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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER XLICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
RULE §229.441Minimum Standards for Licensure

(a) Minimum requirements. All distributors or manufacturers of devices engaged in the design, manufacture, packaging, labeling, storage, installation, and servicing of devices must comply with the minimum standards of this section in addition to the statutory requirements contained in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act). For the purpose of this section, the policies described in the United States Food and Drug Administration's (FDA's) Compliance Policy Guides as they apply to devices shall be the policies of the Department of State Health Services (department).

(b) Federal establishment registration and device listing. All persons who operate as device distributors or manufacturers in Texas shall meet the applicable requirements in 21 Code of Federal Regulations (CFR), Part 807, titled "Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices." Devices distributed by device distributors or manufacturers shall have met, if applicable, the premarket notification requirements of 21 CFR, Part 807 or the premarket approval provisions of 21 CFR, Part 814, titled "Premarket Approval of Medical Devices."

(c) Good manufacturing practices. Device distributors or manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices shall be in compliance with the applicable requirements of 21 CFR, Part 820, titled "Quality System Regulation." The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

(d) Buildings and facilities.

  (1) All manufacturing, assembling, packaging, packing, holding, testing, or labeling of devices by manufacturers shall take place in buildings and facilities described in 21 CFR, Part 820, Subpart L, titled "Handling, Storage, Distribution, and Installation."

  (2) No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of devices by manufacturers or distributors shall be conducted in any personal residence.

  (3) Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices shall:

    (A) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

    (B) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;

    (C) have a quarantine area for storage of devices that are outdated, damaged, deteriorated, misbranded, or adulterated;

    (D) be maintained in a clean and orderly condition; and

    (E) be free from infestation by insects, rodents, birds, or vermin of any kind.

(e) Storage of devices. All devices stored by distributors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such devices.

(f) Device labeling. Devices distributed by device distributors or manufacturers shall meet the labeling requirements of the Act and 21 CFR, Part 801, titled "Labeling."

(g) Device labeling exemptions. Device labeling or packaging exemptions adopted under the Federal Food, Drug, and Cosmetic Act, as amended, shall apply to devices in Texas except insofar as modified or rejected by rules of the Executive Commissioner of the Health and Human Services Commission.

(h) Reconditioned devices. Reconditioned devices must comply with the provisions of the Act and these sections and are subject to the provisions of the Texas Food, Drug, Device and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.

(i) Medical device reporting. Device distributors or manufacturers shall meet the applicable medical device reporting requirements of 21 CFR, Part 803, titled "Medical Device Reporting".

(j) Radiation emitting devices. Devices which emit electronic product radiation and are distributed by device distributors or manufacturers shall meet the applicable requirements of the Act and 21 CFR, Subchapter J, titled "Radiological Health."

(k) Distribution of prescription devices.

  (1) A prescription device in the possession of a device distributor or manufacturer licensed under these sections of this subchapter is exempt from Health and Safety Code, §431.112(f)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR, §801.109, titled "Prescription devices" and 801.110, titled "Retail exemption for prescription devices".

  (2) Each device distributor or manufacturer who distributes prescription devices shall maintain a record for every prescription device, showing the identity and quantity received or manufactured and the disposition of each device.

  (3) Each device distributor or manufacturer who delivers a prescription device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.

(l) Sale of contact lenses at flea markets. Contact lenses may not be sold by persons at flea markets unless:

  (1) the person selling the contact lenses has complied with the requirements of Business and Commerce Code, §35.55; and

  (2) the person selling the contact lenses has complied with the requirements of the Texas Contact Lens Prescription Act, Texas Civil Statutes, Article 4552-A.


Source Note: The provisions of this §229.441 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective March 7, 2007, 32 TexReg 1076

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