SECTIONS 111615-111656.13

111615.  No person shall manufacture any drug or device in thisstate unless he or she has a valid license from the department. Thelicense is valid for two calendar years from the date of issue,unless it is revoked. The license is not transferable. The department may require any manufacturer, wholesaler, orimporter of any prescription ophthalmic device in this state toobtain a license.111620.  A separate license is required for each place ofmanufacture.111625.  A license application shall be completed biennially andaccompanied by an application fee as prescribed in Section 111630.This fee is not refundable if the license is refused.111630.  The department shall by regulation establish theapplication form and set the fee for licensure and renewal of alicense. The penalty for failure to apply for renewal of a licensewithin 30 days after its expiration is ten dollars ($10) and shall beadded to the renewal fee and be paid by the applicant before therenewal license may be issued. All moneys collected as fees shall beexpended when appropriated by the Legislature in the carrying out ofthe provisions of this part and the regulations adopted pursuant tothis part. Any person licensed pursuant to this section shall immediatelynotify the department of any change in the information reported inthe license application.111635.  (a) Prior to issuing a license required by Section 111615,the department shall inspect each place of business. (b) The department shall subsequently inspect the place ofbusiness of each person licensed under Section 111615 once every twoyears. The department shall conduct these inspections to determineownership, adequacy of facilities, and personnel qualifications.Where the United States Food and Drug Administration has conducted aninspection of the place of business within the previous two years,the department shall use the information contained in the writtendocumentation pertaining to that inspection rather than conductingits own inspection pursuant to this subdivision. The department may,if necessary, inspect to obtain information not included or notsufficiently clear in the United States Food and Drug Administrationwritten documentation pertaining to the inspection and needed todetermine ownership, adequacy of facilities, personnelqualifications, and compliance with this part. (c) The department may, in lieu of all or part of any inspectionrequired under this section, use information from audits conductedpursuant to the provisions of the International StandardsOrganization (ISO) 9000 series or European (EN) 46000 series qualitysystem standards, or other information identified by the departmentby regulation.111640.  The department shall make investigations or inspectionsauthorized by Article 2 (commencing with Section 110410) of Chapter 2as it deems necessary to carry out this chapter.111645.  Any violation of any provision of this part or anyregulation adopted pursuant to this part shall be grounds for denyinga license or for suspending or revoking a license. Proceedings forthe denial, suspension, or revocation of a license shall be conductedpursuant to Section 100171.111650.  Drug manufacturers who have obtained a license or who areapplying for a license pursuant to this article shall submit to theCalifornia State Board of Pharmacy information as the Board ofPharmacy deems reasonably necessary to carry out its drugdistribution responsibilities including, but not limited to,information on drug inventories or restricted dangerous drugs.Failure of any manufacturer to report the information to the Board ofPharmacy in a timely fashion shall be grounds for the department todeny, suspend, or revoke the manufacturer's license. The California State Board of Pharmacy may adopt regulations thatare reasonably necessary to implement this section.111655.  The licensing provisions of this chapter shall not apply toany of the following: (a) Any pharmacy that maintains establishments in conformance withprovisions of the Pharmacy Law, Chapter 9 (commencing with Section4000) of Division 2 of the Business and Professions Code, regulatingthe practice of pharmacy, and that is regularly engaged in dispensingprescription drugs or devices, upon prescriptions of any personlicensed to administer the drugs or devices to patients under thecare of the person in the course of his or her professional practice,and that does not manufacture, prepare, propagate, compound, orprocess drugs or devices for sale other than in the regular course ofhis or her business of dispensing or selling drugs or devices atretail. (b) Any pharmacy that solely engages in providing drugs or devicesto a person licensed by law to administer the drug or device for hisor her use in the course of his or her professional practice. (c) Any pharmacy that solely provides drugs or devices to anotherpharmacy in order to meet a temporary inventory shortage. (d) Any person who is licensed by law to prescribe or administerdrugs or devices and who manufactures, prepares, propagates,compounds, or processes drugs or devices solely for use in the courseof his or her professional practice. (e) Any person who manufactures, prepares, propagates, compounds,or processes any drug or device solely for use in nonclinicalresearch, teaching, or chemical analysis and not for sale. (f) Any wholesaler, as defined in Section 4038 of the Business andProfessions Code. (g) Any such other class of persons as the department may byregulation exempt from the application of this article upon a findingthat licensing by a class of persons in accordance with this articleis not necessary for the protection of the public health. (h) Any registered dispensing optician licensed pursuant to theprovisions of Chapter 5.5 (commencing with Section 2550) of Division2 of the Business and Professions Code, who is regularly engaged indispensing or selling prescription lenses and frames, and not engagedin the manufacture, preparation, processing or assembling of lensesor frames for sale other than in the regular course of his or herbusiness of dispensing or selling lenses or frames at retail.111656.  (a) No person shall conduct a home medical device retailfacility business in the State of California unless he or she hasobtained a license from the department. A license shall be requiredfor each home medical device retail facility owned or operated by aspecific person. A separate license shall be required for each of thepremises of any person operating a home medical device retailfacility in more than one location. The license shall be renewedannually and shall not be transferable. The licensee shall beresponsible for assuring compliance with all requirements of thisarticle pertaining to home medical device retail facilities. (b) Applications for a home medical device retail facility licenseshall be made on a form furnished by the department. The departmentmay require any information it deems reasonably necessary to carryout the purposes of this section. (c) A warehouse owned by a home medical device retail facility theprimary purpose of which is storage, not dispensing of home medicaldevices to patients, shall be licensed at a fee one-half of that fora home medical device retail facility. There shall be no separate oradditional license fee for warehouse premises owned by a home medicaldevice retail facility that are physically connected to the retailpremises or that share common access. (d) The department may, at its discretion, issue a temporarylicense when the ownership of a home medical device retail facilityis transferred from one person to another upon any conditions and forthe periods of time as the department determines to be in the publicinterest. A temporary license fee shall be established by thedepartment at an amount not to exceed the annual fee for renewal of alicense to conduct a home medical device retail facility. (e) Notwithstanding any other provision of law, a licensed homemedical device retail facility may furnish a prescription device to alicensed health care facility for storage in a secured emergencypharmaceutical supplies container maintained within the facility inaccordance with facility regulations of the State Department ofHealth Services set forth in Title 22 of the California Code ofRegulations. (f) The licensure requirements of this section shall not apply tothe following entities or practitioners, unless the entities orpractitioners furnish home medical devices or home medical deviceservices through a separate entity including, but not limited to, acorporate entity, division, or other business entity: (1) Home health agencies that do not have a Part B Medicaresupplier number. (2) Hospitals, excluding providers of home medical devices thatare owned or related to a hospital. (3) Manufacturers and wholesale distributors, if not sellingdirectly to the patient. (4) Health care practitioners authorized to prescribe or orderhome medical devices or who use home medical devices or who use homemedical devices to treat their patients. (5) Licensed pharmacists and pharmacies. Pharmacies that sell orrent home medical devices shall be governed by the provisions ofChapter 9 (commencing with Section 4000) of Division 2 of theBusiness and Professions Code and any rules and regulations adoptedby 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.111656.1.  (a) After January 1, 2002, prior to issuing a licenserequired by Section 111656, the department shall inspect each placeof business to determine ownership, adequacy of facilities, andpersonnel qualifications. The department shall inspect each licenseeat least annually thereafter. Nothing in this section shall prohibitthe department from inspecting any medical device retail facilityprior to January 1, 2002. (b) The annual license fee for a home medical device retailfacility shall be eight hundred fifty dollars ($850) until adjustedpursuant to subdivision (c). (c) The annual license fee required by Sections 111656 and 111630shall be adjusted annually, commencing July 1, 2003, by thedepartment so that license fee revenues cover the estimated licensingprogram costs. Adjusted fee amounts shall take into account theresources required for inspections and other activities to supportlicensing during the previous year and shall take into accountprojected workload and changes in department overhead costs duringthe upcoming year. (d) Commencing July 1, 2003, the department shall by July 30 ofeach year, publish the amount of fees to be charged as adjustedpursuant to this section. This adjustment of fees shall not besubject to the requirements of Chapter 3.5 (commencing with Section11340) of Part 1 of Division 3 of Title 2 of the Government Code. (e) Commencing January 1, 2003, the department shall, on or beforeJanuary 10 of each year, provide the Legislature with a reportrecommending fee rates. The report shall describe the estimatedlicensing program costs for the next fiscal year to carry out thelicensing, regulating, inspecting, and other duties andresponsibilities of the department in carrying out the provisions ofthis article. The department shall describe the projected license feeamount so that license fee revenues cover the estimated licensingprogram costs. Projected fee amounts shall take into account theresources required for inspections and other activities to supportlicensing during the previous year and shall take into accountprojected workload and changes in department overhead costs duringthe upcoming year. (f) The Drug and Device Safety Fund is hereby created as a specialfund in the State Treasury. All moneys collected by the departmentunder this section and Sections 111656.7, 111656.8, 111656.12, and111630, and fines and penalties collected by the department in theenforcement of this article, shall be deposited in the fund for useby the department upon appropriation by the Legislature for thepurposes of providing funds necessary to carry out and implement theprovisions of this article relating to drugs and devices.111656.2.  (a) The following standards shall apply to all homemedical device retail facilities: (1) Each retail facility shall store prescription devices in amanner that does not allow a customer direct access or self-service. (2) Each retail facility shall maintain the premises, fixtures,and equipment in a clean and orderly condition. (3) Each retail facility shall maintain the premises in a dry,well-ventilated condition, free from contamination or otherconditions that may render home medical devices unfit for theirintended use. (b) The department may by regulation impose any other standardspertaining to the acquisition, storage, and maintenance ofprescription devices or other goods or to the maintenance orcondition of the licensed premises of any home medical device retailfacility as the department determines are reasonably necessary.111656.3.  (a) Each home medical device retail facility shall havewritten policies and procedures related to home medical devicehandling and, if authorized by the department pursuant to Section111656.4, the dispensing of prescription devices. Those writtenpolicies and procedures shall be adequate to assure compliance withthis article and shall include, but not be limited to: (1) Training of staff, patients, and caregivers. (2) Cleaning, storage, and maintenance of home medical devicesnecessary to prevent damage or contamination and to assure theiroperation in accordance with manufacturer specifications. (3) Emergency services. If home medical device malfunction maythreaten a patient's health, access to emergency services 24 hoursper day, 365 days per year shall be available for device maintenanceor replacement. (4) Maintaining all records required by this article and anyregulations adopted pursuant to the provisions of this article. (5) Storage and security requirements to assure that prescriptiondevices are dispensed in accordance with this article. (6) Quality assurance. (b) The home medical device retail facility shall makeconsultation available to the patient or primary caregiver about theproper use of devices and related supplies furnished by the homemedical device retail facility. The home medical device retailfacility shall notify the patient or primary care giver that thisconsultation is available. (c) Each home medical device retail facility shall ensure allpersonnel who engage in the taking of orders for, the selling of, orthe fitting of prescription devices, if authorized by the departmentpursuant to Section 111656.4, shall have training and demonstrateinitial and continuing competence in the order-taking, fitting, andsale of prescription devices that the home medical device retailfacility furnishes pursuant to Section 111656.4. (d) Each home medical device retail facility shall prepare andmaintain records of training and demonstrated employee competencerequired under this article for employees of the home medical deviceretail facility. The records shall be maintained for three years fromand after the last date of employment. (e) Each home medical device retail facility shall have anongoing, documented quality assurance program that includes, but isnot limited to, the following: (1) Monitoring personnel performance to assure compliance withthis article. (2) Storage, maintenance, and dispensing of prescription devicesto assure that prescription devices are dispensed in accordance withthis article. (f) The records and documents specified in subdivisions (a) and(e) shall be maintained for three years from the date of making. Therecords and documents described in subdivisions (a), (d), and (e),shall be open to inspection at all times during business hours byauthorized agents of the department or an inspector from theCalifornia State Board of Pharmacy for the purpose of investigating apharmacist.111656.4.  Section 4051 of the Business and Professions Code shallnot prohibit a home medical device retail facility from selling ordispensing prescription devices if the department finds thatsufficient qualified supervision is employed by the home medicaldevice retail facility to adequately safeguard and protect the publichealth. Each person applying to the department for this exemptionshall meet the following requirements to obtain and maintain theexemption: (a) A licensed pharmacist or an exemptee who meets therequirements set forth in paragraphs (1) to (5), inclusive, and whoselicense of exemption is currently valid, shall be in charge of thehome medical device retail facility. (1) He or she shall be a high school graduate or possess a generaleducation development equivalent. (2) He or she shall have a minimum of one year of paid workexperience related to the distribution or dispensing of dangerousdrugs or dangerous devices. (3) He or she shall complete a training program that addresseseach of the following subjects that are applicable to his or herduties: (A) Knowledge and understanding of state and federal laws relatingto the distribution of dangerous drugs and dangerous devices. (B) Knowledge and understanding of state and federal laws relatingthe distribution of controlled substances. (C) Knowledge and understanding of quality control systems. (D) Knowledge and understanding of the United States Pharmacopoeiastandards relating to the safe storage and handling of drugs. (E) Knowledge and understanding relating to the safe storage andhandling of home medical devices. (F) Knowledge and understanding of prescription terminology,abbreviations, and format. (4) The department may, by regulation, require training programsthat include additional material. (5) The department shall not issue an exemptee a license until theapplicant provides proof of completion of the required training thatthe department determines is adequate to fulfill these requirements. (b) The licensed pharmacist or exemptee shall be on the premisesat all times that prescription devices are available for sale orfitting unless the prescription devices are stored separately fromother merchandise and are under the exclusive control of the licensedpharmacist or exemptee. A licensed pharmacist or an exemptee neednot be present in the warehouse facility of a home medical deviceretail facility unless the department establishes that requirement byregulation based upon the need to protect the public. (c) The department may require an exemptee to complete adesignated number of hours of coursework in department-approvedcourses of home health education in the disposition of anydisciplinary action taken against the exemptee. (d) Each premises maintained by a home medical device retailfacility shall have a license issued by the department and shall havea licensed pharmacist or exemptee on the premises if prescriptiondevices are furnished, sold, or dispensed. (e) A home medical device retail facility may establish lockedstorage (a lock box or locked area) for emergency or after workinghours furnishing of prescription devices. Locked storage may beinstalled or placed in a service vehicle of the home medical deviceretail facility for emergency or after hours service to patientshaving prescriptions for prescription devices. (f) The department may by regulation authorize a licensedpharmacist or exemptee to direct an employee of the home medicaldevice retail facility who operates the service vehicle equipped withlocked storage described in subdivision (e) to deliver aprescription device from the locked storage to patients havingprescriptions for prescription devices. These regulations shallestablish inventory requirements for the locked storage by a licensedpharmacist or exemptee to take place shortly after a prescriptiondevice has been delivered from the locked storage to a patient.111656.5.  (a) A person other than a licensed pharmacist, an internpharmacist, an exemptee, as specified in Section 111656.4, or anauthorized agent of the department or a person authorized toprescribe, may not be permitted in that area, place, or premisesdescribed in the license issued by the department whereinprescription devices are stored, possessed, prepared, manufactured,or repacked, except that a licensed pharmacist or exemptee shall beresponsible for any individual who enters the medical device retailfacility for the purposes of receiving, fitting, or consultation fromthe licensed pharmacist or exemptee or any person performingclerical, inventory control, housekeeping, delivery, maintenance, orsimilar functions relating to the home medical device retailfacility. The licensed pharmacist or exemptee shall remain present inthe home medical device retail facility any time an individual ispresent who is seeking a fitting or consultation. However, a licensedpharmacist or an exemptee need not be present on the premises of ahome medical device retail facility at all times of its operation andneed not be present in a warehouse facility owned by a home medicaldevice retail facility unless the department establishes thatrequirement by regulation based upon the need to protect the public.The exemptee need not be present if the prescription devices arestored in a secure locked area under the exclusive control of theexemptee and unavailable for dispensing. This subdivision shall applyonly to prescription devices. (b) A "warehouse" as used in this section, is a facility owned bya home medical device retail facility that is used for storage only.There may not be fitting, display, or sales at that location. Alicensed pharmacist or exemptee shall be designated as "in charge" ofa warehouse but need not be present during its operation. Thelicensed pharmacist or exemptee may permit others to possess a key tothe warehouse. (c) Notwithstanding the remainder of this section, a home medicaldevice retail facility may establish a locked facility, meeting therequirements of Section 111656.4, for furnishing prescription devicesto patients having prescriptions for prescription devices inemergencies or after working hours. (d) The department may establish reasonable security measuresconsistent with this section as a condition of licensing in order toprevent unauthorized persons from gaining access to the area, place,or premises, or to the prescription devices therein. (e) The department may by regulation establish labelingrequirements for prescription devices sold, fitted, or dispensed by ahome medical device retail facility as it deems necessary for theprotection of the public.111656.6.  Home medical devices for rental purposes shall at alltimes while under the control of the home medical device retailfacility, be maintained in a clean and sanitary condition and in goodworking order following, where available, manufacturerspecifications.111656.7.  (a) Without registering as an out-of-state home medicaldevice retail facility, an out-of-state home medical device retailfacility shall not sell or distribute prescription devices in thisstate through any person or media other than a wholesaler who islicensed pursuant to Chapter 9 (commencing with Section 4000) ofDivision 2 of the Business and Professions Code. (b) Applications for an out-of-state home medical device retailfacility registration shall be made on a form furnished by thedepartment. The department may require any information it deemsreasonably necessary to carry out the purposes of this section. (c) The Legislature by enacting this section does not intend aregistration issued to any out-of-state home medical device retailfacility pursuant to this section to change or affect the taxliability imposed by Chapter 3 (commencing with Section 23501) ofPart 11 of Division 2 of the Revenue and Taxation Code on anyout-of-state home medical device retail facility. (d) The Legislature by enacting this section does not intend aregistration issued to any out-of-state home medical device retailfacility pursuant to this section to serve as any evidence that theout-of-state home medical device retail facility is doing businesswithin this state.111656.8.  (a) No person acting as principal or agent for anyout-of-state home medical device retail facility who has not obtaineda registration from the department pursuant to this article and whosells or distributes prescription devices in this state that are notobtained through a wholesaler who has obtained a license pursuant toChapter 9 (commencing with Section 4000) of Division 2 of theBusiness and Professions Code, or that are not obtained through aselling or distribution outlet of an out-of-state manufacturer thatis licensed as a wholesaler pursuant to Chapter 9 (commencing withSection 4000) of Division 2 of the Business and Professions Code,shall conduct the business of selling or distributing prescriptiondevices within this state without registering with the departmentpursuant to this article. (b) Registration of persons under this section shall be made on aform furnished by the department. The department may require anyinformation as the department deems reasonably necessary to carry outthe purposes of this section including, but not limited to, the nameand address of the registrant and the name and address of themanufacturer whose prescription devices he or she is selling ordistributing. (c) The department may deny, revoke, or suspend the registrationof persons registered under this article for any violation of thisarticle or Chapter 9 (commencing with Section 4000) of Division 2 ofthe Business and Professions Code or for any violation of Part 5(commencing with Section 109875) of Division 104. The department maydeny, revoke, or suspend the person's registration if themanufacturer whose prescription devices he or she is selling ordistributing violates this article or Chapter 9 (commencing withSection 4000) of Division 2 of the Business and Professions Code orPart 5 (commencing with Section 109875) of Division 104. (d) Registration under this section shall be renewed annually.111656.9.  When, in the opinion of the department, a high standardof patient safety, consistent with good patient care, can be providedby the licensure of a home medical device retail facility that doesnot meet all of the requirements for licensure as a home medicaldevice retail facility, the department may waive any licensingrequirements for that medical device retail facility.111656.10.  (a) The department may void the license of a homemedical device retail facility, if the licensed premises remainclosed, as defined in subdivision (e), other than by order of thedepartment. For good cause shown, the department may void a licenseafter a shorter period of closure. To void a license pursuant to thissubdivision, the department shall make a diligent, good faith effortto give notice by personal service on the licensee. If no writtenobjection is received within 10 days after personal service is madeor a diligent, good faith effort to give notice by personal serviceon the licensee has failed, the department may void the licensewithout the necessity of a hearing. If the licensee files a writtenobjection, the department shall file an accusation based on thelicensee remaining closed. Proceedings shall be conducted inaccordance with Chapter 5 (commencing with Section 11500) of Part 1of Division 3 of Title 2 of the Government Code, and the departmentshall have all the powers granted in that chapter. (b) In the event that the license of a home medical device retailfacility is voided pursuant to subdivision (a) or revoked or a homemedical device retail facility notifies the department of its intentto remain closed or to discontinue business, the licensee shall,within 10 days thereafter, arrange for the transfer of allprescription devices to another licensee authorized to possess theprescription devices. The licensee transferring the prescriptiondevices shall immediately confirm in writing to the department thatthe transfer has taken place. (c) If a home medical device retail facility fails to comply withsubdivision (b), the department may seek and obtain an order from thesuperior court in the county in which the home medical device retailfacility is located, authorizing the department to enter the homemedical device retail facility and inventory and store, transfer,sell, or arrange for the sale of, prescription devices found in thehome medical device retail facility. (d) In the event that the department sells or arranges for thesale of any prescription devices pursuant to subdivision (c), thedepartment may retain from the proceeds of the sale an amount equalto the cost to the department of obtaining and enforcing an orderissued pursuant to subdivision (c), including the cost of disposingof the prescription devices. The remaining proceeds, if any, shall bereturned to the licensee from whose premises the prescriptiondevices were removed. (1) The licensee shall be notified of his or her right to theremaining proceeds by personal service or by certified mail, postageprepaid. (2) Where a statute or regulation requires the licensee to filewith the department his or her address, and any change of address,the notice required by this subdivision may be sent by certifiedmail, postage prepaid, to the latest address on file with thedepartment, and service of notice in this manner shall be deemedcompleted on the 10th day after the mailing. (3) If the licensee is notified as provided in this subdivision,and the licensee fails to contact the department for the remainingproceeds within 30 calendar days after the personal service has beenmade or service by certified mail, postage prepaid, is deemedcompleted, the remaining proceeds shall be deposited by thedepartment into the Drug and Device Safety Fund. These deposits shallbe deemed to have been received pursuant to Chapter 7 (commencingwith Section 1500) of Title 10 of Part 3 of the Code of CivilProcedure and shall be subject to claim or other disposition asprovided in that chapter. (e) For the purposes of this section, "closed" means not engagedin the ordinary activity for which a license has been issued for atleast one day each calendar week during any 120-day period. (f) Nothing in this section shall be construed as requiring a homemedical device retail facility to be open seven days a week.111656.11.  (a) It is unlawful for any person who is neither alicensed pharmacist nor an exemptee to take charge of a home medicaldevice retail facility or to furnish prescription devices except asotherwise provided in this article. (b) It is unlawful for any person who has obtained a license toconduct a home medical device retail facility to fail to place alicensed pharmacist or exemptee in charge of that home medical deviceretail facility or for any person to, by himself or herself, or byany other person, permit the compounding or dispensing ofprescriptions, except by a licensed pharmacist or exemptee or asotherwise provided in this article.111656.12.  (a) The fee for examination and investigation for anexemptee license under Section 111656.4 shall be one hundred dollars($100). (b) The fee for an exemptee license and annual renewal underSection 111656.4 shall be one hundred fifty dollars ($150). (c) The fee for registration as an out-of-state home medicaldevice retail facility or as the principal or agent of anout-of-state home medical device retail facility shall be one hundredfifty dollars ($150).111656.13.  (a) Any entity that prior to July 1, 2001, held acurrent, valid license as a medical device retailer pursuant toSection 4130 of the Business and Professions Code, shall be deemed tobe a licensed home medical device retail facility until theexpiration of that license if the entity is in compliance with allapplicable criteria for obtaining a license as a home medical deviceretail facility. (b) Any entity that was not required to obtain a license as amedical device retailer in order to provide equipment or servicesprior to July 1, 2001, and that is required to obtain a license as ahome medical device retail facility pursuant to Section 111656, shallapply for a license as a home medical device retail facility by July1, 2001; however, the requirement for licensure shall only apply tothose entities on and after January 1, 2002.