals; or (3) intended to affect the structure or any function of the body of man or
other animals; and which do not achieve any of their principal intended purposes through chemical action within or
on the body of man or other animals and which are not dependent upon being metabolized for the achievement of
any of their principal intended purposes. (Source: P.A. 84-891.)
(410 ILCS 620/2.6) (from Ch. 56 1/2, par. 502.6)
Sec. 2.6. "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into,
or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term
shall not include soap. (Source: Laws 1967, p. 959.)
(410 ILCS 620/2.8) (from Ch. 56 1/2, par. 502.8)
Sec. 2.8. "Label" means a display of written, printed or graphic matter upon the immediate container of any
article; and a requirement made by or under authority of this Act that any word, statement, or other information
appear on the label shall not be considered to be complied with unless such word, statement, or other information
also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily
legible through the outside container or wrapper. (Source: Laws 1967, p. 959.)
DPH
77 ILLINOIS ADMINISTRATIVE CODE 720
720
TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER m: FOOD, DRUGS AND COSMETICS
PART 720
FOOD, DRUG AND COSMETIC CODE
Section
720.10
General Regulations
720.20
Definitions
720.25
Referenced Materials
720.30
Prohibited Acts and Penalties
720.35
Certificate of Free Sale
720.40
Food
720.50
Drugs and Devices
720.60
Cosmetics
AUTHORITY: Implementing and authorized by the Illinois Food, Drug and Cosmetic Act [410
ILCS 620].
Section 720.10 General Regulations
a)
The provisions of this Part with respect to the commission of any act
shall be applicable also to the causing of the act to be done.
b)
The definitions and interpretations of terms contained in Section 2 of the Act
shall be applicable also to those terms when used in this Part.
Section 720.20 Definitions
Act − the Illinois Food, Drug and Cosmetic Act.
Apostille − a document that certifies the validity of an Illinois notary public, county
clerk, circuit clerk or local registrar.
Certificate of Free Sale − a document issued to Illinois food and dairy manufacturers,
processors, packers or warehousers that are inspected by the Department, verifying that
the specified items are freely marketed in the United States and eligible for export to any
foreign country as long as that particular manufacturer, processor, packer or warehouser
has no unresolved enforcement actions pending before the Department in accordance
with this Part, the Act, the Grade A Pasteurized Milk and Milk Products Act and Grade
A Pasteurized Milk and Milk Products administrative rules, the Manufactured Dairy
Products Code, and the Manufacturing, Processing, Packing or Holding of Food Code.
A Certificate of Free Sale may be issued as an equivalent certificate to include a
Certificate of Origin, Certificate of Good Manufacturing Practices, or Certificate of
Sanitation.
DPH
77 ILLINOIS ADMINISTRATIVE CODE 720
720
Certificate of Good Manufacturing Practices − equivalent to a certificate of free sale that
certifies that the items were made using good manufacturing practices in an Illinois
manufacturing facility.
Certificate of Origin − equivalent to a certificate of free sale to certify that the items
were manufactured in Illinois.
Certificate of Sanitation − equivalent to a certificate of free sale to certify that the food
items manufactured in Illinois meet applicable food sanitation standards.
Difference of Opinion Among Experts − the existence of a difference of opinion, among
experts qualified by scientific training and experience, as to whether the truth of a
representation made or suggested in the labeling is a fact (among other facts), the failure
to reveal which may render the labeling misleading, if there is a material weight of
opinion contrary to the representation.
FDA − United States Food and Drug Administration.
Item − each single unit listed on the Certificate of Free Sale request form.
Labeling − all written, printed or graphic matter accompanying an article at anytime
while the article is for sale or delivery, held for sale or offered for sale in Illinois.
Single-service Plant − an Illinois facility that manufactures single-service containers and
closures for milk and milk products in accordance with the Grade A Pasteurized Milk
and Milk Products Code and FDA Pasteurized Milk Ordinance (PMO) Appendix J.
Section 720.25 Referenced Materials
a)
The following Illinois statutes are referenced in this Part:
1)
Illinois Food, Drug and Cosmetic Act [410 ILCS 620]
2)
Grade A Pasteurized Milk and Milk Products Act [410 ILCS 635]
b)
The following federal statutes are referenced in
this Part: Food, Drug and Cosmetic Act (21 USC 352)
c)
The following Illinois administrative rules are referenced in this Part:
1)
Grade A Pasteurized Milk and Milk Products (77 Ill. Adm. Code 775)
2)
Manufactured Dairy Products Code (77 Ill. Adm. Code 785)
3)
Manufacturing, Processing, Packing or Holding of Food Code (77 Ill.
Adm. Code 73)