Fillable Printable Drug Manufacturing License Application Form - California
Fillable Printable Drug Manufacturing License Application Form - California
Drug Manufacturing License Application Form - California
State of California—Health and Human Services Agency California Department of Public Health
Food and Drug Branch
CDPH 8678 (02/11)
Fund 0082 Index 5623 PCA 76202 Receipt Source 125700 Agency Source 0044
Page 1 of 2
COSMETIC MANUFACTURING REGISTRATION APPLICATION
PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED
See Page 2 for Instructions
NEW APPLICANT
RELOCATION
OWNERSHIP CHANGE
OWNERSHIP AND LOCATION CHANGE
RENEWAL
1. Legal Name of Firm
9. Facility Operator (name and title)
2. DBA (List additional DBAs on separate sheet if necessary.) 10. Facility Telephone Number
( )
11. Facility FAX Number
( )
3. Facility Address (number, street) 12. 24-Hour Emergency Telephone Number
( )
13. E-Mail Address
4. Facility Address (continued) 14. Correspondent (name and title)
5. City State ZIP Code 15. Correspondent Telephone Number
( )
16. Correspondent FAX Number
( )
6. Mailing Address (if different or P.O. Box number) 17. County 18. Country (if other than United States)
7. Mailing Address (continued) 19. Web Site (URL)
8. City State ZIP Code
20. Type of Ownership: Individual/Sole Proprietorship Partnership Corporation/Limited Liability Company Nonprofit Other:
(attach copy of Partnership agreement or Articles of Incorporation)
21. Corporate Name (if applicable) State of Incorporation
22. Owners’ or Officers’ Names and Titles Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)
23. Size of Facility (square feet):________________
Business days and hours:____________________
Number of Employees at this Facility:____________________
24
.
Business License Number:_____________ Seller’s Permit:________________
Fictitious Business Name (FBN) Yes No
(attach copy of business license, Seller’s Permit and FBN)
25. Products manufactured at this location (check all that apply): (If denoted with an asterisk, submit a list of ingredients and labeling exemplars for each product.)
Acne products*
Hair care i.e., shampoo, conditioner, coloring agents, relaxers
Antiperspirants* Lubricants, i.e., personal, sexual, massage oil*
Bath products, i.e., salts, oils
Oral products, i.e. mouthwash, toothpaste*
Color cosmetic, i.e., eye brow pencils, eyeliner, lipsticks Perfumes/colognes
Halloween makeup
Skin bleaching, i.e., skin lighteners, age-spot removers*
Deodorants, i.e., underarm, vaginal Shaving creams
Depilatories
Sunscreen, i.e., any products claiming SPF*
Eye area products, i.e., products designed exclusively for Topical dry skin care i.e., pressed powder, talc dusting powder
sensitive eye area Topical liquid skin care, i.e., moisturizer, toner, astringent
Facial mask Wrinkle cream
Fingernail preparations, i.e., polish, remover, artificial nails Other (specify):__________________________________
* ALL APPLICANTS: In order to receive a Cosmetic Manufacturing Registration from this Department, if you manufacture ACNE PRODUCTS, ANTIPERSPIRANTS, LUBRICANTS,
ORAL PRODUCTS, SKIN BLEACHING PRODUCTS or SUNCREENS, you must submit a list of ingredients and labeling exemplars for each product manufactured along with this
application form, as you may be required to obtain a Drug Manufacturing License for these products.
NEW APPLICANTS: In order to receive a Cosmetic Manufacturing Registration from the Department you must submit a copy of the Secretary of State Corporation Name form and
Fictitious Name statement (if applicable) with the Cosmetic Manufacturing Registration Application form.
Registration Fee: $507
(Fee is Non-Refundable)
MAKE CHECKS PAYABLE TO: CA DEPARTMENT OF PUBLIC HEALTH
See page 2 for mailing address
The Food & Drug Branch MUST BE NOTIFIED IMMEDIATELY of any change in the application information per the CA Health & Safety Code, §111805.
By signature, I declare under penalty of perjury that all information provided herein is true and correct.
26. Signature
Printed Name
Title
Date
PLEASE DO NOT WRITE BELOW THIS LINE.
Registration Number Expiration Date
CDPH 8678 (02/11)
Fund 0082 Index 5623 PCA 76202 Receipt Source 125700 Agency Source 0044
Page 2 of 2
COSMETIC MANUFACTURING REGISTRATION APPLICATION INSTRUCTIONS
A separate application is required for each place of business. Please complete and/or amend this application as is most
appropriate to your facility. Include the appropriate fee for each application and make payable to: CA DEPARTMENT OF
PUBLIC HEALTH. The fee must accompany this application or it cannot be processed. Unsigned or incomplete applications
cannot be processed. The following are further instructions on how to complete this application:
New Applicant: Place an (X) in the box next to New Applicant if your firm has not previously applied for a Cosmetic
Manufacturing Registration at this location while under the current ownership. This registration is non-transferable. If your
firm has changed location, ownership, or both, place an (X) in the appropriate box and also in the box next to New Applicant.
For any section that does not apply to your company, please indicate with (N/A). Do not leave any sections blank .
1.
Name of Firm: Enter full name of business, corporation, company, or organization applying for licensure.
2.
DBA: Enter any other name(s) your company is doing business as.
3.–5.
Facility Address: Enter the number, street, city, state, and ZIP code for this facility location.
6.–8.
Mailing Address: Enter the full mailing address if different from the facility address or P.O Box.
9.
Facility Operator: Enter the full name(s) of the person(s) in charge of cosmetic manufacturing at this facility and their
title(s).
10.
Facility Telephone Number: Enter daytime business telephone number of this facility.
11.
Facility FAX Number: Enter facility FAX number.
12.
24 Hour Emergency Telephone Number: Enter telephone number to be called in the event of an emergency.
13.
E-mail Address: Enter facility e-mail address.
14.
Correspondent: Enter the name of the person to contact for information regarding this application and their title.
15.
Correspondent Telephone Number: Enter the daytime business telephone number of the contact person.
16.
Correspondent FAX Number: Enter the daytime business FAX number of the contact person.
17.
County: Enter the county where your facility is located.
18.
Country: Enter the country where your facility is located, if outside of the United States.
19.
Web site: Enter the web site address for your business, if applicable.
20.
Type of Ownership: Place an (X) in the box next to the appropriate legal description of the facility’s ownership and
attach required copies.
21.
Corporate Name: Enter corporate name if applicable. Enter state of incorporation if applicable. (Attach copy)
22.
Owners’ or Officers’ Names: List the business owners’ or officers’ names and titles. USE ADDITIONAL SHEETS IF
NECESSARY.
23.
Size of Facility: Indicate the approximate size (in square feet) of the facility and the approximate number of employees
at the facility and list business days and hours.
24.
Business license, Seller’s Permit and Fictitious Business Statement (FBN): Enter business license and Seller’s
Permit. Place an (X) in the Yes or No box next to FBN and attach required copies.
25.
Products Manufactured: Place an (X) in the box adjacent to each product area that applies to the cosmetic
manufactured or to be manufactured, and provide the required labels as indicated. Use additional sheets if necessary.
26.
Sign the application, print your name, print your title, and enter the date.
MAKE CHECKS PAYABLE TO: CA DEPARTMENT OF PUBLIC HEALTH
MAIL APPLICATION AND CHECK TO:
Regular Mail: Californi
a Department of Public Health
Overnight Mail: California Department of Public Health
Food and Drug Branch - Cashier Food and Drug Branch - Cashier
MS 7602 1500 Capitol Avenue, MS-7602
P.O. Box 997435 Sacramento, CA 95814
Sacramento, CA 95899-7435
**
LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES
If you have any further questions, please contact the Food and Drug Branch, License Desk for Cosmetic Registration, or visit
our web site at: http://www.cdph.ca.gov.
The CDPH Food & Drug Branch MUST BE NOTIFIED IMMEDIATELY of any change in the application information as
provided by California Health & Safety Code, Section 111805.
