ARTICLE 6. Licenses

Article 6 added by Stats. 1995, Ch. 415, Sec. 6.

§§ 111615–111656.13 · 24 sections

§ 111615 No person shall manufacture any drug or device in this state unless he or she has a valid license from the department. The license is valid for two calendar…
§ 111620 A separate license is required for each place of manufacture.
§ 111625 A license application shall be completed biennially and accompanied by an application fee as prescribed in Section 111630. This fee is not refundable if the…
§ 111630 The department shall by regulation establish the application form and set the fee for licensure and renewal of a license. The penalty for failure to apply for…
§ 111633 The State Department of Public Health shall require that an applicant for a human prescription drug manufacturing license submit fingerprints to the Department…
§ 111635 (a) Prior to issuing a license required by Section 111615 to any place of business where a drug or device is manufactured, the department shall receive from…
§ 111640 The department shall make investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry…
§ 111645 Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a license or for suspending or…
§ 111650 Drug manufacturers who have obtained a license or who are applying for a license pursuant to this article shall submit to the California State Board of…
§ 111655 The licensing provisions of this chapter shall not apply to any of the following: (a) Any pharmacy that maintains establishments in conformance with provisions…
§ 111656 (a) No person shall conduct a home medical device retail facility business in the State of California unless he or she has obtained a license from the…
§ 111656.1 (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine…
§ 111656.2 (a) The following standards shall apply to all home medical device retail facilities: (1) Each retail facility shall store prescription devices in a manner…
§ 111656.3 (a) Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the…
§ 111656.4 Section 4051 of the Business and Professions Code shall not prohibit a home medical device retail facility from selling or dispensing prescription devices if…
§ 111656.5 (a) A person other than a licensed pharmacist, an intern pharmacist, an exemptee, as specified in Section 111656.4, or an authorized agent of the department or…
§ 111656.6 Home medical devices for rental purposes shall at all times while under the control of the home medical device retail facility, be maintained in a clean and…
§ 111656.7 (a) Without registering as an out-of-state home medical device retail facility, an out-of-state home medical device retail facility shall not sell or…
§ 111656.8 (a) No person acting as principal or agent for any out-of-state home medical device retail facility who has not obtained a registration from the department…
§ 111656.9 When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home…
§ 111656.10 (a) The department may void the license of a home medical device retail facility, if the licensed premises remain closed, as defined in subdivision (e), other…
§ 111656.11 (a) It is unlawful for any person who is neither a licensed pharmacist nor an exemptee to take charge of a home medical device retail facility or to furnish…
§ 111656.12 (a) The fee for examination and investigation for an exemptee license under Section 111656.4 shall be one hundred dollars ($100). (b) The fee for an exemptee…
§ 111656.13 (a) Any entity that prior to July 1, 2001, held a current, valid license as a medical device retailer pursuant to Section 4130 of the Business and Professions…