75R9495 PEP-F
By Hirschi H.B. No. 226
Substitute the following for H.B. No. 226:
By Hirschi C.S.H.B. No. 226
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to laws regulating the distribution and dispensation of
1-3 Schedule II controlled substances.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Subchapter C, Chapter 481, Health and Safety
1-6 Code, may be cited as the Controlled Substance Accessibility and
1-7 Anti-Diversion Act.
1-8 SECTION 2. Section 481.075, Health and Safety Code, is
1-9 amended to read as follows:
1-10 Sec. 481.075. REPORTING SCHEDULE II PRESCRIPTIONS. (a) A
1-11 pharmacist who dispenses a controlled substance listed in Schedule
1-12 II shall transmit to a central repository designated by the
1-13 department the following information:
1-14 (1) the date the controlled substance was dispensed;
1-15 (2) the National Drug Code number of the controlled
1-16 substance, if available, the quantity prescribed, the instructions
1-17 for use, and the intended use of the controlled substance or the
1-18 diagnosis for which it was prescribed;
1-19 (3) the quantity dispensed;
1-20 (4) the name, address, and Federal Drug Enforcement
1-21 Administration number of the dispensing pharmacy and the name of
1-22 the pharmacist who filled the prescription;
1-23 (5) the name, address, and age of the person for whom
1-24 the controlled substance was prescribed;
2-1 (6) if available, the driver's license or other
2-2 identification number of the person for whom the controlled
2-3 substance was prescribed or the person to whom the controlled
2-4 substance was dispensed;
2-5 (7) if the controlled substance was prescribed for use
2-6 by an animal, the name, address, age, and driver's license or other
2-7 identification number, if available, of the animal's owner;
2-8 (8) the date the controlled substance was prescribed;
2-9 and
2-10 (9) the name, address, department registration number,
2-11 and Federal Drug Enforcement Administration number of the
2-12 practitioner who prescribed the controlled substance.
2-13 (b) Except as provided by Subsection (c), the pharmacist
2-14 shall transmit the information required by Subsection (a):
2-15 (1) not later than the 15th day after the date the
2-16 controlled substance was dispensed; and
2-17 (2) on an electronic device compatible with the
2-18 receiving device of the central repository or by computer diskette,
2-19 magnetic tape, facsimile transmission, or pharmacy universal claim
2-20 form that meets applicable specifications stated in rules adopted
2-21 by the director.
2-22 (c) A pharmacist who dispenses a Schedule II controlled
2-23 substance in partial quantities in accordance with Section
2-24 481.074(f) shall transmit the information required by Subsection
2-25 (a) not later than the 15th day after the date the pharmacist
2-26 completes dispensing the prescription.
2-27 (d) The director shall control all access to information
3-1 submitted to the central repository under this section. The
3-2 information is confidential and the director may not permit any
3-3 person to have access to the information except:
3-4 (1) an investigator for the Texas State Board of
3-5 Medical Examiners, the Texas State Board of Podiatry Examiners, the
3-6 State Board of Dental Examiners, the State Board of Veterinary
3-7 Medical Examiners, or the Texas State Board of Pharmacy;
3-8 (2) an authorized officer of the department engaged in
3-9 investigation of suspected criminal violations of this chapter who
3-10 obtains access with the approval of an investigator covered by
3-11 Subdivision (1); or
3-12 (3) a person engaged in research, educational
3-13 activities, or demographic studies approved by the commissioner of
3-14 health, provided that the information is provided in a format that
3-15 does not reveal to the person the identities of prescribers or
3-16 recipients of Schedule II controlled substances.
3-17 (e) An investigator covered by Subsection (d)(1) shall
3-18 cooperate with the authorized officers of the department in
3-19 obtaining information for investigations of suspected criminal
3-20 violations of this chapter.
3-21 (f) Information submitted to the central repository under
3-22 this section may be used only for:
3-23 (1) drug-related criminal investigatory or evidentiary
3-24 purposes;
3-25 (2) investigatory or evidentiary purposes in
3-26 connection with the functions of an agency listed in Subsection
3-27 (d)(1); or
4-1 (3) research, educational activities, or demographic
4-2 studies approved by the commissioner of health.
4-3 (g) The central repository must:
4-4 (1) be capable of providing the collected information
4-5 in formats required by the department, including dispensations by:
4-6 (A) practioner name or registration number;
4-7 (B) dispenser name or registration number;
4-8 (C) recipient name or driver's license or other
4-9 identification number;
4-10 (D) type of controlled substance; or
4-11 (E) date, frequency, quantity, or location of
4-12 dispensation;
4-13 (2) provide the department with on-line access to the
4-14 collected information at all times;
4-15 (3) secure the collected information against access by
4-16 an unauthorized person; and
4-17 (4) if the relationship between the department and
4-18 central repository is terminated, provide the department in a
4-19 timely manner with all collected information in a format readily
4-20 usable by the department.
4-21 (h) The department may:
4-22 (1) contract with a vendor to serve as or provide the
4-23 central repository; or
4-24 (2) purchase necessary equipment to create the central
4-25 repository within the department.
4-26 (i) The department shall ensure that information that
4-27 reveals the identity of a recipient of a controlled substance is
5-1 removed from the central repository and destroyed so that the
5-2 information is irretrievable not later than the end of the 12th
5-3 calendar month after the month in which the information is
5-4 submitted to the central repository. Notwithstanding this
5-5 subsection, the department may allow information that identifies a
5-6 recipient to be retained until the end of the month in which the
5-7 necessity for retention ends if the information is necessary for:
5-8 (1) use in a specific ongoing investigation conducted
5-9 in accordance with this section; or
5-10 (2) research, educational activities, or demographic
5-11 studies approved by the commissioner of health.
5-12 (j) The department shall issue a report semiannually, based
5-13 on the state fiscal year, to the Legislative Budget Board that
5-14 certifies compliance with Subsection (i) and that provides detailed
5-15 results of monthly audits showing that identities of recipients
5-16 have been removed from the central repository and made
5-17 irretrievable as required by Subsection (i). The department shall
5-18 correct any failure to comply with Subsection (i) as soon as
5-19 practicable after discovery. A person who is responsible for a
5-20 failure to comply with Subsection (i) is subject to disciplinary
5-21 action, including dismissal.
5-22 (k) The director shall adopt rules to implement this
5-23 section.
5-24 (l) In this section, "department" means the Department of
5-25 Public Safety. [TRIPLICATE PRESCRIPTION PROGRAM. (a) A
5-26 practitioner who prescribes a controlled substance listed in
5-27 Schedule II shall record the prescription on a prescription form
6-1 that meets the requirements of Subsection (b). The Department of
6-2 Public Safety shall issue the forms to practitioners for a fee
6-3 covering the actual cost of printing and processing the forms,
6-4 mailing containers, and binders and the actual cost of mailing the
6-5 forms at 100 forms a package. Before delivering forms to a
6-6 practitioner, the department shall print on the forms the
6-7 practitioner's name, address, Department of Public Safety
6-8 registration number, and Federal Drug Enforcement Administration
6-9 number. A person may not obtain the prescription forms unless the
6-10 person is a practitioner or an institutional practitioner.]
6-11 [(b) Each prescription form used to prescribe a controlled
6-12 substance must be serially numbered and in triplicate, with the
6-13 original copy labeled "Copy 1," the duplicate copy labeled "Copy
6-14 2," and the triplicate copy labeled "Copy 3." Each form must
6-15 contain spaces for:]
6-16 [(1) the date the prescription is written;]
6-17 [(2) the date the prescription is filled;]
6-18 [(3) the drug prescribed, the dosage, and instructions
6-19 for use;]
6-20 [(4) the name, address, and Federal Drug Enforcement
6-21 Administration number of the dispensing pharmacy and the name of
6-22 the pharmacist who fills the prescription; and]
6-23 [(5) the name, address, and age of the person for whom
6-24 the controlled substance is prescribed.]
6-25 [(c) Not more than one prescription may be recorded on a
6-26 prescription form.]
6-27 [(d) Except for oral prescriptions prescribed under Section
7-1 481.074(b), the prescribing practitioner shall:]
7-2 [(1) legibly fill in, or direct a designated agent to
7-3 legibly fill in, on all three copies of the form in the space
7-4 provided:]
7-5 [(A) the date the prescription is written;]
7-6 [(B) the drug prescribed, the quantity (shown
7-7 numerically followed by the number written as a word), instructions
7-8 for use, and the intended use of the drug or the diagnosis for
7-9 which the controlled substance is prescribed; and]
7-10 [(C) the name, address, and age of the patient
7-11 or, in the case of an animal, its owner, for whom the controlled
7-12 substance is prescribed;]
7-13 [(2) sign Copies 1 and 2 of the form and give them to
7-14 the person authorized to receive the prescription; and]
7-15 [(3) retain Copy 3 of the form with the practitioner's
7-16 records for at least two years after the date the prescription is
7-17 written.]
7-18 [(e) In the case of an oral prescription prescribed under
7-19 Section 481.074(b), the prescribing practitioner shall give the
7-20 dispensing pharmacy the information needed to complete the form.]
7-21 [(f) Each dispensing pharmacist shall:]
7-22 [(1) fill in on Copies 1 and 2 of the form in the
7-23 space provided the information not required to be filled in by the
7-24 prescribing practitioner or the Department of Public Safety;]
7-25 [(2) indicate the total quantity dispensed on the face
7-26 of the triplicate prescription form;]
7-27 [(3) retain Copy 2 with the records of the pharmacy
8-1 for at least two years; and]
8-2 [(4) sign Copy 1 and send it to the Department of
8-3 Public Safety not later than the 30th day after the date the
8-4 prescription is filled or not later than the 30th day after the
8-5 completion of a prescription dispensed under Section 481.074(f).]
8-6 [(g) A medication order written for a patient who is
8-7 admitted to a hospital at the time the medication order is written
8-8 and filled is not required to be on a form that meets the
8-9 requirements of this section.]
8-10 [(h) Not later than the seventh day after the date a
8-11 practitioner's Department of Public Safety registration number,
8-12 Federal Drug Enforcement Administration number, or license to
8-13 practice has been denied, suspended, canceled, surrendered, or
8-14 revoked, the practitioner shall return to the department all forms
8-15 in the practitioner's possession that are issued under Subsection
8-16 (a) and have not been used for prescriptions.]
8-17 [(i) The director may adopt rules to implement this section
8-18 and Section 481.076.]
8-19 SECTION 3. Section 481.068(b), Health and Safety Code, is
8-20 amended to read as follows:
8-21 (b) Except as provided by Section [Sections] 481.074(b) [and
8-22 481.075(d)], a practitioner engaged in authorized medical practice
8-23 or research may not be required to furnish the name or identity of
8-24 a patient or research subject to the Department of Public Safety,
8-25 the director of the Texas Commission on Alcohol and Drug Abuse, or
8-26 any other agency, public official, or law enforcement officer. A
8-27 practitioner may not be compelled in a state or local civil,
9-1 criminal, administrative, legislative, or other proceeding to
9-2 furnish the name or identity of an individual that the practitioner
9-3 is obligated to keep confidential.
9-4 SECTION 4. Sections 481.074(b), (c), and (f), Health and
9-5 Safety Code, are amended to read as follows:
9-6 (b) Except in an emergency as defined by rule of the
9-7 director [or as provided by Section 481.075(g)], a person may not
9-8 dispense or administer a controlled substance listed in Schedule II
9-9 without the written prescription of a practitioner [on a form] that
9-10 provides any information from the practitioner necessary to enable
9-11 the person to comply [meets the requirements of and is completed by
9-12 the practitioner in accordance] with Section 481.075, and if the
9-13 controlled substance is to be dispensed, the practitioner must be
9-14 registered under Section 481.063. In an emergency, a person may
9-15 dispense or administer a controlled substance listed in Schedule II
9-16 on the oral or telephonically communicated prescription of a
9-17 practitioner. The person who administers or dispenses the
9-18 substance shall promptly write the oral or telephonically
9-19 communicated prescription and shall include in the written record
9-20 of the prescription [the name, address, and Federal Drug
9-21 Enforcement Administration number of the prescribing practitioner,]
9-22 all information required to be provided [by the practitioner] under
9-23 Section 481.075 [481.075(d), and all information required to be
9-24 provided by the dispensing pharmacist under Section 481.075(f).
9-25 The person shall send a copy of the written record to the
9-26 Department of Public Safety not later than the 30th day after the
9-27 date the prescription is filled].
10-1 (c) Not later than 72 hours after authorizing an emergency
10-2 oral or telephonically communicated prescription, the prescribing
10-3 practitioner shall cause a written prescription[, completed in the
10-4 manner required by Section 481.075,] to be delivered in person or
10-5 mailed to the dispensing pharmacist at the pharmacy where the
10-6 prescription was dispensed. The envelope of a prescription
10-7 delivered by mail must be postmarked not later than 72 hours after
10-8 the prescription was authorized. On receipt of the prescription,
10-9 the dispensing pharmacy shall file the transcription of the
10-10 telephonically communicated prescription and the written
10-11 prescription [pharmacy copy. The pharmacist or the pharmacy that
10-12 employs the pharmacist shall send to the Department of Public
10-13 Safety the department's copy not later than the 30th day after the
10-14 date the prescription was dispensed].
10-15 (f) A prescription for a Schedule II controlled substance
10-16 written for a patient in a long-term care facility (LTCF) or for a
10-17 patient with a medical diagnosis documenting a terminal illness may
10-18 be filled in partial quantities to include individual dosage units.
10-19 If there is any question about whether a patient may be classified
10-20 as having a terminal illness, the pharmacist must contact the
10-21 practitioner prior to partially filling the prescription. Both the
10-22 pharmacist and the practitioner have a corresponding responsibility
10-23 to assure that the controlled substance is for a terminally ill
10-24 patient. The pharmacist must record on the prescription whether
10-25 the patient is "terminally ill" or an "LTCF patient." A
10-26 prescription that is partially filled and does not contain the
10-27 notation "terminally ill" or "LTCF patient" shall be deemed to have
11-1 been filled in violation of this Act. For each partial filling,
11-2 the dispensing pharmacist shall record on the back of [Copy 1 and
11-3 Copy 2 of] the prescription the date of the partial filling, the
11-4 quantity dispensed, the remaining quantity authorized to be
11-5 dispensed, and the identification of the dispensing pharmacist.
11-6 Prior to any subsequent partial filling the pharmacist is to
11-7 determine that the additional partial filling is necessary. The
11-8 total quantity of Schedule II controlled substances dispensed in
11-9 all partial fillings must not exceed the total quantity prescribed.
11-10 Schedule II prescriptions for patients in a long-term care facility
11-11 or patients with a medical diagnosis documenting a terminal illness
11-12 shall be valid for a period not to exceed 30 days from the issue
11-13 date unless sooner terminated by discontinuance of the medication.
11-14 SECTION 5. Section 481.127(a), Health and Safety Code, is
11-15 amended to read as follows:
11-16 (a) A person commits an offense if the person intentionally
11-17 or knowingly gives, permits, or obtains unauthorized access to
11-18 information submitted to the central repository [Department of
11-19 Public Safety] under Section 481.075.
11-20 SECTION 6. Section 481.128(a), Health and Safety Code, is
11-21 amended to read as follows:
11-22 (a) A registrant or dispenser commits an offense if the
11-23 registrant or dispenser knowingly or intentionally:
11-24 (1) distributes, delivers, administers, or dispenses a
11-25 controlled substance in violation of Sections 481.070-481.074;
11-26 (2) manufactures a controlled substance not authorized
11-27 by the person's registration or distributes or dispenses a
12-1 controlled substance not authorized by the person's registration to
12-2 another registrant or other person;
12-3 (3) refuses or fails to make, keep, or furnish a
12-4 record, report, notification, order form, statement, invoice, or
12-5 information required by this chapter;
12-6 (4) [prints, manufactures, possesses, or produces a
12-7 triplicate prescription form without the approval of the Department
12-8 of Public Safety;]
12-9 [(5) delivers or possesses a counterfeit triplicate
12-10 prescription;]
12-11 [(6)] refuses an entry into a premise for an
12-12 inspection authorized by this chapter;
12-13 [(7) refuses or fails to return a triplicate
12-14 prescription form as required by Section 481.075(h);] or
12-15 (5) [(8)] refuses or fails to make, keep, or furnish a
12-16 record, report, notification, order form, statement, invoice, or
12-17 information required by a rule adopted before June 1, 1991, by the
12-18 director.
12-19 SECTION 7. Section 481.129(a), Health and Safety Code, is
12-20 amended to read as follows:
12-21 (a) A person commits an offense if the person knowingly or
12-22 intentionally:
12-23 (1) distributes as a registrant or dispenser a
12-24 controlled substance listed in Schedule I or II, unless the person
12-25 distributes the controlled substance under an order form as
12-26 required by Section 481.069;
12-27 (2) uses in the course of manufacturing, prescribing,
13-1 or distributing a controlled substance a registration number that
13-2 is fictitious, revoked, suspended, or issued to another person;
13-3 (3) [uses a triplicate prescription form issued to
13-4 another person to prescribe a controlled substance;]
13-5 [(4)] possesses or attempts to possess a controlled
13-6 substance:
13-7 (A) by misrepresentation, fraud, forgery,
13-8 deception, or subterfuge;
13-9 (B) through use of a fraudulent prescription
13-10 form; or
13-11 (C) through use of a fraudulent oral or
13-12 telephonically communicated prescription; or
13-13 (4) [(5)] furnishes false or fraudulent material
13-14 information in or omits material information from an application,
13-15 report, record, or other document required to be kept or filed
13-16 under this chapter.
13-17 SECTION 8. Section 3.06(d)(6)(J)(i), Medical Practice Act
13-18 (Article 4495b, Vernon's Texas Civil Statutes), is amended to read
13-19 as follows:
13-20 (i) A physician may delegate to a
13-21 physician assistant providing [offering] obstetrical services [and
13-22 certified by the board as specializing in obstetrics] or an
13-23 advanced nurse practitioner recognized by the Texas State Board of
13-24 Nurse Examiners as a nurse midwife the act or acts of administering
13-25 or providing controlled substances to the nurse midwife's or
13-26 physician assistant's clients during intra-partum and immediate
13-27 post-partum care. [The physician shall not delegate the use or
14-1 issuance of a triplicate prescription form under the triplicate
14-2 prescription program, Section 481.075, Health and Safety Code.]
14-3 SECTION 9. Section 552.118, Government Code, is amended to
14-4 read as follows:
14-5 Sec. 552.118. EXCEPTION: CERTAIN PRESCRIPTIONS [TRIPLICATE
14-6 PRESCRIPTION FORM]. Information relating to a prescription for a
14-7 controlled substance submitted to the central repository under
14-8 Section 481.075, Health and Safety Code, is excepted from the
14-9 requirements of Section 552.021 [if it is information on or derived
14-10 from a triplicate prescription form filed with the Department of
14-11 Public Safety under Section 481.075, Health and Safety Code].
14-12 SECTION 10. The following provisions of the Health and
14-13 Safety Code are repealed:
14-14 (1) Section 481.002(47); and
14-15 (2) Section 481.076.
14-16 SECTION 11. The change in law made by this Act does not
14-17 affect any retention, use, or destruction requirement of Section
14-18 481.075 or 481.076, Health and Safety Code, that relates to a
14-19 prescription written under the triplicate prescription program
14-20 before January 1, 1998. A provision of those sections relating to
14-21 retention of a triplicate record by a practitioner or pharmacist or
14-22 the use or destruction of information obtained through the
14-23 triplicate prescription program by the Department of Public Safety
14-24 continues in effect for the purpose of governing the disposition of
14-25 any triplicate prescription record or information arising from a
14-26 triplicate prescription written before January 1, 1998.
14-27 SECTION 12. A change in law made by this Act to Section
15-1 481.127(a), 481.128(a), or 481.129(a), Health and Safety Code,
15-2 applies only to an offense committed under any of those sections on
15-3 or after January 1, 1998. An offense committed before January 1,
15-4 1998, is covered by the law in effect on the date the offense was
15-5 committed, and the former law is continued in effect for this
15-6 purpose. For purposes of this section, an offense was committed
15-7 before January 1, 1998, if any element of the offense occurred
15-8 before that date.
15-9 SECTION 13. (a) Except as provided by Subsection (b) of
15-10 this section, this Act takes effect January 1, 1998.
15-11 (b) Beginning on the date this Act becomes law, the
15-12 Department of Public Safety and its director may adopt rules and
15-13 take all action necessary to ensure that the central repository is
15-14 prepared to begin accepting information under Section 481.075,
15-15 Health and Safety Code, as amended by this Act, on January 1, 1998.
15-16 SECTION 14. The importance of this legislation and the
15-17 crowded condition of the calendars in both houses create an
15-18 emergency and an imperative public necessity that the
15-19 constitutional rule requiring bills to be read on three several
15-20 days in each house be suspended, and this rule is hereby suspended,
15-21 and that this Act take effect and be in force according to its
15-22 terms, and it is so enacted.