Bill Text: TX HB751 | 2015-2016 | 84th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relating to the prescription and pharmaceutical substitution of biological products; amending provisions subject to a criminal penalty.
Spectrum: Moderate Partisan Bill (Republican 7-1)
Status: (Passed) 2015-06-19 - Effective on 9/1/15 [HB751 Detail]
Download: Texas-2015-HB751-Introduced.html
Bill Title: Relating to the prescription and pharmaceutical substitution of biological products; amending provisions subject to a criminal penalty.
Spectrum: Moderate Partisan Bill (Republican 7-1)
Status: (Passed) 2015-06-19 - Effective on 9/1/15 [HB751 Detail]
Download: Texas-2015-HB751-Introduced.html
84R3483 NC-F | ||
By: Zerwas | H.B. No. 751 |
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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) [ |
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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) [ |
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[ |
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container. | ||
(d) [ |
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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) [ |
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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) [ |
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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) [ |
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(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) [ |
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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) [ |
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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 [ |
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interchangeable biological product and [ |
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(e) [ |
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indicate otherwise to a pharmacy on the prescription order form | ||
under Subsection (d) [ |
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equivalent drug or interchangeable biological product. | ||
(f) [ |
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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) [ |
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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 [ |
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(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. |