Controlled Substances - Pharmacist Digest

STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change

STAT

NOVEMBER 11, 2022

Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy.

Controlled Substances

Controlled Substances Labelling

Telehealth patients are scrambling for in-person care amid crackdown on online controlled substances

STAT

JANUARY 17, 2023

Catherine was getting nervous about her ADHD prescription. In 2022, the 29-year-old New Yorker had started using Done, a direct-to-consumer telehealth company that treats attention deficit hyperactivity disorder.

Controlled Substances

Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — 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. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

Controlled Substances

Controlled Substances Documentation Communication

Uh Oh, A Controlled Substance Bottle Spilled or Broke. Now What?

epicur

NOVEMBER 10, 2022

Have you ever broken or spilled a bottle of a controlled substance? 5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance A spill or breakage does not constitute a loss because the registrant can account for the controlled substance. If so, did you document it?

Controlled Substances

Controlled Substances Documentation Compounding Pharmacies Compounding

Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Controlled Substances

Controlled Substances Hospitals

Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Controlled Substances

Controlled Substances Hospitals

Controlled Substance Transfers: Ensuring Internal Management from Site to Site

Pharmacy Times

DECEMBER 22, 2023

Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages.

Controlled Substances

DEA’s Proposed Rules on Controlled Substances Prescribing via Telemedicine and Their Uncertain Impact on the Pharmacy Community

Pharmacy Times

APRIL 28, 2023

Proposed rules would permit a telehealth provider to prescribe only up to a 30-day supply of a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider.

Controlled Substances

How to Leverage the Revised ASHP Guidelines to Prevent the Diversion of Controlled Substances at Hospitals

Pharmacy Times

DECEMBER 21, 2022

A controlled substances diversion prevention program (CSDPP) that aligns with the revised ASHP guidelines is critical to ensure patients are protected from occurrences of drug diversion.

Controlled Substances

Controlled Substances Hospitals

STAT+: California wants to revoke a CVS mail-order license for illegally filling opioid and ADHD prescriptions

STAT

DECEMBER 21, 2022

California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients.

Mail-Order Pharmacies

Mail-Order Pharmacies Controlled Substances

DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs

STAT

MAY 3, 2023

The DEA announced Wednesday that it was temporarily extending its Covid-era emergency telehealth policies, allowing doctors continued leniency in how they prescribe some controlled substances. Read the rest…

Controlled Substances

Opinion: Breakthrough Therapies Act: Good idea, wrong solution

STAT

DECEMBER 2, 2022

as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.)

Controlled Substances

Controlled Substances Drug Development

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection

Pharmacy Times

SEPTEMBER 14, 2023

AI is able to quickly analyze, identify, and route data for investigation.

Controlled Substances

Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

MARCH 13, 2024

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

Controlled Substances

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — 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. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

Controlled Substances

Controlled Substances Documentation Dosage Prescription Filling

DEA Updates Special Surveillance List of Precursor Chemicals and Equipment

FDA Law Blog: Biosimilars

OCTOBER 30, 2023

Houck — 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. 73,044 (Oct. DEA’s notice of updates with the Special Surveillance List is attached here.

Controlled Substances

What happens to patients when telehealth businesses shutter?

STAT

SEPTEMBER 6, 2022

Telehealth prescription company Cerebral, which used pandemic-era regulatory flexibility to virtually treat mental health conditions like ADHD, has largely halted controlled substance prescriptions in light of scrutiny from federal and state regulators.

Controlled Substances

Prescribing Controlled Substances Goes Electronic

Pharmacy Times

SEPTEMBER 22, 2022

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists, providers.

Controlled Substances

Controlled Substances Prescribing Goes Electronic

Pharmacy Times

OCTOBER 12, 2022

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists and providers.

Controlled Substances

A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

FDA Law Blog: Biosimilars

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

Controlled Substances

Controlled Substances Long-Term Care Facilities Dosage Communication

DEA Proposes Additions to Longstanding Precursor Chemical Special Surveillance List

FDA Law Blog: Biosimilars

JUNE 26, 2023

Houck — 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. 21 U.S.C. §

Controlled Substances

Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 21 U.S.C. §

Controlled Substances

Controlled Substances Documentation

Join Us for an HP&M Webinar – Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections (Wednesday, May 24: 12:00-12:45)

FDA Law Blog: Biosimilars

MAY 3, 2023

Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

Controlled Substances

DEA To Host Supply Chain Conference

FDA Law Blog: Biosimilars

MARCH 30, 2023

Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical requirements in Houston on May 2-4, 2023. By Larry K.

Controlled Substances

Court Addresses Liability in Dispensing Controlled Substances

Pharmacy Times

SEPTEMBER 28, 2022

Lawsuit asserts physician, pharmacist negligence in patient’s fatal overdose after she received alprazolam, oxycodone, oxymorphone.

Controlled Substances

Global Prevalence of Sleep Disorders Demands a Team-Based Approach

Pharmacy Times

JANUARY 18, 2024

Because medications to treat these conditions are often controlled substances, including pharmacists on the multidisciplinary team (MDT) is invaluable.

Controlled Substances

Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It?

FDA Law Blog: Biosimilars

MAY 31, 2023

On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. While this decision was pending, Morris & Dickson remained an authorized DEA registrant to continue to handle controlled substances.

Controlled Substances

May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

FDA Law Blog: Biosimilars

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. part 1306 (which include DEA’s general requirements for prescribing controlled substances); 88 Fed. By Karla L. 1307.41and 42 C.F.R. at 30,039 (emphasis added).

Controlled Substances

Controlled Substances Communication

REMINDER: HP&M’s Webinar “Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections”

FDA Law Blog: Biosimilars

MAY 22, 2023

Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

Controlled Substances

Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

FDA Law Blog: Biosimilars

AUGUST 21, 2023

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 (“CSA”). 16, 2023 ( DOJ Press Release ).

Controlled Substances

Controlled Substances General Merchandise Stores Grocery Stores Compounding

Idorsia Urges DEA to Deschedule Chronic Insomnia Drug Class

Pharma Leaders

APRIL 11, 2023

Currently, the class is listed as Schedule IV under the Controlled Substances Act, which includes habit-forming drugs such as Valium and Xanax. Idorsia Pharmaceuticals has petitioned the Drug Enforcement Administration (DEA) to deschedule dual orexin receptor antagonists (DORA), a class of chronic insomnia medications.

Controlled Substances

DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I Chemical

FDA Law Blog: Biosimilars

APRIL 18, 2023

Houck — 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. By Larry K.

Controlled Substances

Supreme Court Sides With Doctors Accused of Running Pill Mills

NY Times

JUNE 27, 2022

In a unanimous ruling, the justices ordered federal appeals courts to reconsider the cases of two doctors convicted of violating the Controlled Substances Act.

Controlled Substances

TO BE CONTINUED (!?): DEA Announces It is Issuing a “Temporary Rule” to Address Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

FDA Law Blog: Biosimilars

MAY 7, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”

Controlled Substances

CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

FDA Law Blog: Biosimilars

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.

Controlled Substances

HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation Conference

FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

Controlled Substances

Pain Management & Opioid CME Requirements by State

Board Vitals - Pharmacist

JANUARY 9, 2021

Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Connecticut – 1 credit The Connecticut Medical Examining Board requires 1 credit hour of training in prescribing controlled substances and pain management.

Controlled Substances

Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

Some of the services HP&M offers include: comprehensive regulatory assessments pre-launch licensing support license gap analysis support for new product/company acquisitions, regulatory diligences DEA registrations and state-controlled substance licenses With the complexities of licensure, Sara M. Palmer , Larry K.

Controlled Substances

Controlled Substances Documentation Pharmaceutical Manufacturing Communication

Gabapentin Presents High Potential for Misuse

Pharmacy Times

NOVEMBER 24, 2022

Although the anticonvulsant is not considered a controlled substance, some state legislation focuses on monitoring the use of or reclassifying it.

Controlled Substances

Sage and Biogen receive FDA approval for PPD therapy

Pharmaceutical Business Review

AUGUST 6, 2023

Shortly after scheduling as a controlled substance by the US Drug Enforcement Administration, the therapy is anticipated to be launched and will be commercially available in the fourth quarter of this year.

Controlled Substances

A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — 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. By Larry K. 21 U.S.C. §

Controlled Substances

JOIN HP&M FOR A WEBINAR: “The ‘End’ of the COVID-19 Emergency: The Ryan Haight Act, Telemedicine, and Next Steps?” on Thursday, March 23, 2023 at 12 Noon EST

FDA Law Blog: Biosimilars

MARCH 12, 2023

We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlled substances and non-controlled drugs.

Controlled Substances

White House pharmacy under the microscope

STAT

JANUARY 23, 2024

In a searing new report, the inspector general recounts a doctor asking a pharmacy staffer to “hook up” someone with a controlled substance as a “parting gift.”

Controlled Substances

Pharmacist Challenges Revocation of License to Practice

Pharmacy Times

JUNE 22, 2023

Guilty plea relates to shortcomings in recordkeeping of controlled substances 10 years earlier.

Controlled Substances

STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change

Telehealth patients are scrambling for in-person care amid crackdown on online controlled substances

Trending Sources

Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

Uh Oh, A Controlled Substance Bottle Spilled or Broke. Now What?

Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

Controlled Substance Transfers: Ensuring Internal Management from Site to Site

DEA’s Proposed Rules on Controlled Substances Prescribing via Telemedicine and Their Uncertain Impact on the Pharmacy Community

How to Leverage the Revised ASHP Guidelines to Prevent the Diversion of Controlled Substances at Hospitals

STAT+: California wants to revoke a CVS mail-order license for illegally filling opioid and ADHD prescriptions

DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs

Opinion: Breakthrough Therapies Act: Good idea, wrong solution

Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection

Bright Green invests $250m to expand facility in New Mexico, US

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

DEA Updates Special Surveillance List of Precursor Chemicals and Equipment

What happens to patients when telehealth businesses shutter?

Prescribing Controlled Substances Goes Electronic

Controlled Substances Prescribing Goes Electronic

A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

DEA Proposes Additions to Longstanding Precursor Chemical Special Surveillance List

Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

Join Us for an HP&M Webinar – Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections (Wednesday, May 24: 12:00-12:45)

DEA To Host Supply Chain Conference

Court Addresses Liability in Dispensing Controlled Substances

Global Prevalence of Sleep Disorders Demands a Team-Based Approach

Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It?

May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

REMINDER: HP&M’s Webinar “Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections”

Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

Idorsia Urges DEA to Deschedule Chronic Insomnia Drug Class

DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I Chemical

Supreme Court Sides With Doctors Accused of Running Pill Mills

TO BE CONTINUED (!?): DEA Announces It is Issuing a “Temporary Rule” to Address Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

HP&M’s Larry Houck A Panelist at FDLI’s Cannabis Regulation Conference

Pain Management & Opioid CME Requirements by State

Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

Gabapentin Presents High Potential for Misuse

Sage and Biogen receive FDA approval for PPD therapy

A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research

JOIN HP&M FOR A WEBINAR: “The ‘End’ of the COVID-19 Emergency: The Ryan Haight Act, Telemedicine, and Next Steps?” on Thursday, March 23, 2023 at 12 Noon EST

White House pharmacy under the microscope

Pharmacist Challenges Revocation of License to Practice

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