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

    • 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 …

    • DEA Tweaks Order Form RequirementJuly 28th, 2021

      Last week the Drug Enforcement Administration (“DEA”) issued a direct final rule clarifying requirements about who may record the supplier’s DEA registration number on a single-sheet DEA Form 222 (“single-sheet form”).  Clarification Regarding the Supplier’s DEA Registration Number on the Single-Sheet DEA Form 222, 86 …

    • DEA To Mobile Narcotic Treatment Programs: “Hit the Road, Jack, But You Better Come Back”July 12th, 2021

      The Drug Enforcement Administration (“DEA”) recently issued its final rule authorizing the use of mobile narcotic treatment programs (“MNTPs”) to allow registered Narcotic Treatment Programs (“NTPs”) employing mobile units to dispense medication for maintenance or detoxification treatment remotely.  Registration Requirements for Narcotic Treatment Programs with …

    • I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 3)June 28th, 2021

      This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections.  Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them.  Part 1, …

    • I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)May 21st, 2021

      Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown.  We are providing a post in three parts on …