By Hirschi H.B. No. 226
75R521 KKA-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to dispensing Schedule II controlled substances; providing
1-3 a penalty.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 481.075, Health and Safety Code, is
1-6 amended to read as follows:
1-7 Sec. 481.075. REPORTING SCHEDULE II PRESCRIPTIONS. (a) A
1-8 pharmacist who dispenses a controlled substance listed in Schedule
1-9 II shall transmit to a central repository designated by the
1-10 department the following information:
1-11 (1) the date the controlled substance was dispensed;
1-12 (2) the National Drug Code number of the controlled
1-13 substance, the quantity prescribed, instructions for use, and the
1-14 intended use of the controlled substance or the diagnosis for which
1-15 it was prescribed;
1-16 (3) the quantity dispensed;
1-17 (4) the name, address, and Federal Drug Enforcement
1-18 Administration number of the dispensing pharmacy and the name of
1-19 the pharmacist who filled the prescription;
1-20 (5) the name, address, and age of the person for whom
1-21 the controlled substance was prescribed;
1-22 (6) if available, the driver's license or other
1-23 identification number of the person for whom the controlled
1-24 substance was prescribed or the person to whom the controlled
2-1 substance was dispensed;
2-2 (7) if the controlled substance was prescribed for use
2-3 by an animal, the name, address, age, and driver's license or other
2-4 identification number, if available, of the animal's owner;
2-5 (8) the date the controlled substance was prescribed;
2-6 and
2-7 (9) the name, address, department registration number,
2-8 and Federal Drug Enforcement Administration number of the
2-9 practitioner who prescribed the controlled substance.
2-10 (b) Except as provided by Subsection (c), the pharmacist
2-11 shall transmit the information required by Subsection (a):
2-12 (1) not later than the 15th day after the date the
2-13 controlled substance was dispensed; and
2-14 (2) on an electronic device compatible with the
2-15 receiving device of the central repository or by computer diskette,
2-16 magnetic tape, or pharmacy universal claim form that meets
2-17 applicable specifications stated in rules adopted by the director.
2-18 (c) A pharmacist who dispenses a Schedule II controlled
2-19 substance in partial quantities in accordance with Section
2-20 481.074(f) shall transmit the information required by Subsection
2-21 (a) not later than the 15th day after the date the pharmacist
2-22 completes dispensing the prescription.
2-23 (d) The director shall control all access to information
2-24 submitted to the central repository under this section. The
2-25 information is confidential and the director may not permit any
2-26 person to have access to the information except:
2-27 (1) an investigator for the Texas State Board of
3-1 Medical Examiners, the Texas State Board of Podiatry Examiners, the
3-2 State Board of Dental Examiners, the State Board of Veterinary
3-3 Medical Examiners, or the Texas State Board of Pharmacy;
3-4 (2) an authorized officer of the department engaged in
3-5 investigation of suspected criminal violations of this chapter who
3-6 obtains access with the approval of an investigator covered by
3-7 Subdivision (1); or
3-8 (3) a person engaged in research, educational
3-9 activities, or demographic studies approved by the commissioner of
3-10 health, provided that the information is provided in a format that
3-11 does not reveal to the person the identities of prescribers or
3-12 recipients of Schedule II controlled substances.
3-13 (e) An investigator covered by Subsection (d)(1) shall
3-14 cooperate with the authorized officers of the department in
3-15 obtaining information for investigations of suspected criminal
3-16 violations of this chapter.
3-17 (f) Information submitted to the central depository under
3-18 this section may be used only for:
3-19 (1) drug-related criminal investigatory or evidentiary
3-20 purposes;
3-21 (2) investigatory or evidentiary purposes in
3-22 connection with the functions of an agency listed in Subsection
3-23 (d)(1); or
3-24 (3) research, educational activities, or demographic
3-25 studies approved by the commissioner of health.
3-26 (g) The central repository must:
3-27 (1) be capable of providing the collected information
4-1 in formats required by the department, including dispensations by:
4-2 (A) practioner name or registration number;
4-3 (B) dispenser name or registration number;
4-4 (C) recipient name or driver's license or other
4-5 identification number;
4-6 (D) type of controlled substance; or
4-7 (E) date, frequency, quantity, or location of
4-8 dispensation;
4-9 (2) provide the department with on-line access to the
4-10 collected information at all times;
4-11 (3) secure the collected information against access by
4-12 an unauthorized person; and
4-13 (4) if the relationship between the department and
4-14 central repository is terminated, provide the department in a
4-15 timely manner with all collected information in a format readily
4-16 usable by the department.
4-17 (h) The department may:
4-18 (1) contract with a vendor to serve as or provide the
4-19 central repository; or
4-20 (2) purchase necessary equipment to create the central
4-21 repository within the department.
4-22 (i) The department shall ensure that information that
4-23 reveals the identity of a recipient of a controlled substance is
4-24 removed from the central repository and destroyed so that the
4-25 information is irretrievable not later than the end of the 12th
4-26 calendar month after the month in which the information is
4-27 submitted to the central repository. Notwithstanding this
5-1 subsection, the department may allow information that identifies a
5-2 recipient to be retained until the end of the month in which the
5-3 necessity for retention ends if the information is necessary for:
5-4 (1) use in a specific ongoing investigation conducted
5-5 in accordance with this section; or
5-6 (2) research, educational activities, or demographic
5-7 studies approved by the commissioner of health.
5-8 (j) The department shall issue a report semiannually, based
5-9 on the state fiscal year, to the Legislative Budget Board that
5-10 certifies compliance with Subsection (i) and that provides detailed
5-11 results of monthly audits showing that identities of recipients
5-12 have been removed from the central repository and made
5-13 irretrievable as required by Subsection (i). The department shall
5-14 correct any failure to comply with Subsection (i) as soon as
5-15 practicable after discovery. A person who is responsible for a
5-16 failure to comply with Subsection (i) is subject to disciplinary
5-17 action, including dismissal.
5-18 (k) The director shall adopt rules to implement this
5-19 section.
5-20 (l) In this section, "department" means the Department of
5-21 Public Safety. [TRIPLICATE PRESCRIPTION PROGRAM. (a) A
5-22 practitioner who prescribes a controlled substance listed in
5-23 Schedule II shall record the prescription on a prescription form
5-24 that meets the requirements of Subsection (b). The Department of
5-25 Public Safety shall issue the forms to practitioners for a fee
5-26 covering the actual cost of printing and processing the forms,
5-27 mailing containers, and binders and the actual cost of mailing the
6-1 forms at 100 forms a package. Before delivering forms to a
6-2 practitioner, the department shall print on the forms the
6-3 practitioner's name, address, Department of Public Safety
6-4 registration number, and Federal Drug Enforcement Administration
6-5 number. A person may not obtain the prescription forms unless the
6-6 person is a practitioner or an institutional practitioner.]
6-7 [(b) Each prescription form used to prescribe a controlled
6-8 substance must be serially numbered and in triplicate, with the
6-9 original copy labeled "Copy 1," the duplicate copy labeled "Copy
6-10 2," and the triplicate copy labeled "Copy 3." Each form must
6-11 contain spaces for:]
6-12 [(1) the date the prescription is written;]
6-13 [(2) the date the prescription is filled;]
6-14 [(3) the drug prescribed, the dosage, and instructions
6-15 for use;]
6-16 [(4) the name, address, and Federal Drug Enforcement
6-17 Administration number of the dispensing pharmacy and the name of
6-18 the pharmacist who fills the prescription; and]
6-19 [(5) the name, address, and age of the person for whom
6-20 the controlled substance is prescribed.]
6-21 [(c) Not more than one prescription may be recorded on a
6-22 prescription form.]
6-23 [(d) Except for oral prescriptions prescribed under Section
6-24 481.074(b), the prescribing practitioner shall:]
6-25 [(1) legibly fill in, or direct a designated agent to
6-26 legibly fill in, on all three copies of the form in the space
6-27 provided:]
7-1 [(A) the date the prescription is written;]
7-2 [(B) the drug prescribed, the quantity (shown
7-3 numerically followed by the number written as a word), instructions
7-4 for use, and the intended use of the drug or the diagnosis for
7-5 which the controlled substance is prescribed; and]
7-6 [(C) the name, address, and age of the patient
7-7 or, in the case of an animal, its owner, for whom the controlled
7-8 substance is prescribed;]
7-9 [(2) sign Copies 1 and 2 of the form and give them to
7-10 the person authorized to receive the prescription; and]
7-11 [(3) retain Copy 3 of the form with the practitioner's
7-12 records for at least two years after the date the prescription is
7-13 written.]
7-14 [(e) In the case of an oral prescription prescribed under
7-15 Section 481.074(b), the prescribing practitioner shall give the
7-16 dispensing pharmacy the information needed to complete the form.]
7-17 [(f) Each dispensing pharmacist shall:]
7-18 [(1) fill in on Copies 1 and 2 of the form in the
7-19 space provided the information not required to be filled in by the
7-20 prescribing practitioner or the Department of Public Safety;]
7-21 [(2) indicate the total quantity dispensed on the face
7-22 of the triplicate prescription form;]
7-23 [(3) retain Copy 2 with the records of the pharmacy
7-24 for at least two years; and]
7-25 [(4) sign Copy 1 and send it to the Department of
7-26 Public Safety not later than the 30th day after the date the
7-27 prescription is filled or not later than the 30th day after the
8-1 completion of a prescription dispensed under Section 481.074(f).]
8-2 [(g) A medication order written for a patient who is
8-3 admitted to a hospital at the time the medication order is written
8-4 and filled is not required to be on a form that meets the
8-5 requirements of this section.]
8-6 [(h) Not later than the seventh day after the date a
8-7 practitioner's Department of Public Safety registration number,
8-8 Federal Drug Enforcement Administration number, or license to
8-9 practice has been denied, suspended, canceled, surrendered, or
8-10 revoked, the practitioner shall return to the department all forms
8-11 in the practitioner's possession that are issued under Subsection
8-12 (a) and have not been used for prescriptions.]
8-13 [(i) The director may adopt rules to implement this section
8-14 and Section 481.076.]
8-15 SECTION 2. Section 481.068(b), Health and Safety Code, is
8-16 amended to read as follows:
8-17 (b) Except as provided by Section [Sections] 481.074(b) [and
8-18 481.075(d)], a practitioner engaged in authorized medical practice
8-19 or research may not be required to furnish the name or identity of
8-20 a patient or research subject to the Department of Public Safety,
8-21 the director of the Texas Commission on Alcohol and Drug Abuse, or
8-22 any other agency, public official, or law enforcement officer. A
8-23 practitioner may not be compelled in a state or local civil,
8-24 criminal, administrative, legislative, or other proceeding to
8-25 furnish the name or identity of an individual that the practitioner
8-26 is obligated to keep confidential.
8-27 SECTION 3. Sections 481.074(b), (c), and (f), Health and
9-1 Safety Code, are amended to read as follows:
9-2 (b) Except in an emergency as defined by rule of the
9-3 director [or as provided by Section 481.075(g)], a person may not
9-4 dispense or administer a controlled substance listed in Schedule II
9-5 without the written prescription of a practitioner [on a form] that
9-6 provides any information from the practitioner necessary to enable
9-7 the person to comply [meets the requirements of and is completed by
9-8 the practitioner in accordance] with Section 481.075, and if the
9-9 controlled substance is to be dispensed, the practitioner must be
9-10 registered under Section 481.063. In an emergency, a person may
9-11 dispense or administer a controlled substance listed in Schedule II
9-12 on the oral or telephonically communicated prescription of a
9-13 practitioner. The person who administers or dispenses the
9-14 substance shall promptly write the oral or telephonically
9-15 communicated prescription and shall include in the written record
9-16 of the prescription [the name, address, and Federal Drug
9-17 Enforcement Administration number of the prescribing practitioner,]
9-18 all information required to be provided [by the practitioner] under
9-19 Section 481.075 [481.075(d), and all information required to be
9-20 provided by the dispensing pharmacist under Section 481.075(f).
9-21 The person shall send a copy of the written record to the
9-22 Department of Public Safety not later than the 30th day after the
9-23 date the prescription is filled].
9-24 (c) Not later than 72 hours after authorizing an emergency
9-25 oral or telephonically communicated prescription, the prescribing
9-26 practitioner shall cause a written prescription[, completed in the
9-27 manner required by Section 481.075,] to be delivered in person or
10-1 mailed to the dispensing pharmacist at the pharmacy where the
10-2 prescription was dispensed. The envelope of a prescription
10-3 delivered by mail must be postmarked not later than 72 hours after
10-4 the prescription was authorized. On receipt of the prescription,
10-5 the dispensing pharmacy shall file the transcription of the
10-6 telephonically communicated prescription and the written
10-7 prescription [pharmacy copy. The pharmacist or the pharmacy that
10-8 employs the pharmacist shall send to the Department of Public
10-9 Safety the department's copy not later than the 30th day after the
10-10 date the prescription was dispensed].
10-11 (f) A prescription for a Schedule II controlled substance
10-12 written for a patient in a long-term care facility (LTCF) or for a
10-13 patient with a medical diagnosis documenting a terminal illness may
10-14 be filled in partial quantities to include individual dosage units.
10-15 If there is any question about whether a patient may be classified
10-16 as having a terminal illness, the pharmacist must contact the
10-17 practitioner prior to partially filling the prescription. Both the
10-18 pharmacist and the practitioner have a corresponding responsibility
10-19 to assure that the controlled substance is for a terminally ill
10-20 patient. The pharmacist must record on the prescription whether
10-21 the patient is "terminally ill" or an "LTCF patient." A
10-22 prescription that is partially filled and does not contain the
10-23 notation "terminally ill" or "LTCF patient" shall be deemed to have
10-24 been filled in violation of this Act. [For each partial filling,
10-25 the dispensing pharmacist shall record on the back of Copy 1 and
10-26 Copy 2 of the prescription the date of the partial filling, the
10-27 quantity dispensed, the remaining quantity authorized to be
11-1 dispensed, and the identification of the dispensing pharmacist.]
11-2 Prior to any subsequent partial filling the pharmacist is to
11-3 determine that the additional partial filling is necessary. The
11-4 total quantity of Schedule II controlled substances dispensed in
11-5 all partial fillings must not exceed the total quantity prescribed.
11-6 Schedule II prescriptions for patients in a long-term care facility
11-7 or patients with a medical diagnosis documenting a terminal illness
11-8 shall be valid for a period not to exceed 30 days from the issue
11-9 date unless sooner terminated by discontinuance of the medication.
11-10 SECTION 4. Section 481.127(a), Health and Safety Code, is
11-11 amended to read as follows:
11-12 (a) A person commits an offense if the person intentionally
11-13 or knowingly gives, permits, or obtains unauthorized access to
11-14 information submitted to the central repository [Department of
11-15 Public Safety] under Section 481.075.
11-16 SECTION 5. Subchapter D, Chapter 481, Health and Safety
11-17 Code, is amended by adding Section 481.1271 to read as follows:
11-18 Sec. 481.1271. OFFENSE: FAILURE TO TRANSMIT INFORMATION.
11-19 (a) A pharmacist who intentionally or knowingly fails to transmit
11-20 information required by Section 481.075 in the time and manner
11-21 required by that section commits an offense.
11-22 (b) An offense under this section is a Class B misdemeanor.
11-23 SECTION 6. Section 481.128(a), Health and Safety Code, is
11-24 amended to read as follows:
11-25 (a) A registrant or dispenser commits an offense if the
11-26 registrant or dispenser knowingly or intentionally:
11-27 (1) distributes, delivers, administers, or dispenses a
12-1 controlled substance in violation of Sections 481.070-481.074;
12-2 (2) manufactures a controlled substance not authorized
12-3 by the person's registration or distributes or dispenses a
12-4 controlled substance not authorized by the person's registration to
12-5 another registrant or other person;
12-6 (3) refuses or fails to make, keep, or furnish a
12-7 record, report, notification, order form, statement, invoice, or
12-8 information required by this chapter;
12-9 (4) [prints, manufactures, possesses, or produces a
12-10 triplicate prescription form without the approval of the Department
12-11 of Public Safety;]
12-12 [(5) delivers or possesses a counterfeit triplicate
12-13 prescription;]
12-14 [(6)] refuses an entry into a premise for an
12-15 inspection authorized by this chapter;
12-16 [(7) refuses or fails to return a triplicate
12-17 prescription form as required by Section 481.075(h);] or
12-18 (5) [(8)] refuses or fails to make, keep, or furnish a
12-19 record, report, notification, order form, statement, invoice, or
12-20 information required by a rule adopted before June 1, 1991, by the
12-21 director.
12-22 SECTION 7. Section 481.129(a), Health and Safety Code, is
12-23 amended to read as follows:
12-24 (a) A person commits an offense if the person knowingly or
12-25 intentionally:
12-26 (1) distributes as a registrant or dispenser a
12-27 controlled substance listed in Schedule I or II, unless the person
13-1 distributes the controlled substance under an order form as
13-2 required by Section 481.069;
13-3 (2) uses in the course of manufacturing, prescribing,
13-4 or distributing a controlled substance a registration number that
13-5 is fictitious, revoked, suspended, or issued to another person;
13-6 (3) [uses a triplicate prescription form issued to
13-7 another person to prescribe a controlled substance;]
13-8 [(4)] possesses or attempts to possess a controlled
13-9 substance:
13-10 (A) by misrepresentation, fraud, forgery,
13-11 deception, or subterfuge;
13-12 (B) through use of a fraudulent prescription
13-13 form; or
13-14 (C) through use of a fraudulent oral or
13-15 telephonically communicated prescription; or
13-16 (4) [(5)] furnishes false or fraudulent material
13-17 information in or omits material information from an application,
13-18 report, record, or other document required to be kept or filed
13-19 under this chapter.
13-20 SECTION 8. Section 3.06(d)(6)(J)(i), Medical Practice Act
13-21 (Article 4495b, Vernon's Texas Civil Statutes), is amended to read
13-22 as follows:
13-23 (i) A physician may delegate to a
13-24 physician assistant offering obstetrical services and certified by
13-25 the board as specializing in obstetrics or an advanced nurse
13-26 practitioner recognized by the Texas State Board of Nurse Examiners
13-27 as a nurse midwife the act or acts of administering or providing
14-1 controlled substances to the nurse midwife's or physician
14-2 assistant's clients during intra-partum and immediate post-partum
14-3 care. [The physician shall not delegate the use or issuance of a
14-4 triplicate prescription form under the triplicate prescription
14-5 program, Section 481.075, Health and Safety Code.]
14-6 SECTION 9. Section 552.118, Government Code, is amended to
14-7 read as follows:
14-8 Sec. 552.118. EXCEPTION: CERTAIN PRESCRIPTIONS [TRIPLICATE
14-9 PRESCRIPTION FORM]. Information relating to a prescription for a
14-10 controlled substance submitted to the central repository under
14-11 Section 481.075, Health and Safety Code, is excepted from the
14-12 requirements of Section 552.021 [if it is information on or derived
14-13 from a triplicate prescription form filed with the Department of
14-14 Public Safety under Section 481.075, Health and Safety Code].
14-15 SECTION 10. The following provisions of the Health and
14-16 Safety Code are repealed:
14-17 (1) Section 481.002(47); and
14-18 (2) Section 481.076.
14-19 SECTION 11. The change in law made by this Act does not
14-20 affect the retention, use, and destruction requirements of Sections
14-21 481.075 and 481.076, Health and Safety Code, that relate to
14-22 prescriptions written under the triplicate prescription program
14-23 before January 1, 1998. The provisions of those sections relating
14-24 to retention of triplicate records by practitioners and pharmacists
14-25 and the use and destruction of information obtained through the
14-26 triplicate prescription program by the Department of Public Safety
14-27 continue in effect for the purpose of governing the disposition of
15-1 triplicate prescription records and information arising from
15-2 triplicate prescriptions written before January 1, 1998.
15-3 SECTION 12. The amendment by this Act of Sections
15-4 481.127(a), 481.128(a), and 481.129(a), Health and Safety Code,
15-5 does not apply to an offense committed under any of those sections
15-6 before January 1, 1998. An offense committed before that date is
15-7 covered by those sections as they existed on the date the offense
15-8 was committed, and the former law is continued in effect for this
15-9 purpose.
15-10 SECTION 13. (a) Except as provided by Subsection (b) of
15-11 this section, this Act takes effect January 1, 1998.
15-12 (b) Beginning on the date this Act becomes law, the
15-13 Department of Public Safety and its director may adopt rules and
15-14 take all action necessary to ensure that the central repository is
15-15 prepared to begin accepting information under Section 481.075,
15-16 Health and Safety Code, as amended by this Act, on January 1, 1998.
15-17 SECTION 14. The importance of this legislation and the
15-18 crowded condition of the calendars in both houses create an
15-19 emergency and an imperative public necessity that the
15-20 constitutional rule requiring bills to be read on three several
15-21 days in each house be suspended, and this rule is hereby suspended,
15-22 and that this Act take effect and be in force according to its
15-23 terms, and it is so enacted.