LAC 46:LIII.2501. Prescription Drugs and Devices

A. Prescription Drugs or Devices. A prescription drug or device is a medication or mechanism that may only be dispensed by a pharmacist on the order of a licensed practitioner and shall bear the "Rx Only" notation or any other designation of similar import required by law on the label of a commercial container. 1. Dispensing. Prescription drugs or devices shall be dispensed only by a Louisiana-licensed pharmacist. 2. Possession. Prescription drugs or devices shall be procured and possessed in the course of the practice of pharmacy by a permitted pharmacy. 3. Storage a. Prescription drugs or devices shall be stored in a permitted pharmacy under the immediate control and responsibility of a pharmacist. b. All areas where drugs are stored shall be maintained under environmental conditions which will ensure the integrity of the drug, as specified by the United States Pharmacopeia (USP) and/or manufacturer’s or distributor’s product information or labeling. 4. Delivery. To complete the dispensing process, pharmacies may deliver prepared prescriptions to the patient or their authorized agent upon request, 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. The pharmacy is responsible for the safe and accurate delivery of prescription drugs and remains accountable for any issues that may arise during the process. a. Standards. The pharmacy shall ensure that all prescription drugs are delivered to the patient or their authorized agent in compliance with nationally recognized standards, including those established by the manufacturer or the United States Pharmacopeia (USP). b. Notification. The pharmacy shall notify the patient or their authorized agent of the delivery. c. Packaging. Prescription drugs delivered by a common or contract carrier shall be enclosed in tamper-evident packaging. d. Temperature Control. Throughout the delivery process, until the medication is received by the patient or their authorized agent, 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. e. 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. f. Compromised Product. If it is determined 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 their agent's choice. B. Misbranded Drugs 1. Misbranded drugs are: a. those drugs whose labeling is false or misleading in any particular manner; or b. those drugs whose label does not bear the name and address of the manufacturer, packer, or distributor, and does not have an accurate statement of the quantities of the active ingredients; or c. those drugs without an accurate monograph; or d. those drugs meeting the qualifications for misbranded drugs as noted in the Federal Food, Drug, and Cosmetic Act, or its successor. 2. It is unlawful to possess or dispense misbranded drugs. C. Adulterated Drugs 1. Adulterated drugs are contaminated medicinal substances having deleterious foreign or injurious materials, which fail to meet safety, quality, and/or purity standards. 2. It is unlawful to possess or dispense adulterated drugs. D. Expired Drugs. Expired drugs shall not be dispensed and shall be removed from the pharmacy drug inventory. E. Recalled Drugs. Recalled drugs shall be removed from the pharmacy inventory immediately upon notice. Recalls are classified as: 1. Class I―a situation in which there is a strong likelihood that the use of, or exposure to, a violative product will cause serious adverse health consequences or death; 2. Class II―a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote; 3. Class III―a situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences.