Texas House Bill HB3785

Texas 2025 - 89th Regular

• Filed: 3/5/25

Caption

Relating to labeling requirements for compounded drug products.

Impact

If enacted, HB3785 will amend the Occupations Code to introduce Section 562.157, which outlines these labeling requirements. This move is significant as it seeks to address past concerns regarding the safety and efficacy of compounded drugs, especially following incidents that raised awareness about quality control in compounding pharmacies. The bill specifies that the labeling must be clear and informative to both patients and pharmacists, thereby improving the overall standard of care in the pharmacy sector across Texas.

Summary

House Bill 3785 focuses on establishing detailed labeling requirements for compounded drug products. Compounded drugs are those that are mixed or altered by pharmacists to meet the specific needs of patients. The bill aims to enhance the safety and transparency of these products by mandating that pharmacies provide comprehensive information on drug labels. This includes the name and contact details of the pharmacy, active ingredients, dosage instructions, and potential side effects, among other information. It is hoped that these requirements will inform patients better and contribute to their safety when receiving compounded medications.

Contention

While the bill appears to have strong support due to its focus on drug safety, there may be concerns among pharmacists about the feasibility of implementing these comprehensive labeling requirements. Some practitioners may argue that overly detailed labeling could complicate their processes or overwhelm patients with information. Additionally, discussions around the additional regulatory burden could surface, particularly regarding how it impacts smaller pharmacies that may struggle with compliance costs relative to larger chains.

Implementation

The Texas State Board of Pharmacy is tasked with adopting these new rules, with a deadline set for December 1, 2025. The bill is scheduled to take effect on September 1, 2025, providing a timeline for pharmacies to prepare for compliance. This demonstrates a legislated balance between making necessary regulatory adjustments and allowing pharmacies adequate time to adapt to new standards.

Texas Constitutional Statutes Affected

Occupations Code

• Chapter 562. Practice By License Holder
  • Section: New Section