Bill Text: TX HB2766 | 2019-2020 | 86th Legislature | Engrossed
Bill Title: Relating to electronic and other controlled substance prescriptions under the Texas Controlled Substances Act; authorizing a fee.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Engrossed - Dead) 2019-05-07 - Referred to Health & Human Services [HB2766 Detail]
Download: Texas-2019-HB2766-Engrossed.html
86R19798 JSC-F | ||
By: Zerwas | H.B. No. 2766 |
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relating to electronic and other controlled substance | ||
prescriptions under the Texas Controlled Substances Act; | ||
authorizing a fee. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Section 552.118, Government Code, is amended to | ||
read as follows: | ||
Sec. 552.118. EXCEPTION: CONFIDENTIALITY OF OFFICIAL | ||
PRESCRIPTION PROGRAM INFORMATION. Information is excepted from the | ||
requirements of Section 552.021 if it is: | ||
(1) information on or derived from an official | ||
prescription form filed with the Texas State Board of Pharmacy | ||
under Section 481.0755, Health and Safety Code, or an electronic | ||
prescription record filed with the Texas State Board of Pharmacy | ||
under Section 481.075, Health and Safety Code; or | ||
(2) other information collected under Section 481.075 | ||
or 481.0755 of that code. | ||
SECTION 2. Sections 481.002(10) and (47), Health and Safety | ||
Code, are amended to read as follows: | ||
(10) "Designated agent" means an individual | ||
designated under Section 481.074(b-2) [ |
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practitioner's instructions to a pharmacist in an emergency. | ||
(47) "Official prescription form" means a | ||
prescription form that is used for a Schedule II controlled | ||
substance under Section 481.0755 and contains the prescription | ||
information required by Section 481.0755(e) [ |
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SECTION 3. Section 481.003(a), Health and Safety Code, is | ||
amended to read as follows: | ||
(a) The director may adopt rules to administer and enforce | ||
this chapter, other than Sections [ |
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481.0755, 481.0756, 481.076, 481.0761, 481.0762, 481.0763, | ||
481.0764, 481.0765, and 481.0766. The board may adopt rules to | ||
administer Sections [ |
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481.0756, 481.076, 481.0761, 481.0762, 481.0763, 481.0764, | ||
481.0765, and 481.0766. | ||
SECTION 4. Section 481.074, Health and Safety Code, is | ||
amended by amending Subsections (b), (c), (e), (f), (g), (h), (k), | ||
and (q) and adding Subsections (b-1) and (b-2) to read as follows: | ||
(b) Except in an emergency as defined by board rule under | ||
Subsection (b-1) [ |
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may not dispense or administer a controlled substance [ |
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that meets the requirements of and is completed by the practitioner | ||
in accordance with Section 481.075. | ||
(b-1) In an emergency as defined by board rule, a person may | ||
dispense or administer a controlled substance [ |
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practitioner. The person who administers or dispenses the | ||
substance shall: | ||
(1) if the person is a prescribing practitioner or a | ||
pharmacist, promptly comply with Subsection (c); or | ||
(2) if the person is not a prescribing practitioner or | ||
a pharmacist, promptly write the oral or telephonically | ||
communicated prescription and include in the written record of the | ||
prescription the name, address, and Federal Drug Enforcement | ||
Administration number issued for prescribing a controlled | ||
substance in this state of the prescribing practitioner, all | ||
information required to be provided by a practitioner under Section | ||
481.075(e)(1), and all information required to be provided by a | ||
dispensing pharmacist under Section 481.075(e)(2). | ||
(b-2) In an emergency described by Subsection (b-1), an | ||
agent designated in writing by a practitioner defined by Section | ||
481.002(39)(A) may communicate a prescription by telephone. A | ||
practitioner who designates a different agent shall designate that | ||
agent in writing and maintain the designation in the same manner in | ||
which the practitioner initially designated an agent under this | ||
subsection. On the request of a pharmacist, a practitioner shall | ||
furnish a copy of the written designation. This subsection does not | ||
relieve a practitioner or the practitioner's designated agent from | ||
the requirement of Subchapter A, Chapter 562, Occupations Code. A | ||
practitioner is personally responsible for the actions of the | ||
designated agent in communicating a prescription to a pharmacist. | ||
(c) Not later than the seventh day after the date a | ||
prescribing practitioner authorizes an emergency oral or | ||
telephonically communicated prescription, the prescribing | ||
practitioner shall cause an [ |
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completed in the manner required by Section 481.075, to be | ||
delivered to the dispensing pharmacist at the pharmacy where the | ||
prescription was dispensed. [ |
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prescription, the pharmacist shall annotate the electronic | ||
prescription record with the original authorization and date of the | ||
emergency oral or telephonically communicated prescription. | ||
(e) The partial filling of a prescription for a controlled | ||
substance listed in Schedule II is permissible in accordance with | ||
applicable federal law[ |
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(f) A prescription for a Schedule II controlled substance | ||
for a patient in a long-term care facility (LTCF) or for a patient | ||
with a medical diagnosis documenting a terminal illness may be | ||
filled in partial quantities to include individual dosage units. | ||
If there is any question about whether a patient may be classified | ||
as having a terminal illness, the pharmacist must contact the | ||
practitioner before partially filling the prescription. Both the | ||
pharmacist and the practitioner have a corresponding | ||
responsibility to assure that the controlled substance is for a | ||
terminally ill patient. The pharmacist must record the | ||
prescription [ |
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electronic prescription record and must indicate [ |
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the patient is "terminally ill" or an "LTCF patient." A | ||
prescription that is partially filled and does not contain the | ||
notation "terminally ill" or "LTCF patient" is considered to have | ||
been filled in violation of this chapter. For each partial filling, | ||
the dispensing pharmacist shall record [ |
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date of the partial filling, the quantity dispensed, the remaining | ||
quantity authorized to be dispensed, and the identification of the | ||
dispensing pharmacist. Before any subsequent partial filling, the | ||
pharmacist must determine that the additional partial filling is | ||
necessary. The total quantity of Schedule II controlled substances | ||
dispensed in all partial fillings may not exceed the total quantity | ||
prescribed. Schedule II prescriptions for patients in a long-term | ||
care facility or patients with a medical diagnosis documenting a | ||
terminal illness are valid for a period not to exceed 60 days | ||
following the issue date unless sooner terminated by discontinuance | ||
of the medication. | ||
(g) A person may not dispense a controlled substance in | ||
Schedule III or IV that is a prescription drug under the Federal | ||
Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) without | ||
a [ |
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prescription of a practitioner defined by Section 481.002(39)(A) or | ||
(D), except that the practitioner may dispense the substance | ||
directly to an ultimate user. A prescription for a controlled | ||
substance listed in Schedule III or IV may not be filled or refilled | ||
later than six months after the date on which the prescription is | ||
issued and may not be refilled more than five times, unless the | ||
prescription is renewed by the practitioner. A prescription under | ||
this subsection must comply with other applicable state and federal | ||
laws. | ||
(h) A pharmacist may dispense a controlled substance listed | ||
in Schedule III, IV, or V under a [ |
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defined by Section 481.002(39)(C) [ |
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determines that the prescription was issued for a valid medical | ||
purpose and in the course of professional practice. A prescription | ||
described by [ |
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refilled later than six months after the date the prescription is | ||
issued and may not be refilled more than five times, unless the | ||
prescription is renewed by the practitioner. | ||
(k) A prescription for a controlled substance must show: | ||
(1) the quantity of the substance prescribed: | ||
(A) [ |
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[ |
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electronic; or | ||
(B) [ |
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orally or telephonically, as transcribed by the receiving | ||
pharmacist; | ||
(2) the date of issue; | ||
(2-a) if the prescription is issued for a Schedule II | ||
controlled substance to be filled at a later date under Subsection | ||
(d-1), the earliest date on which a pharmacy may fill the | ||
prescription; | ||
(3) the name, address, and date of birth or age of the | ||
patient or, if the controlled substance is prescribed for an | ||
animal, the species of the animal and the name and address of its | ||
owner; | ||
(4) the name and strength of the controlled substance | ||
prescribed; | ||
(5) the directions for use of the controlled | ||
substance; | ||
(6) the intended use of the substance prescribed | ||
unless the practitioner determines the furnishing of this | ||
information is not in the best interest of the patient; and | ||
(7) the name, address, Federal Drug Enforcement | ||
Administration number, and telephone number of the practitioner at | ||
the practitioner's usual place of business[ |
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(q) Each dispensing pharmacist shall send all required | ||
information[ |
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electronic transfer or another form approved by the board not later | ||
than the next business day after the date the prescription is | ||
completely filled. | ||
SECTION 5. The heading to Section 481.075, Health and | ||
Safety Code, is amended to read as follows: | ||
Sec. 481.075. SCHEDULE II PRESCRIPTIONS [ |
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SECTION 6. Sections 481.075(a), (e), (g), (h), (i), and | ||
(j), Health and Safety Code, are amended to read as follows: | ||
(a) A practitioner who prescribes a controlled substance | ||
listed in Schedule II shall, except as provided by Section | ||
481.074(b-1) or 481.0755 or a rule adopted under Section 481.0761, | ||
record the prescription [ |
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electronic prescription that includes the information required by | ||
this section. | ||
(e) Each [ |
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prescription used to prescribe a Schedule II controlled substance | ||
must contain: | ||
(1) information provided by the prescribing | ||
practitioner, including: | ||
(A) the date the prescription is issued; | ||
(B) the controlled substance prescribed; | ||
(C) the quantity of controlled substance | ||
prescribed, shown[ |
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(D) the intended use of the controlled substance, | ||
or the diagnosis for which the controlled substance [ |
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prescribed, and the instructions for use of the substance; | ||
(E) the practitioner's name, address, and | ||
Federal Drug Enforcement Administration number issued for | ||
prescribing a controlled substance in this state; | ||
(F) the name, address, and date of birth or age of | ||
the person for whom the controlled substance is prescribed; and | ||
(G) if the prescription is issued to be filled at | ||
a later date under Section 481.074(d-1), the earliest date on which | ||
a pharmacy may fill the prescription; | ||
(2) information provided by the dispensing | ||
pharmacist, including the date the prescription is filled; and | ||
(3) [ |
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electronic signature or other secure method of validation | ||
authorized by federal law. | ||
(g) Except for an emergency oral or telephonically | ||
communicated prescription described by [ |
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481.074(b-1) [ |
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(1) record [ |
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agent to record [ |
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required to be provided by the prescribing practitioner under | ||
Subsection (e)(1), unless the practitioner determines that: | ||
(A) under rule adopted by the board for this | ||
purpose, it is unnecessary for the practitioner or the | ||
practitioner's agent to provide the patient identification number; | ||
or | ||
(B) it is not in the best interest of the patient | ||
for the practitioner or practitioner's agent to provide information | ||
regarding the intended use of the controlled substance or the | ||
diagnosis for which it is prescribed; and | ||
(2) [ |
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validate the electronic prescription as authorized by federal law | ||
and transmit the prescription to the dispensing pharmacy. | ||
(h) In the case of an emergency oral or telephonically | ||
communicated prescription described by [ |
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481.074(b-1) [ |
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the dispensing pharmacy the information needed to complete the | ||
[ |
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(i) Each dispensing pharmacist shall: | ||
(1) [ |
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note in the electronic prescription record each item of information | ||
given orally to the dispensing pharmacy under Subsection (h) and | ||
the date the prescription is filled[ |
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appropriately record the identity of the dispensing pharmacist in | ||
the electronic prescription record; | ||
(2) retain with the records of the pharmacy for at | ||
least two years: | ||
(A) [ |
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electronic prescription record[ |
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(B) the name or other patient identification | ||
required by Section 481.074(m) or (n); and | ||
(3) send all required information, including any | ||
information required to complete an [ |
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electronic prescription record, to the board by electronic transfer | ||
or another form approved by the board not later than the next | ||
business day after the date the prescription is completely filled. | ||
(j) A medication order written for a patient who is admitted | ||
to a hospital at the time the medication order is written and filled | ||
is not required to be recorded [ |
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in an electronic prescription record that meets the requirements of | ||
this section. | ||
SECTION 7. Subchapter C, Chapter 481, Health and Safety | ||
Code, is amended by adding Sections 481.0755 and 481.0756 to read as | ||
follows: | ||
Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY | ||
COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections 481.074 | ||
and 481.075, a prescription for a controlled substance is not | ||
required to be issued electronically and may be issued in writing if | ||
the prescription is issued: | ||
(1) by a veterinarian; | ||
(2) in circumstances in which electronic prescribing | ||
is not available due to temporary technological or electronic | ||
failure, as prescribed by board rule; | ||
(3) by a practitioner to be dispensed by a pharmacy | ||
located outside this state, as prescribed by board rule; | ||
(4) when the prescriber and dispenser are in the same | ||
location or under the same license; | ||
(5) in circumstances in which necessary elements are | ||
not supported by the most recently implemented national data | ||
standard that facilitates electronic prescribing; | ||
(6) for a drug for which the United States Food and | ||
Drug Administration requires additional information in the | ||
prescription that is not possible with electronic prescribing; | ||
(7) for a non-patient-specific prescription pursuant | ||
to a standing order, approved protocol for drug therapy, | ||
collaborative drug management, or comprehensive medication | ||
management, in response to a public health emergency or in other | ||
circumstances in which the practitioner may issue a | ||
non-patient-specific prescription; | ||
(8) for a drug under a research protocol; | ||
(9) by a practitioner who has received a waiver under | ||
Section 481.0756 from the requirement to use electronic | ||
prescribing; or | ||
(10) under circumstances in which the practitioner has | ||
the present ability to submit an electronic prescription but | ||
reasonably determines that it would be impractical for the patient | ||
to obtain the drugs prescribed under the electronic prescription in | ||
a timely manner and that a delay would adversely impact the | ||
patient's medical condition. | ||
(b) A dispensing pharmacist who receives a controlled | ||
substance prescription in a manner other than electronically is not | ||
required to verify that the prescription is exempt from the | ||
requirement that it be submitted electronically. The pharmacist | ||
may dispense a controlled substance pursuant to an otherwise valid | ||
written, oral, or telephonically communicated prescription | ||
consistent with the requirements of this subchapter. | ||
(c) Except in an emergency, a practitioner must use a | ||
written prescription to submit a prescription described by | ||
Subsection (a). In an emergency, the practitioner may submit an | ||
oral or telephonically communicated prescription as authorized | ||
under Section 481.074(b-1). | ||
(d) A written prescription for a controlled substance other | ||
than a Schedule II controlled substance must include the | ||
information required under Section 481.074(k) and the signature of | ||
the prescribing practitioner. | ||
(e) A written prescription for a Schedule II controlled | ||
substance must be on an official prescription form and include the | ||
information required for an electronic prescription under Section | ||
481.075(e), the signature of the practitioner, and the signature of | ||
the dispensing pharmacist after the prescription is filled. | ||
(f) The board by rule shall authorize a practitioner to | ||
determine whether it is necessary to obtain a particular patient | ||
identification number and to provide that number on the official | ||
prescription form. | ||
(g) On request of a practitioner, the board shall issue | ||
official prescription forms to the practitioner for a fee covering | ||
the actual cost of printing, processing, and mailing the forms. | ||
Before mailing or otherwise delivering prescription forms to a | ||
practitioner, the board shall print on each form the number of the | ||
form and any other information the board determines is necessary. | ||
(h) Each official prescription form must be sequentially | ||
numbered. | ||
(i) A person may not obtain an official prescription form | ||
unless the person is a practitioner as defined by Section | ||
481.002(39)(A) or an institutional practitioner. | ||
(j) Not more than one Schedule II prescription may be | ||
recorded on an official prescription form. | ||
(k) Not later than the 30th day after the date a | ||
practitioner's Federal Drug Enforcement Administration number or | ||
license to practice has been denied, suspended, canceled, | ||
surrendered, or revoked, the practitioner shall return to the board | ||
all official prescription forms in the practitioner's possession | ||
that have not been used for prescriptions. | ||
(l) Each prescribing practitioner: | ||
(1) may use an official prescription form only to | ||
submit a prescription described by Subsection (a); | ||
(2) shall date or sign an official prescription form | ||
only on the date the prescription is issued; and | ||
(3) shall take reasonable precautionary measures to | ||
ensure that an official prescription form issued to the | ||
practitioner is not used by another person to violate this | ||
subchapter or a rule adopted under this subchapter. | ||
(m) In the case of an emergency oral or telephonically | ||
communicated prescription described by Section 481.074(b-1), the | ||
prescribing practitioner shall give the dispensing pharmacy the | ||
information needed to complete the official prescription form if | ||
the pharmacy is not required to use the electronic prescription | ||
record. | ||
(n) Each dispensing pharmacist receiving an oral or | ||
telephonically communicated prescription under Subsection (m) | ||
shall: | ||
(1) fill in on the official prescription form each | ||
item of information given orally to the dispensing pharmacy under | ||
Subsection (m) and the date the prescription is filled and fill in | ||
the dispensing pharmacist's signature; | ||
(2) retain with the records of the pharmacy for at | ||
least two years: | ||
(A) the official prescription form; and | ||
(B) the name or other patient identification | ||
required by Section 481.074(m) or (n); and | ||
(3) send all required information, including any | ||
information required to complete an official prescription form, to | ||
the board by electronic transfer or another form approved by the | ||
board not later than the next business day after the date the | ||
prescription is completely filled. | ||
Sec. 481.0756. WAIVERS FROM ELECTRONIC PRESCRIBING. (a) | ||
The appropriate regulatory agency that issued the license, | ||
certification, or registration to a prescriber is authorized to | ||
grant a prescriber a waiver from the electronic prescribing | ||
requirement under the provisions of this section. | ||
(b) The board shall convene an interagency workgroup that | ||
includes representatives of each regulatory agency that issues a | ||
license, certification, or registration to a prescriber. | ||
(c) The work group described by Subsection (b) shall | ||
establish recommendations and standards for circumstances in which | ||
a waiver from the electronic prescribing requirement is appropriate | ||
and a process under which a prescriber may request and receive a | ||
waiver. | ||
(d) The board shall adopt rules establishing the | ||
eligibility for a waiver, including: | ||
(1) economic hardship; | ||
(2) technological limitations not reasonably within | ||
the control of the prescriber; or | ||
(3) other exceptional circumstances demonstrated by | ||
the prescriber. | ||
(e) Each regulatory agency that issues a license, | ||
certification, or registration to a prescriber shall adopt rules | ||
for the granting of waivers consistent with the board rules adopted | ||
under Subsection (d). | ||
(f) A waiver may be issued to a prescriber for a period of | ||
one year. On expiration of the waiver, the prescriber may reapply | ||
for a waiver if the circumstances that necessitated the waiver | ||
continue. | ||
SECTION 8. Sections 481.0761(c) and (d), Health and Safety | ||
Code, are amended to read as follows: | ||
(c) The board by rule may: | ||
(1) [ |
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multiple prescriptions of a Schedule II controlled substance under | ||
Section 481.074(d-1); | ||
(2) remove from or return to the official prescription | ||
program any aspect of a practitioner's or pharmacist's hospital | ||
practice, including administering or dispensing; | ||
(3) waive or delay any requirement relating to the | ||
time or manner of reporting; | ||
(4) establish compatibility protocols for electronic | ||
data transfer hardware, software, or format, including any | ||
necessary modifications for participation in a database described | ||
by Section 481.076(j); | ||
(5) establish a procedure to control the release of | ||
information under Sections 481.074, 481.075, and 481.076; and | ||
(6) establish a minimum level of prescription activity | ||
below which a reporting activity may be modified or deleted. | ||
(d) The board by rule shall authorize a practitioner to | ||
determine whether it is necessary to obtain a particular patient | ||
identification number and to provide that number [ |
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SECTION 9. Section 481.128(a), Health and Safety Code, is | ||
amended to read as follows: | ||
(a) A registrant or dispenser commits an offense if the | ||
registrant or dispenser knowingly: | ||
(1) distributes, delivers, administers, or dispenses | ||
a controlled substance in violation of Subchapter C [ |
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(2) manufactures a controlled substance not | ||
authorized by the person's Federal Drug Enforcement Administration | ||
registration or distributes or dispenses a controlled substance not | ||
authorized by the person's registration to another registrant or | ||
other person; | ||
(3) refuses or fails to make, keep, or furnish a | ||
record, report, notification, order form, statement, invoice, or | ||
information required by this chapter; | ||
(4) prints, manufactures, possesses, or produces an | ||
official prescription form without the approval of the board; | ||
(5) delivers or possesses a counterfeit official | ||
prescription form; | ||
(6) refuses an entry into a premise for an inspection | ||
authorized by this chapter; | ||
(7) refuses or fails to return an official | ||
prescription form as required by Section 481.0755(k) [ |
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(8) refuses or fails to make, keep, or furnish a | ||
record, report, notification, order form, statement, invoice, or | ||
information required by a rule adopted by the director or the board; | ||
or | ||
(9) refuses or fails to maintain security required by | ||
this chapter or a rule adopted under this chapter. | ||
SECTION 10. Section 481.129(a), Health and Safety Code, is | ||
amended to read as follows: | ||
(a) A person commits an offense if the person knowingly: | ||
(1) distributes as a registrant or dispenser a | ||
controlled substance listed in Schedule I or II, unless the person | ||
distributes the controlled substance as authorized under the | ||
federal Controlled Substances Act (21 U.S.C. Section 801 et seq.); | ||
(2) uses in the course of manufacturing, prescribing, | ||
or distributing a controlled substance a Federal Drug Enforcement | ||
Administration registration number that is fictitious, revoked, | ||
suspended, or issued to another person; | ||
(3) issues a prescription bearing a forged or | ||
fictitious signature; | ||
(4) uses a prescription issued to another person to | ||
prescribe a Schedule II controlled substance; | ||
(5) possesses, obtains, or attempts to possess or | ||
obtain a controlled substance or an increased quantity of a | ||
controlled substance: | ||
(A) by misrepresentation, fraud, forgery, | ||
deception, or subterfuge; | ||
(B) through use of a fraudulent prescription | ||
form; [ |
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(C) through use of a fraudulent oral or | ||
telephonically communicated prescription; or | ||
(D) through the use of a fraudulent electronic | ||
prescription; or | ||
(6) furnishes false or fraudulent material | ||
information in or omits material information from an application, | ||
report, record, or other document required to be kept or filed under | ||
this chapter. | ||
SECTION 11. Section 554.051(a-1), Occupations Code, is | ||
amended to read as follows: | ||
(a-1) The board may adopt rules to administer Sections | ||
[ |
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481.0761, 481.0762, 481.0763, 481.0764, 481.0765, and 481.0766, | ||
Health and Safety Code. | ||
SECTION 12. Section 565.003, Occupations Code, is amended | ||
to read as follows: | ||
Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING | ||
APPLICANT FOR OR HOLDER OF NONRESIDENT PHARMACY LICENSE. Unless | ||
compliance would violate the pharmacy or drug statutes or rules in | ||
the state in which the pharmacy is located, the board may discipline | ||
an applicant for or the holder of a nonresident pharmacy license if | ||
the board finds that the applicant or license holder has failed to | ||
comply with: | ||
(1) Section 481.074, [ |
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481.0756, Health and Safety Code; | ||
(2) Texas substitution requirements regarding: | ||
(A) the practitioner's directions concerning | ||
generic substitution; | ||
(B) the patient's right to refuse generic | ||
substitution; or | ||
(C) notification to the patient of the patient's | ||
right to refuse substitution; | ||
(3) any board rule relating to providing drug | ||
information to the patient or the patient's agent in written form or | ||
by telephone; or | ||
(4) any board rule adopted under Section 554.051(a) | ||
and determined by the board to be applicable under Section | ||
554.051(b). | ||
SECTION 13. Sections 481.073, 481.074(o) and (p), and | ||
481.075(b), (c), (d), (f), (k), and (l), Health and Safety Code, are | ||
repealed. | ||
SECTION 14. This Act takes effect January 1, 2021. |