1 | 1 | | 89R13930 AND-D |
---|
2 | 2 | | By: Menéndez S.B. No. 2470 |
---|
3 | 3 | | |
---|
4 | 4 | | |
---|
5 | 5 | | |
---|
6 | 6 | | |
---|
7 | 7 | | A BILL TO BE ENTITLED |
---|
8 | 8 | | AN ACT |
---|
9 | 9 | | relating to the requirements for the labeling and dispensing of a |
---|
10 | 10 | | prescription drug or biological product. |
---|
11 | 11 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
---|
12 | 12 | | SECTION 1. Section 562.006, Occupations Code, is amended by |
---|
13 | 13 | | amending Subsections (b) and (f) and adding Subsection (g) to read |
---|
14 | 14 | | as follows: |
---|
15 | 15 | | (b) In addition to the information required by Subsection |
---|
16 | 16 | | (a), the label on the dispensing container of a drug or biological |
---|
17 | 17 | | product dispensed by a Class A or Class E pharmacy must [indicate]: |
---|
18 | 18 | | (1) indicate: |
---|
19 | 19 | | (A) the name, address, and telephone number of |
---|
20 | 20 | | the pharmacy; |
---|
21 | 21 | | (B) [(2)] the date the prescription is |
---|
22 | 22 | | dispensed; |
---|
23 | 23 | | (C) [(3)] the name of the prescribing |
---|
24 | 24 | | practitioner; |
---|
25 | 25 | | (D) [(4)] the name of the patient or, if the drug |
---|
26 | 26 | | or biological product was prescribed for an animal, the species of |
---|
27 | 27 | | the animal and the name of the owner; |
---|
28 | 28 | | (E) [(5)] instructions for use; |
---|
29 | 29 | | (F) [(6)] the quantity dispensed; |
---|
30 | 30 | | (G) [(7)] if the drug or biological product is |
---|
31 | 31 | | dispensed in a container other than the manufacturer's original |
---|
32 | 32 | | container, the date after which the prescription should not be |
---|
33 | 33 | | used, determined according to criteria established by board rule |
---|
34 | 34 | | based on standards in the United States Pharmacopeia-National |
---|
35 | 35 | | Formulary; and |
---|
36 | 36 | | (H) [(8)] any other information required by |
---|
37 | 37 | | board rule; and |
---|
38 | 38 | | (2) include, in a format accessible to the patient |
---|
39 | 39 | | through a mobile Internet application or assistive technology |
---|
40 | 40 | | electronic device available to the patient at no cost, the |
---|
41 | 41 | | information described by Subdivision (1) and information regarding |
---|
42 | 42 | | potential side effects and contraindicated medications. |
---|
43 | 43 | | (f) The [board shall adopt rules requiring the] label on a |
---|
44 | 44 | | dispensing container must [to] be in plain language and printed in |
---|
45 | 45 | | Times New Roman with a minimum of 12-point [an easily readable] font |
---|
46 | 46 | | size [for the consumer]. |
---|
47 | 47 | | (g) A pharmacist at a Class A or Class E pharmacy shall, on a |
---|
48 | 48 | | patient's request, provide to the patient a large-print data sheet |
---|
49 | 49 | | containing: |
---|
50 | 50 | | (1) the information required under Subsection (b)(1) |
---|
51 | 51 | | to be on the label on a dispensing container of a drug or biological |
---|
52 | 52 | | product dispensed to the patient; and |
---|
53 | 53 | | (2) information regarding potential side effects and |
---|
54 | 54 | | contraindicated medications for the drug or biological product |
---|
55 | 55 | | dispensed to the patient. |
---|
56 | 56 | | SECTION 2. Not later than January 1, 2026, the Texas State |
---|
57 | 57 | | Board of Pharmacy shall adopt any rules necessary to implement the |
---|
58 | 58 | | changes in law made by this Act. |
---|
59 | 59 | | SECTION 3. The changes in law made by this Act apply only to |
---|
60 | 60 | | a drug or biological product dispensed on or after March 1, 2026. A |
---|
61 | 61 | | drug or biological product dispensed before March 1, 2026, is |
---|
62 | 62 | | governed by the law in effect immediately before the effective date |
---|
63 | 63 | | of this Act, and the former law is continued in effect for that |
---|
64 | 64 | | purpose. |
---|
65 | 65 | | SECTION 4. This Act takes effect September 1, 2025. |
---|