BILL ANALYSIS

C.S.H.B. 4539

By: Johnson

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

The bill author has informed the committee that, during the past decade, Texas ophthalmologists have found increasing challenges in locating medicines in local pharmacies that they prescribe for their patients to manage ocular conditions treated in their offices and that the low-volume nature of these agents makes them cost-ineffective or impractical for most retail pharmacies to stock and manage. The bill author has also informed the committee that most pharmacies can secure or arrange to have these medicines delivered to patients within a few days, but the patient needs to begin using the medicine every few hours following treatment in the physician's office. C.S.H.B. 4539 seeks to permit ophthalmologists to dispense commercially sealed and packaged nonsystemic dangerous drugs in drop or ointment form directly to their patients for certain treatments.

CRIMINAL JUSTICE IMPACT

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

RULEMAKING AUTHORITY

It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.

ANALYSIS

C.S.H.B. 4539 amends the Occupations Code to authorize a physician specializing in ophthalmology to dispense to the physician's patients commercially sealed and packaged nonsystemic dangerous drugs in drop or ointment form for initial, post-examination,
post-procedural, or emergent ophthalmic treatment. The bill authorizes a physician to charge and receive reimbursement for stocking, storing, and labeling a dispensed nonsystemic dangerous drug without obtaining a license to practice pharmacy. The bill requires a physician who dispenses nonsystemic dangerous drugs to do the following:

· comply with each labeling provision under statutory provisions relating to pharmacy and pharmacists applicable to that class of drugs; and

· ensure compliance with packaging and recordkeeping provisions applicable to that class of drugs.

The bill defines "dangerous drug" and "dispense" by reference to the Texas Dangerous Drug Act.

C.S.H.B. 4539 establishes that the Texas Pharmacy Act does not prevent a practitioner from dispensing dangerous drugs to a patient as provided by the bill's provisions.

EFFECTIVE DATE

On passage, or, if the bill does not receive the necessary vote, September 1, 2025.

COMPARISON OF INTRODUCED AND SUBSTITUTE

While C.S.H.B. 4539 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill.

The substitute specifies that the nonsystemic dangerous drugs a physician specializing in ophthalmology may dispense to the physician's patients are commercially sealed and packaged, which the introduced did not do, and changes the purpose for which the drugs are dispensed from ophthalmic use, as in the introduced, to initial, post-examination, post-procedural, or emergent ophthalmic treatment.