Title HSC — California Health & Safety Code

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 in the drug or device being misbranded.

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 to the specifications of the foreign purchaser. (b) It is not in conflict with the laws of the importing country. (c) It i…

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 relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Reg…

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 the drug or device, or upon an oral prescription of the licensee that is reduced promptly to writing and filed by the ph…

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 sale.

(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, a…

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 …

(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 “…

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…

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…

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 t…

(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 al…

As used in this article, “experimental drug” means any of the following: A drug intended for investigational use under Section 111595.

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

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.

(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 sha…

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.

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 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.

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

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 …

(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 …

(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 inv…

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, …

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 suspend…

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 groun…

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 …

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.

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 informati…

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 experienc…

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

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.

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 requiremen…

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 submis…

(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 shal…

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…

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 manufac…

A separate license is required for each place of manufacture.

A license application shall be completed biennially and accompanied by an application fee as prescribed in Section 111630. This fee is not refundable if the license is refused.

The department shall by regulation establish the application form and set the fee for licensure and renewal of a license. The penalty for failure to apply for renewal of a license within 30 days after its expiration is ten dollars ($10) and shall be added to the renewal fee and b…

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 s…

(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 operat…

The department shall make investigations or inspections authorized by Article 2 (commencing with Section 110410) of Chapter 2 as it deems necessary to carry out this chapter.

Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a license or for suspending or revoking a license. Proceedings for the denial, suspension, or revocation of a license shall be conducted pursuant to Section 10…

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 inc…

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, regula…

(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 se…

(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 lic…

(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 closur…

(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 lic…