California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10376 - Drug and Device Manufacturing Licenses

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.