By: Huffman, et al. S.B. No. 190
(Zerwas, S. Davis of Harris, Thompson of Harris, Bonnen of Galveston)Galveston)Galveston)
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. Section 562.001, Occupations Code, is amended by
adding Subdivision (4) to read as follows:
(4) "Biological product," "biosimilar,"
"interchangeable," and "reference product" have the meanings
assigned by Section 351, Public Health Service Act (42 U.S.C.
Section 262). For purposes of this subchapter, a biological
product is not an injectable suspension.
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 or an
interchangeable biosimilar biological product for certain brand
name drug or 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 biosimilar 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 generically equivalent drug or 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 product [drug] 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. 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) If a pharmacist dispenses an interchangeable biosimilar
biological product to a patient, the pharmacist shall notify the
prescribing practitioner. The notification required 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.
(f-1) Subsection (f) and this subsection expire December
31, 2015.
(g) [(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 6. Section 562.008, Occupations Code, is amended to
read as follows:
Sec. 562.008. GENERIC EQUIVALENT OR INTERCHANGEABLE
BIOSIMILAR 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 biosimilar 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 biosimilar biological products may dispense
any of the generic equivalents or interchangeable biosimilar
biological products.
SECTION 7. Section 562.009, Occupations Code, is amended to
read as follows:
Sec. 562.009. REQUIREMENTS CONCERNING SELECTION OF
GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE BIOSIMILAR
BIOLOGICAL PRODUCT. (a) Before delivery of a prescription for a
generically equivalent drug or 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 generically equivalent drug or interchangeable
biosimilar 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
biosimilar biological product and the brand prescribed.
(b) [(a-1)] In addition to the requirements of Subsection
(a), a pharmacist must display, in a prominent place that is in
clear public view where prescription drugs are dispensed, a sign in
block letters not less than one inch in height that reads, in both
English and Spanish:
"TEXAS LAW REQUIRES A PHARMACIST TO INFORM YOU IF A LESS
EXPENSIVE GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE
BIOSIMILAR BIOLOGICAL PRODUCT IS AVAILABLE FOR CERTAIN BRAND NAME
DRUGS AND TO ASK YOU TO CHOOSE BETWEEN THE GENERIC OR
INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCT AND THE BRAND NAME
DRUG. YOU HAVE A RIGHT TO ACCEPT OR REFUSE THE GENERICALLY
EQUIVALENT DRUG OR INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCT."
(c) [(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 biosimilar 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 biosimilar biological product.
(d) [(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 biosimilar biological product
is available for the brand prescribed, the patient or the patient's
agent may choose between the generically equivalent drug or
interchangeable biosimilar 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 biosimilar biological product and [or] the brand
prescribed.
(e) [(d)] If the patient or the patient's agent fails to
indicate otherwise to a pharmacy on the prescription order form
under Subsection (d) [(c)], the pharmacy may dispense a generically
equivalent drug or interchangeable biosimilar biological product.
(f) [(e)] If the prescription is for an immunosuppressant
drug, as defined by Section 562.0141(a)(1), the pharmacist must
comply with the provisions of Section 562.0141. This subsection
expires if Section 562.0141 expires under the requirements of
Section 562.0142.
SECTION 8. Section 562.010, Occupations Code, is amended to
read as follows:
Sec. 562.010. RESPONSIBILITY CONCERNING GENERICALLY
EQUIVALENT DRUG OR INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCT;
LIABILITY. (a) A pharmacist who selects a generically equivalent
drug or interchangeable biosimilar biological product to be
dispensed under this subchapter assumes the same responsibility for
selecting the generically equivalent drug or interchangeable
biosimilar 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 9. 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 BIOSIMILAR
BIOLOGICAL PRODUCT. (a) A pharmacist may not select a generically
equivalent drug or interchangeable biosimilar biological product
unless the generically equivalent drug or interchangeable
biosimilar 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 biosimilar biological product a
professional fee higher than the fee the pharmacist customarily
charges for dispensing the brand name drug prescribed.
SECTION 10. 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, or a biological product
is determined to be interchangeably biosimilar, to the brand
prescribed, drug 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 11. Subsection (a), Section 562.015, 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 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
biosimilar biological product for a brand name drug;
(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 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
447.331(c); and
(5) include an exemption for electronic prescriptions
as provided by Subsection (b).
SECTION 12. The Texas State Board of Pharmacy shall adopt
rules necessary to implement the changes in law made by this Act not
later than March 1, 2014.
SECTION 13. This Act takes effect September 1, 2013.