Preparation, Cooperation Keys to Surviving a DEA Inspection | NCPA 2024
Drug Topics
OCTOBER 26, 2024
The Drug Enforcement Administration gives controlled substance licenses, and can just as easily take them away.
The 2024 Controlled Substance Assessment Quiz
OctariusRx
FEBRUARY 20, 2024
The 2024 controlled substance assessment quiz is about to be released! This is our annual competency assessment focused on controlled substances and regulatory compliance. The quiz focuses on some of the basic elements managing controlled substances. How are you assessing your staff?
Join 5,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Trending Sources
DEA extends pandemic rules for telehealth prescribing through 2024 as agency irons out new policies
Fierce Healthcare
OCTOBER 6, 2023
The Drug Enforcement Administration (DEA) said Friday it will extend telehealth flexibilities that enable clinicians to virtually prescribe controlled medications to their patients through 2024 as | The DEA announced Friday that it is extending pandemic rules for prescribing controlled substances via telemedicine through the end of next year.
Corresponding Responsibility of Pharmacies, DEA to Uphold Controlled Substances Act | ASPL 2024
Drug Topics
NOVEMBER 8, 2024
Joel Ferre, JD, Assistant United States Attorney in Utah, led a discussion covering the DEA and pharmacies’ roles in reporting red flags when dispensing medication.
Is gabapentin a controlled substance?
The Checkup by Singlecare
JULY 3, 2024
At this time, gabapentin isn’t recognized as a controlled substance on the federal level. However, several states have passed laws to classify it as a Schedule V controlled substance. RELATED: What is Gabapentin: Uses, Warnings & Interactions Is gabapentin a controlled substance?
STAT+: Key lawmakers pressure Biden to preserve telehealth prescribing of effective addiction treatment
STAT
OCTOBER 2, 2024
urged the DEA to continue allowing health providers to prescribe buprenorphine, a controlled substance used to treat opioid addiction, without requiring an in-person visit. Prior to the Covid-19 pandemic, any patient who needed a controlled substance was required to be examined in person before receiving a prescription.
Medication Safety Quiz 2024
OctariusRx
AUGUST 19, 2024
The 2024 version of the OctariusRx medication safety quiz is about to be released. The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. The post Medication Safety Quiz 2024 appeared first on OctariusRX. How are you assessing your staff?
DEA To Announce Hearing on Proposed Marijuana Rescheduling
The FDA Law Blog
AUGUST 26, 2024
The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, 2024.
More Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management Summit
The FDA Law Blog
JUNE 10, 2024
Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ). By Larry K. Employee diversion can result in unwanted local and national publicity.
Are Disparate Solutions Causing Visibility Gaps in Your Pharmacy Operation?
Omnicell
SEPTEMBER 5, 2022
billion is forecasted to be spent on electronic health records (EHR) by 2024, many hospitals continue to be burdened with costs. One area where interoperability specifically helps is the management of controlled substances. Disconnected systems also complicate merger and acquisition activity. Although $9.9
The 2024 USP 800 Assessment Quiz
OctariusRx
NOVEMBER 13, 2024
The 2024 version of the OctariusRx USP 800 assessment quiz is about to be released! Earlier this year, we discussed Nursing Medication Calculations, Medication safety and Controlled Substances to help your staff hone their skills and let you assess their abilities. Contact us for assistance.
HP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling Webinar
The FDA Law Blog
JUNE 10, 2024
Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C.
“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices
The FDA Law Blog
JANUARY 11, 2024
HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.
CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency
The FDA Law Blog
OCTOBER 8, 2023
Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. 69,879, 69,880 (Oct. 10, 2023) (emphasis added).
May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA
The FDA Law Blog
MAY 10, 2023
Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.
Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril
The FDA Law Blog
JUNE 27, 2024
District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” 50,372 , 50,377 (June 13, 2024). Last December we blogged on the $275,000 civil penalty imposed by the U.S. 72,694, 72,703 (Dec. 21 U.S.C. §
Thank You to the Massachusetts Association of Ambulatory Surgery Centers
OctariusRx
OCTOBER 28, 2024
Speaking at the “2024 Northeast ASC Conference” is always a great time. My presentation focused on current topics in medication management, including patient safety, safe injection practices and controlled substances. A special thank you to MAASC President, Greg DeConciliis for the invitation to participate.
Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled
The FDA Law Blog
JANUARY 18, 2024
Houck — 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. HHS forwards FDA’s analysis and recommendation to DEA.
FDA 
69
69 
What you should know about prescription Adderall
The Checkup by Singlecare
MARCH 1, 2024
But determining whether someone needs it is challenging, and because it’s a controlled substance, getting a prescription can be, too. The Drug Enforcement Administration (DEA) classifies Adderall as a Schedule II controlled substance , which means it has a high potential for abuse and psychological or physical dependence.
Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules
The FDA Law Blog
DECEMBER 12, 2024
The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. 4, 2024), at 1. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Prehearing Ruling (Dec.
Former DEA Administrators Weigh in on Marijuana Rescheduling
The FDA Law Blog
JULY 1, 2024
Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).
Dosage 52
52 
Bring Out Your Meds! Bring Out Your Meds!
The FDA Law Blog
OCTOBER 20, 2024
Unwanted and expired controlled prescription medication languishing in medicine cabinets are susceptible to theft, misuse and abuse. DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, October 26, 2024, from 10:00 a.m. to 2:00 p.m.
Clear that Cabinet Tour ‘24
The FDA Law Blog
APRIL 17, 2024
DEA, with its law enforcement partners, will host thousands of local drop-off locations nationwide for clearing out and proper disposal of unwanted expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 pm local time on Saturday, April 27, 2024. Events over the years have led to the removal of more than 17.9
ACI’s 42nd FDA Boot Camp – New York City Edition
The FDA Law Blog
JANUARY 24, 2024
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York.
FDA 59
59 
“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace
The FDA Law Blog
APRIL 21, 2024
Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.” Patent Nos.
Labelling 59
59 
Does the Drug Shortage White Paper Fall Short?
The FDA Law Blog
APRIL 8, 2024
The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.
FDA 59
59 
Where can I get phentermine?
The Checkup by Singlecare
APRIL 2, 2024
RELATED: Overweight and obesity statistics 2024 Where can I get phentermine? Since phentermine is a controlled substance, you need to be cautious and ensure that you are purchasing from a reputable and licensed online pharmacy if you have to.” Where can I get phentermine pills?
How much is Contrave without insurance?
The Checkup by Singlecare
AUGUST 15, 2024
Aetna’s Standard Control Plan and a Human Medicare plan are examples of ones not covering the drug in 2024. Consider a cheaper weight-loss drug Generic phentermine costs $5 for a one-month supply, but it is a controlled substance and is only approved for up to six months of use. Is Contrave covered by insurance?
Insurance 52
52 
Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)
The FDA Law Blog
FEBRUARY 27, 2024
On February 8, 2024—the same day the PTO requested information with respect to the multiple PTE applications for idelalisib—the FDA sent a letter to the PTO in response to the PTE applications for for U.S. Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. Patent Nos. 7,214,695 and 7,214,696.
FDA 59
59 
Strattera vs Vyvanse: Differences, Similarities, and Which One is Better For You
The Checkup by Singlecare
MAY 5, 2024
The FDA’s drug shortage database cites all generic manufacturers of lisdexamfetamine as having limited to no product availability as of April 2024. For these reasons, Vyvanse is considered a controlled substance by the Drug Enforcement Administration (DEA). It can be frustrating not to be able to get your prescribed medicine.
Labelling 52
52 
Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana
The FDA Law Blog
MAY 21, 2024
Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). By Larry K.
HP&M’s Larry Houck Presenting “HHS’ Cannabis Rescheduling Recommendation: A Long Strange Trip with Potholes”
The FDA Law Blog
DECEMBER 21, 2023
Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,
DEA finalizes one-year extension of controlled substance prescribing via telehealth, punts final regs to incoming Trump admin
Fierce Healthcare
NOVEMBER 18, 2024
DEA finalizes one-year extension of controlled substance prescribing via telehealth, punts final regs to incoming Trump admin ebeavins Mon, 11/18/2024 - 10:50
Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins Monday
The FDA Law Blog
NOVEMBER 26, 2024
Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.
It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025
The FDA Law Blog
NOVEMBER 21, 2024
Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. By Karla L. The federal telemedicine flexibilities (i.e., The federal telemedicine flexibilities (i.e.,
Blood Sugar, Hashimoto’s, Ozempic, Metformin and Berberine
The Thyroid Pharmacist
NOVEMBER 15, 2024
I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”). June 25, 2024. Accessed November 13, 2024 [link] [20] Tirrell M. Epub 2018 May 14. In: StatPearls.
Immunization 73
73 
Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling
The FDA Law Blog
APRIL 22, 2024
Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for rescheduling to schedule III; and the January 2024 letter from Democratic senators requesting descheduling altogether. The senators write that the U.S.
DEA Concurs: Marijuana Meets Schedule III Criteria
The FDA Law Blog
MAY 5, 2024
Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. treaty obligations in rescheduling. 21 U.S.C. § 812(b)(1).
Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not
The FDA Law Blog
FEBRUARY 11, 2024
Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024). Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.
Democratic Lawmakers Advocate for Prompt Decontrol of Marijuana
The FDA Law Blog
APRIL 29, 2024
Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. April 24, 2024. Vice president criticizes federal cannabis restrictions during White House weed event , March 15, 2024.)
Let's personalize your content