Tex. Health & Safety Code § 431.114 · Subchapter E. DRUGS AND DEVICES
NEW DRUGS.
Text — Current through the 89th 2nd Called Legislative Session, 2025
(a) A person shall not sell, deliver, offer for sale, hold for sale or give away any new drug unless:
(1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and
(2) a copy of the letter of approval or approvability issued by the United States Food and Drug Administration is on file with the department if the product is manufactured in this state.
(b) A person shall not use in or on human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the United States Food and Drug Administration a completed and signed investigational new drug (IND) application in accordance with 21 C.F.R. 312.20-312.38 and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) of the federal Act.
(c) This section shall not apply:
(1) to any drug that is not a new drug as defined in the federal Act;
(2) to any drug that is licensed under the Public Health Service Act (42 U.S.C. 201 et seq.); or
(3) to any drug approved by the department by the authority of any prior law.
Notes and commentary — not statutory text
History
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 157, eff. Sept. 1, 1991; Acts 2003, 78th Leg., ch. 111, Sec. 6, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0970, eff. April 2, 2015.
Source of truth
- Edition
- Current through the 89th 2nd Called Legislative Session, 2025
- Official file
- https://statutes.capitol.texas.gov/Docs/HS/htm/HS.431.htm
- Text hash
- sha256 6772fecbe47415104f7a194d47836018658d9244ce094150a84de5c227e4bb5e
- Composed by
- compose_tx.py 2026-10-05: the Legislative Council's chapter files read in document order; verify_tx.py's independent reading (lxml DOM walk) agrees character for character
Cited by 4 provisions
Provisions in this library whose text cites Tex. Health & Safety Code § 431.114. Each shows the citation as that text prints it.
Health and Safety Code
- Tex. Health & Safety Code § 431.021PROHIBITED ACTS.Printed as Section 431.084, 431.114, or 431.115 | Section 431.114
- Tex. Health & Safety Code § 431.048DETAINED OR EMBARGOED ARTICLE.Printed as Section 431.084, 431.114, or 431.115
- Tex. Health & Safety Code § 431.050CONDEMNATION.Printed as Section 431.084, 431.114, or 431.115
- Tex. Health & Safety Code § 431.059CRIMINAL PENALTY; DEFENSES.Printed as Section 431.084 or 431.114
Procedural information only. Not legal advice and not a substitute for the advice of an attorney. Confirm the current text with the official publisher before relying on it.