Texas § HS.431.114 - NEW DRUGS
Full text of Texas The Texas Constitution § HS.431.114 — NEW DRUGS, with citation guidance and answers to common questions.
§ HS.431.114. NEW DRUGS
NEW DRUGS. (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give away any new drug unless: (1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and (2) a copy of the letter of approval or approvability issued by the United States Food and Drug Administration is on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. 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.
Frequently Asked Questions About Texas § HS.431.114
What does The Texas Constitution § HS.431.114 cover?
Section HS.431.114 ("NEW DRUGS") is part of the The Texas Constitution, the codified statutory law of Texas. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.
How do I cite Texas § HS.431.114?
A common citation format is "The Texas Constitution § HS.431.114" (Texas). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.
Is this the official text of Texas law?
No. This page is for research and education and may not include the most recent amendments. For official current law, check the Texas official source linked on this page or consult a licensed Texas attorney.
How does Texas § HS.431.114 apply to my situation?
Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in Texas can advise on how this section applies to you. Contact your state or local bar association for a referral.
Sources & Verification
Not legal advice. Verify against the official source and consult a licensed attorney in Texas.