Pharmacy Law: advertising certain compounded medications used for obesity or weight management., the official text

An act to add Article 10.5 (commencing with Section 4157) to Chapter 9 of Division 2 of the Business and Professions Code, relating to healing arts.

LEGISLATIVE COUNSEL'S DIGEST

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy within the Department of Consumer Affairs to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. Under existing law, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription unless they are licensed, as specified.
Existing law also requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes advertisements for prescription drugs, if the advertisement conforms with certain requirements, including not containing a false, fraudulent, misleading, or deceptive statement. A violation of the Pharmacy Law is a crime.
This bill would make it unlawful for any person to advertise or otherwise promote certain compounded medications used for obesity or weight management, as provided, unless the advertisement is truthful and not misleading, including not containing an unsubstantiated claim with respect to the product. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.

The people of the State of California do enact as follows:

SECTION 1.
Article 10.5 (commencing with Section 4157) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:
10.5.
Advertising Compounded Medications4157.
(a) For purposes of this section:
(1) “Compounded medication” refers to a compounded drug that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonist or other amino acid polymer intended to be used by humans for obesity or weight management.
(2) “Person” means any individual, partnership, firm, corporation, or other legal entity.
(3) “Unsubstantiated claim” means any statement, representation, or assertion concerning the safety, efficacy, or other attributes of a drug that is not supported by competent and reliable scientific evidence.
(b) It is unlawful for any person to advertise or otherwise promote compounded medications, unless the advertisement is truthful and not misleading. An advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product.
(c) An advertisement of a compounded medication is misleading unless it contains all of the following:
(1) A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including the potential side effects, adverse reactions, contraindications, precautions, and warnings in the labeling of any FDA-approved drug containing the active ingredients named in the compounded drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.
(2) A summary of the specified risk information in the labeling of the FDA-approved drug, when a compounded drug contains an active ingredient that is named as an active ingredient in an FDA-approved drug.
(3) A clear, conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.

SEC. 2.
No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.