84R18015 NC-F
 
  By: Zerwas, Davis of Harris, Sheffield, H.B. No. 751
      Thompson of Harris
 
  Substitute the following for H.B. No. 751:
 
  By:  Crownover C.S.H.B. No. 751
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the prescription and pharmaceutical substitution of
  biological products; amending provisions subject to a criminal
  penalty.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Section 562.001, Occupations Code, is amended by
  amending Subdivision (1) and adding Subdivisions (1-a) and (1-b) to
  read as follows:
               (1)  "Biological product" has the meaning assigned by
  Section 351, Public Health Service Act (42 U.S.C. Section 262).
               (1-a) "Generically equivalent" means a drug that is
  pharmaceutically equivalent and therapeutically equivalent to the
  drug prescribed.
               (1-b) "Interchangeable," in reference to a biological
  product, has the meaning assigned by Section 351, Public Health
  Service Act (42 U.S.C. Section 262), or means a biological product
  that is designated as therapeutically equivalent to another product
  by the United States Food and Drug Administration in the most recent
  edition or supplement of the United States Food and Drug
  Administration's Approved Drug Products with Therapeutic
  Equivalence Evaluations, also known as the Orange Book.
         SECTION 2.  Section 562.002, Occupations Code, is amended to
  read as follows:
         Sec. 562.002.  LEGISLATIVE INTENT. It is the intent of the
  legislature to save consumers money by allowing the substitution of
  lower-priced generically equivalent drug products for certain
  brand name drug products and the substitution of interchangeable
  biological products for certain biological products and for
  pharmacies and pharmacists to pass on the net benefit of the lower
  costs of the generically equivalent drug product or interchangeable
  biological product to the purchaser.
         SECTION 3.  Section 562.003, Occupations Code, is amended to
  read as follows:
         Sec. 562.003.  DISCLOSURE OF PRICE; PATIENT'S OPTION.  If
  the price of a drug or biological product to a patient is lower than
  the amount of the patient's copayment under the patient's
  prescription drug insurance plan, the pharmacist shall offer the
  patient the option of paying for the drug or biological product at
  the lower price instead of paying the amount of the copayment.
         SECTION 4.  Section 562.005, Occupations Code, is amended to
  read as follows:
         Sec. 562.005.  RECORD OF DISPENSED DRUG OR BIOLOGICAL
  PRODUCT.  A pharmacist shall record on the prescription form the
  name, strength, and manufacturer or distributor of a drug or
  biological product dispensed as authorized by this subchapter.
         SECTION 5.  Subchapter A, Chapter 562, Occupations Code, is
  amended by adding Section 562.0051 to read as follows:
         Sec. 562.0051.  COMMUNICATION REGARDING CERTAIN DISPENSED
  BIOLOGICAL PRODUCTS. (a)  Not later than the third business day
  after the date of dispensing a biological product, the dispensing
  pharmacist or the pharmacist's designee shall communicate to
  prescribing practitioners the specific product provided to the
  patient, including the name of the product and the manufacturer or
  national drug code number.
         (b)  The communication must be conveyed by making an entry,
  including information submitted for the payment of claims, into an
  interoperable electronic medical records system or through
  electronic prescribing technology or a pharmacy record that a
  pharmacist reasonably concludes is electronically accessible by
  the prescribing practitioner. Otherwise, the pharmacist or the
  pharmacist's designee shall communicate the biological product
  dispensed to the prescribing practitioner, using facsimile,
  telephone, electronic transmission, or other prevailing means,
  provided that communication is not required if:
               (1)  there is no interchangeable biological product
  approved by the United States Food and Drug Administration for the
  product prescribed; or 
               (2)  a refill prescription is not changed from the
  product dispensed on the prior filling of the prescription.
         (c)  This section expires September 1, 2019.
         SECTION 6.  Section 562.006, Occupations Code, is amended to
  read as follows:
         Sec. 562.006.  LABEL. (a)  Unless otherwise directed by the
  practitioner, the label on the dispensing container must indicate
  the actual drug or biological product dispensed, indicated by
  either:
               (1)  the brand name; or
               (2)  if there is not a brand name, the drug's generic
  name or the name of the biological product, the strength of the drug
  or biological product, and the name of the manufacturer or
  distributor of the drug or biological product.
         (b) [(a-1)]  In addition to the information required by
  Subsection (a), the label on the dispensing container of a drug or
  biological product dispensed by a Class A or Class E pharmacy must
  indicate:
               (1)  the name, address, and telephone number of the
  pharmacy;
               (2)  the date the prescription is dispensed;
               (3)  the name of the prescribing practitioner;
               (4)  the name of the patient or, if the drug or
  biological product was prescribed for an animal, the species of the
  animal and the name of the owner;
               (5)  instructions for use;
               (6)  the quantity dispensed;
               (7)  if the drug or biological product is dispensed in a
  container other than the manufacturer's original container, the
  date after which the prescription should not be used, determined
  according to criteria established by board rule based on standards
  in the United States Pharmacopeia-National Formulary; and
               (8)  any other information required by board rule.
         (c) [(a-2)]  The information required by Subsection (b)(7)
  [(a-1)(7)] may be recorded on any label affixed to the dispensing
  container.
         (d) [(a-3)]  Subsection (b) [(a-1)] does not apply to a
  prescription dispensed to a person at the time of release from
  prison or jail if the prescription is for not more than a 10-day
  supply of medication.
         (e) [(b)]  If a drug or biological product has been selected
  other than the one prescribed, the pharmacist shall place on the
  container the words "Substituted for brand prescribed" or
  "Substituted for 'brand name'" where "brand name" is the name of the
  brand name drug or biological product prescribed.
         (f) [(c)]  The board shall adopt rules requiring the label on
  a dispensing container to be in plain language and printed in an
  easily readable font size for the consumer.
         SECTION 7.  Section 562.008, Occupations Code, is amended to
  read as follows:
         Sec. 562.008.  GENERIC EQUIVALENT OR INTERCHANGEABLE
  BIOLOGICAL PRODUCT AUTHORIZED. (a)  If a practitioner certifies on
  the prescription form that a specific prescribed brand is medically
  necessary, the pharmacist shall dispense the drug or biological
  product as written by the practitioner. The certification must be
  made as required by the dispensing directive adopted under Section
  562.015. This subchapter does not permit a pharmacist to substitute
  a generically equivalent drug or interchangeable biological
  product unless the substitution is made as provided by this
  subchapter.
         (b)  Except as otherwise provided by this subchapter, a
  pharmacist who receives a prescription for a drug or biological
  product for which there is one or more generic equivalents or one or
  more interchangeable biological products may dispense any of the
  generic equivalents or interchangeable biological products.
         SECTION 8.  The heading to Section 562.009, Occupations
  Code, is amended to read as follows:
         Sec. 562.009.  REQUIREMENTS CONCERNING SELECTION OF
  GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT.
         SECTION 9.  Sections 562.009(a), (b), (c), and (d),
  Occupations Code, are amended to read as follows:
         (a)  Before delivery of a prescription for a generically
  equivalent drug or interchangeable biological product, a
  pharmacist must personally, or through the pharmacist's agent or
  employee:
               (1)  inform the patient or the patient's agent that a
  less expensive generically equivalent drug or interchangeable
  biological product is available for the brand prescribed; and
               (2)  ask the patient or the patient's agent to choose
  between the generically equivalent drug or interchangeable
  biological product and the brand prescribed.
         (b)  A pharmacy is not required to comply with the provisions
  of Subsection (a):
               (1)  in the case of the refill of a prescription for
  which the pharmacy previously complied with Subsection (a) with
  respect to the same patient or patient's agent; or
               (2)  if the patient's physician or physician's agent
  advises the pharmacy that:
                     (A)  the physician has informed the patient or the
  patient's agent that a less expensive generically equivalent drug
  or interchangeable biological product is available for the brand
  prescribed; and
                     (B)  the patient or the patient's agent has chosen
  either the brand prescribed or the less expensive generically
  equivalent drug or interchangeable biological product.
         (c)  A pharmacy that supplies a prescription by mail is
  considered to have complied with the provisions of Subsection (a)
  if the pharmacy includes on the prescription order form completed
  by the patient or the patient's agent language that clearly and
  conspicuously:
               (1)  states that if a less expensive generically
  equivalent drug or interchangeable biological product is available
  for the brand prescribed, the patient or the patient's agent may
  choose between the generically equivalent drug or interchangeable
  biological product and the brand prescribed; and
               (2)  allows the patient or the patient's agent to
  indicate the choice between [of] the generically equivalent drug or
  interchangeable biological product and [or] the brand prescribed.
         (d)  If the patient or the patient's agent fails to indicate
  otherwise to a pharmacy on the prescription order form under
  Subsection (c), the pharmacy may dispense a generically equivalent
  drug or interchangeable biological product.
         SECTION 10.  Section 562.010, Occupations Code, is amended
  to read as follows:
         Sec. 562.010.  RESPONSIBILITY CONCERNING GENERICALLY
  EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT; LIABILITY.
  (a)  A pharmacist who selects a generically equivalent drug or
  interchangeable biological product to be dispensed under this
  subchapter assumes the same responsibility for selecting the
  generically equivalent drug or interchangeable biological product
  as the pharmacist does in filling a prescription for a drug
  prescribed by generic or biological product name.
         (b)  The prescribing practitioner is not liable for a
  pharmacist's act or omission in selecting, preparing, or dispensing
  a drug or biological product under this subchapter.
         SECTION 11.  Section 562.011, Occupations Code, is amended
  to read as follows:
         Sec. 562.011.  RESTRICTION ON SELECTION OF AND CHARGING FOR
  GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT.
  (a)  A pharmacist may not select a generically equivalent drug or
  interchangeable biological product unless the generically
  equivalent drug or interchangeable biological product selected
  costs the patient less than the prescribed drug or biological
  product.
         (b)  A pharmacist may not charge for dispensing a generically
  equivalent drug or interchangeable biological product a
  professional fee higher than the fee the pharmacist customarily
  charges for dispensing the brand name drug or biological product
  prescribed.
         SECTION 12.  Section 562.013, Occupations Code, is amended
  to read as follows:
         Sec. 562.013.  APPLICABILITY OF SUBCHAPTER. Unless a drug
  is determined to be generically equivalent to, or a biological
  product is determined to be interchangeable with, the brand
  prescribed, drug or biological product selection as authorized by
  this subchapter does not apply to:
               (1)  an enteric-coated tablet;
               (2)  a controlled release product;
               (3)  an injectable suspension, other than an
  antibiotic;
               (4)  a suppository containing active ingredients for
  which systemic absorption is necessary for therapeutic activity; or
               (5)  a different delivery system for aerosol or
  nebulizer drugs.
         SECTION 13.  Section 562.015(a), Occupations Code, is
  amended to read as follows:
         (a)  The board shall adopt rules to provide a dispensing
  directive to instruct pharmacists on the manner in which to
  dispense a drug or biological product according to the contents of a
  prescription. The rules adopted under this section must:
               (1)  require the use of the phrase "brand necessary" or
  "brand medically necessary" on a prescription form to prohibit the
  substitution of a generically equivalent drug or interchangeable
  biological product for a brand name drug or biological product;
               (2)  be in a format that protects confidentiality as
  required by the Health Insurance Portability and Accountability Act
  of 1996 (Pub. L. No. 104-191) [(29 U.S.C. Section 1181 et seq.)] and
  its subsequent amendments;
               (3)  comply with federal and state law, including
  rules, with regard to formatting and security requirements;
               (4)  be developed to coordinate with 42 C.F.R. Section
  447.512 [447.331(c)]; and
               (5)  include an exemption for electronic prescriptions
  as provided by Subsection (b).
         SECTION 14.  Subchapter A, Chapter 562, Occupations Code, is
  amended by adding Section 562.016 to read as follows:
         Sec. 562.016.  LIST OF APPROVED INTERCHANGEABLE BIOLOGICAL
  PRODUCTS. The board shall maintain on the board's Internet website
  a link to the United States Food and Drug Administration's list of
  approved interchangeable biological products.
         SECTION 15.  (a) Chapter 562, Occupations Code, as amended
  by this Act, applies only to a prescription issued for a biological
  product on or after December 1, 2015. A prescription issued for a
  biological product before December 1, 2015, is governed by the law
  in effect immediately before that date, and the former law is
  continued in effect for that purpose.
         (b)  The Texas State Board of Pharmacy shall adopt rules
  necessary to implement the changes in law made by this Act not later
  than December 1, 2015.
         SECTION 16.  This Act takes effect September 1, 2015.