84R23912 JSC-D
By: Coleman H.B. No. 3651
Substitute the following for H.B. No. 3651:
By: Crownover C.S.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.