TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER m: FOOD, DRUGS AND COSMETICS
PART 720 FOOD, DRUG AND COSMETIC CODE
SECTION 720.35 CERTIFICATE OF FREE SALE


 

Section 720.35  Certificate of Free Sale

 

a)         Requirements for Issuance of Certificate of Free Sale

 

1)         The Department will approve issuance of a certificate of free sale only for items that are from Illinois food and dairy manufacturers, processors, packers or warehousers or an Illinois single-service plant that manufactures single-service containers and closures and is approved for the listing of certified single-service manufacturers in the current publication of the FDA Interstate Milk Shippers (IMS) List. 

 

2)         The Department is authorized, but is not required, upon request, to issue certificates of free sale to Illinois dairy, drug, cosmetic, or medical device manufacturers, processors, packers, or warehousers (Section 21.3 of the Act).  The Department will not approve a certificate of free sale for medical equipment, devices, drugs, cosmetics, vitamins, and dietary supplements as defined in the Act, even if manufactured, processed, packaged or stored in Illinois.

 

3)         The Department will not issue a certificate of free sale to a business, corporation or entity that is only headquartered in Illinois but manufactures, processes, packs or warehouses in another state.

 

4)         The Department will not modify the language on the certificate of free sale from the original wording.

 

5)         The certificate of free sale covers only existing conditions of the items and shall not be interpreted as a guarantee, explicit or implied, for all items of the company at all times in the future.

 

6)         The issuance of a certificate of free sale does not preclude the Department from taking enforcement action against a food or dairy manufacturer, processor, packer or warehouser in the future 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.

 

b)         Application Process for the Certificate of Free Sale

 

1)         The applicant shall complete and submit the Department certificate of free sale request form and payment per the instructions.  The request form will be located on the Department website (www.idph.state.il.us).

 

2)         A certificate of free sale will only be made available in English or Spanish.  If the applicant needs the certificate of free sale in any other language or dialect, the applicant shall pay the cost of the Department's hiring of a translator to create the requested foreign language certificate of free sale. 

 

3)         On the application, the applicant shall provide the Illinois State Identification Number or Illinois Permit Number that has been issued to the Illinois manufacturer, processor, packer, distributor or warehouser upon inspection by the Department.

 

4)         Along with the application, the applicant shall submit a fee to the Department for the certificate of free sale.  A certificate of free sale will include no more than five items.  The fee for each certificate of free sale will be $10.

 

5)         Certificates of free sale issued by the Department will be notarized by a certified State of Illinois notary public.  If the applicant requires a certificate of authority for the signing notary public or requires an apostille to certify the Illinois notary public, then the applicant shall include a cover letter with its application stating the request and a check payable to the "Secretary of State" in an amount in accordance with the Illinois Secretary of State Notary Services found at http://www.cyberdriveillinois.com/departments/index/notary/home.html.

 

(Source:  Added at 38 Ill. Reg. 22215, effective November 14, 2014)