AB 1990 is now before the California Senate.

While recent amendments have significantly narrowed the bill's scope and added important consumer disclosures that the Alliance for Pharmacy Compounding supports, AB 1990 still contains provisions that create unnecessary legal and practical challenges for licensed compounding pharmacies and threaten patient access to compounded medications. 

California can and should require advertising for compounded medications to be truthful, transparent, and not misleading. However, AB 1990 goes further by requiring advertisements for certain compounded medications to include risk information drawn from FDA-approved products even though compounded medications are, by law, distinct from FDA-approved drugs and are customized for individual patients. 

Because compounded medications frequently differ in formulation, dosage, strength, route of administration, or ingredients, applying FDA-approved labeling wholesale can result in warnings that are irrelevant, confusing, and inaccurate for patients.

Why this matters to patients

Patients deserve clear, accurate information about their medications.

AB 1990 would require advertisements for certain compounded medications to include risk information copied from FDA-approved drugs, even when those warnings may not accurately reflect the compounded medication being prescribed. Because compounded medications are customized for individual patients, they often differ from FDA-approved products in their formulation, dosage, strength, ingredients, or route of administration. Federal law recognizes this distinction. The Federal Food, Drug, and Cosmetic Act expressly exempts compounded medications from the labeling requirements that apply to FDA-approved drugs because compounded medications are individualized preparations, not mass-produced commercial products.

Requiring pharmacies to use warnings that may be inaccurate or clinically irrelevant could confuse patients, discourage appropriate treatment, and expose pharmacies to unnecessary legal risk. Faced with that uncertainty, some pharmacies may choose to stop offering certain compounded medications altogether.

The result isn't better patient protection — it is fewer treatment options and reduced access to medically necessary compounded medications for the Californians who rely on them

WE NEED YOUR HELP

Senators should oppose AB 1990 unless it is amended to address the actual problem: misleading advertising and inappropriate marketing by bad actors.

The Legislature can protect consumers while preserving access to legitimate pharmacy compounding.