| (a) General. A person who engages in the wholesale
distribution of prescription drugs in this state for use in humans
is exempt from this subchapter if the person is exempt under:
(1) the Prescription Drug Marketing Act of 1987 (PDMA
Act), (21 United States Code (USC) §353(c)(3)(B));
(2) the regulations adopted by the secretary to administer
and enforce the PDMA Act;
(3) the interpretations of the PDMA Act set forth in
the compliance policy manual of the United States Food and Drug Administration;
or
(4) the Texas Occupations Code §562.154.
(b) Exemptions from licensing. Persons who engage in
the following types of distribution of prescription drugs are exempt
from the licensing requirements of this subchapter, to the extent
it does not violate provisions of the Texas Controlled Substances
Act, Texas Health and Safety Code Chapter 481, or the Texas Dangerous
Drug Act, Texas Health and Safety Code Chapter 483:
(1) intracompany sales of prescription drugs, which
means transactions or transfers of prescription drugs between a division,
subsidiary, parent, or affiliated or related company under common
ownership and control, or any transaction or transfer between co-license
holders of a co-licensed product;
(2) the sale, purchase, trade, or transfer of prescription
drugs or the offer to sell, purchase, trade, or transfer a prescription
drug for emergency medical reasons; including a transfer of a prescription
drug by a retail pharmacy to another retail pharmacy to alleviate
a temporary shortage;
(3) the distribution of prescription drug samples by
a representative of a manufacturer;
(4) the return of drugs by a hospital, health care
entity, or charitable institution in accordance with Title 21, Code
of Federal Regulations (CFR) §203.23;
(5) the sale of reasonable quantities by a retail pharmacy
of a prescription drug to a licensed practitioner for office use;
(6) the sale, purchase, or trade of a drug, an offer
to sell, purchase, or trade a drug, or the dispensing of a drug under
a prescription;
(7) the sale, transfer, merger, or consolidation of
all or part of the business of a pharmacy from or with another pharmacy,
whether accomplished as a purchase and sale of stock or business assets;
(8) the delivery of, or offer to deliver, a prescription
drug by a common carrier solely in the common carrier's usual course
of business of transporting prescription drugs, if the common carrier
does not store, warehouse, or take legal ownership of the prescription
drug;
(9) the sale or transfer from a retail pharmacy or
pharmacy warehouse of expired, damaged, returned, or recalled prescription
drugs to the original manufacturer or to a third-party returns processor
in accordance with procedures set out in 21 CFR §203.23(a)(1)
- (5) for returns;
(10) the purchase or other acquisition by a hospital
or other health care entity that is a member of a group purchasing
organization of a drug for its own use from the group purchasing organization
or from other hospitals or health care entities that are members of
such organizations;
(11) the sale, purchase, or trade of a drug or an offer
to sell, purchase, or trade a drug by a charitable organization described
in the Internal Revenue Code of 1986, 26 USC §501(c)(3), to a
nonprofit affiliate of the organization to the extent otherwise permitted
by law;
(12) the sale, purchase, or trade of a drug or an offer
to sell, purchase, or trade a drug among hospitals or other health
care entities that are under common control; for purposes of this
subchapter, common control means the power to direct or cause the
direction of the management and policies of a person or an organization,
whether by ownership of stock, voting rights, contract, or otherwise;
or
(13) the sale, purchase, or trade of blood and blood
components intended for transfusion.
(c) Applicability of other requirements. An exemption
from the licensing requirements granted in subsection (b) of this
section does not constitute an exemption from other applicable requirements
for prescription drugs under this subchapter or under the Texas Food,
Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.
(d) Exemption from certain requirements for certain
wholesale distributors.
(1) A wholesale distributor that distributes only prescription
drugs that are medical gases is exempt from the following requirements: §229.424(d)
of this subchapter (relating to Licensure Requirements), §229.425(b)(4)
- (5), (c) and (d) of this subchapter (relating to Licensing Procedures);
and §229.424(n) and §229.425(h) of this subchapter concerning
bonds.
(2) A wholesale distributor that is a manufacturer
or a third-party logistics provider on behalf of a manufacturer is
exempt from the following requirements: §229.424(d) of this title; §229.425(b)(4)
- (5), (c) and (d) of this subchapter; and §229.424(n) and §229.425(h)
of this subchapter concerning bonds.
(3) A state agency or a political subdivision of this
state that distributes prescription drugs using federal or state funding
to nonprofit health care facilities or local intellectual and developmental
disability authorities, referred to as local mental health or mental
retardation authorities, for distribution to a pharmacy, practitioner,
or patient is exempt from §229.424(d) and (n) and §229.425(d)
and (h) of this subchapter concerning bonds, and §229.429(f)
of this subchapter (relating to Minimum Standards of Licensure) concerning
pedigree.
(4) The executive commissioner of the Texas Health
and Human Services Commission by rule may exempt specific purchases
of prescription drugs by state agencies and political subdivisions
of this state if the executive commissioner determines the requirements
of this subchapter would result in a substantial cost to the state
or a political subdivision of the state.
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