reglab/statecodes huggingface dataset:
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111550.

111550. No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following:
(a) It is one of the following:
(1) A new drug, and a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355).
(2) A new biologic product for which a license has been issued as required by the federal Public Health Service Act (42 U.S.C. Sec. 262).
(3) A device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)), or is a device exempted pursuant to subsection (l) or (m) of Section 360 of Title 21 of the United States Code, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
(b) The department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended. Any person who files a new drug or device application with the department shall submit, as part of the application, all of the following information:
(1) Full reports of investigations that have been made to show whether or not the new drug or device is safe for use and whether the new drug or device is effective in use under the conditions prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(2) A full list of the articles used as components of the new drug or device.
(3) A full statement of the composition of the new drug or device.
(4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug, or in the case of a new device, a full statement of its composition, properties, and construction, and the principles of its operation.
(5) Samples of the new drug or device and of the articles used as components of the drug or device as the department may require.
(6) Specimens of the labeling and advertisements proposed to be used for the new drug or device.
(Amended by Stats. 2012, Ch. 688, Sec. 1. (AB 1277) Effective January 1, 2013.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111555.

111555. Within 180 days after the filing of an application provided for in Section 111550, or an additional period as shall be agreed upon by the department and the applicant, the department shall do either of the following:
(a)  Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply.
(b)  Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department’s order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111560.

111560. The department shall issue an order refusing to approve an application if, after written notice to the applicant and after giving him or her an opportunity for a hearing, the department makes any of the following findings:
(a)  That the reports of investigation, that are required to be submitted to the department pursuant to Section 111550, do not include adequate tests by all methods reasonably applicable to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device.
(b)  That the results of the tests submitted pursuant to Section 111550 to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device show that the drug or device is unsafe for use under these conditions or do not show that the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(c)  That the methods, facilities, and controls used in the manufacture, processing, or packing of the new drug or device are inadequate to preserve its identity, strength, quality, purity, composition, or other characteristics.
(d)  That upon the basis of information submitted as part of the application, or upon the basis of any other information before it with respect to the new drug or device, that the department has insufficient information to determine whether the drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(e)  That evaluated on the basis of the information submitted as part of the application and any other information before it with respect to the new drug or device, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertisement of the new drug or device.
(f)  That based on an evaluation by the department of all material facts, that the proposed labeling or advertising of the new drug or device is false or misleading in any particular.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111565.

111565. An order pursuant to Section 111560 refusing approval of a new drug application or a new device application shall be revoked whenever the department finds that the facts justify the action.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111570.

111570. In the case of any new drug or device for which an approval of an application filed pursuant to Section 111550 is in effect, the applicant shall establish and maintain records, and make reports to the department, of data relating to clinical experience and other data or information, received or otherwise obtained by the applicant with respect to the new drug or device, as the department may by general regulation, or by order with respect to the application, prescribe. Any regulation or order issued pursuant to this section or pursuant to Section 111595 shall have due regard for the professional ethics of the medical profession and the interest of patients and shall provide, where the department determines that it is reasonably necessary, for the examination upon request, by the persons to whom the regulation or order is applicable, of similar information received or otherwise obtained by the department. Every person required pursuant to this section to maintain records, and every person in charge or in custody of the records, shall, upon request of an authorized agent of the department, permit the agent at all reasonable time to have access to, and copy and verify, the records.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111575.

111575. The department shall issue an order withdrawing approval of an application concerning any new drug or device if, after giving written notice to the applicant and an opportunity for a hearing, the department makes any of the following findings:
(a)  That clinical or other experience, tests, or other scientific data show that the new drug or device is unsafe for use under the conditions of use upon the basis of which the application was approved.
(b)  That new evidence of clinical experience, not contained in the application or not available to the department until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the department when the application was approved, shows that the new drug or device is not shown to be safe for use under the conditions of use upon the basis of which the application was approved.
(c)  On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(d)  That the application contains any untrue statement of a material fact.
(e)  That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(f)  That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(g)  That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111580.

111580. When the department finds that there is an imminent hazard to the public health, it may suspend the approval for the application immediately.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111585.

111585. An order pursuant to Section 111575 or 111580 withdrawing approval of an application concerning any new drug or device shall be revoked whenever the department finds that the facts justify the action.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111590.

111590. Section 111550 does not apply to a drug or device intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) and the regulations adopted pursuant to the federal act.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111595.

111595. Section 111550 does not apply to any drug or device intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if all the following conditions are complied with:
(a)  The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing.
(b)  The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings.
(c)  The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550.
(d)  The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515).
(e)  Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111605.

111605. (a)  In making determinations on requests for approval of AIDS-related drugs, as defined in subdivision (b), in accordance with Section 111550, or for exemptions from these requirements, for purposes of investigations of these drugs, pursuant to Section 111595, the department shall employ persons to conduct reviews of requests for drug marketing approval for AIDS-related drugs, or exemptions from the approval requirements as specified in that section. The AIDS Vaccine Research and Development Advisory Committee shall review and advise the department in its actions under this section.
Where necessary, the department shall enter into contracts with appropriate and qualified persons or entities for the review of these requests, including persons with significant experience in conducting or reviewing clinical trials of drugs or physicians with significant experience in treating AIDS patients.
No person may contract with the department for the review of a request under this subdivision if the person has a financial interest or a conflict of interest involving the drug being evaluated.
(b)  “AIDS-related drug” means either of the following:
(1)  A vaccine to protect against human immunodeficiency virus (HIV) infection.
(2)  Antiviral agent, immune modulator, or other agent to be administered to persons who have been infected with HIV, to counteract the effects of this infection, or any drug to treat opportunistic infections associated with AIDS.
(c)  The immunities provided for in Sections 818.4 and 821.6 of the Government Code shall apply whenever the department grants approval pursuant to Section 111550 or an exemption from the approval requirements pursuant to Section 111595, for an AIDS-related drug.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 5 - New Drugs or Devices › Section 111610.

111610. Section 111550 does not apply to any of the following:
(a)  A drug or device that is sold in this state, or introduced into interstate commerce, at any time prior to the enactment of the federal act, if its labeling and advertising contained the same representations concerning the conditions of its use.
(b)  Any drug that is licensed under the Public Health Service Act of July 1, 1944 (58 Stats. 682, as amended; 42 U.S.C. Sec. 201 et seq.) or under the eighth paragraph of the heading of Bureau of Animal Industry of the act of March 4, 1913 (37 Stat. 832–833; 21 U.S.C. Sec. 151 et seq.), commonly known as the “Virus-Serum-Toxin Act.”
(Amended by Stats. 2000, Ch. 796, Sec. 13. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111615.

111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department. The license is valid for two calendar 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.
(Amended by Stats. 2006, Ch. 74, Sec. 34. Effective July 12, 2006.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111620.

111620. A separate license is required for each place of manufacture.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111625.

111625. A license application shall be completed biennially and accompanied by an application fee as prescribed in Section 111630. This fee is not refundable if the license is refused.
(Amended by Stats. 2006, Ch. 74, Sec. 35. Effective July 12, 2006.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111630.

111630. The department shall by regulation establish the application form and set the fee for licensure and renewal of a license. The penalty for failure to apply for 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111633.

111633. The State Department of Public Health shall require that an applicant for a human prescription drug manufacturing license submit fingerprints to the Department of Justice, and related information as required by the Department of Justice, as required by this chapter, pursuant to subdivision (u) of Section 11105 of the Penal Code. The Department of Justice shall provide a state- or federal-level response pursuant to subdivision (p) of Section 11105 of the Penal Code.
(Added by Stats. 2023, Ch. 198, Sec. 17. (SB 152) Effective September 13, 2023.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111640.

111640. The department shall make investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry out this chapter.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111645.

111645. Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a license or for suspending or revoking a license. Proceedings for the denial, suspension, or revocation of a license shall be conducted pursuant to Section 100171.
(Amended by Stats. 1997, Ch. 220, Sec. 28. Effective August 4, 1997.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111650.

111650. Drug manufacturers who have obtained a license or who are applying for a license pursuant to this article shall submit to the California State Board of 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111655.

111655. The licensing provisions of this chapter shall not apply to any of the following:
(a)  Any pharmacy that maintains establishments in conformance with provisions 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.1.

111656.1. (a) 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.
(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) 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) 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.
(g) This section shall become operative on January 1, 2028.
(Amended (as added by Stats. 2017, Ch. 213, Sec. 2) by Stats. 2022, Ch. 955, Sec. 5. (SB 1500) Effective January 1, 2023. Operative January 1, 2028, by its own provisions.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.2.

111656.2. (a)  The following standards shall apply to all home medical device retail facilities:
(1)  Each retail facility shall store prescription devices in a manner 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.
(Amended by Stats. 2001, Ch. 728, Sec. 72. Effective January 1, 2002.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.5.

111656.5. (a)  A person other than a licensed pharmacist, an intern pharmacist, an exemptee, as specified in Section 111656.4, or an authorized agent of the department or 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.
(Amended by Stats. 2001, Ch. 159, Sec. 135. Effective January 1, 2002.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.6.

111656.6. Home medical devices for rental purposes shall at all times while under the control of the home medical device retail facility, be maintained in a clean and sanitary condition and in good working order following, where available, manufacturer specifications.
(Added by Stats. 2000, Ch. 837, Sec. 38. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.7.

111656.7. (a)  Without registering as an out-of-state home medical device retail facility, an out-of-state home medical device retail facility shall not sell or 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.
(Added by Stats. 2000, Ch. 837, Sec. 39. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.8.

111656.8. (a)  No person acting as principal or agent for any out-of-state home medical device retail facility who has not obtained a registration from the department 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.
(Added by Stats. 2000, Ch. 837, Sec. 40. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.9.

111656.9. When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home 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.
(Added by Stats. 2000, Ch. 837, Sec. 41. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.11.

111656.11. (a)  It is unlawful for any person who is neither a licensed pharmacist nor an exemptee to take charge of a home medical device retail facility or to furnish 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.
(Added by Stats. 2000, Ch. 837, Sec. 43. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.12.

111656.12. (a)  The fee for examination and investigation for an exemptee license under Section 111656.4 shall be one hundred dollars ($100).
(b)  The fee for an exemptee 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).
(Added by Stats. 2000, Ch. 837, Sec. 44. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 6 - Licenses › Section 111656.13.

111656.13. (a)  Any entity that prior to July 1, 2001, held a current, valid license as a medical device retailer pursuant to Section 4130 of the Business and Professions 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.
(Amended by Stats. 2001, Ch. 159, Sec. 136. Effective January 1, 2002.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 1 - General Provisions and Definitions › Section 111660.

111660. As used in this chapter, “hair dye” does not include any eyelash dye or eyebrow dye.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 1 - General Provisions and Definitions › Section 111665.

111665. Any color additive shall be considered unsafe for use with respect to any cosmetic unless there is in effect a regulation adopted pursuant to Section 110090 that prescribes its use in cosmetics.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111670.

111670. A cosmetic is adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement of the cosmetic, or under conditions of use as are customary or usual.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111675.

111675. Section 111670 shall not apply to coal tar hair dye, that is conspicuously labeled as follows:
“Caution—this product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”
The labeling shall also bear adequate directions for such preliminary testing.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111680.

111680. Any cosmetic is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111685.

111685. Any cosmetic is adulterated if it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111690.

111690. Any cosmetic is adulterated if its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111691.

111691. A cosmetic is not adulterated because it includes industrial hemp, as defined in Section 11018.5, as long as the cannabinoids, extracts, or derivatives from industrial hemp meet the requirements established in Chapter 9 (commencing with Section 111920). The sale of a cosmetic that includes industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp provided that the cannabinoids, extracts, or derivatives from industrial hemp meet the requirements established in Chapter 9 (commencing with Section 111920).
(Added by Stats. 2021, Ch. 576, Sec. 9. (AB 45) Effective October 6, 2021.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111695.

111695. Any cosmetic is adulterated if it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of Section 111665.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111700.

111700. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111705.

111705. It is unlawful for any person to adulterate any cosmetic.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111710.

111710. It is unlawful for any person to receive in commerce any cosmetic that is adulterated or to deliver or proffer for delivery any such cosmetic.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7 - Cosmetics › ARTICLE 2 - Adulterated Cosmetics › Section 111715.

111715. While any regulation relating to any color additive referred to in Section 111665 is in effect, any cosmetic that bears or contains a color additive in accordance with these regulations shall not be considered adulterated.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)