S.B. No. 594
AN ACT
relating to the regulation of prescriptions for controlled
substances, including certain procedures applicable to electronic
prescriptions for Schedule II controlled substances.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 481.061, Health and Safety Code, is
amended by adding Subsection (d) to read as follows:
(d) A person shall provide the department with the person's
Federal Drug Enforcement Administration number not later than the
45th day after the director issues a registration to the person
under this subchapter.
SECTION 2. Subsections (b), (c), (d-1), (e) through (h),
(k), and (q), Health and Safety Code, are amended to read as
follows:
(b) Except in an emergency as defined by rule of the
director or as provided by Subsection (o) or Section 481.075(j) or
(m), a person may not dispense or administer a controlled substance
listed in Schedule II without a [the] written prescription of a
practitioner on an official prescription form or without an
electronic prescription that meets the requirements of and is
completed by the practitioner in accordance with Section 481.075.
In an emergency, a person may dispense or administer a controlled
substance listed in Schedule II on the oral or telephonically
communicated prescription of a 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, [department registration number,]
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).
(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 a written or electronic prescription,
completed in the manner required by Section 481.075, to be
delivered [in person or mailed] to the dispensing pharmacist at the
pharmacy where the prescription was dispensed. A written
prescription may be delivered in person or by mail. The envelope of
a prescription delivered by mail must be postmarked not later than
the seventh day after the date the prescription was authorized. On
receipt of a written [the] prescription, the dispensing pharmacy
shall file the transcription of the telephonically communicated
prescription and the pharmacy copy and shall send information to
the director as required by Section 481.075. On receipt of an
electronic prescription, the pharmacist shall annotate the
electronic prescription record with the original authorization and
date of the emergency oral or telephonically communicated
prescription.
(d-1) Notwithstanding Subsection (d), a prescribing
practitioner may issue multiple prescriptions authorizing the
patient to receive a total of up to a 90-day supply of a Schedule II
controlled substance if:
(1) each separate prescription is issued for a
legitimate medical purpose by a prescribing practitioner acting in
the usual course of professional practice;
(2) the prescribing practitioner provides [written]
instructions on each prescription to be filled at a later date
indicating the earliest date on which a pharmacy may fill each
prescription;
(3) the prescribing practitioner concludes that
providing the patient with multiple prescriptions in this manner
does not create an undue risk of diversion or abuse; and
(4) the issuance of multiple prescriptions complies
with other applicable state and federal laws.
(e) The partial filling of a prescription for a controlled
substance listed in Schedule II is permissible, if the pharmacist
is unable to supply the full quantity called for in a written or
electronic prescription or emergency oral prescription and the
pharmacist makes a notation of the quantity supplied on the face of
the written prescription, on the [or] written record of the
emergency oral prescription, or in the electronic prescription
record. The remaining portion of the prescription may be filled
within 72 hours of the first partial filling; however, if the
remaining portion is not or cannot be filled within the 72-hour
period, the pharmacist shall so notify the prescribing individual
practitioner. No further quantity may be supplied beyond 72 hours
without a new prescription.
(f) A prescription for a Schedule II controlled substance
[written] 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 on an official prescription form or in the electronic
prescription record and must indicate on the official prescription
form or in the electronic prescription record whether 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 on the back of the official prescription form or in the
electronic prescription record the 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 written, electronic, oral, or telephonically [or electronically]
communicated 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 written, electronic, oral, or
telephonically [or electronically] communicated prescription
issued by a practitioner defined by Section 481.002(39)(C) and only
if the pharmacist determines that the prescription was issued for a
valid medical purpose and in the course of professional practice. A
prescription issued under this subsection may not be filled or
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) numerically, followed by the number written
as a word, if the prescription is written; [or]
(B) numerically, if the prescription is
electronic; or
(C) if the prescription is communicated 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;
(7) the [legibly printed or stamped] name, address,
Federal Drug Enforcement Administration [registration] number, and
telephone number of the practitioner at the practitioner's usual
place of business, which must be legibly printed or stamped on a
written prescription; and
(8) if the prescription is handwritten, the signature
of the prescribing practitioner[; and
[(9) if the prescribing practitioner is licensed in
this state, the practitioner's department registration number].
(q) Each dispensing pharmacist shall send all information
required by the director, including any information required to
complete the Schedule III through V prescription forms, to the
director by electronic transfer or another form approved by the
director not later than the seventh [15th] day after the date [last
day of the month in which] the prescription is completely filled.
SECTION 3. Subsections (a), (e), and (g) through (j),
Section 481.075, 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 rule adopted
under Section 481.0761, record the prescription on an official
prescription form or in an electronic prescription that includes
the information required by this section.
(e) Each official prescription form or electronic
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
[written];
(B) the controlled substance prescribed;
(C) the quantity of controlled substance
prescribed, shown:
(i) numerically, followed by the number
written as a word, if the prescription is written; or
(ii) numerically, if the prescription is
electronic;
(D) the intended use of the controlled substance
or the diagnosis for which it is prescribed and the instructions for
use of the substance;
(E) the practitioner's name, address,
[department registration number,] 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) for a written prescription, the signatures of the
prescribing practitioner and the dispensing pharmacist or for an
electronic prescription, the prescribing practitioner's electronic
signature or other secure method of validation authorized by
federal law.
(g) Except for an oral prescription prescribed under
Section 481.074(b), the prescribing practitioner shall:
(1) legibly fill in, or direct a designated agent to
legibly fill in, on the official prescription form or in the
electronic prescription, each item of information required to be
provided by the prescribing practitioner under Subsection (e)(1),
unless the practitioner determines that:
(A) under rule adopted by the director 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) sign the official prescription form and give the
form to the person authorized to receive the prescription or, in the
case of an electronic prescription, electronically sign or validate
the electronic prescription as authorized by federal law and
transmit the prescription to the dispensing pharmacy.
(h) In the case of an oral prescription prescribed under
Section 481.074(b), the prescribing practitioner shall give the
dispensing pharmacy the information needed to complete the official
prescription form or electronic prescription record.
(i) Each dispensing pharmacist shall:
(1) fill in on the official prescription form or 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, and:
(A) for a written prescription, fill in the
dispensing pharmacist's signature; or
(B) for an electronic prescription,
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) the official prescription form or the
electronic prescription record, as applicable; and
(B) the name or other patient identification
required by Section 481.074(m) or (n); and
(3) send all information required by the director,
including any information required to complete an official
prescription form or electronic prescription record, to the
director by electronic transfer or another form approved by the
director not later than the seventh [15th] day after the date [last
day of the month in which] 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 on an official prescription [a] form or in an
electronic prescription record that meets the requirements of this
section.
SECTION 4. Subsections (a) and (i), Section 481.076, Health
and Safety Code, are amended to read as follows:
(a) The director may not permit any person to have access to
information submitted to the director under Section 481.074(q) or
481.075 except:
(1) an investigator for the Texas Medical Board, the
Texas State Board of Podiatric Medical Examiners, the State Board
of Dental Examiners, the State Board of Veterinary Medical
Examiners, the Texas Board of Nursing, or the Texas State Board of
Pharmacy;
(2) an authorized officer or member of the department
engaged in the administration, investigation, or enforcement of
this chapter or another law governing illicit drugs in this state or
another state; or
(3) if the director finds that proper need has been
shown to the director:
(A) a law enforcement or prosecutorial official
engaged in the administration, investigation, or enforcement of
this chapter or another law governing illicit drugs in this state or
another state;
(B) a pharmacist or practitioner who is a
physician, dentist, veterinarian, podiatrist, or advanced practice
nurse or physician assistant described by Section 481.002(39)(D)
and is inquiring about a recent Schedule II, III, IV, or V
prescription history of a particular patient of the practitioner;
or
(C) a pharmacist or practitioner who is inquiring
about the person's own dispensing or prescribing activity.
(i) Information submitted to the director under Section
481.074(q) or 481.075 is confidential and remains confidential
regardless of whether the director permits access to the
information under this section.
SECTION 5. Subsection (d), Section 481.0761, Health and
Safety Code, is amended to read as follows:
(d) The director 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 or in the electronic prescription record.
SECTION 6. Section 552.118, Government Code, is amended to
read as follows:
Sec. 552.118. EXCEPTION: OFFICIAL PRESCRIPTION PROGRAM
INFORMATION [FORM]. Information is excepted from the requirements
of Section 552.021 if it is:
(1) information on or derived from an official
prescription form or electronic prescription record filed with the
director of the Department of Public Safety under Section 481.075,
Health and Safety Code; or
(2) other information collected under Section 481.075
of that code.
SECTION 7. Subsection (c), Section 157.059, Occupations
Code, is amended to read as follows:
(c) The physician may not delegate:
(1) the use of a prescription sticker or the use or
issuance of an official prescription form; or
(2) the authority to issue an electronic prescription
under Section 481.075, Health and Safety Code.
SECTION 8. Notwithstanding Section 481.061, Health and
Safety Code, as amended by this Act, a person who holds a valid
registration under Subchapter C, Chapter 481, Health and Safety
Code, on the effective date of this Act is not required to submit
the person's Federal Drug Enforcement Administration number to the
Department of Public Safety of the State of Texas before October 15,
2011.
SECTION 9. The change in law made by this Act applies only
to the issuance of a prescription on or after the effective date of
this Act. The issuance of a prescription before the effective date
of this Act is covered by the law in effect when the prescription
was issued, and the former law is continued in effect for that
purpose.
SECTION 10. This Act takes effect September 1, 2011.
______________________________ ______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 594 passed the Senate on
March 24, 2011, by the following vote: Yeas 31, Nays 0; and that
the Senate concurred in House amendment on May 27, 2011, by the
following vote: Yeas 31, Nays 0.
______________________________
Secretary of the Senate
I hereby certify that S.B. No. 594 passed the House, with
amendment, on May 23, 2011, by the following vote: Yeas 145,
Nays 0, two present not voting.
______________________________
Chief Clerk of the House
Approved:
______________________________
Date
______________________________
Governor