• where experts go to learn about FDA
  • Larry K. Houck

    • Clear that Cabinet Tour ‘24April 18th, 2024

      Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of old meds flowing out the door We will, we will, clear you We will, we will, clear you Back by popular demand, coming to a collection site in your town for …

    • Marijuana: Top Ten Reasons for Descheduling, Rescheduling or NotFebruary 12th, 2024

      With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) …

    • Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation UnveiledJanuary 19th, 2024

      In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  By doing so, FDA determined that marijuana not …

    • Governors’ Push President on Cannabis Rescheduling But Overlook What Schedule III Would RequireDecember 15th, 2023

      Last week, in a letter thanking President Joe Biden for his leadership to federally reschedule cannabis, Democratic governors sought to make the case for rescheduling.  Letter to President Joseph R. Biden, Jr., from Governor Jared Polis et al., Dec. 5, 2023.  The governors (of Colorado, Illinois, …

    • Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary TalesDecember 5th, 2023

      Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances.  On October 10th, based on ability to pay, the U.S. District Court for the Western …

    • DEA Updates Special Surveillance List of Precursor Chemicals and EquipmentOctober 31st, 2023

      The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals.  Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture …

    • We Will Clear You: DEA’s National Prescription Drug Take Back DayOctober 19th, 2023

      Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of meds flowing out the door We will, we will, clear you We will, we will, clear you Were the Drug Enforcement Administration (“DEA”) a rock band, it might promote the upcoming …

    • HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises QuestionsSeptember 6th, 2023

      Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1). Schedule III: • Potential for abuse less than drugs or …

    • Pharmacies Selling PSE: Remember to Train Employees and Self-CertifyAugust 22nd, 2023

      Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act …

    • Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be FilledAugust 10th, 2023

      If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy.  However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do …

    • DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law AdditionsAugust 4th, 2023

      Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S.  Other anabolic steroids are approved only for use in veterinary medicine.  Because anabolic steroids are also abused to enhance athletic performance and …

    • A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial FillsJuly 31st, 2023

      President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016.  CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to …

    • DEA Fine-Tunes the Theft and Significant Loss Reporting Two-StepJune 29th, 2023

      Like the celebrated Texas dance of the same name, reporting controlled substance thefts and significant losses to the Drug Enforcement Administration (“DEA”) requires just that: two steps.  For the first time in eighteen years, DEA has revised its controlled substance theft and significant loss reporting …

    • DEA Proposes Additions to Longstanding Precursor Chemical Special Surveillance ListJune 26th, 2023

      The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List.  Until …

    • DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I ChemicalApril 19th, 2023

      In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances.  As the primary agency enforcing the CSA, the Drug Enforcement Administration (“DEA”) previously designated nine chemicals used …