In recent years, California has taken steps to increase its oversight of compounded medications by overhauling the regulations promulgated by the Board of Pharmacy in the name of patient safety. Narratives from large pharmaceutical manufacturers have dangerously conflated two entirely different issues: the illegal sale of fake drugs and the legitimate medical practice of pharmacy compounding.
The black market of counterfeit drugs bears no resemblance to the highly regulated, safety-driven work of licensed compounding pharmacies, and the two should not be conflated
A new bill, AB 1990, would impose duplicative and overly burdensome requirements that risk patients' ability to access critical medications like GLP-1s without creating any clear evidence of improved safety outcomes.
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Compounding pharmacies do not replace or undermine pharmaceutical innovation; they serve patients whose clinical needs are not met by FDA-approved products. Federal law has long recognized compounding as a complementary, patient-specific practice that relies on prescriber judgment. The value compounders provide is access and customization.
Compounding allows pharmacists to meet legitimate patient needs when:
Many medications, including GLP-1s, have experienced sustained supply disruptions and high costs. Prescription-based 503A compounding enables pharmacists to help patients maintain continuity of care within a regulated framework.
1. Reducing Patient Access and Continuity of Care
Compounding plays a critical role during FDA-recognized drug shortages and when commercially available products are not clinically appropriate, but also during FDA-recognized drug shortages, when patients may have no access to the FDA-approved drug at all. The bill may significantly reduce availability of compounded options, limiting physician ability to tailor therapy and negatively impacting patient outcomes. This bill does nothing to address bad actors but rather punishes those already working within the highly stringent federal and state regulatory framework.
2. Restrictive API Sourcing Requirements
AB 1990 would limit the sourcing of active pharmaceutical ingredients (APIs) to FDA-registered manufacturers with a documented inspection history and no import alerts. This requirement is overly restrictive and does not reflect how pharmaceutical supply chains currently operate. This bill may effectively disrupt or eliminate existing supply chains and reduce overall availability of needed substances.
3. Duplicative Testing, Documentation, and Verification Mandates
The bill would impose additional testing and recordkeeping obligations beyond existing USP and FDA expectations, creating operational inefficiencies and significant cost increases, particularly for small and independent pharmacies.
4. Excessive Penalties and Enforcement Provisions
AB 1990 would establish fines of up to $1,000 per dose, which are arbitrary and disproportionate to existing pharmacy enforcement frameworks. In practice, this will deter pharmacists from compounding medically necessary therapies and could put pharmacies out of business, limiting patient access to care.
5. Advertising and Labeling Requirements Not Aligned with Compounding Practice
AB 1990 would require the use of unprecedented safety disclosures on compounded medications derived from FDA-approved products, an unworkable requirement. This would create patient confusion and conflicts with established federal standards and requirements for pharmacy communications.
Patient safety is enforced through state licensure, inspection, adverse-event reporting, professional liability, and adherence to a multitude of standards. Prescribers and pharmacists remain directly accountable to patients—often with more individualized monitoring than mass-market drugs. This is active clinical oversight and accountability, not deregulation.
We urge California lawmakers to stand with patients and protect pharmacy compounding by opposing AB 1990.
