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TX HB3785
Bill
Status
3/5/2025
Primary Sponsor
Barbara Gervin-Hawkins
Click for details
AI Summary
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Requires pharmacists to label all compounded drugs (sterile and non-sterile) with specific information before dispensing to patients, including patient name, pharmacy contact details and license number, and a statement identifying the drug as a compounded substitute
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Mandates labels include all active ingredients, beyond-use date, quantity dispensed, storage instructions, cautionary statements including hazardous drug warnings, and dosage/administration directions
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Requires disclosure of known side effects from trials and research, whether the drug was prepared in a sterile or non-sterile facility, and whether it was prepared at a location outside the dispensing pharmacy
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Applies to pharmacies compounding preparations and manufacturers/entities distributing compounded drugs through telepharmacy services, over-the-counter sales, or directly from pharmacist to patient
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Directs the Texas State Board of Pharmacy to adopt implementing rules by December 1, 2025, with the act taking effect September 1, 2025
Legislative Description
Relating to labeling requirements for compounded drug products.
Health
Last Action
Failed to receive affirmative vote in comm.
4/28/2025