Form Cdph 52N PDF Details

The State of California sets a high bar for regulatory compliance in the manufacturing of drug products, a benchmark embodied in the rigorously detailed CDPH 52N form provided by the California Department of Public Health's Food and Drug Branch. This form serves as a foundational pillar for entities aiming to secure a new drug manufacturing license, marking an essential step in navigating the complex regulatory landscape. With sections covering everything from the legal name of the firm, type of ownership, types of drug products manufactured, to manufacturing processes and fees, the form encapsulates a comprehensive snapshot of applicant operations. It is meticulously designed to gather pertinent information, including but not limited to, facility details, corporate structure, intended drug destinations, and manufacturing stages at the time of application. Each aspect of the form is structured to ensure that manufacturers meet the stringent standards set forth for drug manufacturing in California, reflecting a commitment to public health and safety. The inclusion of a detailed instruction section further underscores the state's dedication to clarity and compliance, guiding applicants through the process of submitting a fully completed application. This thorough approach facilitates a robust vetting process, ensuring that only qualified manufacturers can navigate the complexities of drug production within the state's jurisdiction.

QuestionAnswer
Form NameForm Cdph 52N
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other names24-Hour, PDMA, 52N, Rx

Form Preview Example

State of California—Health and Human Services Agency

California Department of Public Health

 

Food and Drug Branch

NEW DRUG MANUFACTURING LICENSE 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

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.

Country (if other than United States)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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:

 

 

 

 

 

 

 

 

(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:____________________

Business License Number:_____________

Seller’s Permit:________________

Number of Employees at this Facility:____________________

Federal Employee Identification Number:__________________

24. Stage of Manufacture at Date of Application (check all that apply)

 

 

Manufacturing products

Validation – Completion Date: _______________________

Plant construction/design (Targeted Completion Date: ____________________)

Other (specify): ____________________________________________________

25. Intended Drug Destination (check all that apply)

Commercial distribution

Human clinical trials (investigational use)

California distribution only

U.S. distribution

Export market

26. Type of Drug Product (check all that apply)

Prescription*

Over-the-counter

 

*If Prescription or Both is checked complete the Disclosure Statement form (CDPH53)

Both*

refer to PDMA requirements on instruction page 2.

27. Drug Products Manufactured at this Location (check all that apply)

700 Bulk pharmaceuticals (API)

708 Biologics

701 Medical gases

702Radioactive

703Veterinary

704Controlled substances (schedule: _______________DEA#:_____________(attach copy of DEA certificate)

712Topical

705

Approved New Drug

709 Parenteral

Other (specify):

706

Investigational New Drugs (IND)

710

Oral Dose (solid/liquid)

__________________

707

Biotech

711

Pre-IND

 

28.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

 

 

 

 

29. Payment Code

A—$1600 (Fee is Non-Refundable)

MAKE CHECKS PAYABLE TO: CA DEPT. OF PUBLIC HEALTH

See page 2 for mailing address

30. License Fees Due:

Enter Each Fee Below:

a. License Fee (see #30)

$

 

 

b. PDMA* ($100 If Applicable – see page 2)

$

c. Total Payment Due

$

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 is true and correct.

31. Signature

Printed Name

Title

Date

PLEASE DO NOT WRITE BELOW THIS LINE.

License Number

Expiration Date

Date Received

Payment Type

Amount

$

CDPH 52N (06/09)

Fund 3018 Index 5623 PCA 76213 Receipt Source 125700 Agency Source 44

Page 1 of 2

NEW DRUG MANUFACTURING LICENSE 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 Drug Manufacturing License at this location while under the current ownership. This license 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 drug 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.

Country: Enter the country where your facility is located, if outside of 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. (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. Enter the Business license, FEIN, and Seller’s Permit and provide required copies.

 

 

24.

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.

 

 

 

 

 

 

25.

Intended Drug Destination: Place an (X) in the box adjacent to the destination(s) for your manufactured products. Check all that apply.

26.

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*.

 

 

 

 

 

27.

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. (attach copy of DEA certificate)

 

 

 

 

 

28.

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.

 

 

 

 

 

 

29.

Payment Fee Code: Your license fee is based on the application type **.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Application Type

 

Fee

 

Payment Interval

 

Payment Code

 

 

 

 

 

 

 

 

 

 

 

New, Relocation, or Ownership Change

 

$1600

First License only

 

A

 

 

 

 

 

 

 

 

 

* PDMA (Prescription Drug Marketing Act) Requirements:

If your firm manufactures human prescription (Rx) drugs, an

 

additional $100 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 #23 (instructions provided therein). Information relevant to the PDMA, (e.g., Disclosure Statements and

 

Applicant Fingerprint Live Scan requirements) can be reviewed at: http://www.cdph.ca.gov/fdb/HTML/Drug/PDMA.htm.

**

LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES

30.

License Fee Due: Enter appropriate fees due.

 

 

 

 

 

 

 

a. Enter license fee according to payment codes in #30. (License valid for 1 year.)

 

 

 

b. Add $100 PDMA fee if it applies to your firm. See PDMA requirements above*.

 

 

 

c. Enter Total Payment Due by adding ”A” and “B”

 

 

 

 

 

 

31.

Sign the application, print your name, print your title, and enter the date. All signatures must be original.

 

 

 

Make checks payable to: CA DEPARTMENT OF PUBLIC HEALTH

Mail Application and Check to:

 

 

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 for Drug Manufacturing at (916) 650-6500, or visit our website at: http://www.cdph.ca.gov/programs/Pages/FDB.aspx.

CDPH 52N (06/09)

Fund 3018 Index 5623 PCA 76213 Receipt Source 125700 Agency Source 44

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