| (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starter prescriptions or as replacement for such manufacturer's outdated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.
|
| Source Note: The provisions of this §281.8 adopted to be effective December 30, 1998, 23 TexReg 13073; amended to be effective July 14, 1999, 24 TexReg 5193; amended to be effective December 27, 2000, 25 TexReg 12688; amended to be effective March 12, 2003, 28 TexReg 2082; amended to be effective June 6, 2004, 29 TexReg 5347; amended to be effective March 25, 2007, 32 TexReg 1507; amended to be effective September 14, 2010, 35 TexReg 8355; amended to be effective March 15, 2015, 40 TexReg 1085; amended to be effective March 10, 2016, 41 TexReg 1689; amended to be effective September 11, 2016, 41 TexReg 6695 |
