(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   (A) prescription drugs provided by a manufacturer as starter prescriptions or as replacement for such manufacturer's outdated drugs;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