84R3483 NC-F
By: Kolkhorst S.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. 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) Within a reasonable time after
dispensing a biological product, the dispensing pharmacist or the
pharmacist's designee shall communicate to the prescribing
practitioner the specific product provided to the patient,
including the name of the product and the manufacturer.
(b) The communication must be conveyed by making an entry
into an interoperable electronic medical records system or through
electronic prescribing technology or a pharmacy record that is
electronically accessible by the prescribing practitioner.
Otherwise, the pharmacist 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.
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. 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.
(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-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 or biological products
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
BIOLOGICAL PRODUCT IS AVAILABLE FOR CERTAIN BRAND NAME DRUGS OR
PRODUCTS AND TO ASK YOU TO CHOOSE BETWEEN THE GENERIC OR
INTERCHANGEABLE BIOLOGICAL PRODUCT AND THE BRAND NAME DRUG OR
PRODUCT. YOU HAVE A RIGHT TO ACCEPT OR REFUSE THE GENERICALLY
EQUIVALENT DRUG OR INTERCHANGEABLE 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 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.
(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 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.
(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 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 9. 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 10. 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 11. 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 12. 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 13. (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 14. This Act takes effect September 1, 2015.