Food and Drug Branch Export Document Program
The California Department of Public Health (CDPH) regulates the production, manufacture, and sale of foods, drugs, medical devices and cosmetics in California pursuant to the Sherman Food, Drug, and Cosmetic Law (California Health and Safety Code (HSC), Division 104, Part 5, [Section 109875 et seq.]). HSC Sections 110190 through 110240 allow CDPH to issue export documents, upon request of CDPH licensed or registered food, drug, medical device, and cosmetic firms who desire to export their products to other countries. This law establishes a one-time fee of $100, plus a fee-for-service charge of $80 per hour, at a minimum charge of $25 per request. Any attendant costs incurred by the department, including but not limited to, the costs of additional inspection, priority mailing, or notary service necessitated by the request shall be paid by the persons applying to the department for export documents. These charges and fees are nonreturnable.
On October 4, 2013, Governor Brown approved Assembly Bill 1400 to extend the term of the export document from 180 days (six months) to one year for certificates issued after January 1, 2014.
In addition to hard copy, the Export Document Program will soon be accepting applications by e-mail or other electronic methods. Please follow the current procedures until this page is updated with links for the electronic submission options.
The text of Assembly Bill 1400 can be reviewed by following this link.
Export Document: The export document certifies that the firm manufactures and distributes products manufactured in the State of California and is registered or licensed with the Department. The export certificate also acknowledges that the manufacturer has been inspected by CDPH to assure its compliance with the applicable provisions of the Federal Good Manufacturing Practice Regulations, which are adopted under California law.
All export document requests must be submitted on the application form found at http://www.cdph.ca.gov/pubsforms/forms/CtrldForms/cdph8582.pdf. The completed form must be submitted directly to CDPH Food and Drug Branch to he address listed on the application form.The application must include the appropriate fees and individual product labels intended for export. If more than four (4) products are to listed on your application, please submit an electronic copy of the product list in either Microsoft Word or Excel format. Product lists must be submitted with the application by mail on a CD or can be submitted by email to FDBExports@cdph.ca.gov making sure to reference the manufacturer’s name, CDPH license/registration number, and check number for the specific request. Applicants will receive an acknowledgement that the submission was received. Legible electronic copies of the product labels will be accepted. Individual product labels are reviewed for content and format during the processing of export applications. Existing products obtaining new labels and new products introduced into the market place, will require a new export application request for these product labels. If applications are submitted without labels, the Department will make one follow-up contact to request labels be submitted. If labels are not submitted within two weeks, the application will be returned. Incomplete applications may result in a denial. Application fees are nonreturnable.
The HSC establishing the requirements for the Export Document Application can be reviewed at http://www.cdph.ca.gov/services/Documents/fdbSFDCA.pdf. These requirements are specifically found in HSC Sections 110190-110240 (beginning on page 14). HSC Section 110200 (page 14 & page 15) describes what information is required to appear on the export certificate and that the applying firm may request adding statements to the export certificate subject to approval by the Department.
Certificate of Manufacture: Certificates of Manufacture are issued to any person who has a valid CDPH registration, license, certificate, or permit to manufacture or produce a food, drug, medical device, or cosmetic in this state. The request for this Certificate of Manufacture may be submitted using the Export Document Application found at http://www.cdph.ca.gov/pubsforms/forms/CtrldForms/cdph8582.pdf Requests for the Department to issue an official copy of the valid registration, license, certificate, or permit cost $15 per certificate.
If you have any questions, please contact the Export Document Program desk at (916) 650-6519 or send an email to FDBExports@cdph.ca.gov.