| 1 | 1 | | By: Guillen H.B. No. 5298 |
|---|
| 2 | 2 | | |
|---|
| 3 | 3 | | |
|---|
| 4 | 4 | | A BILL TO BE ENTITLED |
|---|
| 5 | 5 | | AN ACT |
|---|
| 6 | 6 | | relating to a pilot program under which lockable, tamper-evident |
|---|
| 7 | 7 | | containers are used by participating pharmacies when dispensing |
|---|
| 8 | 8 | | schedule II controlled substances. |
|---|
| 9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
|---|
| 10 | 10 | | SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
|---|
| 11 | 11 | | amended by adding Chapter 442A to read as follows: |
|---|
| 12 | 12 | | CHAPTER 442A. LOCKABLE CONTAINERS FOR SCHEDULE II CONTROLLED |
|---|
| 13 | 13 | | SUBSTANCES PILOT PROGRAM |
|---|
| 14 | 14 | | SUBCHAPTER A. GENERAL PROVISIONS |
|---|
| 15 | 15 | | Sec. 442A.01. DEFINITIONS. In this chapter: |
|---|
| 16 | 16 | | (1) "Board" means the Texas State Board of Pharmacy. |
|---|
| 17 | 17 | | (2) "Controlled substance" has the meaning assigned by |
|---|
| 18 | 18 | | Section 481.002. |
|---|
| 19 | 19 | | (3) "Pharmacy" means a facility licensed under Chapter |
|---|
| 20 | 20 | | 560, Occupations Code. |
|---|
| 21 | 21 | | (3) "Special packaging" has the same meaning as in the |
|---|
| 22 | 22 | | "Poison Prevention Packaging Act of 1970," 15 U.S.C. 1471. |
|---|
| 23 | 23 | | (4) "Prescription drug" has the meaning assigned by |
|---|
| 24 | 24 | | Section 551.003, Occupations Code. |
|---|
| 25 | 25 | | (5) "Lockable container" means a container that meets |
|---|
| 26 | 26 | | all three of the following requirements: (a)Has special packaging; |
|---|
| 27 | 27 | | (b) has a locking mechanism that fits or affixes to the container |
|---|
| 28 | 28 | | medication is dispensed in; (c) can be locked in the following ways: |
|---|
| 29 | 29 | | (a) a container that uses a key or other object |
|---|
| 30 | 30 | | capable of locking and unlocking the container; |
|---|
| 31 | 31 | | (b) a container that requires a numeric or |
|---|
| 32 | 32 | | alphanumeric code. |
|---|
| 33 | 33 | | (6) "Tamper-evident container" means a container that |
|---|
| 34 | 34 | | meets both of the following requirements: |
|---|
| 35 | 35 | | (a) Has special packaging; |
|---|
| 36 | 36 | | (b) Displays a visual sign when there is |
|---|
| 37 | 37 | | unauthorized entry into the container or has a numerical display of |
|---|
| 38 | 38 | | the time that the container was last opened. |
|---|
| 39 | 39 | | (7) "Pilot program" means the tamper proof container |
|---|
| 40 | 40 | | for schedule II substances pilot program established under this |
|---|
| 41 | 41 | | chapter. |
|---|
| 42 | 42 | | 442A.02. PILOT PROGRAM PARAMETERS. (a)The Board shall |
|---|
| 43 | 43 | | operate a two-year pilot program under which schedule II controlled |
|---|
| 44 | 44 | | substances in solid oral dosage formulations are dispensed by |
|---|
| 45 | 45 | | participating pharmacies in lockable containers or tamper-evident |
|---|
| 46 | 46 | | containers. Under the pilot program, the Board shall reimburse |
|---|
| 47 | 47 | | participating pharmacies or provide grants for the expenses they |
|---|
| 48 | 48 | | incur in participating in the program, including a fee determined |
|---|
| 49 | 49 | | by the Board for dispensing all schedule II controlled substances |
|---|
| 50 | 50 | | in solid oral dosage formulations in those containers. |
|---|
| 51 | 51 | | (b) A pharmacist shall dispense a schedule II controlled |
|---|
| 52 | 52 | | substance in a solid oral dosage formulation in a lockable |
|---|
| 53 | 53 | | container or tamper-evident container unless the patient or an |
|---|
| 54 | 54 | | individual acting on behalf of the patient requests that the drug |
|---|
| 55 | 55 | | not be dispensed in such a container. |
|---|
| 56 | 56 | | (c) Not later than six months after the pilot project ends, |
|---|
| 57 | 57 | | the board shall prepare a report describing its findings regarding |
|---|
| 58 | 58 | | the impact of the program. The board shall submit the report to the |
|---|
| 59 | 59 | | Legislature. |
|---|
| 60 | 60 | | (d) The pilot program shall be operated for two years or |
|---|
| 61 | 61 | | until funds appropriated for the program are expended, whichever |
|---|
| 62 | 62 | | occurs first. |
|---|
| 63 | 63 | | (e) The board shall adopt rules prescribing: |
|---|
| 64 | 64 | | (1) the form and scope of the pilot project; and |
|---|
| 65 | 65 | | (2) the evaluation processes. |
|---|
| 66 | 66 | | 442A.03. PHARMACY ELIGIBILITY. (a) Any pharmacy is |
|---|
| 67 | 67 | | eligible may volunteer to participate in the pilot program by |
|---|
| 68 | 68 | | notifying the Board. Each participating pharmacy shall: |
|---|
| 69 | 69 | | (1) be registered with the United States Drug |
|---|
| 70 | 70 | | Enforcement Administration; |
|---|
| 71 | 71 | | (2) not be the subject of state or federal opioid |
|---|
| 72 | 72 | | litigation; and |
|---|
| 73 | 73 | | (3) meets the eligibility requirements established by |
|---|
| 74 | 74 | | board rules. |
|---|
| 75 | 75 | | SUBCHAPTER B. FUNDING |
|---|
| 76 | 76 | | Sec. 442A.101 FUNDING. (a) Money contained in the opioid |
|---|
| 77 | 77 | | abatement account established under Section 403.505, Government |
|---|
| 78 | 78 | | Code, as added by Chapter 781 (S.B. 1827), Acts of the 87th |
|---|
| 79 | 79 | | Legislature, Regular Session, 2021, may be appropriated to the |
|---|
| 80 | 80 | | board to fund the pilot program established under this chapter. |
|---|
| 81 | 81 | | (b) The board may collect gifts, grants, and donations to |
|---|
| 82 | 82 | | fund the program. |
|---|
| 83 | 83 | | SUBCHAPTER C. EXPIRATION |
|---|
| 84 | 84 | | Sec. 442A.201. EXPIRATION. This chapter expires September |
|---|
| 85 | 85 | | 1, 2029. |
|---|
| 86 | 86 | | SECTION 2. As soon as practicable after the effective date |
|---|
| 87 | 87 | | of this Act, the Texas State Board of Pharmacy shall implement the |
|---|
| 88 | 88 | | controlled substance lockable cap pilot program developed under |
|---|
| 89 | 89 | | Chapter 442A, Health and Safety Code, as added by this Act. |
|---|
| 90 | 90 | | SECTION 3. This Act takes effect September 1, 2023. |
|---|