Tex. Health & Safety Code Section 431.114
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an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and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.

Source: Section 431.114 — New Drugs, https://statutes.­capitol.­texas.­gov/Docs/HS/htm/HS.­431.­htm#431.­114 (accessed Jun. 5, 2024).

431.001
Short Title 431.002
Definitions 431.003
Article Misbranded Because of Misleading Labeling or Advertising 431.004
Representation of Drug as Antiseptic 431.005
Provisions Regarding Sale of Food, Drugs, Devices, or Cosmetics 431.006
Certain Combination Products 431.007
Compliance with Other Law 431.008
Applicability of Chapter to Distressed or Reconditioned Merchandise and Certain Licensed Entities 431.009
Applicability of Chapter to Frozen Desserts 431.010
Applicability of Chapter to Milk and Milk Products 431.011
Applicability of Chapter to Consumable Hemp Products and Manufacturers 431.021
Prohibited Acts 431.022
Offense: Transfer of Product Containing Ephedrine 431.023
Limited Exemption for Distressed Food, Drugs, Devices, or Cosmetics 431.041
Definition 431.042
Inspection 431.043
Access to Records 431.044
Access to Records Showing Movement in Commerce 431.045
Emergency Order 431.046
Violation of Rules 431.047
Violation 431.048
Detained or Embargoed Article 431.049
Removal Order for Detained or Embargoed Article 431.050
Condemnation 431.051
Destruction of Article 431.052
Correction by Proper Labeling or Processing 431.053
Condemnation of Perishable Articles 431.054
Administrative Penalty 431.055
Administrative Penalty Assessment Procedure 431.056
Payment of Administrative Penalty 431.057
Refund of Administrative Penalty 431.058
Recovery of Administrative Penalty by Attorney General 431.059
Criminal Penalty 431.060
Initiation of Proceedings 431.061
Minor Violation 431.081
Adulterated Food 431.082
Misbranded Food 431.083
Food Labeling Exemptions 431.084
Emergency Permits for Foods Contaminated with Microorganisms 431.111
Adulterated Drug or Device 431.112
Misbranded Drug or Device 431.113
Exemption for Certain Drugs and Devices 431.114
New Drugs 431.115
New Animal Drugs 431.116
Average Manufacturer Price 431.117
Priority for Health Care Providers in Distribution of Influenza Vaccine 431.141
Adulterated Cosmetic 431.142
Misbranded Cosmetic 431.161
Poisonous or Deleterious Substances 431.171
Designation of Consumer Commodity as Abusable Synthetic Substance 431.172
Applicability of Chapter to Abusable Synthetic Substance 431.181
Fair Packaging and Labeling 431.182
False Advertisement 431.183
False Advertisement of Drug or Device 431.201
Definitions 431.202
License Required 431.203
Contents of License Statement 431.204
Fees 431.206
Change of Location of Place of Business 431.207
Refusal to License 431.208
Reporting of Purchase Price 431.0211
Exception 431.221
Definitions 431.222
License Required 431.223
Contents of License Application 431.224
Fees 431.225
Expiration Date 431.226
Refusal to Grant License 431.227
Food Safety Best Practice Education Program 431.241
Rulemaking Authority 431.242
Contested Case Hearings and Appeals 431.244
Federal Regulations Adopted as State Rules 431.245
Definition or Standard of Identity, Quality, or Fill of Container 431.246
Removal of Adulterated Item from Stores 431.247
Delegation of Powers or Duties 431.248
Memorandum of Understanding with Department of Agriculture 431.249
Dissemination of Information 431.250
Public Comments for Federal Grants and Contracts 431.271
Definitions 431.272
License Required 431.273
Exemption from Licensing 431.274
License Application 431.276
Fees 431.278
Change of Location of Place of Business 431.279
Refusal to License 431.321
Definitions 431.322
Donation of Unused Drugs to Charitable Medical Clinic 431.323
Circumstances Under Which Donated Drugs May Be Accepted and Dispensed 431.324
Rules 431.325
Limitation on Liability 431.401
Definitions 431.402
License Required 431.403
Exemption from Licensing 431.404
License Application 431.405
Qualifications for License 431.406
Effect of Operation in Other Jurisdictions 431.407
Criminal History Record Information 431.409
Fees 431.410
Change of Location of Place of Business 431.411
Minimum Restrictions on Transactions 431.412
Pedigree Required 431.413
Pedigree Contents 431.414
Refusal to License 431.415
Order to Cease Distribution 431.0495
Recall Orders 431.0585
Civil Penalty 431.0805
Definitions 431.2011
Applicability of Subchapter 431.2031
Effect of Operation in Other Jurisdictions 431.2211
Application of Subchapter 431.2245
Processing of Licensing Fees 431.2251
Change in Location of Place of Business 431.4011
Ongoing Relationship 431.4012
Applicability of Subchapter 431.4031
Exemption from Certain Provisions for Certain Wholesale Distributors 431.4045
Inspection Required 431.4095
Renewal Notification
Green check means up to date. Up to date

Accessed:
Jun. 5, 2024

§ 431.114’s source at texas​.gov