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


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.
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