1. (a) Applicability. This section 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.

2. (b) Definitions.

   1. (1) Common carrier--A person or entity who holds out to the general public a willingness to provide transportation of property from place to place for compensation in the normal course of business.
   2. (2) Contract carrier--A person or entity who provides to industrial customers, pursuant to the terms of a bilateral agreement, the transportation of property for compensation in the normal course of business.

3. (c) Delivery by common or contract carrier. A pharmacy may deliver prescription drugs by use of a common or contract carrier as provided in §291.9 of this title (relating to Prescription Pick Up Locations) on request of the patient or patient's agent. A pharmacy that delivers prescription drugs by use of a common or contract carrier providing a same-day courier service is not subject to subsection (c) of this section and shall comply with subsection (d) of this section.

   1. (1) Standards. The pharmacy shall ensure that all prescription drugs are delivered to the patient or patient's agent in accordance with nationally recognized standards, such as those of the manufacturer or the United States Pharmacopeia. The pharmacy is responsible for any problems in the delivery of a prescription drug by a contract carrier.
   2. (2) Packaging. The pharmacy shall ensure that prescription drugs are packaged in commercially available tamper evident packaging.
   3. (3) Temperature. The pharmacy shall ensure that any prescription drug delivered by a common or contract carrier is packaged in a manner that maintains a temperature range appropriate for the drug. This may include, without limitation, use of temperature tags, time temperature strips, insulated packaging, gel ice packs, or a combination of these as necessary.

   4. (4) Irregularity in delivery. The pharmacy shall provide a method by which a patient or patient's agent can notify the pharmacy as to any irregularity in the delivery of the patient's prescription, to include but not be limited to:

      1. (A) timeliness of delivery;
      2. (B) condition of the prescription drug upon delivery; and
      3. (C) failure to receive the proper prescription drug.
   5. (5) Refusal to deliver. The pharmacy shall refuse to deliver by common or contract carrier a prescription drug which in the professional opinion of the dispensing pharmacist may be clinically compromised by delivery by common or contract carrier.

4. (d) Delivery by pharmacy employee or common or contract carrier providing a same-day courier service. A pharmacy may deliver prescription drugs by means of its employee or a common or contract carrier providing a same-day courier service as provided in §291.9 of this title on request of the patient or patient's agent.

   1. (1) Standards. The pharmacy is responsible for any problems in the delivery of the prescription drug.
   2. (2) Temperature. The prescription drug shall 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 or patient's agent.

5. (e) Delivery by unmanned aircraft systems (i.e., "drones"). A pharmacy may deliver prescription drugs, excluding controlled substances or sterile compounded preparations, by use of a common or contract carrier providing an unmanned aircraft system delivery service as provided in §291.9 of this title on request of the patient or patient's agent.

   1. (1) Standards. Unmanned aircraft systems shall maintain appropriate federal registration and comply with all state and federal laws and rules. The pharmacy shall ensure that all prescription drugs are delivered to the patient or patient's agent in accordance with nationally recognized standards, such as those of the manufacturer or the United States Pharmacopeia. The pharmacy is responsible for any problems in the delivery of the prescription drug.

   2. (2) The pharmacist-in-charge is responsible for developing written policies and procedures regarding prescription drug delivery in accordance with this subsection to be used by pharmacy personnel to include, but not be limited to, the following:

      1. (A) training pharmacy personnel engaged in preparing and packaging prescription drugs for delivery;
      2. (B) packaging prescription drugs for delivery;
      3. (C) verification of the correct recipient and delivery address;
      4. (D) maintaining the confidentiality of prescription records;
      5. (E) secure transfer of prescription drugs from the pharmacy;
      6. (F) provision of patient counseling;
      7. (G) remediation of errors in delivery or adverse events; and
      8. (H) recordkeeping.
   3. (3) Packaging. The pharmacy shall ensure that prescription drugs are packaged in commercially available tamper evident packaging.
   4. (4) Temperature. The pharmacy shall ensure that any prescription drug delivered by a common or contract carrier providing an unmanned aircraft system delivery service is packaged in a manner that maintains a temperature range appropriate for the drug. This may include, without limitation, use of temperature tags, time temperature strips, insulated packaging, gel ice packs, or a combination of these as necessary.
   5. (5) Records. The pharmacy shall document each change in the chain of custody of a prescription drug, including departure of the prescription drug from the pharmacy, transfer to the person or entity fulfilling delivery, and delivery to the patient.
   6. (6) Confirmation of presence at selected delivery location. The pharmacy shall receive confirmation from the patient or patient's agent that the patient or patient's agent is present at the selected delivery location before unmanned aircraft system delivery is initiated.
   7. (7) Security. The pharmacy must ensure that delivery is made to a reasonably secure location at the selected delivery location that minimizes the opportunity for unauthorized access to prescription drugs and confidential prescription records.

6. (f) All deliveries. A pharmacy that delivers prescription drugs by common or contract carrier, by pharmacy employee or common or contract carrier providing a same-day courier service, or by common or contract carrier providing an unmanned aircraft system delivery service shall also comply with the following:

   1. (1) Counseling information. The pharmacy shall comply with the requirements of §291.33(c)(1)(F) of this title (relating to Operational Standards).
   2. (2) Notification of delivery. The pharmacy shall notify the patient or patient's agent of the delivery of a prescription drug.
   3. (3) Compromised delivery. If a pharmacist determines a prescription drug is in any way compromised during delivery, the pharmacy shall replace the drug or arrange for the drug to be replaced, either by promptly delivering a replacement to the patient or by promptly contacting the prescriber to arrange for the drug to be dispensed to the patient by a pharmacy of the patient's or patient's agent's choice.

   4. (4) Records. The pharmacy shall maintain records for two years on the following events:

      1. (A) when a prescription drug was sent and delivered to the patient or patient's agent; and
      2. (B) patient complaints regarding compromised deliveries, which may be documented in the patient profile.
   5. (5) Controlled substances. A pharmacy shall comply with all state and federal laws and rules relating to the delivery of controlled substances.

Source Note:The provisions of this §291.12 adopted to be effective June 10, 2024, 49 TexReg 4045; amended to be effective September 1, 2025, 50 TexReg 5702.