Bill > HB3785

This bill establishes comprehensive labeling requirements for compounded drug products in Texas, applying to pharmacies and manufacturers that create sterile or non-sterile drug preparations for distribution. Specifically, pharmacists will now be required to include detailed information on labels such as the patient's name, the pharmacy's contact and license details, a statement that the drug is a compounded substitute, all active ingredients, a beyond-use date, quantity dispensed, storage and cautionary instructions, dosage directions, potential side effects, and whether the drug was prepared in a sterile or non-sterile facility and at the same or a different location from where it will be dispensed. The Texas State Board of Pharmacy is mandated to adopt specific rules about these labeling requirements by December 1, 2025, with the law taking effect on September 1, 2025. This legislation aims to provide patients with comprehensive and transparent information about compounded medications, enhancing patient safety and understanding of their prescribed drugs.

Health and Social Services

https://capitol.texas.gov/BillLookup/History.aspx?LegSess=89R&Bill=HB3785