| (a) General requirements.
(1) 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 the requirements in §229.420 of this subchapter
(relating to Applicable Laws and Regulations).
(2) For the purpose of this section, the policies described
in the United States Food and Drug Administration (FDA) Compliance
Policy Guides as they apply to prescription drugs are the policies
of the department.
(3) Prescription 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.
All persons who operate as prescription drug manufacturers in Texas
must meet the requirements in 21 Code of Federal Regulations (CFR)
Part 207, titled 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. New prescription drugs offered for sale
by wholesale distributors must meet, if applicable, the requirements
of 21 CFR Part 314, Applications for FDA Approval to Market a New
Drug.
(c) Good manufacturing practices. Manufacturers of
prescription 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;
(2) 21 CFR Part 211, Current Good Manufacturing Practice
for Finished Pharmaceuticals;
(3) 21 CFR Part 225, Current Good Manufacturing Practice
for Medicated Feeds;
(4) 21 CFR Part 226, Current Good Manufacturing Practice
for Type A Medicated Articles; 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 United
States Code (USC) §301, et seq., as amended, (Federal Act) as
to safety, and has the identity and strength and meets 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 prescription drug manufacturers must take place in buildings
and facilities described in subsection (c) of this section.
(2) Manufacturing, processing, packing, or holding
of prescription drugs must not be conducted in any personal residence.
(3) Sale of prescription drugs must not 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 must:
(A) comply with §229.420(a)(14) of this subchapter;
(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.
(e) Storage of prescription drugs. All prescription
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.
(f) Minimum restrictions on transactions.
(1) Returns.
(A) A wholesale distributor must receive prescription
drug returns or exchanges from a pharmacy or pharmacy warehouse in
accordance with the terms and conditions of the agreement between
the wholesale distributor and the pharmacy or pharmacy warehouse.
An expired, damaged, recalled, or otherwise nonsalable prescription
drug returned to the wholesale distributor may be distributed by the
wholesale distributor only to either the original manufacturer or
a third party returns processor. The returns or exchanges, salable
or otherwise, received by the wholesale distributor as provided by
this subsection, including any redistribution of returns or exchanges
by the wholesale distributor, are not subject to the pedigree requirement
under Texas Health and Safety Code §431.412, if the returns or
exchanges are exempt from pedigree under:
(i) §503, Prescription Drug Marketing Act of 1987
(21 USC §353(c)(3)(B));
(ii) the regulations adopted by the Secretary of the
U.S. Department of Health and Human Services to administer and enforce
the Act in clause (i) of this subsection; or
(iii) the interpretations of the Act in clause (i)
of this subsection, set out in the compliance policy guide of the
FDA.
(B) Each wholesale distributor and pharmacy must administer
the process of drug returns and exchanges to ensure the process is
secure and does not permit the entry of adulterated or counterfeit
drugs into the distribution channel.
(C) Notwithstanding any provision of state or federal
law to the contrary, a person not otherwise required to obtain a wholesale
license under this subchapter and that is a pharmacy engaging in the
sale or transfer of expired, damaged, returned, or recalled prescription
drugs to the originating wholesale distributor or manufacturer and
pursuant to federal statute, rules, and regulations, including the
FDA applicable guidance implementing the Prescription Drug Marketing
Act of 1987 (Pub. L. No. 100 - 293), is exempt from wholesale licensure
requirements under this subchapter.
(D) All other returns must comply with the requirements
of 21 CFR §203.23(a)(1) - (5).
(2) Distributions. A manufacturer or wholesale distributor
may distribute prescription drugs only to a person licensed under
this subchapter, or the appropriate state licensing authorities, if
an out-of-state wholesaler or retailer, or to a person authorized
by federal law to receive the drug. Before furnishing prescription
drugs to a person not known to the manufacturer or wholesale distributor,
the manufacturer or wholesale distributor must verify the person is
legally authorized by the department or the appropriate state licensing
authority to receive the prescription drugs or is authorized by federal
law to receive the drugs. Wholesale distributors physically located
and conducting operations in another state must verify, before purchasing
or receiving product, the suppliers of drugs are licensed under this
subchapter and physically located in Texas; and must notify the department
of unlicensed wholesale distributors.
(3) Pedigree.
(A) A person, who is engaged in the wholesale distribution
of a prescription drug, including a repackager but excluding the original
manufacturer, must provide a pedigree for each prescription drug for
human consumption that leaves or at any time left the normal distribution
channel and is sold, traded, or transferred to any other person.
(B) A retail pharmacy or pharmacy warehouse is required
to comply with this section only if the pharmacy or warehouse engages
in the wholesale distribution of a prescription drug.
(C) A person who is engaged in the wholesale distribution
of a prescription drug, including a repackager, but excluding the
original manufacturer of the finished form of a prescription drug,
and who is in possession of a pedigree for a prescription drug must
verify before distributing the prescription drug that each transaction
listed on the pedigree has occurred.
(D) A pedigree must include all necessary identifying
information concerning each sale in the product's chain of distribution
from the manufacturer, through acquisition and sale by a wholesale
distributor or repackager, until final sale to a pharmacy or other
person dispensing or administering the drug. At a minimum, the chain
of distribution information must include:
(i) the name, address, telephone number, and, if available,
the e-mail address of each person who owns the prescription drug and
each wholesale distributor of the prescription drug;
(ii) the name and address of each location from which
the product was shipped, if different from the owner's name and address;
(iii) the transaction dates; and
(iv) certification that each recipient has authenticated
the pedigree.
(E) The pedigree must include, at a minimum, the:
(i) name of the prescription drug;
(ii) dosage form and strength of the prescription drug;
Cont'd... |
