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
Universal Citation: 25 TX Admin Code ยง 229.429
Current through Reg. 49, No. 38; September 20, 2024
(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;
(iii) size of the container;
(iv) number of containers;
(v)
lot number of the prescription drug; and
(vi) name of the
manufacturer of the finished dosageform.
(F) Each
pedigree statement must be:
(i) maintained by the purchaser and the
wholesale distributor for at least three years; and
(ii)
available for inspection and duplication not later than the second business day after the date a request is
submitted by the department or a peace officer in this state.
(G) Verification procedures.
(i) Each
transaction listed on the pedigree must be affirmatively authenticated before any wholesale distribution of a
prescription drug.
(ii) A person who is engaged in the wholesale
distribution of a prescription drug, and who is in possession of a pedigree for a prescription drug must
certify, using the following methods, each transaction listed on the pedigree has occurred.
(I) Invoice confirmation. Receipt of an invoice (or shipping document) from
the seller to the purchaser, which may have the prices redacted. Documentation requirements include, at a
minimum, a copy of the invoice or shipping document. If this method is used to authenticate a pedigree, the
wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency with
other invoices or shipping documents from that manufacturer or wholesaler, and must randomly verify the
authenticity of the invoice or shipping document with the seller or shipping point reflected on that document
using one of the methods in the subsections below. Each wholesaler must establish policies and procedures for
the random verification of the authenticity of the invoices or shipping documents according to statistically
sound standards. Each wholesaler must establish policies and procedures for verification with those
wholesalers in the distribution chain with which the wholesaler performing the authentication does not have
an established prescription drug vendor relationship.
(II)
Telephonic confirmation. Documentation requirements include a signed statement by the person placing the
telephone call identifying the person's name and position title representing the seller who provides the
information, the date the information was provided, and verification of the sales transaction between the
parties, including verification of the date of the transaction and the quantity of prescription drugs
involved in the transaction.
(III) Electronic mail confirmation.
Documentation requirements include a copy of the e-mail identifying the person's name and position title
representing the seller who provides the information, the date the information was provided, and verification
of the sales transaction between the parties, including verification of the date of the transaction and
quantity of prescription drugs involved in the transaction.
(IV)
Electronic web-based confirmation. Verification of the transaction per a web-based system established by the
seller or an independent person secure from intentional or unintentional tampering or manipulation to conceal
an accurate and complete history of the prescription drug transactions. Documentation requirements include a
written representation from the seller or independent person that the seller or independent person, as
applicable, is responsible for the information included on the website and has adequate security on the
information posted to prevent unauthorized tampering, manipulation, or modification of the information and a
copy of the dated website page confirming the sales transaction between the parties, including the date of
the transaction and quantity of prescription drugs involved in the transaction.
(V) Notarized copy confirmation. Receipt of a legible and unaltered copy of
a previous transaction's pedigree paper signed under oath at the time of the previous transaction to support
the transaction to which the pedigree paper relates. If this method is used to authenticate a pedigree, the
wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency, and
must randomly verify the authenticity of pedigrees using one of the methods in this subparagraph. Each
wholesaler must establish policies and procedures for the random verification of the authenticity of these
copies of pedigree according to statistically sound standards.
(VI) Exclusive purchasing. A wholesale distributor may use a written
agreement between the wholesale distributor and an authorized distributor of record requiring all
prescription drugs distributed to the wholesale distributor by the authorized distributor of record, be
purchased by the authorized distributor of record from the manufacturer. If this method is used to
authenticate a pedigree, the wholesale distributor must establish policies and procedures for the random
verification of the authenticity of the pedigrees that disclose the authorized distributor of record
purchased the prescription drug from the manufacturer according to statistically sound standards.
(VII) Other methods. Any other method approved by the department.
(4) Premises. Prescription drugs distributed
by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license,
except as listed in paragraph (5) of this subsection. A manufacturer or wholesale distributor may distribute
prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or
wholesale distributor if:
(A) the identity and authorization of the
recipient is properly established; and
(B) delivery is made only
to meet the immediate needs of a particular patient of the authorized person.
(5) Delivery to hospital pharmacies. Prescription drugs may be distributed
to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of
delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between
the receipt and the type and quantity of the prescription drug actually received must be reported to the
delivering manufacturer or wholesale distributor not later than the next business day after the date of
delivery to the pharmacy receiving area.
(g) Prescription drug labeling. Prescription drugs sold by wholesale distributors must meet the labeling requirements of the Act and those adopted in § 229.420(a) of this subchapter.
(h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in § 229.424(c) of this subchapter (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) Prescription drugs that are also cosmetics. Any prescription 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).
(j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs must comply with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices).
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