More recently, the Texas State Board of Pharmacy updated the 30-day window for Schedule II prescription validity again. Previously, this legislation applied only to in-state prescribers; prescriptions for Schedule II medications written outside of Controlled substance management and dispensing The final update to controlled substance law in Texas went into effect in February 2023. TAC §315.6 reflects that, in conjunction with the Texas Prescription Monitoring Program, by the next business day following the dispensing, pharmacists are required to report each controlled substance dispensed. In an update to TAC §315.6, the Board included directions for what to report, which can be found in another Board publication, the Data Submission Guide for Dispensers. This guide explains the various steps for establishing regular reports through the Texas Prescription Monitoring system. Following this guide ensures that pharmacies are in compliance with all Board requirements for controlled substance reporting. Pharmacy Practice Consideration: It is important to verify the legitimacy of controlled substance prescriptions before dispensing them. The Texas State Board of Pharmacy provides a list of “Red Flags” that may assist in determining if a pharmacy has become a target for invalid prescriptions. For instance, if numerous people come to the pharmacy with the same controlled substance prescriptions written by the same provider, the lack of individualized drug therapy may indicate that these prescriptions are fraudulent. For a full list of Red Flags, visit https://www.pharmacy.texas.gov/files_pdf/ You_might_be_a_pill_mill_if.pdf Drug disposal TAC §303.1 outlines the requirements that must be followed when disposing of dangerous drugs or controlled substances. In hospitals and other healthcare facilities, there are strict steps involving an inventory, a witness, and which medications may be destroyed. In a February 2023 update to TAC §303.1, the Texas State Board of Pharmacy adopted a new policy for healthcare facilities utilizing an independent, third-party medical waste disposal service. This update removes inventory-keeping requirements and allows for disposal of both dangerous and controlled substances in the same container as permitted by the Drug Enforcement Agency as long as: Nonsterile compounding TAC §291.131 provides guidance for pharmacies participating in compounding nonsterile products. This rule includes important definitions, operational standards, and approved compounding situations. In August 2022, the Texas State Board of Pharmacy adopted a number of revisions focusing on training and the compounding environment. Regarding training, TAC §291.131 outlines: ● All training must be documented and covered by standard operating practices. ● All personnel involved in nonsterile compounding should be well trained and must undergo continued training, as is relevant. ● Training must include demonstration and education of the following: ○ Hand hygiene. ○ Garbing. ○ Cleaning and sanitizing. ○ Handling and transporting components of and compounded nonsterile preparations. ○ Measuring and mixing. ○ Properly using equipment used in nonsterile compounding. ○ Completely documenting the compounding process.
Texas remained valid for the shorter period of time. Starting in February 2022, however, out-of-state practitioners were ncluded in the update, allowing for 30-day prescription validity for Schedule II controlled substances.
Self-Assessment Quiz Question #2 When an out-of-state prescriber writes a prescription for a Schedule II controlled substance, how many days after it is written is the prescription valid for?
a. 30 days. b. 60 days. c. 14 days. d. 7 days.
● The waste disposal service abides by all rules of the Texas Commission on Environmental Quality and the U.S. Environmental Protection Agency. ● The pharmacist seals the container of disposal-ready medications in the presence of an approved witness (administrator, director, etc.) and seals the container with tamper- resistant tape. ● Records of the container’s transfer to the waste disposal service, as well as subsequent proof of destruction, must be maintained for two years and include: ○ Date of transfer. ○ Name and address of the waste disposal service. ○ Signature of the individual transferring the container to the service. Each nonsterile compounding pharmacy location must have a pharmacist in charge, who is responsible for confirming the completeness and adequacy of the training on an individual basis. This pharmacist should also determine appropriate content and a timeline for continued education in nonsterile compounding methods and safety. The Board also updated requirements for the nonsterile compounding environment within the pharmacy. To this end, TAC §291.131. Pharmacies participating in compounding must have a specific, designated area for non- sterile compounding. This area must be adequately-sized and possess the correct equipment for safe and orderly compounding. Only personnel authorized by a pharmacist-in-charge or responsible pharmacist should be in the area during non-sterile compounding. Non-sterile compounding environments must include a clean, well-maintained sink with hot and cold running water, and must be exclusive from facilities in a rest room. Supplies necessary for adequate washing must be in the immediate area of the sink and include: ● Soap or detergent. ● Air-driers or single-use towels.
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Book Code: RPTTX2024
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