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Article 6. Licenses of California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 6.
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 years from the date of issue,
unless it is revoked. The license is not transferable.
The department may require any manufacturer, wholesaler, or
importer of any prescription ophthalmic device in this state to
obtain a license.
A separate license is required for each place of
manufacture.
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 license is refused.
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 renewal of a license
within 30 days after its expiration is ten dollars ($10) and shall be
added to the renewal fee and be paid by the applicant before the
renewal license may be issued. All moneys collected as fees shall be
expended when appropriated by the Legislature in the carrying out of
the provisions of this part and the regulations adopted pursuant to
this part.
Any person licensed pursuant to this section shall immediately
notify the department of any change in the information reported in
the license application.
(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 each place of business documentation
that evidences ownership and any of the following:
(1) The place of business is operating pursuant to a valid biologics license issued by the United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(2) The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the attestation.
(3) The place of business is operating in compliance with audits conducted pursuant to the International Standards Organization (ISO) 9000 series, ISO 13485:2003 quality management systems standards, ISO 15378:2006 quality management systems standards, pursuant to Parts 210 and 211 of Title 21 of the Code of Federal Regulations, or pursuant to Part 820 of Title 21 of the Code of Federal Regulations.
(4) The place of business is operating pursuant to an approved investigational new drug issued by the federal Food and Drug Administration pursuant to Section 312.20 of Title 21 of the Code of Federal Regulations or pursuant to an approved investigational device exemption issued by the federal Food and Drug Administration pursuant to Section 812.20 of Title 21 of the Code of Federal Regulations.
(b) If the department receives documentation that satisfies the requirements of subdivision (a), the department shall not inspect the place of business prior to issuing a license required by Section 111615. If the department does not receive the documentation required, the department shall inspect the place of business prior to issuing a license required by Section 111615.
(c) Upon request by a place of business licensed under Section 111615, the department shall provide an official copy of the valid license to the place of business in accordance with Sections 110230 and 110235.
(d) Notwithstanding Section 111640, for any place of business where a drug or device is manufactured and the manufacturer has received a license pursuant to this section, the department shall make investigations or inspections authorized by Article 2 (commencing with Section 110140) of Chapter 2 only when any of the following occur:
(1) The department becomes aware of an issue and makes a determination that the health and safety of the public is at risk.
(2) A complaint has been registered with the department and the department makes a determination that the health and safety of the public is at risk.
(3) A notification has been sent by the United States Food and Drug Administration to the department that requests assistance regarding any Class I or II recall action memorandum.
(4) The United States Food and Drug Administration has requested assistance for enforcement activities, including, but not limited to, embargoes, seizures, or injunctions.
(e) Inspections made pursuant to subdivision (d) shall be limited to inspections for compliance with, or violations of, Chapter 4 (commencing with Section 110290) or this chapter.
(1) The place of business is operating pursuant to a valid biologics license issued by the United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(2) The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the attestation.
(3) The place of business is operating in compliance with audits conducted pursuant to the International Standards Organization (ISO) 9000 series, ISO 13485:2003 quality management systems standards, ISO 15378:2006 quality management systems standards, pursuant to Parts 210 and 211 of Title 21 of the Code of Federal Regulations, or pursuant to Part 820 of Title 21 of the Code of Federal Regulations.
(4) The place of business is operating pursuant to an approved investigational new drug issued by the federal Food and Drug Administration pursuant to Section 312.20 of Title 21 of the Code of Federal Regulations or pursuant to an approved investigational device exemption issued by the federal Food and Drug Administration pursuant to Section 812.20 of Title 21 of the Code of Federal Regulations.
(b) If the department receives documentation that satisfies the requirements of subdivision (a), the department shall not inspect the place of business prior to issuing a license required by Section 111615. If the department does not receive the documentation required, the department shall inspect the place of business prior to issuing a license required by Section 111615.
(c) Upon request by a place of business licensed under Section 111615, the department shall provide an official copy of the valid license to the place of business in accordance with Sections 110230 and 110235.
(d) Notwithstanding Section 111640, for any place of business where a drug or device is manufactured and the manufacturer has received a license pursuant to this section, the department shall make investigations or inspections authorized by Article 2 (commencing with Section 110140) of Chapter 2 only when any of the following occur:
(1) The department becomes aware of an issue and makes a determination that the health and safety of the public is at risk.
(2) A complaint has been registered with the department and the department makes a determination that the health and safety of the public is at risk.
(3) A notification has been sent by the United States Food and Drug Administration to the department that requests assistance regarding any Class I or II recall action memorandum.
(4) The United States Food and Drug Administration has requested assistance for enforcement activities, including, but not limited to, embargoes, seizures, or injunctions.
(e) Inspections made pursuant to subdivision (d) shall be limited to inspections for compliance with, or violations of, Chapter 4 (commencing with Section 110290) or this chapter.
The department shall make investigations or inspections
authorized by Article 2 (commencing with Section 110410) of Chapter 2
as it deems necessary to carry out this chapter.
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 revoking a license. Proceedings for
the denial, suspension, or revocation of a license shall be conducted
pursuant to Section 100171.
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 Pharmacy information as the Board of
Pharmacy deems reasonably necessary to carry out its drug
distribution 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 of
Pharmacy in a timely fashion shall be grounds for the department to
deny, suspend, or revoke the manufacturer's license.
The California State Board of Pharmacy may adopt regulations that
are reasonably necessary to implement this section.
The licensing provisions of this chapter shall not apply to
any of the following:
(a) Any pharmacy that maintains establishments in conformance with provisions of the Pharmacy Law, Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, regulating the practice of pharmacy, and that is regularly engaged in dispensing prescription drugs or devices, upon prescriptions of any person licensed to administer the drugs or devices to patients under the care of the person in the course of his or her professional practice, and that does not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of his or her business of dispensing or selling drugs or devices at retail.
(b) Any pharmacy that solely engages in providing drugs or devices to a person licensed by law to administer the drug or device for his or her use in the course of his or her professional practice.
(c) Any pharmacy that solely provides drugs or devices to another pharmacy in order to meet a temporary inventory shortage.
(d) Any person who is licensed by law to prescribe or administer drugs or devices and who manufactures, prepares, propagates, compounds, or processes drugs or devices solely for use in the course of his or her professional practice.
(e) Any person who manufactures, prepares, propagates, compounds, or processes any drug or device solely for use in nonclinical research, teaching, or chemical analysis and not for sale.
(f) Any wholesaler, as defined in Section 4038 of the Business and Professions Code.
(g) Any such other class of persons as the department may by regulation exempt from the application of this article upon a finding that licensing by a class of persons in accordance with this article is not necessary for the protection of the public health.
(h) Any registered dispensing optician licensed pursuant to the provisions of Chapter 5.5 (commencing with Section 2550) of Division 2 of the Business and Professions Code, who is regularly engaged in dispensing or selling prescription lenses and frames, and not engaged in the manufacture, preparation, processing or assembling of lenses or frames for sale other than in the regular course of his or her business of dispensing or selling lenses or frames at retail.
(a) Any pharmacy that maintains establishments in conformance with provisions of the Pharmacy Law, Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code, regulating the practice of pharmacy, and that is regularly engaged in dispensing prescription drugs or devices, upon prescriptions of any person licensed to administer the drugs or devices to patients under the care of the person in the course of his or her professional practice, and that does not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of his or her business of dispensing or selling drugs or devices at retail.
(b) Any pharmacy that solely engages in providing drugs or devices to a person licensed by law to administer the drug or device for his or her use in the course of his or her professional practice.
(c) Any pharmacy that solely provides drugs or devices to another pharmacy in order to meet a temporary inventory shortage.
(d) Any person who is licensed by law to prescribe or administer drugs or devices and who manufactures, prepares, propagates, compounds, or processes drugs or devices solely for use in the course of his or her professional practice.
(e) Any person who manufactures, prepares, propagates, compounds, or processes any drug or device solely for use in nonclinical research, teaching, or chemical analysis and not for sale.
(f) Any wholesaler, as defined in Section 4038 of the Business and Professions Code.
(g) Any such other class of persons as the department may by regulation exempt from the application of this article upon a finding that licensing by a class of persons in accordance with this article is not necessary for the protection of the public health.
(h) Any registered dispensing optician licensed pursuant to the provisions of Chapter 5.5 (commencing with Section 2550) of Division 2 of the Business and Professions Code, who is regularly engaged in dispensing or selling prescription lenses and frames, and not engaged in the manufacture, preparation, processing or assembling of lenses or frames for sale other than in the regular course of his or her business of dispensing or selling lenses or frames at retail.
(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.
(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.
(a) After January 1, 2002, prior to issuing a license
required by Section 111656, the department shall inspect each place
of business to determine ownership, adequacy of facilities, and
personnel qualifications. The department shall inspect each licensee
at least annually thereafter. Nothing in this section shall prohibit
the department from inspecting any medical device retail facility
prior to January 1, 2002.
(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).
(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).
(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
(a) The following standards shall apply to all home
medical device retail facilities:
(1) Each retail facility shall store prescription devices in a manner 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 other conditions that may render home medical devices unfit for their intended use.
(b) The department may by regulation impose any other standards pertaining to the acquisition, storage, and maintenance of prescription devices or other goods or to the maintenance or condition of the licensed premises of any home medical device retail facility as the department determines are reasonably necessary.
(1) Each retail facility shall store prescription devices in a manner 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 other conditions that may render home medical devices unfit for their intended use.
(b) The department may by regulation impose any other standards pertaining to the acquisition, storage, and maintenance of prescription devices or other goods or to the maintenance or condition of the licensed premises of any home medical device retail facility as the department determines are reasonably necessary.
(a) Each home medical device retail facility shall have
written policies and procedures related to home medical device
handling and, if authorized by the department pursuant to Section
111656.4, the dispensing of prescription devices. Those written
policies and procedures shall be adequate to assure compliance with
this article and shall include, but not be limited to:
(1) Training of staff, patients, and caregivers.
(2) Cleaning, storage, and maintenance of home medical devices necessary to prevent damage or contamination and to assure their operation in accordance with manufacturer specifications.
(3) Emergency services. If home medical device malfunction may threaten a patient's health, access to emergency services 24 hours per day, 365 days per year shall be available for device maintenance or replacement.
(4) Maintaining all records required by this article and any regulations adopted pursuant to the provisions of this article.
(5) Storage and security requirements to assure that prescription devices are dispensed in accordance with this article.
(6) Quality assurance.
(b) The home medical device retail facility shall make consultation available to the patient or primary caregiver about the proper use of devices and related supplies furnished by the home medical device retail facility. The home medical device retail facility shall notify the patient or primary care giver that this consultation is available.
(c) Each home medical device retail facility shall ensure all personnel who engage in the taking of orders for, the selling of, or the fitting of prescription devices, if authorized by the department pursuant to Section 111656.4, shall have training and demonstrate initial and continuing competence in the order-taking, fitting, and sale of prescription devices that the home medical device retail facility furnishes pursuant to Section 111656.4.
(d) Each home medical device retail facility shall prepare and maintain records of training and demonstrated employee competence required under this article for employees of the home medical device retail facility. The records shall be maintained for three years from and after the last date of employment.
(e) Each home medical device retail facility shall have an ongoing, documented quality assurance program that includes, but is not limited to, the following:
(1) Monitoring personnel performance to assure compliance with this article.
(2) Storage, maintenance, and dispensing of prescription devices to assure that prescription devices are dispensed in accordance with this article.
(f) The records and documents specified in subdivisions (a) and (e) shall be maintained for three years from the date of making. The records and documents described in subdivisions (a), (d), and (e), shall be open to inspection at all times during business hours by authorized agents of the department or an inspector from the California State Board of Pharmacy for the purpose of investigating a pharmacist.
(1) Training of staff, patients, and caregivers.
(2) Cleaning, storage, and maintenance of home medical devices necessary to prevent damage or contamination and to assure their operation in accordance with manufacturer specifications.
(3) Emergency services. If home medical device malfunction may threaten a patient's health, access to emergency services 24 hours per day, 365 days per year shall be available for device maintenance or replacement.
(4) Maintaining all records required by this article and any regulations adopted pursuant to the provisions of this article.
(5) Storage and security requirements to assure that prescription devices are dispensed in accordance with this article.
(6) Quality assurance.
(b) The home medical device retail facility shall make consultation available to the patient or primary caregiver about the proper use of devices and related supplies furnished by the home medical device retail facility. The home medical device retail facility shall notify the patient or primary care giver that this consultation is available.
(c) Each home medical device retail facility shall ensure all personnel who engage in the taking of orders for, the selling of, or the fitting of prescription devices, if authorized by the department pursuant to Section 111656.4, shall have training and demonstrate initial and continuing competence in the order-taking, fitting, and sale of prescription devices that the home medical device retail facility furnishes pursuant to Section 111656.4.
(d) Each home medical device retail facility shall prepare and maintain records of training and demonstrated employee competence required under this article for employees of the home medical device retail facility. The records shall be maintained for three years from and after the last date of employment.
(e) Each home medical device retail facility shall have an ongoing, documented quality assurance program that includes, but is not limited to, the following:
(1) Monitoring personnel performance to assure compliance with this article.
(2) Storage, maintenance, and dispensing of prescription devices to assure that prescription devices are dispensed in accordance with this article.
(f) The records and documents specified in subdivisions (a) and (e) shall be maintained for three years from the date of making. The records and documents described in subdivisions (a), (d), and (e), shall be open to inspection at all times during business hours by authorized agents of the department or an inspector from the California State Board of Pharmacy for the purpose of investigating a pharmacist.
Section 4051 of the Business and Professions Code shall
not prohibit a home medical device retail facility from selling or
dispensing prescription devices if the department finds that
sufficient qualified supervision is employed by the home medical
device retail facility to adequately safeguard and protect the public
health. Each person applying to the department for this exemption
shall meet the following requirements to obtain and maintain the
exemption:
(a) A licensed pharmacist or an exemptee who meets the requirements set forth in paragraphs (1) to (5), inclusive, and whose license of exemption is currently valid, shall be in charge of the home medical device retail facility.
(1) He or she shall be a high school graduate or possess a general education development equivalent.
(2) He or she shall have a minimum of one year of paid work experience related to the distribution or dispensing of dangerous drugs or dangerous devices.
(3) He or she shall complete a training program that addresses each of the following subjects that are applicable to his or her duties:
(A) Knowledge and understanding of state and federal laws relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of state and federal laws relating the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding relating to the safe storage and handling of home medical devices.
(F) Knowledge and understanding of prescription terminology, abbreviations, and format.
(4) The department may, by regulation, require training programs that include additional material.
(5) The department shall not issue an exemptee a license until the applicant provides proof of completion of the required training that the department determines is adequate to fulfill these requirements.
(b) The licensed pharmacist or exemptee shall be on the premises at all times that prescription devices are available for sale or fitting unless the prescription devices are stored separately from other merchandise and are under the exclusive control of the licensed pharmacist or exemptee. A licensed pharmacist or an exemptee need not be present in the warehouse facility of a home medical device retail facility unless the department establishes that requirement by regulation based upon the need to protect the public.
(c) The department may require an exemptee to complete a designated number of hours of coursework in department-approved courses of home health education in the disposition of any disciplinary action taken against the exemptee.
(d) Each premises maintained by a home medical device retail facility shall have a license issued by the department and shall have a licensed pharmacist or exemptee on the premises if prescription devices are furnished, sold, or dispensed.
(e) A home medical device retail facility may establish locked storage (a lock box or locked area) for emergency or after working hours furnishing of prescription devices. Locked storage may be installed or placed in a service vehicle of the home medical device retail facility for emergency or after hours service to patients having prescriptions for prescription devices.
(f) The department may by regulation authorize a licensed pharmacist or exemptee to direct an employee of the home medical device retail facility who operates the service vehicle equipped with locked storage described in subdivision (e) to deliver a prescription device from the locked storage to patients having prescriptions for prescription devices. These regulations shall establish inventory requirements for the locked storage by a licensed pharmacist or exemptee to take place shortly after a prescription device has been delivered from the locked storage to a patient.
(a) A licensed pharmacist or an exemptee who meets the requirements set forth in paragraphs (1) to (5), inclusive, and whose license of exemption is currently valid, shall be in charge of the home medical device retail facility.
(1) He or she shall be a high school graduate or possess a general education development equivalent.
(2) He or she shall have a minimum of one year of paid work experience related to the distribution or dispensing of dangerous drugs or dangerous devices.
(3) He or she shall complete a training program that addresses each of the following subjects that are applicable to his or her duties:
(A) Knowledge and understanding of state and federal laws relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of state and federal laws relating the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding relating to the safe storage and handling of home medical devices.
(F) Knowledge and understanding of prescription terminology, abbreviations, and format.
(4) The department may, by regulation, require training programs that include additional material.
(5) The department shall not issue an exemptee a license until the applicant provides proof of completion of the required training that the department determines is adequate to fulfill these requirements.
(b) The licensed pharmacist or exemptee shall be on the premises at all times that prescription devices are available for sale or fitting unless the prescription devices are stored separately from other merchandise and are under the exclusive control of the licensed pharmacist or exemptee. A licensed pharmacist or an exemptee need not be present in the warehouse facility of a home medical device retail facility unless the department establishes that requirement by regulation based upon the need to protect the public.
(c) The department may require an exemptee to complete a designated number of hours of coursework in department-approved courses of home health education in the disposition of any disciplinary action taken against the exemptee.
(d) Each premises maintained by a home medical device retail facility shall have a license issued by the department and shall have a licensed pharmacist or exemptee on the premises if prescription devices are furnished, sold, or dispensed.
(e) A home medical device retail facility may establish locked storage (a lock box or locked area) for emergency or after working hours furnishing of prescription devices. Locked storage may be installed or placed in a service vehicle of the home medical device retail facility for emergency or after hours service to patients having prescriptions for prescription devices.
(f) The department may by regulation authorize a licensed pharmacist or exemptee to direct an employee of the home medical device retail facility who operates the service vehicle equipped with locked storage described in subdivision (e) to deliver a prescription device from the locked storage to patients having prescriptions for prescription devices. These regulations shall establish inventory requirements for the locked storage by a licensed pharmacist or exemptee to take place shortly after a prescription device has been delivered from the locked storage to a patient.
(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 a person authorized to
prescribe, may not be permitted in that area, place, or premises
described in the license issued by the department wherein
prescription devices are stored, possessed, prepared, manufactured,
or repacked, except that a licensed pharmacist or exemptee shall be
responsible for any individual who enters the medical device retail
facility for the purposes of receiving, fitting, or consultation from
the licensed pharmacist or exemptee or any person performing
clerical, inventory control, housekeeping, delivery, maintenance, or
similar functions relating to the home medical device retail
facility. The licensed pharmacist or exemptee shall remain present in
the home medical device retail facility any time an individual is
present who is seeking a fitting or consultation. However, a licensed
pharmacist or an exemptee need not be present on the premises of a
home medical device retail facility at all times of its operation and
need not be present in a warehouse facility owned by a home medical
device retail facility unless the department establishes that
requirement by regulation based upon the need to protect the public.
The exemptee need not be present if the prescription devices are
stored in a secure locked area under the exclusive control of the
exemptee and unavailable for dispensing. This subdivision shall apply
only to prescription devices.
(b) A "warehouse" as used in this section, is a facility owned by a home medical device retail facility that is used for storage only. There may not be fitting, display, or sales at that location. A licensed pharmacist or exemptee shall be designated as "in charge" of a warehouse but need not be present during its operation. The licensed pharmacist or exemptee may permit others to possess a key to the warehouse.
(c) Notwithstanding the remainder of this section, a home medical device retail facility may establish a locked facility, meeting the requirements of Section 111656.4, for furnishing prescription devices to patients having prescriptions for prescription devices in emergencies or after working hours.
(d) The department may establish reasonable security measures consistent with this section as a condition of licensing in order to prevent unauthorized persons from gaining access to the area, place, or premises, or to the prescription devices therein.
(e) The department may by regulation establish labeling requirements for prescription devices sold, fitted, or dispensed by a home medical device retail facility as it deems necessary for the protection of the public.
(b) A "warehouse" as used in this section, is a facility owned by a home medical device retail facility that is used for storage only. There may not be fitting, display, or sales at that location. A licensed pharmacist or exemptee shall be designated as "in charge" of a warehouse but need not be present during its operation. The licensed pharmacist or exemptee may permit others to possess a key to the warehouse.
(c) Notwithstanding the remainder of this section, a home medical device retail facility may establish a locked facility, meeting the requirements of Section 111656.4, for furnishing prescription devices to patients having prescriptions for prescription devices in emergencies or after working hours.
(d) The department may establish reasonable security measures consistent with this section as a condition of licensing in order to prevent unauthorized persons from gaining access to the area, place, or premises, or to the prescription devices therein.
(e) The department may by regulation establish labeling requirements for prescription devices sold, fitted, or dispensed by a home medical device retail facility as it deems necessary for the protection of the public.
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 sanitary condition and in good
working order following, where available, manufacturer
specifications.
(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 distribute prescription devices in this
state through any person or media other than a wholesaler who is
licensed pursuant to Chapter 9 (commencing with Section 4000) of
Division 2 of the Business and Professions Code.
(b) Applications for an out-of-state home medical device retail facility registration 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) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility pursuant to this section to change or affect the tax liability imposed by Chapter 3 (commencing with Section 23501) of Part 11 of Division 2 of the Revenue and Taxation Code on any out-of-state home medical device retail facility.
(d) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility pursuant to this section to serve as any evidence that the out-of-state home medical device retail facility is doing business within this state.
(b) Applications for an out-of-state home medical device retail facility registration 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) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility pursuant to this section to change or affect the tax liability imposed by Chapter 3 (commencing with Section 23501) of Part 11 of Division 2 of the Revenue and Taxation Code on any out-of-state home medical device retail facility.
(d) The Legislature by enacting this section does not intend a registration issued to any out-of-state home medical device retail facility pursuant to this section to serve as any evidence that the out-of-state home medical device retail facility is doing business within this state.
(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 pursuant to this article and who
sells or distributes prescription devices in this state that are not
obtained through a wholesaler who has obtained a license pursuant to
Chapter 9 (commencing with Section 4000) of Division 2 of the
Business and Professions Code, or that are not obtained through a
selling or distribution outlet of an out-of-state manufacturer that
is licensed as a wholesaler pursuant to Chapter 9 (commencing with
Section 4000) of Division 2 of the Business and Professions Code,
shall conduct the business of selling or distributing prescription
devices within this state without registering with the department
pursuant to this article.
(b) Registration of persons under this section shall be made on a form furnished by the department. The department may require any information as the department deems reasonably necessary to carry out the purposes of this section including, but not limited to, the name and address of the registrant and the name and address of the manufacturer whose prescription devices he or she is selling or distributing.
(c) The department may deny, revoke, or suspend the registration of persons registered under this article for any violation of this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or for any violation of Part 5 (commencing with Section 109875) of Division 104. The department may deny, revoke, or suspend the person's registration if the manufacturer whose prescription devices he or she is selling or distributing violates this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or Part 5 (commencing with Section 109875) of Division 104.
(d) Registration under this section shall be renewed annually.
(b) Registration of persons under this section shall be made on a form furnished by the department. The department may require any information as the department deems reasonably necessary to carry out the purposes of this section including, but not limited to, the name and address of the registrant and the name and address of the manufacturer whose prescription devices he or she is selling or distributing.
(c) The department may deny, revoke, or suspend the registration of persons registered under this article for any violation of this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or for any violation of Part 5 (commencing with Section 109875) of Division 104. The department may deny, revoke, or suspend the person's registration if the manufacturer whose prescription devices he or she is selling or distributing violates this article or Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code or Part 5 (commencing with Section 109875) of Division 104.
(d) Registration under this section shall be renewed annually.
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 medical device retail facility that does
not meet all of the requirements for licensure as a home medical
device retail facility, the department may waive any licensing
requirements for that medical device retail facility.
(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 than by order of the
department. For good cause shown, the department may void a license
after a shorter period of closure. To void a license pursuant to this
subdivision, the department shall make a diligent, good faith effort
to give notice by personal service on the licensee. If no written
objection is received within 10 days after personal service is made
or a diligent, good faith effort to give notice by personal service
on the licensee has failed, the department may void the license
without the necessity of a hearing. If the licensee files a written
objection, the department shall file an accusation based on the
licensee remaining closed. Proceedings shall be conducted in
accordance with Chapter 5 (commencing with Section 11500) of Part 1
of Division 3 of Title 2 of the Government Code, and the department
shall have all the powers granted in that chapter.
(b) In the event that the license of a home medical device retail facility is voided pursuant to subdivision (a) or revoked or a home medical device retail facility notifies the department of its intent to remain closed or to discontinue business, the licensee shall, within 10 days thereafter, arrange for the transfer of all prescription devices to another licensee authorized to possess the prescription devices. The licensee transferring the prescription devices shall immediately confirm in writing to the department that the transfer has taken place.
(c) If a home medical device retail facility fails to comply with subdivision (b), the department may seek and obtain an order from the superior court in the county in which the home medical device retail facility is located, authorizing the department to enter the home medical device retail facility and inventory and store, transfer, sell, or arrange for the sale of, prescription devices found in the home medical device retail facility.
(d) In the event that the department sells or arranges for the sale of any prescription devices pursuant to subdivision (c), the department may retain from the proceeds of the sale an amount equal to the cost to the department of obtaining and enforcing an order issued pursuant to subdivision (c), including the cost of disposing of the prescription devices. The remaining proceeds, if any, shall be returned to the licensee from whose premises the prescription devices were removed.
(1) The licensee shall be notified of his or her right to the remaining proceeds by personal service or by certified mail, postage prepaid.
(2) Where a statute or regulation requires the licensee to file with the department his or her address, and any change of address, the notice required by this subdivision may be sent by certified mail, postage prepaid, to the latest address on file with the department, and service of notice in this manner shall be deemed completed 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 remaining proceeds within 30 calendar days after the personal service has been made or service by certified mail, postage prepaid, is deemed completed, the remaining proceeds shall be deposited by the department into the Drug and Device Safety Fund. These deposits shall be deemed to have been received pursuant to Chapter 7 (commencing with Section 1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall be subject to claim or other disposition as provided in that chapter.
(e) For the purposes of this section, "closed" means not engaged in the ordinary activity for which a license has been issued for at least one day each calendar week during any 120-day period.
(f) Nothing in this section shall be construed as requiring a home medical device retail facility to be open seven days a week.
(b) In the event that the license of a home medical device retail facility is voided pursuant to subdivision (a) or revoked or a home medical device retail facility notifies the department of its intent to remain closed or to discontinue business, the licensee shall, within 10 days thereafter, arrange for the transfer of all prescription devices to another licensee authorized to possess the prescription devices. The licensee transferring the prescription devices shall immediately confirm in writing to the department that the transfer has taken place.
(c) If a home medical device retail facility fails to comply with subdivision (b), the department may seek and obtain an order from the superior court in the county in which the home medical device retail facility is located, authorizing the department to enter the home medical device retail facility and inventory and store, transfer, sell, or arrange for the sale of, prescription devices found in the home medical device retail facility.
(d) In the event that the department sells or arranges for the sale of any prescription devices pursuant to subdivision (c), the department may retain from the proceeds of the sale an amount equal to the cost to the department of obtaining and enforcing an order issued pursuant to subdivision (c), including the cost of disposing of the prescription devices. The remaining proceeds, if any, shall be returned to the licensee from whose premises the prescription devices were removed.
(1) The licensee shall be notified of his or her right to the remaining proceeds by personal service or by certified mail, postage prepaid.
(2) Where a statute or regulation requires the licensee to file with the department his or her address, and any change of address, the notice required by this subdivision may be sent by certified mail, postage prepaid, to the latest address on file with the department, and service of notice in this manner shall be deemed completed 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 remaining proceeds within 30 calendar days after the personal service has been made or service by certified mail, postage prepaid, is deemed completed, the remaining proceeds shall be deposited by the department into the Drug and Device Safety Fund. These deposits shall be deemed to have been received pursuant to Chapter 7 (commencing with Section 1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall be subject to claim or other disposition as provided in that chapter.
(e) For the purposes of this section, "closed" means not engaged in the ordinary activity for which a license has been issued for at least one day each calendar week during any 120-day period.
(f) Nothing in this section shall be construed as requiring a home medical device retail facility to be open seven days a week.
(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 prescription devices except as
otherwise provided in this article.
(b) It is unlawful for any person who has obtained a license to conduct a home medical device retail facility to fail to place a licensed pharmacist or exemptee in charge of that home medical device retail facility or for any person to, by himself or herself, or by any other person, permit the compounding or dispensing of prescriptions, except by a licensed pharmacist or exemptee or as otherwise provided in this article.
(b) It is unlawful for any person who has obtained a license to conduct a home medical device retail facility to fail to place a licensed pharmacist or exemptee in charge of that home medical device retail facility or for any person to, by himself or herself, or by any other person, permit the compounding or dispensing of prescriptions, except by a licensed pharmacist or exemptee or as otherwise provided in this article.
(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 license and annual renewal under Section 111656.4 shall be one hundred fifty dollars ($150).
(c) The fee for registration as an out-of-state home medical device retail facility or as the principal or agent of an out-of-state home medical device retail facility shall be one hundred fifty dollars ($150).
(b) The fee for an exemptee license and annual renewal under Section 111656.4 shall be one hundred fifty dollars ($150).
(c) The fee for registration as an out-of-state home medical device retail facility or as the principal or agent of an out-of-state home medical device retail facility shall be one hundred fifty dollars ($150).
(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 Code, shall be deemed to
be a licensed home medical device retail facility until the
expiration of that license if the entity is in compliance with all
applicable criteria for obtaining a license as a home medical device
retail facility.
(b) Any entity that was not required to obtain a license as a medical device retailer in order to provide equipment or services prior to July 1, 2001, and that is required to obtain a license as a home medical device retail facility pursuant to Section 111656, shall apply for a license as a home medical device retail facility by July 1, 2001; however, the requirement for licensure shall only apply to those entities on and after January 1, 2002.
(b) Any entity that was not required to obtain a license as a medical device retailer in order to provide equipment or services prior to July 1, 2001, and that is required to obtain a license as a home medical device retail facility pursuant to Section 111656, shall apply for a license as a home medical device retail facility by July 1, 2001; however, the requirement for licensure shall only apply to those entities on and after January 1, 2002.
