Hello,
On June 10, 2024, changes to the Texas State Board of Pharmacy (TSBP) Rule 291.12 took effect. Does it apply to your pharmacy?
There are two simple criteria:
- Are you a Class A, Class A-S, Class E or Class E-S pharmacy?
- Do you ship prescription drugs by common carriers to patients in Texas?
If you answered “Yes,” then Rule 291.12 applies to you.
This TSBP rule reiterates the requirement of shipping drugs in accordance with temperature ranges allowed by the United States Pharmacopeia or manufacturer recommendations and only using tamper- evident packaging.
What’s new is the temperature monitoring requirement: Safe temperature ranges must be maintained with packaging insulation/gel ice packs, or any combination of both, and verified through the use of temperature-monitoring indicators.
Pharmacists also are required keep records on any temperature excursion that occurs in transit and are responsible for replacing any prescription drugs compromised during delivery. If you’d like to know more specifics about the requirements of Rule 291.12, please visit our FAQ page.
Here’s what else you need to know: The temperature-monitoring indicator requirement is easy to meet.
For about $1 per prescription, you and your patients can get immediate clarity on the temperature safety of shipped prescriptions.