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

    • 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 …

    • Bring Out Your Meds! Bring Out Your Meds!April 14th, 2023

      Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead,” in the 1975 comedy classic, Monty Python and the Holy Grail.  The Drug Enforcement Administration (“DEA”) could voice a modern variation, “Bring out your meds,” as the agency and its law enforcement …

    • A Long Strange Trip: Companion Bills Would Facilitate Psychedelics ResearchApril 11th, 2023

      Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision.  21 U.S.C. § …

    • DEA To Host Supply Chain ConferenceMarch 31st, 2023

      Perhaps you obtain controlled substance quotas or submit ARCOS reports?  Maybe you identify and report suspicious orders or thefts/losses.  Or you obtain import or export permits, submit import or export declarations or listed chemical DEA-486s.  Do you want to learn more?  You have your chance. DEA’s …

    • When the Attorney General Talks (Cannabis), People ListenMarch 15th, 2023

      Like EF Hutton television commercials of the 1970s and ‘80s, when Attorney General Merrick Garland talks, people listen.  With Hutton it was about investing, for the Attorney General it is cannabis.  AG Garland most recently talked cannabis during a Senate Judiciary Committee hearing last week …

    • DEA Reaffirms Synthetic THC Compounds Are Schedule I Controlled SubstancesMarch 1st, 2023

      The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press.  That determination, however, was neither a stretch nor a …

    • Two Steps Forward, One Step…? FDA Addresses Cannabidiol in the Existing Regulatory Frameworks for Foods and SupplementsFebruary 22nd, 2023

      Last October, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing current marijuana scheduling under federal law.  Then, Congress passed and the President signed the Medical Marijuana and Cannabidiol Research Expansion …

    • Cannabis Advocates High On Recent Medical Marijuana Research LegislationJanuary 9th, 2023

      In October, when pardoning those federally convicted of cannabis possession, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.”  See President Biden Gives …