HB 3785

relating to labeling requirements for compounded drug products.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1.  Subchapter D, Chapter 562, Occupations Code, is
amended by adding Section 562.157 to read as follows:
Sec. 562.157.  LABELING OF COMPOUNDED DRUG PRODUCTS.  (a)
(1)  a pharmacy that compounds a sterile or non-sterile
(2)  a manufacturer or other entity that compounds a
drug intended to be distributed:
(A)  through a telepharmacy service;
(B)  by over-the-counter sale; or
(C)  directly from a pharmacist to a patient.
(b)  A pharmacist may not furnish or dispense a compounded
drug to a patient unless the drug is labeled with the following
(2)  the name, address, telephone number, and license
(A)  the pharmacy furnishing or dispensing the
(B)  the pharmacy that prepared the compounded
drug, if that is not the same pharmacy described by Paragraph (A);
(3)  the statement "Compounded Drug, Substitute for
(insert name of drug applicable to the compound)";
(4)  all active ingredients used to prepare the
(5)  the compounded drug's beyond-use date, as
determined by the pharmacist using appropriate documented
(6)  the quantity or amount of the compounded drug in
the container dispensed to the patient;
(7)  appropriate ancillary instructions, including:
(B)  cautionary instructions or statements,
including any hazardous drug warning;
(8)  directions for use, including all appropriate:
(B)  other administration directions, including
as applicable, the appropriate dosage level per time interval;
(9)  any side effects noted from trials, research, and
other appropriate information sources;
(10)  whether the compounded drug was prepared in a
sterile facility or a non-sterile facility; and
(11)  whether the compounded drug was prepared in a
location outside of the pharmacy that furnishes the drug to the
(c)  The board shall adopt rules regarding the labeling
requirements of Subsection (b) in accordance with other existing
SECTION 2.  Not later than December 1, 2025, the Texas State
Board of Pharmacy shall adopt the rules required by Section
562.157, Occupations Code, as added by this Act.
SECTION 3.  This Act takes effect September 1, 2025.