Cal. Code Regs. Tit. 17, § 10376 - Drug and Device Manufacturing Licenses

(a) The fee for a manufacturer's license as required by Sections 26685 and 26688 of the Health and Safety Code is $200.00 and will cover a period of 12 months. The license is not transferable and will not be prorated.

(b) Manufacturers of human prescription drugs shall pay an additional license fee of $100.00 per year, plus the fingerprint processing fee charged by the California Department of Justice.

(c) Application for Drug Manufacturing License shall be made on State Department of Health form #EH-52 (Rev. 4/93). Applications for a Device Manufacturing License shall be made on State Department of Health form #EH-72.

(d) Applications for a Drug Manufacturing License shall include the following information on or attached to the application form:

(1) The name of the license applicant, and the full business address and telephone number of the manufacturing facility;

(2) All trade or business names used by the license applicant;

(3) Name(s) of the person(s) in charge of manufacturing;

(4) Name, address and telephone number of the person responsible for correspondence;

(5) The type of ownership or operation (for example, partnership, association, corporation, or individual/sole proprietorship);

(6) The name(s) of the owner and/or operator of the license applicant, including:

(A) If an individual, the name of the individual; if a sole proprietorship, the name of the sole proprietor and the name of the business entity;

(B) If a partnership or other unincorporated association, the name of each partner or member, and name of the partnership or association;

(C) If a corporation, the corporate name, and the state of incorporation, the name and title of each corporate officer and director; and

(D) The name of each person holding more than 5 percent equity, or debt liability of the applicant.

(7) Types of products to be manufactured;

(8) Type of processing to be utilized;

(9) Signature of license applicant under penalty of perjury affirming that the information in the application is true and accurate;

(10) Printed name and title of the individual signing the application;

(11) Date application was signed; and

(12) For human prescription drug manufacturers only:

(A) properly completed Disclosure Statement (form #EH-53 (rev. 4/93)), two properly completed fingerprint cards, and fingerprint processing fee for each person in charge of manufacturing and each person whose name is required to be included in the license application under Paragraphs (d)(6)(A) through (d)(6)(C). However, where the license applicant is a corporation, partnership, or other business association and the total number of partners, members, or corporate officers, directors, and shareholders (as the case may be) exceeds five, the application shall so state, and the documents and fee described in this Paragraph shall only be submitted for each person in charge of manufacturing, and

1. For corporations: of the corporate officers who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five highest ranking officers in this group, and

2. For partnerships, joint ventures, and similar business association: of the partners or members who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five persons in this group who own the largest interests in the applicant entity.

(B) Fingerprint cards and fingerprint processing fee shall only be submitted once for each person. If there is a change of any person in charge of manufacturing or any person occupying a position listed in Paragraphs (d)(6)(A) through (d)(6)(C), fingerprint cards and processing fee shall be submitted for each new or additional person.

(C) Other persons listed in Paragraph (d)(6) may be required by the Department to submit the documents described in this Paragraph as necessary to determine the qualifications of the applicant.

(e) Within 30 calendar days of receipt of a drug manufacturing license application, the Department shall inform the applicant in writing that it is either complete and accepted for filing or that the application is deficient and what specific information or documentation is required to complete the application. An application is considered complete when all information, documents, and fees required in this Section have been received by the Department.

(f) Within 240 calendar days from the date of filing of a completed drug manufacturing license application, the Department shall inform the applicant in writing of its decision regarding a drug manufacturing license application. The median time for the Department to process a drug manufacturing license application from acceptance of the initial application to the final license decision has been 29 calendar days; the minimum time was one calendar day; the maximum time was 919 calendar days.

Notes

Cal. Code Regs. Tit. 17, § 10376

1. New section filed 5-16-69 as an emergency; designated effective 7-1-69 (Register 69, No. 20).
2. Certificate of Compliance--section 11422.1, Gov. Code, filed 7-29-69 (Register 69, No. 31).
3. Amendment filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).
4. Amendment of section heading, new subsection (b) and renumbering and amendment of following paragraph and repealer of subsections (c)-(d) and new subsections (d)-(f) and amendment of NOTE filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.
5. Amendment refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.
6. Editorial correction of HISTORY 5. (Register 93, No. 20).
7. Certificate of Compliance as to 1-20-93 order including amendment of subsections (c) and (d)(12)(A), and repealer and new subsections (d)(12)(A)1.-2. transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

Note: Authority cited: Section 15376, Government Code and Sections 102, 208, 26202, 26209 and 26688, Health and Safety Code. Reference: Sections 26685, 26687, 26688 and 26689, Health and Safety Code.

1. New section filed 5-16-69 as an emergency; designated effective 7-1-69 (Register 69, No. 20).
2. Certificate of Compliance -section 11422.1, Gov. Code, filed 7-29-69 (Register 69, No. 31).
3. Amendment filed 7-21-76; effective thirtieth day thereafter (Register 76, No. 30).
4. Amendment of section heading, new subsection (b) and renumbering and amendment of following paragraph and repealer of subsections (c)-(d) and new subsections (d)-(f) and amendment of N ote filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.
5. Amendment refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.
6. Editorial correction of History 5. (Register 93, No. 20).
7. Certificate of Compliance as to 1-20-93 order including amendment of subsections (c) and (d)(12)(A), and repealer and new subsections (d)(12)(A)1.-2. transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).