text:
(a) A drug or device sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the drug or device bears a label displaying all of the following:

(1) Except when the prescriber orders otherwise, either the manufacturer’s trade name of the drug, or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients.

(2) The directions for the use of the drug or device.

(3) The name of the patient(s).

(4) The name of the prescriber.

(5) The date of issue.

(6) The name, address of the furnisher, and prescription number or other means of identifying the prescription.

(7) The strength of the drug or drugs dispensed.

(8) The quantity of the drug or drugs dispensed.

(9) The expiration date of the effectiveness of the drug or device if the information is included on the original label of the manufacturer of the drug or device.

(b) Brand name or generic mifepristone or any drug used for medication abortion sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the label complies with subdivision (g) of Section 4076 of the Business and Professions Code.

(c) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care or other health care facility, the requirements of subdivision (a) shall be satisfied if the unit dose medication system contains the information required pursuant to subdivision (a) or the information is otherwise readily available at the time of drug administration.

(d) The exemption in subdivision (a) shall not apply to any drug or device dispensed in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail, or to a drug or device dispensed in violation of Section 111470.

history: (History: Amended by Stats. 2025, Ch. 136, Sec. 18. (AB 260) Effective September 26, 2025.)

article: 3. Misbranded Drugs or Devices


kind: section

code: HSC

text: The department may, by regulation, remove any drug or device subject to Sections 111350 and 111550 from the requirements of Section 111470, when the requirements are not necessary for the protection of the public health. Any drug removed from the prescription requirements of the federal act by regulations adopted pursuant to the federal act is removed from the requirements of Section 111470. The department may, however, by regulation, continue the applicability of Section 111470 for any drug or device, or make these sections inapplicable to any drug or device, whether or not the inclusion or exclusion of the drug or device is in accordance with the regulations adopted pursuant to the federal act.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

division: 104. ENVIRONMENTAL HEALTH

chapter: 6. Drugs and Devices

article: 3. Misbranded Drugs or Devices

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 3. Misbranded Drugs or Devices


text:
(a) A drug or device that is subject to Section 111470 is misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: federal law prohibits dispensing without prescription,” or “Caution: state law prohibits dispensing without prescription,” or “R x only.” A drug or device to which Section 111470 does not apply is misbranded if at any time prior to dispensing its label bears the caution statement or “R x only” quoted in the preceding sentence.

(b) A device that is subject to Section 111470 is misbranded if, at any time prior to dispensing, its label fails to bear the statement “Caution: federal law restricts this device to sale by or on the order of a ____ ,” the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. A device to which Section 111470 does not apply is misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 12. Effective January 1, 2001.)

part: 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS

article: 3. Misbranded Drugs or Devices


text: Nothing in this article shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or that may hereafter be included within the classification stated in Division 10 (commencing with Section 11000) or in the applicable federal law relating to controlled substances.

article: 3. Misbranded Drugs or Devices


text: A physician, dentist, podiatrist, or veterinarian may personally furnish his or her own patient with drugs as are necessary in the treatment of the condition for which he or she attends the patient provided that the drug is properly labeled to show all the information required in Section 111480 except the prescription number.

article: 3. Misbranded Drugs or Devices


text:
For purposes of Section 111510, the following definitions shall apply:

(a) “Distributor” means any corporation, person, or other entity, not engaged in the manufacture of a legend drug product, who distributes for resale and distribution a legend drug product under the label of the corporation, person, or entity.

(b) “Legend drug” means any controlled substance subject to the Federal Controlled Substances Act (Title II, P.L. 91-513) or subject to the Uniform Controlled Substances Act, Division 10 (commencing with Section 11000), and any drug described in Section 4211 of the Business and Professions Code or Section 111470.

(c) “Solid dosage forms” means capsules or tablets intended for oral administration.

(d) “Code imprint” means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, or marks or monograms unique to the manufacturer, distributor, or both. The National Drug Code may be used as a code imprint.

article: 3. Misbranded Drugs or Devices


text:
(a) No legend drug in solid dosage form may be manufactured or distributed for sale in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug. Manufacturers or distributors who only repack an already finished dosage form of a legend drug shall not have the responsibility to do the imprint.

(b) On or before July 1, 1982, manufacturers or distributors of legend drugs, depending on whether the manufacturer’s or distributor’s code imprint will appear on the surface of the solid dosage form, shall provide to the department a list of their legend drugs and the intended code imprints. The department shall provide for the distribution of the information required to be submitted under this subdivision to all poison control centers in the state. Manufacturers, distributors, and the department shall provide to any licensed health care provider, upon request, lists of legend drugs and code imprints provided to the department under this section, but may charge a reasonable fee to cover copying and postage costs. Updated lists shall be provided to the department annually or as changes or revisions occur.

(c) The department may grant exemptions from the requirements of this section upon application of a manufacturer or distributor indicating size or other characteristics that render the product impractical for the imprinting required by this section.

(d) A legend drug that does not meet the requirements is misbranded.

(e) It is the intent of the Legislature that all legend drugs having solid dosage forms be imprinted regardless of by whom they are distributed.

(f) This section shall apply to all legend drugs sold in California on or after January 1, 1983.

(g) Pharmacists, pharmacies, and licensed wholesalers shall only be liable for knowing and willful violations of this section, except that no liability shall accrue if the pharmacist acts pursuant to Section 4229.5 of the Business and Professions Code.

(h) The provisions of subdivisions (a) to (g), inclusive, shall not apply to any of the following:

(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1983, and held in stock for resale.

(2) Drugs that are the subject of an investigation pursuant to Section 111590 or 111595.

(3) Drugs that are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and that are to be used solely by the patient for whom prescribed.

article: 3. Misbranded Drugs or Devices


text:
As used in this article, “experimental drug” means any of the following:

A drug intended for investigational use under Section 111595.

article: 4. Experimental Use of Drugs

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 4. Experimental Use of Drugs


text: No person shall prescribe or knowingly administer an experimental drug to another person in violation of this article.

article: 4. Experimental Use of Drugs


text: Prior to prescribing or administering an experimental drug, consent to the use of the drug shall be obtained in the method and manner specified in Chapter 1.3 (commencing with Section 24170) of Division 20.

article: 4. Experimental Use of Drugs


text:
(a) Notwithstanding the provisions of Section 24175, if the subject is a minor, consent shall be provided by a parent or guardian of the subject and shall also be provided by the subject if the subject is seven years of age or older.

(b) Consent given pursuant to this section shall only be for the prescribing or administering of an experimental drug that is related to maintaining or improving the health of the subject or related to obtaining information about a pathological condition of the subject.

article: 4. Experimental Use of Drugs


text: Consent given pursuant to Section 111525 may be revoked at any time by either verbal or written communication to the practitioner supervising the administration of the experimental drug.

article: 4. Experimental Use of Drugs


text: Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be reviewed and approved by a committee for the protection of human subjects that is acceptable, as determined by the department. A committee for the protection of human subjects that operates under a general or special assurance approved by the federal Department of Health, Education, and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations shall be an acceptable committee for purposes of this section. A copy of the consent procedures approved by a committee for the protection of human subjects shall be filed with the department prior to the commencement of the experiment.

article: 4. Experimental Use of Drugs


text: A person having an ownership interest in a skilled nursing facility or intermediate care facility, as those terms are defined in Section 1250, may not prescribe an experimental drug for a patient in the facility.

article: 4. Experimental Use of Drugs


text: This article shall be known and may be cited as the Right to Try Act.

history: (History: Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)

article: 4.5. Right to Try Act

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 4.5. Right to Try Act


text:
For purposes of this article, unless the context otherwise requires, the following definitions shall apply:

(a) “Consulting physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act who performs all of the following:

(1) Examines the qualified individual and his or her relevant medical records.

(2) Confirms, in writing, the primary physician’s diagnosis and prognosis.

(3) Verifies, in the opinion of the consulting physician, that the eligible patient is competent, acting voluntarily, and has made an informed decision.

(b) “Eligible patient” means a person who meets all of the following conditions:

(1) Has an immediately life-threatening disease or condition.

(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration.

(3) Has not been accepted to participate in the nearest clinical trial to his or her home for the immediately life-threatening disease or condition identified in paragraph (1) within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial due to the patient’s current condition and stage of disease.

(4) Has received a recommendation from his or her primary physician and a consulting physician for an investigational drug, biological product, or device.

(5) Has given written informed consent for the use of the investigational drug, biological product, or device, or, if he or she lacks the capacity to consent, his or her legally authorized representative has given written informed consent on his or her behalf.

(6) Has documentation from his or her primary physician and a consulting physician attesting that the patient has met the requirements of this subdivision.

(c) “Health benefit plan” means a plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. “Health benefit plan” includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer.

(d) “Immediately life-threatening disease or condition” means a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months.

(e) “Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration.

(f) “Primary physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act.

(g) “State regulatory board” means the Medical Board of California or the Osteopathic Medical Board of California.

(h) (1) “Written, informed consent” means a written document that has been approved by the primary physician’s institutional review board or an accredited independent institutional review board, is signed by an eligible patient, or his or her legally authorized representative when the patient lacks the capacity to consent, and attested to by the patient’s primary physician and a witness that, at a minimum, does all of the following:

(A) Explains the currently approved products and treatments for the immediately life-threatening disease or condition from which the patient suffers.

(B) Attests to the fact that the patient, or when the patient lacks the capacity to consent his or her legally authorized representative, concurs with the patient’s primary physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life.

(C) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use.

(D) Describes the potentially best and worst outcomes of using the investigational drug, biological product, or device and describes the most likely outcome. This description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the primary physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition.

(E) Clearly states that the patient’s health benefit plan, if any, and health care provider are not obligated to pay for the investigational drug, biological product, or device or any care or treatments consequent to use of the investigational drug, biological product, or device.

(F) Clearly states that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment and that care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements.

(G) Clearly states that in-home health care may be denied if treatment begins.

(H) States that the patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device, and that this liability extends to the patient’s estate, except as otherwise provided in the patient’s health benefit plan or a contract between the patient and the manufacturer of the drug, biological product, or device.

(2) Written, informed consent for purposes of this article shall be consistent with the informed consent requirements of the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20).

article: 4.5. Right to Try Act


text:
(a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.

(b) A manufacturer may do both of the following:

(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation.

(2) Require an eligible patient to pay the costs of, or associated with, the manufacture of the investigational drug, biological product, or device.

(c) (1) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code.

(2) This article does not require a health benefit plan to provide coverage for the cost of any investigational drug, biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or device under this article. A health benefit plan may provide coverage for an investigational drug, biological product, or device made available pursuant to this section.

(d) If the clinical trial for an investigational drug, biological product, or device is closed due to the lack of efficacy or for toxicity, the investigational drug, biological product, or device shall not be offered. If notice of closure of a clinical trial is given for an investigational drug, biological product, or device taken by a patient outside of a clinical trial, the manufacturer and the patient’s primary physician shall notify the patient of the information from the safety committee of the clinical trial.

(e) If an eligible patient dies while being treated by an investigational drug, biological product, or device made available pursuant to this article, the patient’s heirs and health benefit plan, except to the extent the plan provided coverage pursuant to paragraph (2) of subdivision (c), are not liable for any outstanding debt related to the treatment or lack of insurance for the treatment.

article: 4.5. Right to Try Act


text:
(a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board.

(b) The physician’s institutional review board or an accredited institutional review board shall biannually report the following information to the State Department of Public Health, the Medical Board of California, and the Osteopathic Medical Board of California:

(1) The number of requests made for an investigational drug, biological product, or device.

(2) The status of the requests made.

(3) The duration of the treatment.

(4) The costs of the treatment paid by eligible patients.

(5) The success or failure of the investigational drug, biological product, or device in treating the immediately life-threatening disease or condition from which the patient suffers.

(6) Any adverse event for each investigational drug, biological product, or device.

(c) A state agency shall not alter any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an investigational drug, biological product, or device.

(d) A violation of this section shall not be subject to Chapter 8 (commencing with Section 111825).

article: 4.5. Right to Try Act


text: This article does not create a private cause of action, and actions taken pursuant to this article shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was a failure to exercise reasonable care.

article: 4.5. Right to Try Act


text:
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.

history: (History: Amended by Stats. 2012, Ch. 688, Sec. 1. (AB 1277) Effective January 1, 2013.)

article: 5. New Drugs or Devices

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 5. New Drugs or Devices


text:
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.

article: 5. New Drugs or Devices


text:
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.

article: 5. New Drugs or Devices


text: 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.

article: 5. New Drugs or Devices


text: 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.

article: 5. New Drugs or Devices


text:
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.

article: 5. New Drugs or Devices


text: When the department finds that there is an imminent hazard to the public health, it may suspend the approval for the application immediately.

article: 5. New Drugs or Devices


text: 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.

article: 5. New Drugs or Devices


text: 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.

article: 5. New Drugs or Devices


text:
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.

article: 5. New Drugs or Devices


text:
(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.

article: 5. New Drugs or Devices


text:
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.”

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 13. Effective January 1, 2001.)

article: 5. New Drugs or Devices


text:
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.

history: (History: Amended by Stats. 2006, Ch. 74, Sec. 34. Effective July 12, 2006.)

article: 6. Licenses

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 6. Licenses


text: A separate license is required for each place of manufacture.

article: 6. Licenses


text: 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.

history: (History: Amended by Stats. 2006, Ch. 74, Sec. 35. Effective July 12, 2006.)

article: 6. Licenses


text:
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.

article: 6. Licenses


text: 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.

history: (History: Added by Stats. 2023, Ch. 198, Sec. 17. (SB 152) Effective September 13, 2023.)

article: 6. Licenses


text:
(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.

history: (History: Amended by Stats. 2012, Ch. 688, Sec. 2. (AB 1277) Effective January 1, 2013.)

article: 6. Licenses


text: 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.

article: 6. Licenses


text: 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.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 28. Effective August 4, 1997.)

article: 6. Licenses


text:
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.

article: 6. Licenses


text:
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.

article: 6. Licenses


text:
(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.

history: (History: Amended by Stats. 2001, Ch. 728, Sec. 71. Effective January 1, 2002.)

article: 6. Licenses


text:
(a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.

(2) (A) After the initial inspection pursuant to paragraph (1), the department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee.

(B) A licensee shall only be deemed to be accredited and subject to inspection pursuant to subparagraph (A) if all of the following conditions exist:

(i) The licensee is accredited by the accrediting organization at least every three years.

(ii) The licensee is subject to unannounced onsite midcycle surveys by the accrediting organization to validate ongoing compliance.

(iii) Within 30 days following an inspection by the accrediting organization, the accrediting organization notifies the department regarding the status of the licensee’s accreditation.

(iv) If the licensee is less than fully accredited, the accrediting organization notifies the department of the reasons for the lack of full accreditation and any corrective action plan recommended to the licensee.

(C) The department shall inspect a licensee that ceased to be accredited in compliance with subparagraph (B) pursuant to paragraph (3).

(3) The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.

(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.

(g) This section shall remain in effect only until January 1, 2028, and as of that date is repealed.

history: (History: Amended (as amended by Stats. 2017, Ch. 213, Sec. 1) by Stats. 2022, Ch. 955, Sec. 4. (SB 1500) Effective January 1, 2023. Repealed as of January 1, 2028, by its own provisions. See later operative version, as amended by Sec. 5 of Stats. 2022, Ch. 955.)

article: 6. Licenses


text:
(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.

history: (History: 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.)

article: 6. Licenses


text:
(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.

history: (History: Amended by Stats. 2001, Ch. 728, Sec. 72. Effective January 1, 2002.)

article: 6. Licenses


text:
(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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 35. Effective January 1, 2001.)

article: 6. Licenses


text:
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.

history: (History: Amended by Stats. 2002, Ch. 1013, Sec. 88. Effective January 1, 2003.)

article: 6. Licenses


text:
(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.

history: (History: Amended by Stats. 2001, Ch. 159, Sec. 135. Effective January 1, 2002.)

article: 6. Licenses


text: 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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 38. Effective January 1, 2001.)

article: 6. Licenses


text:
(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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 39. Effective January 1, 2001.)

article: 6. Licenses


text:
(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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 40. Effective January 1, 2001.)

article: 6. Licenses


text: 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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 41. Effective January 1, 2001.)

article: 6. Licenses


text:
(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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 42. Effective January 1, 2001.)

article: 6. Licenses


text:
(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.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 43. Effective January 1, 2001.)

article: 6. Licenses


text:
(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).

history: (History: Added by Stats. 2000, Ch. 837, Sec. 44. Effective January 1, 2001.)

article: 6. Licenses


text:
(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.

history: (History: Amended by Stats. 2001, Ch. 159, Sec. 136. Effective January 1, 2002.)

article: 6. Licenses


text: As used in this chapter, “hair dye” does not include any eyelash dye or eyebrow dye.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

chapter: 7. Cosmetics

article: 1. General Provisions and Definitions

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 7. Cosmetics > 1. General Provisions and Definitions


text: 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.

article: 1. General Provisions and Definitions


text: 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.

article: 2. Adulterated Cosmetics

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 7. Cosmetics > 2. Adulterated Cosmetics


text:
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.

article: 2. Adulterated Cosmetics


text: Any cosmetic is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance.

article: 2. Adulterated Cosmetics


text: 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.

article: 2. Adulterated Cosmetics


text: 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.

article: 2. Adulterated Cosmetics


text: A cosmetic is not adulterated because it includes industrial hemp, raw extract, or raw hemp product, as defined in Section 111920, if the industrial hemp, raw extract, or raw hemp product meets the requirements established in Chapter 9 (commencing with Section 111920). The sale of a cosmetic that includes industrial hemp, raw extract, or raw hemp product shall not be restricted or prohibited based solely on the inclusion of industrial hemp provided that the industrial hemp, raw extract, or raw hemp product meets the requirements established in Chapter 9 (commencing with Section 111920).

history: (History: Amended by Stats. 2025, Ch. 248, Sec. 30. (AB 8) Effective January 1, 2026.)

article: 2. Adulterated Cosmetics


text: 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.

article: 2. Adulterated Cosmetics


text: It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated.

article: 2. Adulterated Cosmetics


text: It is unlawful for any person to adulterate any cosmetic.

article: 2. Adulterated Cosmetics


text: 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.

article: 2. Adulterated Cosmetics


text: 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.

article: 2. Adulterated Cosmetics


text:
Any cosmetic intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements:

(a) It accords to the specifications of the foreign purchaser.

(b) It is not in conflict with the laws of the importing country.

(c) It is labeled on the outside of the shipping package to show that it is intended for export.

If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part.

article: 2. Adulterated Cosmetics


text: A cosmetic is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Part 700 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.

article: 2. Adulterated Cosmetics


text: Any cosmetic is misbranded if its labeling is false or misleading in any particular.

article: 3. Misbranded Cosmetics

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 7. Cosmetics > 3. Misbranded Cosmetics


text: Any cosmetic is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290).

article: 3. Misbranded Cosmetics


text:
Any cosmetic is misbranded if it is in package form and it does not bear a label containing all of the following information:

(a) The name and place of business of the manufacturer, packer, or distributor.

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

Reasonable variations shall be permitted from the requirements of subdivision (b) of this section. Requirements for placement and prominence of the information and exemptions as to small packages shall be established by regulations adopted pursuant to Section 110380.

article: 3. Misbranded Cosmetics


text: A cosmetic is misbranded if any word, statement, or other information required pursuant to this part to appear on the label or labeling is not prominently placed upon the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

article: 3. Misbranded Cosmetics


text: Any cosmetic is misbranded if its container is so made, formed, or filled as to be misleading.

article: 3. Misbranded Cosmetics


text: A cosmetic is misbranded if it is a color additive, unless its packaging and labeling are in conformity with the packaging and labeling requirements applicable to color additives prescribed under the provisions of Section 110090. This section does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.

article: 3. Misbranded Cosmetics


text: Any cosmetic is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700.

article: 3. Misbranded Cosmetics


text: It is unlawful for any person to manufacture, or sell any cosmetic that is misbranded.

article: 3. Misbranded Cosmetics


text: It is unlawful for any person to misbrand any cosmetic.

article: 3. Misbranded Cosmetics


text: It is unlawful for any person to receive in commerce any cosmetic that is misbranded, or to deliver or proffer for delivery any cosmetic.

article: 3. Misbranded Cosmetics


text: It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any cosmetic if the act results in the cosmetic being misbranded, while held for sale.

article: 3. Misbranded Cosmetics


text:
Any cosmetic intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements:

(a) It accords to the specifications of the foreign purchaser.

(b) It is not in conflict with the laws of the country to which it is intended for export.

(c) It is labeled on the outside of the shipping package to show that it is intended for export.

If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part.

article: 3. Misbranded Cosmetics


text: A cosmetic is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Part 700 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.

article: 3. Misbranded Cosmetics


text: This article shall be known, and may be cited, as the California Safe Cosmetics Act of 2005.

history: (History: Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.)

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 7. Cosmetics > 3.5. Chronic Health Effects of Cosmetics


text:
For purposes of this article, the following terms have the following meanings:

(a) “Authoritative body” means any agency or formally organized program or group recognized pursuant to Section 12306 of Title 22 of the California Code of Regulations as being authoritative for the purpose of identifying chemicals that cause cancer or reproductive toxicity.

(b) “Chemical identified as causing cancer or reproductive toxicity” means a chemical identified pursuant to Section 25249.8 or identified by an authoritative body as any of the following:

(1) A substance listed as known or reasonably anticipated to be a human carcinogen in a National Toxicology Report on carcinogens.

(2) A substance given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International Agency for Research on Cancer.

(3) A substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency.

(4) A substance identified as having some or clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction.

(c) “Division” means the Division of Environmental and Occupational Disease Control within the State Department of Health Services.

(d) “Ingredient” has the same meaning as that term is defined in subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21 of the Code of Federal Regulations and does not include any incidental ingredient as defined in subdivision (l) of Section 701.3 of Part 701 of Chapter 1 of Title 21 of the Code of Federal Regulations.

(e) “Manufacturer” means any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.

article: 3.5. Chronic Health Effects of Cosmetics


text:
(a) The manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this state shall, on a schedule and in electronic or other format, as determined by the division, provide the division with a complete and accurate list of its cosmetic products that, as of the date of submission, are sold in the state and that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity, including any chemical that meets either of the following conditions:

(1) A chemical contained in the product for purposes of fragrance or flavoring.

(2) A chemical identified by the phrase “and other ingredients” and determined to be a trade secret pursuant to the procedure established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations. Any ingredient identified pursuant to this paragraph shall be considered to be a trade secret and shall be treated by the division in a manner consistent with the requirements of Part 20 and Part 720 of Title 21 of the Code of Federal Regulations. Any ingredients considered to be a trade secret shall not be subject to the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code) for the purposes of this section.

(b) Any information submitted pursuant to subdivision (a) shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained.

(c) If an ingredient identified pursuant to this section subsequently is removed from the product in which it was contained, is removed from the list of chemicals known to cause cancer or reproductive toxicity published under Section 25249.8, or is no longer a chemical identified as causing cancer or reproductive toxicity by an authoritative body, the manufacturer of the product containing the ingredient shall submit the new information to the division. Upon receipt of new information, the division, after verifying the accuracy of that information, shall revise the manufacturer’s information on record with the division to reflect the new information. The manufacturer shall not be under obligation to submit subsequent information on the presence of the ingredient in the product unless subsequent changes require submittal of the information.

(d) This section shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of California, of less than one million dollars ($1,000,000), based on the manufacturer’s most recent tax year filing.

(e) On or before December 31, 2013, the State Department of Public Health shall develop and make operational a consumer-friendly, public internet website that creates a database of the information collected pursuant to this section. The database shall be searchable to accommodate a wide range of users, including users with limited technical and scientific literacy. Data shall be presented in an educational manner with, among other things, hypertext links that explain the meanings of technical terms, including, but not limited to, “carcinogenic” and “reproductive toxicity.” The internet website shall be designed to be easily navigable and to enable users to compare and contrast products and reportable ingredients. The internet website shall include hypertext links to other educational and informational internet websites to enhance consumer understanding.

history: (History: Amended by Stats. 2021, Ch. 615, Sec. 277. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.)


text:
(a) In order to determine potential health effects of exposure to ingredients in cosmetics sold in the state, the division may conduct an investigation of one or more cosmetic products that contain chemicals identified as causing cancer or reproductive toxicity or other ingredients of concern to the division.

(b) An investigation conducted pursuant to subdivision (a) may include, but not be limited to, a review of available health effects data and studies, worksite health hazard evaluations, epidemiological studies to determine the health effects of exposures to chemicals in various subpopulations, and exposure assessments to determine total exposures to individuals in various settings.

(c) If an investigation is conducted pursuant to subdivision (a), the manufacturer of any product subject to the investigation may submit relevant health effects data and studies to the division.

(d) In order to further the purposes of an investigation, the division may require manufacturers of products subject to the investigation to submit to the division relevant health effects data and studies available to the manufacturer and other available information as requested by the division, including, but not limited to, the concentration of the chemical in the product, the amount by volume or weight of the product that comprises the average daily application or use, and sales and use data necessary to determine where the product is used in the occupational setting.

(e) The division shall establish reasonable deadlines for the submittal of information required pursuant to subdivision (d). Failure by a manufacturer to submit the information in compliance with the requirements of the division shall constitute a violation of this part.