Form CDPH 52R Biennial Drug Manufacturing License Renewal Application - California

Form CDPH52R is a California Department of Public Health form also known as the "Biennial Drug Manufacturing License Renewal Application". The latest edition of the form was released in April 1, 2018 and is available for digital filing.

Download an up-to-date Form CDPH52R in PDF-format down below or look it up on the California Department of Public Health Forms website.

ADVERTISEMENT
License Number
Expiration Date
Date Received
Payment Type
Amount
$
State of California—Health and Human Services Agency
California Department of PublicHealth
Food and Drug Branch
BIENNIAL DRUG MANUFACTURING LICENSE RENEWAL APPLICATION
PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED
See Page 2 for Instructions
1. Legal Name of Firm
9. Facility Operator (name and title)
10. Facility Telephone Number
11. Facility FAX Number
2. DBA (List additional DBAs on separate sheet if necessary.)
(
)
(
)
12. 24-Hour Emergency Telephone Number
3. Facility Address (number, street)
13. E-Mail Address
(
)
4. Facility Address (continued)
14. Correspondent (name and title)
15. Correspondent Telephone Number
16. Correspondent FAX Number
5. City
State
ZIP Code
(
)
(
)
6. Mailing Address (if different or P.O. Box number)
17. County
7. Mailing Address (continued)
18. Website (URL)
8. City
State
ZIP Code
19. Interstate Commerce
Product Shipped
Product or Raw Materials Received
N/A
20. Type of Ownership
Individual/Sole Proprietorship
Partnership
Corporation/Limited Liability Company
Nonprofit
Other:
21. Corporate Name (if applicable)
State of Incorporation
Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)
22. Owners’ or Officers’ Names and Titles
23. Previous CDPH - FDB LicenseNumber(s):
Associated California Board of Pharmacy License Number:
24. Size of Facility (square feet):
Number of Employees at thisFacility
Business days and hours
25. Stage of Manufacture at Date of Application (check all thatapply)
Manufacturing products
Validation – Completion Date:
Other (specify):
26. Intended Drug Destination (check all that apply)
Commercial distribution
Human clinical trials (investigational use)
California distribution only
U.S. distribution
Export market
27. Type of Drug Product (check all that apply)
*If Prescription or Both is checked complete the Disclosure Statement form (CDPH53);
Prescription*
Over-the-counter
Both*
Refer to PDMA requirements on instruction page 2.
28. Drug Products Manufactured at this Location (check all that apply)
700 Bulk pharmaceuticals (API)
704 Controlled substances(schedule:
DEA#:
(attach copy of DEA certificate)
701 Medical gases
706 Investigational New Drugs (IND)
710 Oral Dose (solid/liquid)
702 Radioactive
707 Biotech
711 Pre-IND
703 Veterinary
708 Biologics
712 Topical
705 Approved New Drug
709 Parenteral
Other (specify):
29. Manufacturing processes/activities employed or planned in the manufacture of the drugs listed above. Indicate if these processes/activities will be done at
this location (in-house) or by a contract. List other processes using additional sheets, if necessary. (Check at least one or more.)
Processes/Activities
In-house
Contract
Processes/Activities
In-house Contract
Aerosolization
Powder Mixing
Aseptic
Relabel Only
Coating
Repackage Only
Emulsification
Sterilization
Encapsulation
Suspension
Fermentation/tissue culture viral
Tableting
vector/gene therapy
Other (Specify):
Liquid Mixing
30.Payment Code
A — $3,988 (Fee is due at the time application is submitted and is Non-Refundable)
B — $ 200 PDMA* (if Applicable – see page 2)
C — $ 10 Late Fee (if over 30 days late)
$
Total Payment Due
31. Please attach:
Evidence of ownership and one of the following:
A copy of a valid biologics license issued by the U.S. Food and Drug Administration (FDA)
A copy of a valid establishment registration pursuant to Section 510 of the federal act and an attestation that a federal inspection was completed within the
last two years
A copy of documentation demonstrating compliance with audits conducted pursuant to International Organization for Standardization (ISO) ISO standards
(ISO 9000 series, ISO 13485:2003, ISO 15378:2006)
A copy of an approved investigational new drug application
The Food and Drug Branch MUST BE NOTIFIED of any change in the application information as provided by CA Health and Safety Code, §111630.
By signature, I declare under penalty of perjury that all information provided herein, including any supplemental documentation hereto, is true and correct .
Printed Name
Title
Date
32. Signature
PLEASE DO NOT WRITE BELOW THIS LINE.
Page 1 of 2
Fund 3018
Index 5623
PCA 76213
Receipt Source 125700
Agency Source 0044
CDPH 52R (04/18)
License Number
Expiration Date
Date Received
Payment Type
Amount
$
State of California—Health and Human Services Agency
California Department of PublicHealth
Food and Drug Branch
BIENNIAL DRUG MANUFACTURING LICENSE RENEWAL APPLICATION
PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED
See Page 2 for Instructions
1. Legal Name of Firm
9. Facility Operator (name and title)
10. Facility Telephone Number
11. Facility FAX Number
2. DBA (List additional DBAs on separate sheet if necessary.)
(
)
(
)
12. 24-Hour Emergency Telephone Number
3. Facility Address (number, street)
13. E-Mail Address
(
)
4. Facility Address (continued)
14. Correspondent (name and title)
15. Correspondent Telephone Number
16. Correspondent FAX Number
5. City
State
ZIP Code
(
)
(
)
6. Mailing Address (if different or P.O. Box number)
17. County
7. Mailing Address (continued)
18. Website (URL)
8. City
State
ZIP Code
19. Interstate Commerce
Product Shipped
Product or Raw Materials Received
N/A
20. Type of Ownership
Individual/Sole Proprietorship
Partnership
Corporation/Limited Liability Company
Nonprofit
Other:
21. Corporate Name (if applicable)
State of Incorporation
Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)
22. Owners’ or Officers’ Names and Titles
23. Previous CDPH - FDB LicenseNumber(s):
Associated California Board of Pharmacy License Number:
24. Size of Facility (square feet):
Number of Employees at thisFacility
Business days and hours
25. Stage of Manufacture at Date of Application (check all thatapply)
Manufacturing products
Validation – Completion Date:
Other (specify):
26. Intended Drug Destination (check all that apply)
Commercial distribution
Human clinical trials (investigational use)
California distribution only
U.S. distribution
Export market
27. Type of Drug Product (check all that apply)
*If Prescription or Both is checked complete the Disclosure Statement form (CDPH53);
Prescription*
Over-the-counter
Both*
Refer to PDMA requirements on instruction page 2.
28. Drug Products Manufactured at this Location (check all that apply)
700 Bulk pharmaceuticals (API)
704 Controlled substances(schedule:
DEA#:
(attach copy of DEA certificate)
701 Medical gases
706 Investigational New Drugs (IND)
710 Oral Dose (solid/liquid)
702 Radioactive
707 Biotech
711 Pre-IND
703 Veterinary
708 Biologics
712 Topical
705 Approved New Drug
709 Parenteral
Other (specify):
29. Manufacturing processes/activities employed or planned in the manufacture of the drugs listed above. Indicate if these processes/activities will be done at
this location (in-house) or by a contract. List other processes using additional sheets, if necessary. (Check at least one or more.)
Processes/Activities
In-house
Contract
Processes/Activities
In-house Contract
Aerosolization
Powder Mixing
Aseptic
Relabel Only
Coating
Repackage Only
Emulsification
Sterilization
Encapsulation
Suspension
Fermentation/tissue culture viral
Tableting
vector/gene therapy
Other (Specify):
Liquid Mixing
30.Payment Code
A — $3,988 (Fee is due at the time application is submitted and is Non-Refundable)
B — $ 200 PDMA* (if Applicable – see page 2)
C — $ 10 Late Fee (if over 30 days late)
$
Total Payment Due
31. Please attach:
Evidence of ownership and one of the following:
A copy of a valid biologics license issued by the U.S. Food and Drug Administration (FDA)
A copy of a valid establishment registration pursuant to Section 510 of the federal act and an attestation that a federal inspection was completed within the
last two years
A copy of documentation demonstrating compliance with audits conducted pursuant to International Organization for Standardization (ISO) ISO standards
(ISO 9000 series, ISO 13485:2003, ISO 15378:2006)
A copy of an approved investigational new drug application
The Food and Drug Branch MUST BE NOTIFIED of any change in the application information as provided by CA Health and Safety Code, §111630.
By signature, I declare under penalty of perjury that all information provided herein, including any supplemental documentation hereto, is true and correct .
Printed Name
Title
Date
32. Signature
PLEASE DO NOT WRITE BELOW THIS LINE.
Page 1 of 2
Fund 3018
Index 5623
PCA 76213
Receipt Source 125700
Agency Source 0044
CDPH 52R (04/18)
Biennial Drug Manufacturing License Renewal 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 check payable to: CA DEPARTMENT OF PUBLIC HEALTH. The fee must accompany this application or it
cannot be processed. Please apply within 30 days of expiration; failing to do so requires an additional $10 penalty added to the renewal fee before the
license is issued. Unsigned or incomplete applications cannot be processed. The following are further instructions on how to complete this application:
Renewal Status: This license is non-transferable. If your firm has changed location, ownership, or both, use the application titled “New Drug Manufacturing
License Application” (CDPH 52N). For any section that does not apply to your company, please indicate with (N/A). Do not leave any sections blank.
1.
Legal Name of Firm: Enter full name of business, corporation, company, or organization applying forlicensure.
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 facilityaddress.
9.
Facility Operator: Enter the full name(s) of the person(s) in charge of drug manufacturing at this facility and theirtitle(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 theirtitle.
15.
Correspondent Telephone Number: Enter the daytime business telephone number of the contactperson.
16.
Correspondent FAX Number: Enter the daytime business FAX number of the contact person.
17.
County: Enter where your facility is located, if outside the United States
18.
Website: Enter the website address for your business, if applicable.
19.
Interstate Commerce: Place an (X) in all appropriate boxes that correctly describe your business’ receipt or distribution of products or materials
through or into interstate commerce.
20.
Type of Ownership: Place an (X) in the box next to the appropriate legal description of the facility’s ownership.
21.
Corporate Name: Enter corporate name if applicable. Enter state of incorporation if applicable.
22.
Owners’ or Officers’ Names: List the business owners’ or officers’ names and titles. USE ADDITIONAL SHEETS IFNECESSARY.
23.
List previous California Department of Public Health - Food and Drug Branch License Number(s) if applicable.
24.
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.
25.
Stage of Manufacture: Place an (X) in the box next to the stage of manufacture your products are in at the time of application submission. Check
all that apply.
26.
Intended Drug Destination: Place an (X) in the box adjacent to the destination(s) for your manufactured products. Check all that apply.
27.
Types of Products: Place an (X) in each box that applies to each type of drugs manufactured or to be manufactured. For human prescription (Rx)
drug manufacturers, refer to PDMA requirements below*.
28.
Products Manufactured: Place an (X) in the box adjacent to each product area that applies to the drugs manufactured or to be manufactured. Use
additional sheets if necessary.
29.
Manufacturing Processes: Place an (X) in the columns adjacent to all applicable processes to be performed in-house and/or contracted out.
Leave line blank if the indicated process will not be applied to the manufacturing of listed drugs. List additional processes or methods as needed
herein or on additional sheets if necessary.
30.
Payment Fee Code: Your license fee is based on the application type **.
Application Type
Fee
Payment Interval
Payment Code
Renewal
$3,988
Biennially on Renewal
A
*PDMA
$ 200
Biennially on Renewal
B
$ 10
Late Fee (if over 30 days late)
C
*
PDMA (Prescription Drug Marketing Act) Requirements:
If your firm manufactures human prescription (Rx) drugs, an
additional $200 must be added to the license fee and a Disclosure Statement (Form CDPH 53) must be submitted for each person
listed on lines #9 and #22 (instructions provided therein). Information relevant to the PDMA, (e.g., Disclosure Statements and
Applicant Fingerprint Live Scan requirements) can be reviewed
in the online
application.
**
LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES
A.
Enter license fee according to payment codes above. (License valid for 2 years.)
B.
Add $200 PDMA fee if it applies to your firm. See PDMA requirements above*.
C.
Add $10 late fee due, if renewal application is over 30 days late.
D.
Enter Total Payment Due by adding A, B, and C.
31.
Attach Evidence of Ownership and U.S. Food and Drug Administration (FDA) or International Organization for Standardization (ISO)
Standards Documents and place an (X) in the appropriate box(es) for the items that you are submitting with this application. For more information
regarding this requirement, please refer to the California Health and Safety Code Section111635.
32.
Sign the application, print your name, print your title, and enter the date. All signatures must be original.
Make checks payable to:
CA DEPARTMENT OFPUBLIC HEALTH
Mail Application and Check to: (below)
Regular Mail: California 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
If you have any questions about this application, please contact the FDB License Desk at (916) 341-7354, (800) 495-3232, or visit our website.
Page 2 of 2
Fund 3018
Index 5623
PCA 76213
Receipt Source 125700
Agency Source 0044
CDPH 52R (04/18)

Download Form CDPH 52R Biennial Drug Manufacturing License Renewal Application - California

1319 times
Rate
4.4(4.4 / 5) 79 votes
ADVERTISEMENT
Page of 2