85R12510 EES-F
 
  By: Roberts H.B. No. 3273
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the licensing and regulation of pharmacies,
  pharmacists, and pharmacy technicians.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Section 551.003(9), Occupations Code, is amended
  to read as follows:
               (9)  "Compounding" means the preparation, mixing,
  assembling, packaging, and [or] labeling of a drug or device:
                     (A)  as the result of a practitioner's
  prescription drug order based on the
  practitioner-patient-pharmacist relationship in the course of
  professional practice;
                     (B)  for administration to a patient by a
  practitioner as the result of a practitioner's initiative based on
  the practitioner-patient-pharmacist relationship in the course of
  professional practice;
                     (C)  in anticipation of a prescription drug order
  based on a routine, regularly observed prescribing pattern; or
                     (D)  for or as an incident to research, teaching,
  or chemical analysis and not for selling or dispensing, except as
  allowed under Section 562.154 or Chapter 563.
         SECTION 2.  The heading to Section 554.004, Occupations
  Code, is amended to read as follows:
         Sec. 554.004.  ADMINISTRATION OF IMMUNIZATIONS AND
  VACCINATIONS [MEDICATION].
         SECTION 3.  Section 554.004(a), Occupations Code, is amended
  to read as follows:
         (a)  The board shall specify conditions under which a
  pharmacist may administer immunizations and vaccinations
  [medication, including an immunization and vaccination]. The
  conditions must ensure that:
               (1)  [a licensed health care provider authorized to
  administer the medication is not reasonably available to administer
  the medication;
               [(2)     failure to administer the medication, other than
  an immunization or vaccination, might result in a significant delay
  or interruption of a critical phase of drug therapy;
               [(3)]  the pharmacist possesses the necessary skill,
  education, and certification as specified by the board to
  administer the immunization or vaccination [medication];
               (2) [(4)]  within a reasonable time after
  administering an immunization or vaccination [medication], the
  pharmacist notifies the licensed health care provider responsible
  for the patient's care that the immunization or vaccination
  [medication] was administered;
               (3) [(5)     the pharmacist may not administer medication
  to a patient at the patient's residence, except at a licensed
  nursing home or hospital;
               [(6)]  the pharmacist administers an immunization or
  vaccination under a physician's written protocol and meets the
  standards established by the board; and
               (4) [(7)]  the authority of a pharmacist to administer
  immunizations or vaccinations [medication] may not be delegated.
         SECTION 4.  Subchapter C, Chapter 560, Occupations Code, is
  amended by adding Section 560.1025 to read as follows:
         Sec. 560.1025.  PHARMACY OPERATIONS REQUIRED. The board
  shall revoke a pharmacy license issued under this chapter if the
  pharmacy has not begun operations as a pharmacy within six months
  after the date the pharmacy license is issued. 
         SECTION 5.  Chapter 561, Occupations Code, is amended by
  adding Section 561.006 to read as follows:
         Sec. 561.006.  PROHIBITED ISSUANCE OF CERTAIN RENEWAL
  CERTIFICATES. The board may not issue a license renewal
  certificate for a pharmacy that the board determines, on inspection
  of the address of the pharmacy on file with the board, is not
  operating at that location. 
         SECTION 6.  Section 565.002(a), Occupations Code, is amended
  to read as follows:
         (a)  The board may discipline an applicant for or the holder
  of a pharmacy license, including a Class E pharmacy license subject
  to Section 565.003, if the board finds that the applicant or license
  holder has:
               (1)  been convicted of or placed on deferred
  adjudication community supervision or deferred disposition or the
  applicable federal equivalent for:
                     (A)  a misdemeanor:
                           (i)  involving moral turpitude; or
                           (ii)  under Chapter 481, 482, [or] 483, or
  486, Health and Safety Code, or the Comprehensive Drug Abuse
  Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.);
  or
                     (B)  a felony;
               (2)  advertised a prescription drug or device in a
  deceitful, misleading, or fraudulent manner;
               (3)  violated any provision of this subtitle or any
  rule adopted under this subtitle or that an owner or employee of a
  pharmacy has violated any provision of this subtitle or any rule
  adopted under this subtitle;
               (4)  sold without legal authorization a prescription
  drug or device to a person other than:
                     (A)  a pharmacy licensed by the board;
                     (B)  a practitioner;
                     (C)  a person who procures a prescription drug or
  device for lawful research, teaching, or testing, and not for
  resale;
                     (D)  a manufacturer or wholesaler licensed by the
  commissioner of public health as required by Chapter 431, Health
  and Safety Code; or
                     (E)  a carrier or warehouseman;
               (5)  allowed an employee who is not a pharmacist to
  practice pharmacy;
               (6)  sold an adulterated or misbranded prescription or
  nonprescription drug;
               (7)  failed to engage in or ceased to engage in the
  business described in the application for a license;
               (8)  failed to maintain records as required by this
  subtitle, Chapter 481 or 483, Health and Safety Code, the
  Comprehensive Drug Abuse Prevention and Control Act of 1970 (21
  U.S.C. Section 801 et seq.), or any rule adopted under this subtitle
  or Chapter 483, Health and Safety Code;
               (9)  failed to establish and maintain effective
  controls against diversion of prescription drugs into other than a
  legitimate medical, scientific, or industrial channel as provided
  by this subtitle, another state statute or rule, or a federal
  statute or rule;
               (10)  engaged in fraud, deceit, or misrepresentation as
  defined by board rule in operating a pharmacy or in applying for a
  license to operate a pharmacy;
               (11)  violated a disciplinary order;
               (12)  had [been responsible for] a drug audit shortage;
               (13)  been disciplined by the regulatory board of
  another state for conduct substantially equivalent to conduct
  described under this subsection; or
               (14)  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.
         SECTION 7.  Section 568.001(a), Occupations Code, is amended
  to read as follows:
         (a)  In establishing rules under Section 554.053(c), the
  board shall require that:
               (1)  a pharmacy technician:
                     (A)  have a high school diploma or a high school
  equivalency certificate or be working to achieve an equivalent
  diploma or certificate; [and]
                     (B)  have passed a board-approved pharmacy
  technician certification examination; and
                     (C)  have completed a training program that meets
  criteria established by board rule; and 
               (2)  a pharmacy technician trainee have a high school
  diploma or a high school equivalency certificate or be working to
  achieve an equivalent diploma or certificate.
         SECTION 8.  Subchapter C, Chapter 481, Health and Safety
  Code, is amended by adding Section 481.0751 to read as follows:
         Sec. 481.0751.  SUBMISSION OF CERTAIN INFORMATION TO BOARD.
  (a)  If any pharmacist who is an owner or employee of a pharmacy is
  not required to submit information to the board under Section
  481.074(q) or 481.075 for a seven-day period, the pharmacy shall
  notify the board that the pharmacy did not fill a prescription that
  required the submission of information under those sections during
  that period. The pharmacy shall send the notice not later than the
  seventh day after the last day of the period.
         (b)  The board by rule shall establish a standardized process
  for a pharmacy to transmit electronically the notification required
  by this section.
         SECTION 9.  Section 481.353(a), Health and Safety Code, is
  amended to read as follows:
         (a)  The work group shall meet as necessary at the call of the
  chair [at least quarterly].
         SECTION 10.  (a)  Sections 554.016, 556.0555, 560.001(c),
  560.0525, and 562.111, Occupations Code, are repealed.
         (b)  Subchapter E, Chapter 562, Occupations Code, is
  repealed.
         SECTION 11.  Section 565.002(a), Occupations Code, as
  amended by this Act, applies only to conduct that occurs on or after
  the effective date of this Act. Conduct that occurred before the
  effective date of this Act is governed by the law in effect on the
  date the conduct occurred, and the former law is continued in effect
  for that purpose. For purposes of this section, conduct occurred
  before the effective date of this Act if any part of the conduct
  occurred before that date.
         SECTION 12.  This Act takes effect September 1, 2017.