LAC 46:LIII.1141. Centralized Prescription Dispensing

A. General Requirements 1. An on-site pharmacy may obtain centralized prescription dispensing services from a remote dispenser provided the pharmacies: a. have the same owner or have entered into a written contract or agreement that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws, rules, and regulations; and b. share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to provide the requested services. 2. Labeling. The remote dispenser shall label the container in compliance with Section 2527 of this Part, using the on-site pharmacy’s information. The label shall also include the remote dispenser’s name indicating that the prescription was filled at the remote dispenser. 3. Audit Trail Information. The remote dispenser and on-site pharmacy shall maintain a complete audit trail identifying pharmacy personnel involved in the dispensing process. 4. Delivery Between Remote Dispenser and On-Site Pharmacy. Delivery of prepared prescriptions between the remote dispenser and the on-site pharmacy is permissible using a common carrier, contract carrier, or pharmacy employee. Proper safeguards shall be in place to ensure the integrity of the medication—preserving its safety, identity, strength, quality, and purity throughout the delivery process. a. Standards. The pharmacy shall ensure that all prescription drugs are delivered in compliance with nationally recognized standards, including those established by the manufacturer or the United States Pharmacopeia (USP). b. Packaging. Prescription drugs delivered by a common or contract carrier shall be enclosed in tamper-evident packaging. c. Temperature Control. Throughout the delivery process, prescription drugs shall be maintained within the temperature range specified by the United States Pharmacopeia (USP) or as recommended by the manufacturer, with allowances for permitted excursions. d. Possession and Control. When a pharmacy relinquishes physical possession and control of a prescription drug during delivery, the drug shall not be returned to the pharmacy for reuse. i. Common or Contract Carrier. If there is no formal agreement in place with a common or contract carrier that ensures delivery integrity standards and grants the pharmacy control during transit, prescription drugs shall not be returned to the pharmacy for reuse. ii. Pharmacy Employee. When a pharmacy employee delivers a prescription drug, the pharmacy retains physical possession and control of the medication throughout the delivery process. e. Compromised Product. If it is determined a prescription drug is in any way compromised during delivery, it shall not be dispensed. 5. The on-site pharmacy shall return to the remote dispenser prepared prescriptions not dispensed to the patient, if the pharmacies do not have the same owner. 6. Centralized prescription dispensing of controlled substances shall comply with all applicable provisions of 21 CFR Parts 1300 - 1399. B. Policies and Procedures 1. On-site pharmacies and remote dispensers engaging in the acquisition or provision of centralized dispensing services shall maintain a policy and procedure manual for reference by all personnel; it shall be made available for inspection and copying by the board. 2. At a minimum, the manual shall include policies for: a. a description of how the parties will comply with federal and state laws and regulations; b. the maintenance of appropriate records to identify the responsible pharmacist(s) in the dispensing and counseling processes; c. the maintenance of a mechanism for tracking the prescription drug order during each step in the dispensing process; d. the maintenance of a mechanism to identify on the prescription label all pharmacies involved in the dispensing the prescription drug order; and e. the provision of adequate security to protect the confidentiality and integrity of patient information and to prevent its illegal use or disclosure.