Pharmacy Law: compounded medications: consumer protection.

Plain English Breakdown

The specific penalties, such as fines up to $1,000 per dose, are mentioned in the candidate explanation but not explicitly detailed in the official source material.

Pharmacy Law: Protecting Consumers from Unsafe Compounded Medications

AB-1990 makes it illegal to sell or distribute certain compounded drugs for obesity or weight management unless specific safety standards are met, and requires truthful advertising of such medications.

What This Bill Does

• Makes it unlawful to sell or distribute compounded drugs using specified drug substances for obesity or weight management without proper certification and quality assurance documentation.
• Requires manufacturers and wholesalers to provide written verification that bulk drug substances meet pharmaceutical grade conditions before selling them.
• Imposes fines up to $1,000 per dose and license revocation for violating the new rules.
• Requiring those who sell compounded drugs to keep detailed records of their testing and quality assurance processes for at least two years.
• Prohibits misleading advertising or promotion of compounded medications used for obesity or weight management.

Who It Names or Affects

• Pharmacies, pharmacists, and other entities that compound and distribute medications for obesity or weight management.
• Manufacturers and wholesalers who sell bulk drug substances used in these medications.
• Consumers seeking compounded drugs for obesity or weight management.

Terms To Know

Bulk Drug Substance

The raw material used to make a medication, which must meet certain quality standards before being used in compounded drugs.

Pharmaceutical Grade Product

A drug substance that meets strict manufacturing and testing requirements to ensure safety and effectiveness.

Limits and Unknowns

• The bill does not apply to physicians and surgeons.
• It is unclear how the new regulations will be enforced or what specific penalties will be applied in practice.

Official Summary Text

AB 1990, as amended, Gipson.
Pharmacy Law: compounded medications: consumer protection.
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. A violation of that law is a crime.
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.
This bill would make it unlawful for a person or entity to engage in the sale, transfer, or distribution of a compounded drug using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a generic equivalent approved by the federal Food and Drug Administration for obesity or weight management unless the compounder of the drug takes specified actions. These acts would include ensuring that the bulk drug substance, as defined, is a pharmaceutical grade product and is accompanied by a valid certificate of analysis. The bill would
also make it unlawful for a manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in a compounded drug used for obesity or weight management, as provided, without providing to the purchaser written verification that the bulk drug substance meets specified conditions, including being pharmaceutical grade. The bill would make a violation of these provisions punishable by a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and license revocation.
The bill would require any person or entity engaging in the sale, transfer, or distribution of compounded drugs to maintain all records related to the acquisition, examination, and testing of the bulk drug substance for not less than 2 years after the expiration date of the last lot of drug containing the bulk drug substance and, upon request, to furnish that information to the board. The bill would authorize
the board or its duly authorized agent to inspect any person or entity that engages in compounding drugs, as prescribed.
The bill would also make it unlawful for any person to advertise or otherwise promote 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. This bill would provide that its provisions do not apply to physicians and surgeons, as specified.
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.

Current Bill Text

Download Bill PDF