BILL ANALYSIS |
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C.S.H.B. 3651 |
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By: Coleman |
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Public Health |
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Committee Report (Substituted) |
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BACKGROUND AND PURPOSE
Currently, it is difficult to prosecute a person who manufactures, sells, distributes, or misrepresents a drug that is not approved by the U.S. Food and Drug Administration (FDA) because the relevant laws are limited in scope. These unapproved drugs can be dangerous to the public because the manufacturing and supply chain is outside of the FDA's regulatory control. The purpose of C.S.H.B. 3651 is to put pressure on both the supply side and the demand side to combat the dangers of unapproved drugs.
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CRIMINAL JUSTICE IMPACT
It is the committee's opinion that this bill expressly does one or more of the following: creates a criminal offense, increases the punishment for an existing criminal offense or category of offenses, or changes the eligibility of a person for community supervision, parole, or mandatory supervision.
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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.
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ANALYSIS
C.S.H.B. 3651 amends the Health and Safety Code to make it a state jail felony to manufacture, sell, distribute, or possess with the intent to deliver an unapproved drug, defined by the bill as a drug that is unsafe for self-medication, not approved by the U.S. Food and Drug Administration (FDA), and not listed in Schedules I through V or Penalty Groups 1 through 4 of the Texas Controlled Substances Act. The bill excludes from this offense any drug, regardless of whether the drug is FDA-approved, that is manufactured, packaged, distributed, or possessed for use in pharmaceutical compounding by a licensed pharmacist, physician, or registered outsourcing facility in compliance with federal law or a foreign drug that is not FDA-approved and is imported in compliance with federal or state law or an announcement by the FDA authorizing the import of the drug.
C.S.H.B. 3651 makes it a state jail felony to falsely represent to an individual to whom the actor or another person is selling or distributing a substance that the substance is a drug approved for human use by the FDA or intended for use in the cure, mitigation, treatment, or prevention of disease in humans and enhances the penalty for the offense to a third degree felony if the substance is an unapproved drug. The bill makes it a state jail felony to falsely represent to an individual to whom the actor or another person is selling or distributing a drug that is approved for human use by the FDA that the drug is a different drug approved for human use by the FDA or intended for use in the cure, mitigation, treatment, or prevention of a disease in humans when the drug is not approved or used in clinical practice for that purpose and enhances the penalty for the offense to a third degree felony if the drug is authorized to be dispensed only by prescription or is not approved for use in humans.
C.S.H.B. 3651 makes it a Class A misdemeanor to possess for use or use an unapproved drug and establishes a defense to prosecution for the offense if the actor obtained the unapproved drug from a practitioner, pharmacist, or other person authorized to dispense prescription drugs and the person dispensing the unapproved drug made the representation to the actor that the drug was approved by the FDA for prescription use. The bill establishes that a person who is subject to prosecution under the bill's provisions or other law may be prosecuted under either or both laws.
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EFFECTIVE DATE
September 1, 2015. |
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COMPARISON OF ORIGINAL AND SUBSTITUTE
While C.S.H.B. 3651 may differ from the original in minor or nonsubstantive ways, the following comparison is organized and formatted in a manner that indicates the substantial differences between the introduced and committee substitute versions of the bill.
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