Texas Pharmacy Rule §291.12 outlines the requirements for delivering prescription drugs from a pharmacy to patients in Texas. It was adopted to improve the health, safety and welfare of patients. It covers packaging, temperature control, and procedures for handling delivery issues. The rule applies to deliveries via common carrier, pharmacy employees, or same-day couriers.
Highlights:
- Applicability:
This rule applies to the delivery of prescription drugs by various pharmacy classes, including Class A, Class A-S, Class E, and Class E-S pharmacies.
- Packaging and Standards:
Pharmacies must ensure prescription drugs are delivered in commercially available tamper-evident packaging, maintaining the temperature range allowed by the manufacturer and the United States Pharmacopeia (USP).
- Temperature Control:
For deliveries by common carrier, the pharmacy must package drugs to maintain the appropriate temperature range, using a combination of temperature monitoring devices, insulated packaging and gel packs.
The rule mandates that the pharmacy provides a method for patients or their agents to report any irregularity in delivery of their medication.
- Timeliness of delivery
- Condition of the medication upon delivery
- Failure to receive the correct prescription medication
- The pharmacy can refuse to deliver by a common carrier if the dispensing pharmacist thinks the medication may be clinically compromised.
Pharmacies are obligated to refuse delivery by common carriers if the dispensing pharmacist believes the drug's integrity could be compromised during transit.
- If a pharmacist determines the medication was compromised during delivery, they are required to replace the medication.
The pharmacy needs to notify the patient or the patient’s agent of the delivery and comply with the requirements of §291.33(c)(1)(F) for counseling information.
- Date meds were sent and delivered
- Patient complaints regarding compromised deliveries
- Follow state and federal laws for controlled substances
- Maintain records for 2 years
