CHAPTER 6. Drugs and Devices [111225. - 111656.13.]

Chapter 6 added by Stats. 1995, Ch. 415, Sec. 6.

§§ 111225–111656.13 · 105 sections

1. ARTICLE 1. General Provisions §§ 111225–111246 · 6 sections

   • § 111225 As used in this chapter, with respect to a drug or drug ingredient, “established name” means either of the following: (a) The name designated pursuant to…
   • § 111230 Any drug represented in its labeling or advertisement as an antiseptic shall be considered to be represented as a germicide, except in the case of a drug that…
   • § 111235 Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the…
   • § 111240 Any added poisonous or deleterious substance, or color additive, shall be considered unsafe for use with respect to any drug or device unless there is in…
   • § 111245 The department may establish performance standards for devices, that shall be designed to provide reasonable assurance of safe and effective performance and,…
   • § 111246 Commencing January 1, 2002, any product used for the treatment of lice or scabies in human beings that contains the pesticide Lindane shall not be used or sold…
2. ARTICLE 2. Adulterated Drugs or Devices §§ 111250–111325 · 16 sections

   • § 111250 Any drug or device is adulterated if it consists, in whole or in part, of any filthy, putrid, or decomposed substance.
   • § 111255 Any drug or device is adulterated if it has been produced, prepared, packed, or held under conditions whereby it may have been contaminated with filth, or…
   • § 111260 Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are…
   • § 111265 Any drug or device is adulterated if it is packaged and its container is composed, in whole or in part, of any poisonous or deleterious substance that may…
   • § 111270 Any drug or device is adulterated if it bears or contains for the purpose of coloring only a color additive that is unsafe within the meaning of Section 111240.
   • § 111275 Any drug or device is adulterated if it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, and it is…
   • § 111280 Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its…
   • § 111285 Any drug or device is adulterated if its strength differs from, or its purity or quality is below, that which it is represented to possess.
   • § 111290 Any drug or device is adulterated if any substance has been mixed or packed with it so as to reduce its quality or strength or if any substance has been…
   • § 111295 It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is adulterated.
   • § 111300 It is unlawful for any person to adulterate any drug or device.
   • § 111305 It is unlawful for any person to receive in commerce any drug or device that is adulterated or to deliver or proffer for delivery any drug or device.
   • § 111310 While any regulation described in Section 110090 relating to any color additive is in effect, any drug or device that bears or contains the color additive in…
   • § 111315 Any drug or device intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements: (a) It accords…
   • § 111320 Any device is adulterated that fails to meet the applicable performance standard, if any, as provided in Section 111245.
   • § 111325 A drug or device is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration as…
3. ARTICLE 3. Misbranded Drugs or Devices §§ 111330–111510 · 35 sections

   • § 111330 Any drug or device is misbranded if its labeling is false or misleading in any particular.
   • § 111335 Any drug or device is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290).
   • § 111340 Any drug or device is misbranded unless it bears a label containing all of the following information: (a) The name and place of business of the manufacturer,…
   • § 111345 Any drug or device is misbranded if any word, statement, or other information required by or under this part to appear on the label or labeling is not…
   • § 111355 (a) Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the…
   • § 111360 Any drug subject to Section 111470 is misbranded unless the manufacturer, packer, or distributor of the drug includes, in all advertisements and other…
   • § 111365 Any drug subject to Section 111470 is misbranded unless the established name of the prescription drug or prescription drug ingredient is printed on the label…
   • § 111375 Any drug or device is misbranded unless its labeling bears all of the following information: (a) Adequate directions for use. (b) Such adequate warnings…
   • § 111376 (a) The department may adopt regulations relating to brand name or generic mifepristone or any drug used for medication abortion by including brand name or…
   • § 111380 Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the…
   • § 111385 Any drug or device is misbranded if the department determines that the drug or device is liable to deterioration, unless it is packaged in that form and manner…
   • § 111390 Any drug or device is misbranded if its container is so made, formed, or filled as to be misleading.
   • § 111395 Any drug is misbranded in any of the following cases: (a) It is an imitation of another drug. (b) It is offered for sale under the name of another drug. (c)…
   • § 111397 (a) Any foreign dangerous drug that is not approved by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain…
   • § 111400 Any drug or device is misbranded if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested…
   • § 111415 Any drug is misbranded if it is a color additive, intended for use in or on drugs for the purpose of coloring only and its packaging and labeling fail to…
   • § 111420 A drug or device is misbranded if a trademark, trade name, or other identifying mark, imprint, or device of another person, or any likeness of the trademark,…
   • § 111425 A drug or device is misbranded if it was manufactured in this state in an establishment not duly licensed as provided in this part.
   • § 111430 A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the…
   • § 111435 Any drug is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700.
   • § 111440 It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.
   • § 111445 It is unlawful for any person to misbrand any drug or device.
   • § 111450 It is unlawful for any person to receive in commerce any drug or device that is misbranded or to deliver or proffer for delivery any drug or device.
   • § 111455 It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any drug or device if the act results…
   • § 111460 Any drug or device intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements: (a) It accords…
   • § 111465 A drug or device is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration…
   • § 111470 The following drugs or devices, that are intended for use by man, shall be sold only upon a written prescription of a practitioner licensed by law to prescribe…
   • § 111475 The act of selling a drug or device contrary to Section 111470 shall be deemed to be an act that results in the drug or device being misbranded while held for…
   • § 111480 (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…
   • § 111485 The department may, by regulation, remove any drug or device subject to Sections 111350 and 111550 from the requirements of Section 111470, when the…
   • § 111490 (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:…
   • § 111495 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…
   • § 111500 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…
   • § 111505 For purposes of Section 111510, the following definitions shall apply: (a) “Distributor” means any corporation, person, or other entity, not engaged in the…
   • § 111510 (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…
4. ARTICLE 4. Experimental Use of Drugs §§ 111515–111545 · 7 sections

   • § 111515 As used in this article, “experimental drug” means any of the following: A drug intended for investigational use under Section 111595.
   • § 111520 No person shall prescribe or knowingly administer an experimental drug to another person in violation of this article.
   • § 111525 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…
   • § 111530 (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…
   • § 111535 Consent given pursuant to Section 111525 may be revoked at any time by either verbal or written communication to the practitioner supervising the…
   • § 111540 Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be…
   • § 111545 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…
5. ARTICLE 4.5. Right to Try Act §§ 111548–111548.5 · 5 sections

   • § 111548 This article shall be known and may be cited as the Right to Try Act.
   • § 111548.1 For purposes of this article, unless the context otherwise requires, the following definitions shall apply: (a) “Consulting physician” means a physician and…
   • § 111548.2 (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the…
   • § 111548.3 (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…
   • § 111548.5 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…
6. ARTICLE 5. New Drugs or Devices §§ 111550–111610 · 12 sections

   • § 111550 No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following: (a) It is one of the following: (1) A new…
   • § 111555 Within 180 days after the filing of an application provided for in Section 111550, or an additional period as shall be agreed upon by the department and the…
   • § 111560 The department shall issue an order refusing to approve an application if, after written notice to the applicant and after giving him or her an opportunity for…
   • § 111565 An order pursuant to Section 111560 refusing approval of a new drug application or a new device application shall be revoked whenever the department finds that…
   • § 111570 In the case of any new drug or device for which an approval of an application filed pursuant to Section 111550 is in effect, the applicant shall establish and…
   • § 111575 The department shall issue an order withdrawing approval of an application concerning any new drug or device if, after giving written notice to the applicant…
   • § 111580 When the department finds that there is an imminent hazard to the public health, it may suspend the approval for the application immediately.
   • § 111585 An order pursuant to Section 111575 or 111580 withdrawing approval of an application concerning any new drug or device shall be revoked whenever the department…
   • § 111590 Section 111550 does not apply to a drug or device intended solely for investigational use by experts qualified by scientific training and experience to…
   • § 111595 Section 111550 does not apply to any drug or device intended solely for investigational use by experts qualified by scientific training and experience to…
   • § 111605 (a) In making determinations on requests for approval of AIDS-related drugs, as defined in subdivision (b), in accordance with Section 111550, or for…
   • § 111610 Section 111550 does not apply to any of the following: (a) A drug or device that is sold in this state, or introduced into interstate commerce, at any time…
7. ARTICLE 6. Licenses §§ 111615–111656.13 · 24 sections

   • § 111615 No person shall manufacture any drug or device in this state unless he or she has a valid license from the department. The license is valid for two calendar…
   • § 111620 A separate license is required for each place of manufacture.
   • § 111625 A license application shall be completed biennially and accompanied by an application fee as prescribed in Section 111630. This fee is not refundable if the…
   • § 111630 The department shall by regulation establish the application form and set the fee for licensure and renewal of a license. The penalty for failure to apply for…
   • § 111633 The State Department of Public Health shall require that an applicant for a human prescription drug manufacturing license submit fingerprints to the Department…
   • § 111635 (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…
   • § 111640 The department shall make investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry…
   • § 111645 Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a license or for suspending or…
   • § 111650 Drug manufacturers who have obtained a license or who are applying for a license pursuant to this article shall submit to the California State Board of…
   • § 111655 The licensing provisions of this chapter shall not apply to any of the following: (a) Any pharmacy that maintains establishments in conformance with provisions…
   • § 111656 (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…
   • § 111656.1 (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…
   • § 111656.2 (a) The following standards shall apply to all home medical device retail facilities: (1) Each retail facility shall store prescription devices in a manner…
   • § 111656.3 (a) Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the…
   • § 111656.4 Section 4051 of the Business and Professions Code shall not prohibit a home medical device retail facility from selling or dispensing prescription devices if…
   • § 111656.5 (a) A person other than a licensed pharmacist, an intern pharmacist, an exemptee, as specified in Section 111656.4, or an authorized agent of the department or…
   • § 111656.6 Home medical devices for rental purposes shall at all times while under the control of the home medical device retail facility, be maintained in a clean and…
   • § 111656.7 (a) Without registering as an out-of-state home medical device retail facility, an out-of-state home medical device retail facility shall not sell or…
   • § 111656.8 (a) No person acting as principal or agent for any out-of-state home medical device retail facility who has not obtained a registration from the department…
   • § 111656.9 When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home…
   • § 111656.10 (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…
   • § 111656.11 (a) It is unlawful for any person who is neither a licensed pharmacist nor an exemptee to take charge of a home medical device retail facility or to furnish…
   • § 111656.12 (a) The fee for examination and investigation for an exemptee license under Section 111656.4 shall be one hundred dollars ($100). (b) The fee for an exemptee…
   • § 111656.13 (a) Any entity that prior to July 1, 2001, held a current, valid license as a medical device retailer pursuant to Section 4130 of the Business and Professions…