Bill Text: TX HB3651 | 2015-2016 | 84th Legislature | Engrossed

Texas House Bill 3651 (Prior Session Legislation)

Bill Title: Relating to the manufacture, sale, distribution, possession, and use of drugs not approved by the United States Food and Drug Administration and the false representation that a substance is a drug approved by the United States Food and Drug Administration or intended for the prevention or treatment of diseases in humans; creating criminal offenses.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Engrossed - Dead) 2015-05-13 - Referred to Health & Human Services [HB3651 Detail]

Download: Texas-2015-HB3651-Engrossed.html

	84R23912 JSC-D

	By: Coleman, Walle	H.B. No. 3651



	A BILL TO BE ENTITLED
	AN ACT
	relating to the manufacture, sale, distribution, possession, and
	use of drugs not approved by the United States Food and Drug
	Administration and the false representation that a substance is a
	drug approved by the United States Food and Drug Administration or
	intended for the prevention or treatment of diseases in humans;
	creating criminal offenses.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
	SECTION 1. Chapter 431, Health and Safety Code, is amended
	by adding Subchapter E-1 to read as follows:
	SUBCHAPTER E-1. DRUGS NOT APPROVED BY THE UNITED STATES FOOD AND
	DRUG ADMINISTRATION
	Sec. 431.121. DEFINITION. In this subchapter, "unapproved
	drug" means a drug that is:
	(1) unsafe for self-medication;
	(2) not approved by the United States Food and Drug
	Administration; and
	(3) not listed in Schedules I through V or Penalty
	Groups 1 through 4 of Chapter 481.
	Sec. 431.122. OFFENSE: MANUFACTURE, SALE, OR DISTRIBUTION
	OF UNAPPROVED DRUG. (a) A person commits an offense if the person
	manufactures, sells, distributes, or possesses with the intent to
	deliver an unapproved drug.
	(b) An offense under this section is a state jail felony.
	(c) This section does not apply to:
	(1) any drug, regardless of whether approved by the
	United States Food and Drug Administration, 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
	(2) a foreign drug not approved by the United States
	Food and Drug Administration that is imported in compliance with:
	(A) federal or state law; or
	(B) an announcement by the United States Food and
	Drug Administration authorizing the import of the drug, including
	for clinical research, drug shortages, and pandemic preparedness
	and response.
	Sec. 431.123. OFFENSE: MISREPRESENTATION OF SUBSTANCE OR
	DRUG. (a) A person commits an offense if the person falsely
	represents to an individual to whom the actor or another person is
	selling or distributing a substance that the substance is:
	(1) a drug approved for human use by the United States
	Food and Drug Administration; or
	(2) intended for use in the cure, mitigation,
	treatment, or prevention of disease in humans.
	(b) A person commits an offense if the person falsely
	represents to an individual to whom the actor or another person is
	selling or distributing a drug that is approved for human use by the
	United States Food and Drug Administration that the drug is:
	(1) a different drug approved for human use by the
	United States Food and Drug Administration; or
	(2) 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.
	(c) An offense under Subsection (a) is a state jail felony,
	except that if the substance is an unapproved drug, the offense is a
	felony of the third degree.
	(d) An offense under Subsection (b) is a state jail felony,
	except that if the drug may be dispensed only by prescription or is
	not approved for use in humans, the offense is a felony of the third
	degree.
	Sec. 431.124. OFFENSE: POSSESSION OR USE OF UNAPPROVED
	DRUG. (a) A person commits an offense if the person possesses for
	use or uses an unapproved drug.
	(b) An offense under this section is a Class A misdemeanor.
	(c) It is a defense to prosecution under this section that:
	(1) the actor obtained the unapproved drug from a
	practitioner, pharmacist, or other person authorized to dispense
	prescription drugs; and
	(2) the person dispensing the unapproved drug made the
	representation to the person that the drug was approved by the
	United States Food and Drug Administration for prescription use.
	Sec. 431.125. EFFECT ON OTHER LAWS. A person who is subject
	to prosecution under this subchapter or other law may be prosecuted
	under either or both laws.
	SECTION 2. This Act takes effect September 1, 2015.