(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 department. A license shall be required for each home medical device retail facility owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a home medical device retail facility in more than one location. The license shall be renewed annually and shall not be transferable. The licensee shall be responsible for assuring compliance with all requirements of this article pertaining to home medical device retail facilities.
(b) Applications for a home medical device retail facility license shall be made on a form furnished by the department. The department may require any information it deems reasonably necessary to carry out the purposes of this section.
(c) A warehouse owned by a home medical device retail facility the primary purpose of which is storage, not dispensing of home medical devices to patients, shall be licensed at a fee one-half of that for a home medical device retail facility. There shall be no separate or additional license fee for warehouse premises owned by a home medical device retail facility that are physically connected to the retail premises or that share common access.
(d) The department may, at its discretion, issue a temporary license when the ownership of a home medical device retail facility is transferred from one person to another upon any conditions and for the periods of time as the department determines to be in the public interest. A temporary license fee shall be established by the department at an amount not to exceed the annual fee for renewal of a license to conduct a home medical device retail facility.
(e) Notwithstanding any other provision of law, a licensed home medical device retail facility may furnish a prescription device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Health Services set forth in Title 22 of the California Code of Regulations.
(f) The licensure requirements of this section shall not apply to the following entities or practitioners, unless the entities or practitioners furnish home medical devices or home medical device services through a separate entity including, but not limited to, a corporate entity, division, or other business entity:
(1) Home health agencies that do not have a Part B Medicare supplier number.
(2) Hospitals, excluding providers of home medical devices that are owned or related to a hospital.
(3) Manufacturers and wholesale distributors, if not selling directly to the patient.
(4) Health care practitioners authorized to prescribe or order home medical devices or who use home medical devices or who use home medical devices to treat their patients.
(5) Licensed pharmacists and pharmacies. Pharmacies that sell or rent home medical devices shall be governed by the provisions of Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code and any rules and regulations adopted by the California State Board of Pharmacy.
(6) Licensed hospice programs.
(7) Licensed nursing homes.
(8) Licensed veterinarians.
(9) Licensed dentists.
(10) Emergency medical services provider.
(11) Breast feeding support programs.
(Amended by Stats. 2001, Ch. 728, Sec. 71. Effective January 1, 2002.)
Last modified: October 25, 2018