| (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).
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