Tex. Health & Safety Code Section 431.111
Adulterated Drug or Device


A drug or device shall be deemed to be adulterated:

(a)

(1) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or

(2)

(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

(B)

if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or

(3)

if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(4)

if it:

(A)

bears or contains, for purposes of coloring only, a color additive that is unsafe under Section 431.161 (Poisonous or Deleterious Substances)(a); or

(B)

is a color additive, the intended use of which in or on drugs or devices is for purposes of coloring only, and is unsafe under Section 431.161 (Poisonous or Deleterious Substances)(a); or

(5)

if it is a new animal drug that is unsafe under Section 512 of the federal Act;

(b)

if it purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. Such determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under the authority of the federal Act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standards of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standards is plainly stated on its label. Whenever a drug is recognized in The United States Pharmacopeia and The National Formulary (USP-NF), it shall be subject to the requirements of the USP-NF;

(c)

if it is not subject to Subsection (b) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

(d)

if it is a drug and any substance has been:

(1)

mixed or packed therewith so as to reduce its quality or strength; or

(2)

substituted wholly or in part therefor;

(e)

if it is, or purports to be or is represented as, a device that is subject to a performance standard established under Section 514 of the federal Act, unless the device is in all respects in conformity with the standard;

(f)

(1) if it is a class III device:

(A)

(i) that is required by a regulation adopted under Section 515(b) of the federal Act to have an approval under that section of an application for premarket approval and that is not exempt from Section 515 as provided by Section 520(g) of the federal Act; and
(ii)
(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the United States Food and Drug Administration by the 90th day after the date of adoption of the regulation; or
(II)
for which that application was filed and approval was denied or withdrawn, for which that notice was filed and was declared incomplete, or for which approval of the device under the protocol was withdrawn;

(B)

that was classified under Section 513(f) of the federal Act into class III, which under Section 515(a) of the federal Act is required to have in effect an approved application for premarket approval, that is not exempt from Section 515 as provided by Section 520(g) of the federal Act, and that does not have the application in effect; or

(C)

that was classified under Section 520(l) of the federal Act into class III, which under that section is required to have in effect an approved application under Section 515 of the federal Act, and that does not have the application in effect, except that:

(2)

(A) in the case of a device classified under Section 513(f) of the federal Act into class III and intended solely for investigational use, Subdivision (1)(B) does not apply to the device during the period ending on the 90th day after the date of adoption of the regulations prescribing the procedures and conditions required by Section 520(g)(2) of the federal Act; and

(B)

in the case of a device subject to a regulation adopted under Section 515(b) of the federal Act, Subdivision (1) does not apply to the device during the period ending on whichever of the following dates occurs later:
(i)
the last day of the 30-day calendar month beginning after the month in which the classification of the device into class III became effective under Section 513 of the federal Act; or
(ii)
the 90th day after the date of adoption of the regulation;

(g)

if it is a banned device;

(h)

if it is a device and the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installations are not in conformity with applicable requirements under Section 520(f)(1) of the federal Act or an applicable condition as prescribed by an order under Section 520(f)(2) of the federal Act; or

(i)

if it is a device for which an exemption has been granted under Section 520(g) of the federal Act for investigational use and the person who was granted the exemption or any investigator who uses the device under the exemption fails to comply with a requirement prescribed by or under that section.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 440, Sec. 2, eff. Sept. 1, 1993.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0968, eff. April 2, 2015.

Source: Section 431.111 — Adulterated Drug or Device, https://statutes.­capitol.­texas.­gov/Docs/HS/htm/HS.­431.­htm#431.­111 (accessed Mar. 23, 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

Accessed:
Mar. 23, 2024

§ 431.111’s source at texas​.gov