22 Tex. Admin. Code § 281.8 - Grounds for Discipline for a Pharmacy License
(a) For the purposes of §565.002(a)(9)
of the Act, a pharmacy fails to establish and maintain effective controls
against diversion of prescription drugs when:
(1) there is inadequate security or
procedures to prevent unauthorized access to prescription drugs; or
(2) there is inadequate security or
procedures to prevent the diversion of prescription drugs.
(b) For the purposes of §565.002(a)(3)
of the Act, it is grounds for discipline for a pharmacy license when:
(1) during the time an individual's license
to practice pharmacy, either as a pharmacist or a pharmacist-intern, or a
pharmacy technician's registration has been disciplined by the Board, resulting
in the license or registration being revoked, canceled, retired, surrendered,
denied or suspended, the pharmacy employs or allows such individual access to
prescription drugs;
(2) the
pharmacy possesses or engages in the sale, purchase, or trade or the offer to
sell, purchase, or trade prescription drug samples; provided however, this
paragraph does not apply to:
(A) prescription
drugs provided by a manufacturer as starter prescriptions or as replacement for
such manufacturer's outdated drugs;
(B) prescription drugs provided by a
manufacturer in replacement for such manufacturer's drugs that were dispensed
pursuant to written starter prescriptions; or
(C) prescription drug samples possessed by a
pharmacy of a health care entity which provides health care primarily to
indigent or low income patients at no or reduced cost and if:
(i) the samples are possessed in compliance
with the Prescription Drug Marketing Act of 1987;
(ii) the pharmacy is owned by a charitable
organization described in the Internal Revenue Code of 1986, §501(c)(3),
or by a city, state or county government; and
(iii) the samples are for dispensing or
provision at no charge to patients of such health care entity;
(3) the pharmacy
possesses or engages in the sale, purchase, or trade or the offer to sell,
purchase, or trade of prescription drugs:
(A)
sold for export use only;
(B)
purchased by a public or private hospital or other health care entity;
or
(C) donated or supplied at a
reduced price to a charitable organization described in the Internal Revenue
Code of 1986, §501(c)(3), and possessed by a pharmacy other than one owned
by the charitable organization;
(D)
provided that subparagraphs (A) - (C) of this paragraph do not apply to:
(i) the purchase or other acquisition by a
hospital or other health care entity which is a member of a group purchasing
organization or from other hospitals or health care entities which are members
of such organization;
(ii) the
sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
drug by an organization described in paragraph (2)(C)(ii) of this subsection to
a nonprofit affiliate of the organization to the extent otherwise permitted by
law;
(iii) 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 which are under common control;
(iv) the sale, purchase, or trade of a drug
or an offer to sell, purchase, or trade a drug for emergency medical reasons
including the transfer of a drug between pharmacies to alleviate temporary
shortages of the drug arising from delays in or interruptions of regular
distribution schedules;
(v) the
dispensing of a prescription drug pursuant to a valid prescription drug order
to the extent otherwise permitted by law;
(4) the pharmacy engages in the sale,
purchase, or trade or the offer to sell, purchase, or trade of:
(A) misbranded prescription drugs;
or
(B) prescription drugs beyond
the manufacturer's expiration date.
(5) the owner or managing officer has
previously been disciplined by the board; or
(6) a non-resident pharmacy fails to
reimburse the board or its designee for all expenses, including travel,
incurred by the board in inspecting the non-resident pharmacy as specified in
§556.0551 of the Act;
(7) the
owner, managing officer(s), or other pharmacy employee(s) displays abusive,
intimidating, or threatening behavior toward a board member or employee during
the performance of such member's or employee's lawful duties; or
(8) the pharmacy waived, discounted, or
reduced, or offered to waive, discount, or reduce, a patient copayment or
deductible for a compounded drug in the absence of:
(A) a legitimate, documented financial
hardship of the patient; or
(B)
evidence of a good faith effort to collect the copayment or deductible from the
patient.
(c)
For the purposes of §565.002(a)(10) of the Act, the terms "fraud,"
"deceit," or "misrepresentation" in operating a pharmacy or in seeking a
license to operate shall be defined as follows:
(1) "Fraud" means an intentional perversion
of truth for the purpose of inducing another in reliance upon it to part with
some valuable thing belonging to him, or to surrender a legal right, or to
issue a license; a false representation of a matter of fact, whether by words
or by conduct, by false or misleading allegations, or by concealment of that
which should have been disclosed, which deceives or is intended to deceive
another;
(2) "Deceit" means the
assertion, as a fact, of that which is not true by any means whatsoever to
deceive or defraud another; and
(3)
"Misrepresentation" means a manifestation by words or other conduct which is a
false representation of a matter of fact.
Notes
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