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

    • 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 …

    • CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient CareNovember 30th, 2022

      On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline.  Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,  CDC Clinical Practice Guideline for Prescribing Opioids for Pain — …

    • Retail Inventory Services Settle for Employee Thefts from PharmaciesNovember 11th, 2022

      When you have followed Drug Enforcement Administration (“DEA”)/Department of Justice (“DOJ”) civil settlements for as long as we have, you cannot help but think that you’ve seen it all.  Then something novel comes along.  Unlike virtually all DEA/DOJ civil settlements that we are aware of, …

    • Unlike a Cluttered Desk, A Cluttered Medicine Cabinet…October 20th, 2022

      If, as Albert Einstein supposedly quipped, a cluttered desk is the sign of a cluttered mind, what then does a cluttered medicine cabinet signify?  More than a mere sign, a cluttered medicine cabinet can be hazardous if it contains unneeded and expired prescription medication susceptible …

    • Biden Administration Facing Renewed Pressure to Legalize CannabisAugust 2nd, 2022

      At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.  Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to …

    • Corporate Liability from Employee Diversion: Costly on Many FrontsJune 22nd, 2022

      On June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that   Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in southern Virginia, had entered into a non-prosecution agreement (“NPA”) and $4.36 million civil settlement due in large …

    • Attorney General Garland: Marijuana Enforcement Remains Low DOJ Enforcement Priority in States Where Activity Is LegalMay 3rd, 2022

      Last week, Attorney General Merrick Garland reiterated the position expressed during his confirmation hearing that enforcement of marijuana cases in states where activities are legal is an inefficient use of Department of Justice (“DOJ”) resources.  Responding to Senator Brian Schatz (D-Hawaii) during a Senate Appropriations …

    • “It’s In the Mail” Will Soon No Longer Apply to DEA Registration ApplicationsApril 20th, 2022

      Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically.  DEA issued a final rule on April 11, 2022, eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more …

    • Not An April Fool’s Joke: California BOP Establishes Loss Reporting ThresholdsApril 4th, 2022

      Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form.  Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates …

    • CDC Proposes Updating Practice Guideline for Prescribing Opioids, Warning Against Continued MisapplicationMarch 18th, 2022

      The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago.  (We blogged on the final 2016 guideline here on March 17, 2016).  On February 10th, the agency published a comprehensive proposal …

    • Identifying and Resolving Red Flags: DEA Continues to “Run it Up the Flagpole”February 9th, 2022

      The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags.  While the Final Order does not necessarily introduce any …