83R3487 NC-F
By: Zerwas H.B. No. 542
A BILL TO BE ENTITLED
AN ACT
relating to the prescription and pharmaceutical substitution of
biological products.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 562, Occupations Code, is amended by
adding Subchapter F to read as follows:
SUBCHAPTER F. PRESCRIPTION AND SUBSTITUTION REQUIREMENTS FOR
BIOLOGICAL PRODUCTS
Sec. 562.251. DEFINITIONS. In this subchapter, "biological
product," "biosimilar," "interchangeable," and "reference product"
have the meanings assigned by Section 351, Public Health Service
Act (42 U.S.C. Section 262).
Sec. 562.252. PRESCRIPTION TRANSMITTED ORALLY BY
PRACTITIONER. A pharmacist to whom a prescription for a biological
product is transmitted orally shall:
(1) note on the file copy of the prescription the
dispensing instructions of the practitioner or the practitioner's
agent; and
(2) retain the prescription for the period specified
by law for pharmacy records.
Sec. 562.253. RECORD OF DISPENSED BIOLOGICAL PRODUCT. (a)
A pharmacist shall record on the prescription form the name,
strength, and manufacturer or distributor of a biological product
dispensed as authorized by this subchapter.
(b) A record established under this subchapter is subject to
the recordkeeping requirements applicable to pharmacy records.
Sec. 562.254. LABEL. (a) Unless otherwise directed by the
practitioner, the label on the dispensing container must indicate
the actual biological product dispensed by:
(1) the brand name; or
(2) if there is not a brand name, the actual name of
the biological product, the strength of the biological product, and
the name of the manufacturer or distributor of the biological
product.
(b) In addition to the information required by Subsection
(a), the label on the dispensing container of a biological product
dispensed by a Class A, Class C, Class D, 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 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 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 the United States Food and
Drug Administration; and
(8) any other information required by board rule.
(c) The information required by Subsection (b)(7) may be
recorded on any label affixed to the dispensing container.
(d) If a 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 biological
product prescribed.
(e) 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.
Sec. 562.255. OTHER PRESCRIPTION INFORMATION. The board
shall adopt rules specifying the information a pharmacist must
provide to a consumer when dispensing a prescription for a
biological product to the consumer for self-administration. The
information must be:
(1) written in plain language;
(2) relevant to the prescription; and
(3) printed in an easily readable font size.
Sec. 562.256. REFILLS. Except as provided by Section
562.0545, a properly authorized prescription refill must follow the
original dispensing instruction unless otherwise indicated by the
practitioner or the practitioner's agent.
Sec. 562.257. INTERCHANGEABLE BIOSIMILAR BIOLOGICAL
PRODUCT AUTHORIZED. (a) A pharmacy may not substitute a biosimilar
biological product for a prescribed reference product unless the
United States Food and Drug Administration has determined that the
biosimilar biological product is interchangeable with the
prescribed reference product for the specified indicated use.
(b) If a practitioner certifies on the prescription form
that a specific prescribed reference product is medically
necessary, the pharmacist shall dispense the reference product as
written by the practitioner. The certification must be made as
required by the dispensing directive adopted under Section 562.263.
(c) Except as otherwise provided by this subchapter, a
pharmacist who receives a prescription for a reference product for
which there is one or more interchangeable biosimilar biological
products may dispense any of the interchangeable biosimilar
biological products for the specified indicated use.
Sec. 562.258. REQUIREMENTS CONCERNING SELECTION OF
INTERCHANGEABLE BIOSIMILAR. (a) Before delivery of a prescription
for an interchangeable biosimilar 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 interchangeable biosimilar biological product is
available for the reference product prescribed; and
(2) ask the patient or the patient's agent to choose
between the interchangeable biosimilar biological product and the
reference product 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 interchangeable biosimilar
biological product is available for the reference product
prescribed; and
(B) the patient or the patient's agent has chosen
either the reference product prescribed or the less expensive
interchangeable biosimilar 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 interchangeable
biosimilar biological product is available for the reference
product prescribed, the patient or the patient's agent may choose
between the interchangeable biosimilar biological product and the
reference product prescribed; and
(2) allows the patient or the patient's agent to
indicate the choice of the interchangeable biosimilar biological
product or the reference product 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 an interchangeable
biosimilar biological product.
Sec. 562.259. DISCLOSURE OF PRICE; PATIENT'S OPTION. If
the price of an interchangeable biosimilar 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 biosimilar
biological product at the lower price instead of paying the amount
of the copayment.
Sec. 562.260. NOTIFICATION OF SUBSTITUTION. (a) If a
pharmacist dispenses an interchangeable biosimilar biological
product to a patient, the pharmacist shall notify the prescribing
practitioner.
(b) The notification required under Subsection (a) must:
(1) be transmitted in writing or electronically;
(2) identify the name, strength, and manufacturer or
distributor of the biological product dispensed to the patient; and
(3) be transmitted to the prescribing practitioner not
later than the third day after the date the biological product is
dispensed.
Sec. 562.261. RESPONSIBILITY CONCERNING BIOSIMILAR
BIOLOGICAL PRODUCTS; LIABILITY. (a) A pharmacist who selects an
interchangeable biosimilar biological product to be dispensed
under this subchapter assumes the same responsibility for selecting
the biosimilar biological product as the pharmacist does in filling
a prescription for a reference product.
(b) The prescribing practitioner is not liable for a
pharmacist's act or omission in selecting, preparing, or dispensing
a biological product under this subchapter.
Sec. 562.262. RESTRICTION ON SELECTION OF AND CHARGING FOR
BIOSIMILAR BIOLOGICAL PRODUCTS. (a) A pharmacist may not select an
interchangeable biosimilar biological product unless the
interchangeable product selected costs the patient less than the
prescribed reference product.
(b) A pharmacist may not charge for dispensing an
interchangeable biosimilar biological product a professional fee
higher than the fee the pharmacist customarily charges for
dispensing the reference product prescribed.
Sec. 562.263. DISPENSING DIRECTIVE; COMPLIANCE WITH
FEDERAL LAW. The board shall adopt rules to provide a dispensing
directive to instruct pharmacists on the manner in which to
dispense a 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 an interchangeable biosimilar biological product
for a reference product;
(2) be in a format that protects confidentiality as
required by the Health Insurance Portability and Accountability Act
of 1996 (29 U.S.C. Section 1181 et seq.); and
(3) comply with federal and state law, including
rules, with regard to formatting and security requirements.
SECTION 2. The Texas State Board of Pharmacy shall adopt
rules necessary to implement Subchapter F, Chapter 562, Occupations
Code, as added by this Act, not later than January 1, 2014.
SECTION 3. (a) Except as provided by Subsection (b) of this
section, this Act takes effect September 1, 2013.
(b) Subchapter F, Chapter 562, Occupations Code, as added by
this Act, takes effect January 1, 2014.