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Texas State Board of Pharmacy Rule 291.12 FAQs

What is Texas Rule 291.12?

Rule 291.12 consists of requirements for the delivery of prescription drugs to a patient or patient’s agent. There are three subsections of the rule, relating to (1) delivery by common carrier, (2) delivery by pharmacy employee or common carrier providing a same-day courier service, and (3) all deliveries.

  1. Delivery by common carrier (this section does not apply to pharmacies providing a same-day courier service).
  • Standards. All prescription drugs must be delivered to the patient in accordance with nationally recognized standards (e.g., manufacturer, United States Pharmacopeia).
  • Packaging. Only commercially available, tamper-evident packaging can be used. 
  • Temperature. Prescription drugs must be packaged in a way that maintains a temperature range appropriate for the drug, including: the use of temperature-monitoring indicators (e.g., tags, time strips, labels, etc.); insulated packaging; gel ice packs; or a combination of any of these. 
    • Irregularity in delivery. Pharmacies must provide a means for patients to notify them of any issues with their prescription delivery, including, but not limited to:
      • Timeliness of delivery
      • Condition of the prescription drug upon delivery
      • Failure to receive the proper prescription drug
  • Refusal to deliver. Pharmacies can refuse to deliver a prescription drug by common carrier if the dispensing pharmacist is of the professional opinion that the drug may be clinically compromised during shipping. 
  • Delivery by pharmacy employee or common carrier providing a same-day courier service.
  • Standards. Pharmacies are responsible for any problems in the delivery of the prescription drug.
  • Temperature. The prescription drug must be maintained within the temperature range allowed by the United States Pharmacopeia or manufacturer recommendations until it’s delivered and received by the patient.
  • All deliveries. Regardless of the means of delivery, pharmacies must comply with the following:
  • Notification of delivery. Pharmacies must notify the patient of delivery of the prescription drug.
  • Compromised delivery. If a pharmacist determines a prescription drug is in any way compromised during delivery, the pharmacy is required to replace the drug or arrange for the drug to be replaced, either by promptly delivering a replacement to the patient or contacting the prescriber to arrange for the drug to be dispensed to the patient by a pharmacy of the patient’s choice.

Records. Records must be kept for two years within (1) when a prescription drug was sent/delivered to the patient/patient’s agent and (2) patient complaints about compromised deliveries. For more information on recordkeeping, see Rule 291.34.

When did Rule 291.12 take effect?

June 10, 2024, though it was under discussion for at least the past year, according to board meeting records.

Who/what does the rule apply to?

If the patient’s prescription delivery address is in Texas, Rule 291.12 is applicable.

Rule 291.12 applies to the delivery of prescription drugs by a pharmacy licensed by the board as a Class A, Class A-S, Class E or Class E-S pharmacy. It further applies to all prescription drugs shipped by common carriers from pharmacies in Texas or pharmacies outside the state of Texas shipping prescription drugs to patients/patient agents in the state of Texas. 

Why was Rule 291.12 adopted?

According to the Texas State Board of Pharmacy, Rule 291.12 was adopted to improve the health, safety and welfare of patients by ensuring the safety and efficacy of prescription drugs that are delivered to a patient or patient’s agent by Class A, Class A-S, Class E and Class E-S pharmacies. 

We can also speculate that due to the rapidly increasing rates of prescription drug delivery necessitated by the COVID-19 pandemic (a current annual average of 10 million in Texas alone), the rate of consumer complaints related to issues with prescription drug delivery, packaging, package tampering, incorrect prescription drugs, and/or temperature-affected prescription drugs has directly increased. Texas’ extreme climate seriously exacerbates the latter issue. 

The board investigates every complaint they receive, which may have also led to a significant strain on their compliance resources. 

We confirmed that there was at least a year of discussion about adopting Rule 291.12, prompted by public comments, adoption of similar rules by other states, and concern over a spike in consumer complaints about the compromised integrity of their delivered prescriptions. 

Rule 291.12 is an obvious way to counteract these growing concerns, protect both consumers and pharmacies, and potentially ease the compliance burden on the Texas State Board of Pharmacy.

What are the penalties or risks for non-compliance?

Disciplinary action is specific to each infraction and spans a spectrum, from a verbal warning to full revocation of a pharmacy/pharmacist/pharmacy technician license. 

For a complete listing of grounds and specific disciplinary actions, see the Texas State Board of Pharmacy website, rules 281.7 through 281.9. 

What does the rule require specific to the packaging and temperature of shipped prescription drugs?

There are four components of the stipulations relating to packaging and temperature maintenance/monitoring of prescription drugs shipped by common carrier:

  • Standards. All prescription drugs must be delivered to the patient in accordance with nationally recognized standards (e.g., manufacturer, United States Pharmacopeia). The prescription drug must be maintained within the temperature range allowed by the United States Pharmacopeia or recommended by the manufacturer until the delivery has been received by the patient.

    1. Packaging. Only commercially available, tamper-evident packaging can be used.

  • Temperature. Prescription drugs must be packaged in a way that maintains a temperature range appropriate for the drug, including: the use of temperature-monitoring indicators (tags, time strips, labels, etc.); insulated packaging; gel ice packs; or a combination of any of these.

  • Compromised delivery. If a pharmacist determines a prescription drug is in any way compromised during delivery, the pharmacy is required to replace the drug or arrange for the drug to be replaced, either by promptly delivering a replacement to the patient or contacting the prescriber to arrange for the drug to be dispensed to the patient by a pharmacy of the patient’s choice. Additionally, pharmacies must provide a means for patients to notify them of any issues with their prescription delivery, including, but not limited to:
  • Timeliness of delivery
  • Condition of the prescription drug upon delivery
  • Failure to receive the proper prescription drug
Where can I find temperature-monitoring indicators to comply with Rule 291.12?

Small- and medium-size pharmacies as well as enterprise-size pharmacy companies can achieve compliance with the new Texas rule with SpotSee temperature indicators. 

When a prescription drug has been exposed to temperatures that are hotter or colder than the ranges specified by the drug manufacturer, the SpotSee indicators change color. Patients and pharmacists can see at a glance when the home-delivered medications have been compromised and need to be replaced. 

Four SpotSee single-use temperature indicators available today can help pharmacists comply with the new Texas rule:

    • ColdMark® indicators provide irreversible evidence of exposure to unacceptable conditions. They change color from clear to violet when the temperature goes below a predetermined threshold.
    • WarmMark® time-temperature indicator stickers turn red when they reach the temperature threshold selected by the pharmacy.
    • Thermax® labels permanently record the highest temperature reached. Temperature-sensitive elements change color to provide a temperature history of the package being monitored.
  • ColdChain Complete senses and indicates cold and hot temperature excursions and can easily be inserted into a shipping box or insulated container.


Visit the SpotSee website for more information or to order.

Where can I get more information about Rule 291.12?

There are several easy, reliable options:

If you have any further questions about Texas Rule 291.12, the Rules Queue is run by the Texas State Board of Pharmacy and answered live on weekdays. They can be reached at (512) 305-8070.

Disclaimer: This information is not meant to substitute legal advice and does not constitute an official statement from the Texas State Board of Pharmacy. All information is subject to change at the discretion and authority of the Texas State Board of Pharmacy. Please check the Texas State Board of Pharmacy website for the most recent information on proposed and adopted rule changes.

About SpotSee

At SpotSee, every degree matters. As a global leader in condition-indicating and monitoring solutions, the company helps customers identify changing conditions to protect life sciences and ensure supply chain integrity. SpotSee provides products that enable more than 4,500 customers and partners in 62 countries to detect changes in the condition of everything from vaccines to spaceships. The company’s solutions include temperature, impact, tilt, vibration, humidity and liquid detection monitoring devices, available via visual, RFID, QR code, cellular or satellite connection. Its products such as WarmMark, ColdMark, HemoTemp II, ThermoStrip, Thermax, BriteLine, ShockWatch, ShockLog and TiltWatch are widely used in the life sciences, energy, transportation, aerospace, defense, food, manufacturing and consumer products sectors. The company is headquartered in Dallas, Texas, and operates five facilities in Texas, Illinois, Mexico and the United Kingdom. For more information, visit www.spotsee.io.