Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.429 - Minimum Standards for Licensure

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  General requirements. All persons engaged in the wholesale distribution of
				  prescription drugs must comply with the applicable minimum standards in this
				  section, in addition to the statutory requirements contained in the Texas Food,
				  Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) and those
				  requirements in §
										229.420
				  of this title (relating to Applicable Laws and Regulations). 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 prescription
				  drugs shall be the policies of the department.
(b) Federal establishment registration and
				  drug listing. All persons who operate as prescription drug manufacturers in
				  Texas shall meet the requirements in 21 Code of Federal Regulations (CFR), Part
				  207, titled "Registration of Producers of Drugs and Listing of Drugs in
				  Commercial Distribution." New prescription drugs offered for sale by wholesale
				  distributors shall have met, if applicable, the requirements of 21 CFR, Part
				  314, titled "Applications for FDA Approval to Market a New Drug."
(c) Good manufacturing practices.
				  Manufacturers of prescription drug products shall be in compliance with the
				  applicable requirements in 21 CFR, Part 210, titled "Current Good Manufacturing
				  Practice in Manufacturing, Processing, Packing, or Holding of Drugs"; 21 CFR,
				  Part 211, titled "Current Good Manufacturing Practice for Finished
				  Pharmaceuticals; General"; 21 CFR, Part 225, titled "Current Good Manufacturing
				  Practice for Medicated Feeds"; and 21 CFR, Part 226, titled "Current Good
				  Manufacturing Practice for Type A Medicated Articles." The regulations in these
				  parts govern the methods used in, and the facilities or controls used for, the
				  manufacture, processing, packing, or holding of a drug to assure that each drug
				  meets the requirements of the Federal Act as to safety, and has the identity
				  and strength and meets the quality and purity characteristics that it purports
				  or is represented to possess.
(d)
				  Buildings and facilities.
(1) All
				  manufacturing, processing, packing, or holding of drugs by prescription drug
				  manufacturers shall take place in buildings and facilities described in
				  subsection (c) of this section.
(2)
				  No manufacturing, processing, packing, or holding of prescription drugs shall
				  be conducted in any personal residence.
(3) No sale of prescription drugs shall be
				  conducted in any flea market.
(4)
				  Any place of business used by a wholesale distributor of prescription drugs who
				  is not a manufacturer to store, warehouse, hold, offer, transport, or display
				  drugs shall:
(A) be in compliance with the
				  requirements adopted in §
												229.420(a)(14)
				  of this title;
(B) be of suitable
				  size and construction to facilitate cleaning, maintenance, and proper
				  operations;
(C) have storage areas
				  designed to provide adequate lighting, ventilation, temperature, sanitation,
				  humidity, and space;
(D) be
				  maintained in a clean and orderly condition;
(E) be free from infestation by insects,
				  rodents, birds, or vermin of any kind; and
(F) have a quarantine area for storage of
				  drugs that are outdated, damaged, deteriorated, misbranded, or
				  adulterated.