Current through Reg. 49, No. 38; September 20, 2024
(a) General requirements.
(1) All persons engaged in the wholesale distribution of nonprescription
drugs must comply with the applicable minimum standards in this section, in addition to the statutory
requirements contained in the Act and in §
229.242 of this subchapter (relating to Applicable Laws and
Regulations).
(2) For the purpose of this section, the policies
that apply to nonprescription drugs as described in the United States Food and Drug Administration's (FDA)
Compliance Policy Guides are the policies of the department.
(3)
Nonprescription drug wholesalers must not purchase or receive drugs in this state other than from drug
distributors licensed by the department.
(b) Federal
establishment registration and drug listing.
(1) All persons who operate as
nonprescription drug manufacturers in Texas must meet the requirements in 21 Code of Federal Regulations
(CFR) Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs,
Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National
Drug Code.
(2) New nonprescription drugs offered for sale by
wholesale distributors must have met, if applicable, the requirements of 21 CFR Part 314, Applications for
FDA Approval to Market a New Drug.
(c) Good
manufacturing practices. Manufacturers of nonprescription drug products must comply with the applicable
requirements in:
(1) 21 CFR Part 210, Current Good Manufacturing Practice in
Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;
(2) 21 CFR Part 211, Current Good Manufacturing Practice for Finished
Pharmaceuticals, as amended;
(3) 21 CFR Part 225, Current Good
Manufacturing Practice for Medicated Feeds, as amended
(4) 21 CFR
Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended; and
(5) the regulations in this subsection governing the methods used in, and
the facilities or controls used for, the manufacture, processing, packing, or holding of a drug to ensure
each drug meets the requirements of the Federal Food, Drug, and Cosmetic Act,
21 USC §
301, et
seq., as amended, (Federal Act) as to safety, and has the identity and strength meeting the quality and
purity characteristics it purports or is represented to possess.
(d) Buildings and facilities.
(1) All
manufacturing, processing, packing, or holding of drugs by nonprescription drug manufacturers must take place
in buildings and facilities described in subsection (c) of this section.
(2) Manufacturing, processing, packing, or holding of nonprescription drugs
must not be conducted in any personal residence.
(3) Sale of
nonprescription drugs must not be conducted in any flea market.
(4) Any place of business used by a wholesale distributor of
nonprescription drugs who is not a manufacturer to store, warehouse, hold, offer, transport, or display drugs
must:
(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) be maintained in a clean and orderly condition and in good repair,
including the walls, ceilings, windows, doors, and floors of the premises;
(D) be free from infestation by insects, rodents, birds, or vermin of any
kind; and
(E) utilize a quarantine area for storage of drugs that
are outdated, damaged, deteriorated, returned, recalled, misbranded, or adulterated, that is clearly
designated and separated from other sections where drugs are stored so drugs in this subchapter are not
confused with usable drugs.
(e) Storage of
nonprescription drugs. All nonprescription drugs stored by wholesale distributors must be held at appropriate
temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of
such drugs and the standards set forth in the latest edition of the United States Pharmacopeia/National
Formulary (USP/NF). If no storage requirements are established for a nonprescription drug, the
nonprescription drug may be held at controlled room temperature, as defined in the USP/NF, to help ensure
that its identity, strength, quality, and purity are not adversely affected. Prior to storage in inventory, a
wholesale distributor must:
(1) upon receipt, visually examine each outside
shipping container for identity and to prevent the acceptance of contaminated drugs otherwise unfit for
distribution; and
(2) carefully inspect each outgoing shipment
for identity of the drug and to prevent delivery of drugs that have been damaged in storage, including drugs
held under improper conditions.
(f) Operating
procedures for wholesale distributors who are not manufacturers. Written procedures describing the holding of
nonprescription drug products by wholesale distributors of nonprescription drugs who are not manufacturers
must be established and followed and include:
(1) a procedure for
identifying and retrieving nonprescription drug products subject to a recall; and
(2) a quarantine procedure for nonprescription drug products that have
expired; are subject to recall; or are otherwise determined to be adulterated or misbranded, for the return,
destruction, or other disposal of those items.
(g)
Nonprescription drug labeling. Nonprescription drugs sold by wholesale distributors must meet the labeling
requirements of the Act and 21 CFR Part 201, Labeling.
(h)
Nonprescription drugs that are combination products. Any nonprescription drug that is a combination product
as described in §
229.246(c) of this title (relating to Licensure
Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to
Licensing of Device Distributors and Manufacturers).
(i)
Nonprescription drugs that are also cosmetics. Any nonprescription drug that is also a cosmetic or component
thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to
Regulation of Cosmetics).
